Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate

Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate




Ipsen expands early development pipeline with Simcere Zaiming’s innovative antibody drug conjugate

  • Ipsen gains exclusive global rights, outside of Greater China, for development, manufacturing and commercialization of SIM0613, a LRRC15-targeting antibody-drug conjugate
  • SIM0613 is optimally designed for superior tumor penetration with robust preclinical efficacy data
  • Program expected to enter Phase I clinical development in H2 2026
  • Simcere Zaiming is eligible to receive up to $1.06B in total payments

PARIS, FRANCE; 22 DECEMBER 2025 – Ipsen (Euronext: IPN; ADR: IPSEY) announced today an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. Targeting the LRRC15 protein, SIM0613 is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs.

“Today’s announcement underscores our bold vision to lead innovation and shape the future of oncology,” said Christelle Huguet, PhD EVP and Head of Research & Development, Ipsen. “By advancing first- and best-in-class therapies early, we maximize the potential to transform patient outcomes globally. The addition of the SIM0613 ADC is testament to this ambition—pioneering science that opens new possibilities for those who need it most and builds on Ipsen’s rapidly evolving research and early development portfolio, with over 20 programs added since 2020.”

“SIM0613 is developed via Simcere Zaiming’s proprietary antibody-drug conjugate platform,” said Renhong Tang, PhD, CEO of Simcere Zaiming. “We are excited to partner with Ipsen on this novel drug candidate and look forward to working together to advance the clinical development of SIM0613. “

Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06B comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on sales, contingent upon successful development and regulatory approvals. Ipsen will have manufacturing rights, following the tech transfer process and will assume responsibility for all activities outside Greater China including Phase I preparation activities and submission of the Investigational New Drug and Clinical Trial applications. 

About SIM0613
SIM0613 targets the leucine-rich repeat-containing 15 (LRRC15), a protein highly expressed on varies tumor types and cancer-associated fibroblasts but with limited expression on normal cells. Upon binding to the LRRC15 protein, SIM0613 is internalized where the cytotoxic payload is released, killing the cancer cell and therefore sparing healthy cells. SIM0613 is specifically engineered for deep tumor and cancer-associated fibroblast penetration, resulting in robust tumor regressions in multiple in vivo preclinical models.

About Ipsen
We are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries.

Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com.

About Simcere Zaiming
Simcere Zaiming is an oncology-focused bipharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere Zaiming dedicated to developing ground breaking therapies to meet the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several innovative products in China, including Enzeshu®, COSELA®, Enweida®, Endostar®, and Enlituo®. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners.

About antibody-drug-conjugates
Antibody-Drug Conjugates are comprised of three main components: the antibody, a payload and a linker. The antibody selectively targets an identified tumor antigen. Payloads are the pharmaceutically active component to treat the cancer, attached to the antibody via a chemical linker. The linker connects the antibody and the payload and reduces the amount of payload that reaches non-tumor tissue.

Ipsen Contacts
Investors
Henry Wheeler                henry.wheeler@ipsen.com        +33 7766471149
Khalid Deojee                khalid.deojee@ipsen.com        +33 666019526

Media
Sally Bain                sally.bain@ipsen.com                +1 8573200517
Anne Liontas                 anne.liontas.ext@ipsen.com        +33 0767347296

Disclaimers and/or forward-looking statements
The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com.

Attachment

FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma

FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma




FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma

  • Lunsumio VELO reduces administration time from 2-4 hours to approximately one minute
  • Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences
  • Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse1,2

Basel, 22 December 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the phase I/II GO29781 study.1 Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial.

“Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.”

Lunsumio VELO reduces treatment administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated.

“This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr Ian Flinn, MD, PhD, Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.”

The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively.1 The median duration of response was 22.4 months (95% CI: 16.8–22.8).1 The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhoea.1 The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15).1 CRS can be severe and life-threatening.

Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorisation of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy.

Roche continues to advance its bispecific antibody programme in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL.

About the GO29781 study
The GO29781 [NCT02500407] study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO™ (mosunetuzumab) was established on the basis of objective response rate and duration of response.

About follicular lymphoma
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.3,4 The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis.2 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.4,5

About Lunsumio VELO™ (mosunetuzumab)
Lunsumio VELO is a subcutaneous formulation of mosunetuzumab, a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab administered intravenously), Lunsumio SC/VELO™ (mosunetuzumab administered subcutaneously) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Roche data on file.
[2] Fowler NH, at al. Moving T-Cell Therapies into the Standard of Care for Patients with Relapsed or Refractory Follicular Lymphoma: A Review. Targ Oncol. 2024;19:495–510.
[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited December 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.
[4] Cancer.Net. Lymphoma – Non-Hodgkin: Subtypes. [Internet; cited December 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.

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Investor Relations North America

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Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

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Windward Bio Expands Immunology Pipeline With WIN027, a Long-Acting, Clinical-Stage Bispecific Targeting TSLP and IL-13

Windward Bio Expands Immunology Pipeline With WIN027, a Long-Acting, Clinical-Stage Bispecific Targeting TSLP and IL-13




Windward Bio Expands Immunology Pipeline With WIN027, a Long-Acting, Clinical-Stage Bispecific Targeting TSLP and IL-13

  • Windward Bio and Qyuns Therapeutics announce licensing agreement for WIN027, a highly potent, long-acting bispecific antibody with best-in-disease potential in respiratory and dermatology
  • WIN027 blocks 2 well-validated and synergistic drivers of inflammation — TSLP and IL‑13 — that play integral roles in respiratory and dermatology diseases
  • WIN027 deepens the company’s immunology pipeline and is currently in Phase 1

BASEL, Switzerland, Dec. 21, 2025 (GLOBE NEWSWIRE) — Windward Bio AG, a private, clinical-stage biotechnology company committed to improving the lives of people living with advanced immunological diseases, today announced a licensing agreement between its affiliate, LE2025 Therapeutics AG, and Qyuns Therapeutics for the development and commercialization of WIN027 (also known as QX027N), a potential best-in-disease, long-acting bispecific antibody targeting TSLP and IL-13.

Under the terms of the agreement, Windward Bio will gain exclusive rights to develop, manufacture, and commercialize WIN027 outside of China.* Total deal value is up to $700M, including upfront payment, equity, and milestones that may be paid to Qyuns Therapeutics, contingent upon the achievement of specific development, regulatory, and commercial milestones, as well as tiered royalties on product sales.

“We are excited to add WIN027 to our growing pipeline of immunology therapies,” said Luca Santarelli, MD, Founder, Chief Executive Officer, and Board Chair of Windward Bio. “Its high potency against TSLP and IL-13, as well as an extended dosing interval, has the potential to provide people with respiratory and dermatology diseases enhanced efficacy, greater convenience, and better control over their disease.”

This marks the second licensing deal announced by Windward Bio in 2025, underscoring the company’s strategic focus on growing its immunology pipeline and accelerating the development of differentiated therapies for patients living with serious immunological diseases. The company’s lead program, WIN378, a long-acting anti-TSLP monoclonal antibody, is currently being evaluated in POLARIS, a global Phase 2 trial in asthma patients, with initial data expected in 2026. Together, WIN027 and WIN378 are complementary therapies that can address significant unmet needs across a broad array of immunological diseases, representing a market opportunity of more than $50B.

About WIN027

WIN027 is a potential best-in–class, humanized IgG1 bispecific monoclonal antibody with subpicomolar affinity for TSLP and IL-13, well-validated targets in immunological conditions. It has been engineered to extend half-life and enable less frequent dosing. Through this dual, long‑acting inhibition, WIN027 is designed to set a new standard of efficacy in conditions such as asthma, COPD, and atopic dermatitis, potentially delivering deeper and more durable disease control than existing biologics. WIN027 is currently in Phase 1.

About WIN378

WIN378 is a next-generation, recombinant, fully human monoclonal antibody that potently binds to the TSLP ligand, a well-validated cytokine that plays a key role in the development and progression of a wide array of immunological diseases, including asthma and COPD. WIN378 has been engineered to achieve a half-life extension (HLE) and a silenced effector function and is subcutaneously administered. WIN378 has been studied in a Phase 1 trial, which confirmed its half-life for extended dosing, demonstrated a low rate of antidrug antibodies, and showed it was safe and well tolerated up to the highest tested dose. Windward Bio licensed the global rights (excluding Greater China and several Southeast and West Asian countries) of WIN378 from Kelun Biotech (also known as SKB378) and Harbour BioMed (also known as HBM9378). WIN378 is currently being evaluated in the POLARIS Phase 2 asthma study with initial readouts expected in 2026, and a Phase 2 study in COPD is also expected to begin in 2026.

About Windward Bio AG

Windward Bio is a clinical-stage biotechnology company with deep discovery, development, and commercialization expertise committed to transforming the treatment of people living with advanced immunological conditions. Its lead program is WIN378, a potential best-in-disease, long-acting anti-TSLP monoclonal antibody currently in Phase 2 trials for asthma. The pipeline also includes WIN027, a clinical-stage, long-acting anti-TSLPxIL-13 bispecific, which has broad therapeutic application across immunological diseases. The company is building a pipeline of long-acting bispecific antibodies, targeting validated biology in respiratory and dermatological conditions. Windward Bio launched earlier this year with a $200M Series A led by top-tier investors.

Contacts

For media, business, or investor inquiries, please contact: media@windwardbio.com

*Qyuns Therapeutics territory includes China, Hong Kong, Macao, and Taiwan.

Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions




Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions

MELBOURNE, Australia and INDIANAPOLIS, Dec. 22, 2025 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today provides a precision medicine portfolio update in relation to:

  • TLX591-CDx (Illuccix® in approved jurisdictions, 68Ga-PSMA-11): Positive data from Phase 3 study in Chinese patients provides the basis for near-term NDA submission in China.
  • TLX101-CDx (Pixclara®1, 18F-floretyrosine), PET imaging candidate for glioma: Following collaborative interactions with the FDA, finalizing NDA resubmission and expect to provide a further near-term update on FDA acceptance of the file.
  • TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab), PET imaging candidate for ccRCC: Positive Type A meeting held with the FDA to align on remediation of CMC deficiencies identified in the CRL.

Further details on each of these updates is provided below.

Illuccix China Phase 3 Registration Study
Telix is pleased to announce positive top-line results from its Phase 3 registration study of TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11) for prostate cancer imaging in Chinese patients. The Illuccix China2 trial met its primary endpoint of patient-level positive predictive value (PPV) for the detection of tumors in patients with biochemical recurrence (BCR) of prostate cancer following prior radical prostatectomy or radiation therapy. The study confirms that the clinical experience of TLX591-CDx PSMA-PET3 imaging in Chinese patients is comparable to that observed in patients studied elsewhere.

Illuccix China is a Phase 3 prospective, open-label, single-arm, multicenter study conducted in collaboration with Telix’s strategic commercial partner for the Greater China region, Grand Pharmaceutical Group Limited (Grand Pharma). The study in 140 patients delivered a strong result for the primary endpoint, with an overall patient-level PPV of 94.8% for the detection of tumors with TLX591-CDx (95% confidence interval [CI]: 85.9%, 98.2%), with the lower bound of the 95% CI (85.9%). The region-level PPV was 100.0% in the prostate bed and in the extra-pelvic soft tissue, lymph nodes, and organ metastases (non-bone); 94.7% in the pelvic region outside of the prostate bed, including lymph nodes; and 87.0% in bone metastases.

In the study, patients with suspected BCR were stratified into groups according to their baseline prostate specific antigen (PSA) levels. TLX591-CDx PSMA-PET imaging demonstrated high PPV in all patient groups, including at very low baseline PSA levels.

Baseline PSA PPV (95% CI)
≥ 5.0 ng/mL 100.0% (78.5%, 100.0%)
< 5.0 to 2.0 ng/mL 100.0% (67.6%, 100.0%)
< 2.0 to 1.0 ng/mL 90.9% (62.3%, 98.4%)
< 1.0 to 0.5 ng/mL 90.0% (59.6%, 98.2%)
< 0.5 to 0.2 ng/mL 93.3% (70.2%, 98.8%)

More than two-thirds (67.2%) of patients experienced a change in their treatment plan as a consequence of TLX591-CDx PSMA-PET imaging compared with the initial plan at baseline. This outcome confirms that PSMA-PET imaging with TLX591-CDx had a meaningful impact on clinical decision-making in Chinese patients, potentially leading to improved treatment strategies for participants with BCR. Final data from the study will be submitted for peer-reviewed publication.

Dr. David N. Cade, Group Chief Medical Officer, Telix, commented, “This is an outstanding result. The primary endpoint of the study was met decisively, with the positive predictive value significantly exceeding the performance threshold agreed with the Chinese regulator. Importantly, the high PPV was consistent even in patients with very low PSA values, and across differing metastatic locations, demonstrating broad clinical applicability. These compelling data will enable Telix and our partner Grand Pharma to submit a New Drug Application for Illuccix in China, a strategically important market.”

In China, more than 134,000 men were diagnosed with prostate cancer in 20224, increasing by approximately 6% each year5. In line with government policy supporting wider geographic access to nuclear medicine, the number of PET/CT cameras installed in China is expected to surpass 1,600 by the end of 20256, compared with 133 in 20107.

FDA Resubmission Update: TLX101-CDx
Telix advises that its New Drug Application (NDA) resubmission for TLX101-CDx, (Pixclara®1, 18F-floretyrosine) to the United States (U.S.) Food and Drug Administration (FDA), is progressing well. The Company has had collaborative interactions with the FDA around providing additional clinical data and a revised statistical analysis plan.

Following a productive Type A meeting to review the basis of the Complete Response Letter (CRL)8, Telix is currently finalizing its package for resubmission. The Company will provide a further near-term update when the resubmission has been filed and accepted by the FDA. The approved Expanded Access Program (EAP)9 remains active for TLX101-CDx, reflective of Telix’s commitment to serving patients.

FDA Resubmission Update: TLX250-CDx
Telix has recently participated in a Type A meeting to discuss the CRL it received following review of the Biologics License Application (BLA)10 for TLX250-CDx (Zircaix®1, 89Zr-DFO-girentuximab). Telix believes it has reached alignment with the FDA on the remediation of identified deficiencies regarding the product’s chemistry, manufacturing, and controls (CMC) package, which formed the substantive basis of the CRL.

The FDA has collaboratively granted Telix an additional meeting in January to review Telix’s plan for the additional data requested to establish comparability between the drug product used in the ZIRCON Phase 3 clinical trial11 and the scaled-up manufacturing process intended for commercial use. Telix will provide a further update following receipt of the official FDA meeting minutes of both Type A meetings. The approved Expanded Access Program (EAP)12 remains active for TLX250-CDx, reflective of Telix’s commitment to serving patients.

About Telix Pharmaceuticals Limited 
Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX).

Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s first generation PSMA-PET imaging agent, has been approved in multiple markets globally. Gozellix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) has been approved by the U.S. FDA13.

TLX101-CDx is Telix’s PET imaging candidate for glioma, a rare and life-threatening brain cancer. TLX250-CDx is Telix’s PET imaging candidate for the diagnosis and characterization of clear cell renal cell carcinoma, the most common kidney cancer subtype. TLX101-CDx and TLX250-CDx have not received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn, X and Facebook.

Telix Investor Relations (Global)

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Telix Investor Relations (U.S.)

Annie Kasparian
Telix Pharmaceuticals Limited
Director Investor Relations and Corporate Communications
Email: annie.kasparian@telixpharma.com

Media Contact

Eliza Schleifstein
917.763.8106 (Mobile)
Eliza@schleifsteinpr.com

This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

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Cautionary Statement Regarding Forward-Looking Statements. 

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

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1
Brand name subject to final regulatory approval.
2 ClinicalTrials.gov ID: NCT05847348.
3 Imaging of prostate-specific membrane antigen with positron emission tomography.
4 Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.
5 Ye Dingwei et al. Lancet Oncology, 2022.
6 Yang et al. J Nuc. Med. 2024.
7 Goetz Partners research 2020.
8 Telix ASX disclosure 28 April 2025.
9 ClinicalTrials.gov ID: NCT06743100.
10 Telix ASX disclosure 28 August 2025.
11 ClinicalTrials.gov ID: NCT03849118.
12 ClinicalTrials.gov ID: NCT06090331.
13 Telix ASX disclosure 21 March 2025.

What Is the Best GLP-1 Supplement for Weight Loss? Industry Analysis Reveals Probiotic Akkermansia Formulas as Affordable Ozempic Alternatives

What Is the Best GLP-1 Supplement for Weight Loss? Industry Analysis Reveals Probiotic Akkermansia Formulas as Affordable Ozempic Alternatives




What Is the Best GLP-1 Supplement for Weight Loss? Industry Analysis Reveals Probiotic Akkermansia Formulas as Affordable Ozempic Alternatives

Health Journey Addresses ‘Best GLP-1 Supplement’ Question with Akkermansia-Based Formula Analysis as Six-Month Costs Compare at $294-534 vs. $4,800-7,200 for Pharmaceutical GLP-1

LAKELAND, Dec. 20, 2025 (GLOBE NEWSWIRE) — This educational analysis is sponsored by Health Journey, a dietary supplement company whose GLP-1 Booster product is examined as a case study within this report. While Health Journey has provided support for this research compilation, the scientific citations, industry data, and cost comparisons presented are based on publicly available information. This content is educational only, not medical advice. Readers should consult healthcare providers before starting any supplement, especially those with health conditions, taking medications, or who are pregnant/nursing. Dietary supplements discussed are not FDA-evaluated and are not intended to diagnose, treat, cure, or prevent disease. Individual results vary. Pricing information is subject to change. This article contains affiliate links. If you purchase through these links, a commission may be earned at no additional cost to you. This compensation does not influence the accuracy, neutrality, or integrity of the information presented in this release.

What Is the Best GLP-1 Supplement for Weight Loss Industry Analysis Reveals Probiotic Akkermansia Formulas as Affordable Ozempic Alternatives

As millions of Americans begin 2026 with renewed commitments to health and weight management, a stark financial reality confronts them: the most effective pharmaceutical weight loss interventions remain financially out of reach for the majority. With prescription GLP-1 medications like Ozempic and Wegovy costing $800-1,200 per month without insurance coverage—and most insurers denying coverage for weight management indications—consumers are increasingly researching affordable alternatives. This has driven explosive growth in the probiotic GLP-1 supplement category, raising the question: what is the best GLP-1 supplement alternative for budget-conscious Americans seeking natural metabolic support in the year ahead?

Complete formulation details are available at the company website.

The timing is particularly relevant as Americans face what public health experts describe as a perfect storm: record obesity rates colliding with economic constraints that make proven pharmaceutical interventions financially inaccessible to average consumers. According to the Centers for Disease Control and Prevention, 42.4% of U.S. adults currently have obesity, while the American Diabetes Association reports that 34.2 million Americans have diabetes. Healthcare costs associated with obesity exceed $173 billion annually, yet the individuals most affected by metabolic health challenges are often those least able to afford the medications that clinical trials have proven most effective.

The Accessibility Crisis Driving Consumer Behavior

The disconnect between pharmaceutical efficacy and financial accessibility has created what industry analysts describe as a two-tier metabolic health system. Clinical trials of pharmaceutical GLP-1 medications have demonstrated substantial weight loss outcomes—typically 15-20% of body weight over 12-18 months. Wegovy (semaglutide 2.4mg) achieved average 15% body weight loss over 68 weeks in pivotal trials, while Zepbound (tirzepatide 15mg) demonstrated average 20.9% body weight loss over 72 weeks. These are robust, well-documented effects that represent genuine breakthroughs in metabolic health treatment.

However, the cost-benefit equation for average Americans creates a significant barrier. At $800-1,200 per month without insurance coverage, a six-month course of pharmaceutical GLP-1 treatment costs $4,800-7,200. Most insurance plans do not cover these medications for weight management indications, only for diabetes treatment with specific clinical criteria. For the majority of Americans—particularly those with modest savings and no insurance coverage for weight management—these costs are prohibitive regardless of clinical efficacy.

This accessibility gap has driven consumer search behavior in predictable directions. Industry data shows that searches for “Ozempic alternative” increased more than 300% in 2024-2025, becoming one of the fastest-growing health-related search terms. Searches for “GLP-1 supplement,” “probiotic GLP-1,” and “natural GLP-1 support” have similarly surged as consumers seek to understand whether more affordable options can provide meaningful metabolic benefits.

The Science Behind Probiotic GLP-1 Support

To understand what probiotic GLP-1 supplements can and cannot deliver, it’s essential to examine the underlying biological mechanisms and research foundation.

GLP-1 (Glucagon-Like Peptide-1) is a hormone produced naturally in the gut by specialized cells called L-cells located in the intestinal lining. When you eat, these L-cells release GLP-1 into the bloodstream, where it performs several metabolic functions: signaling the pancreas to release insulin in response to rising blood glucose, slowing gastric emptying to promote satiety, and interacting with brain appetite centers to influence feelings of fullness.

The gut microbiome connection to GLP-1 production has emerged as an active area of metabolic research over the past decade. Research has demonstrated that certain gut bacteria produce short-chain fatty acids (SCFAs), such as butyrate, when they ferment dietary fiber. These SCFAs can interact with L-cells in the intestinal lining and may influence GLP-1 secretion.

A study published in the Journal of Biological Chemistry in 2015 established the mechanistic link between butyrate-producing bacteria and GLP-1 production at the cellular level. The research demonstrated that butyrate directly stimulates GLP-1 secretion from intestinal L-cells through activation of specific receptors (GPR41 and GPR43, also called free fatty acid receptors FFAR3 and FFAR2). When these receptors are activated by butyrate, they signal L-cells to secrete GLP-1.

Similarly, research on the bacterial strain Akkermansia muciniphila has shown associations between this bacterium’s abundance in the gut and improved metabolic health markers. A randomized controlled trial published in Nature Medicine in 2019 examined pasteurized Akkermansia muciniphila supplementation in 32 overweight and obese insulin-resistant volunteers. After three months, the Akkermansia group showed improvements in insulin sensitivity, reduced insulin levels, and decreased levels of certain inflammatory markers compared with placebo. The study suggested that even pasteurized (heat-treated) Akkermansia retained beneficial metabolic properties.

Additional research published in ASM Journals has explored the crosstalk between glucagon-like peptide 1 and gut microbiota in metabolic diseases, documenting the complex interactions between gut bacteria composition, bacterial metabolites, and GLP-1 signaling pathways.

This body of research forms the scientific foundation that probiotic GLP-1 supplements are built upon: the hypothesis that optimizing gut microbiome composition with specific bacterial strains may support the body’s natural GLP-1 production.

The Critical Distinction: Mechanism and Magnitude

It’s essential to understand that probiotic GLP-1 supplements work through fundamentally different mechanisms than pharmaceutical medications. Prescription GLP-1 drugs like Ozempic, Wegovy, and Mounjaro are synthetic GLP-1 receptor agonists—meaning they bind to and activate the same receptors that natural GLP-1 activates. However, these synthetic versions are engineered to resist breakdown by the DPP-4 enzyme that rapidly degrades natural GLP-1, remain active in the bloodstream for much longer periods (days to weeks versus minutes for natural GLP-1), and achieve blood concentrations far higher than the body naturally produces.

This creates supraphysiological activation of GLP-1 receptors—levels above what the body naturally produces. The magnitude of metabolic effects observed in pharmaceutical trials reflects this supraphysiological mechanism.

Probiotic GLP-1 supplements, by contrast, aim to support the body’s natural production of GLP-1 by optimizing gut microbiome composition. The GLP-1 produced through this pathway is the body’s own natural hormone, which is rapidly broken down by the DPP-4 enzyme as part of normal metabolism. Blood levels remain within physiological ranges—what the body would naturally produce under optimal conditions.

The practical implication: pharmaceutical medications and probiotic supplements operate at different scales, producing effects within different ranges. Pharmaceutical interventions achieve dramatic outcomes documented in clinical trials. Probiotic approaches lack comparable clinical trial data demonstrating weight loss outcomes of similar magnitude. The ingredient-level research on strains like Akkermansia shows associations with improved metabolic markers and modest changes in some studies, but these effects are substantially smaller than pharmaceutical interventions.

Industry analysts emphasize that consumers must align their expectations with the mechanism: probiotic support works within the body’s natural regulatory systems to potentially optimize GLP-1 production within normal ranges, while pharmaceutical medications override natural regulation to achieve supraphysiological effects.

For detailed product specifications, visit the Health Journey website.

What Makes the Best GLP-1 Supplement? Industry Analysis

Based on available research and industry quality standards, experts analyzing the probiotic GLP-1 supplement category suggest consumers evaluate products based on several key criteria when determining what might constitute the best GLP-1 supplement for their individual needs:

Research-Backed Strain Selection

Not all probiotic bacteria influence GLP-1 pathways equally. Research suggests specific strains have documented roles in metabolic health and GLP-1 production mechanisms:

Akkermansia muciniphila has emerged as one of the most extensively researched bacterial strains for metabolic health, earning designation as a “next-generation probiotic” in scientific literature. Research indicates Akkermansia supports gut barrier integrity, influences GLP-1 secretion through mechanisms still being characterized, and modulates immune and metabolic signaling pathways. Studies have used doses ranging from 100 million to 10 billion CFU daily, with beneficial effects observed across this range.

Butyrate-producing strains such as Clostridium butyricum have documented effects on GLP-1 secretion through short-chain fatty acid production. When these bacteria ferment dietary fiber, they produce butyrate, which activates receptors on L-cells that trigger GLP-1 release. Research doses typically range from 20 million to 2 billion CFU.

Supportive strains like Bifidobacterium species help maintain overall microbiome balance, create favorable conditions for other beneficial bacteria, and support gut barrier function and immune modulation. While not directly targeting GLP-1 pathways as extensively as Akkermansia or butyrate-producers, these strains serve important ecosystem support functions.

Industry experts note that targeted combinations of research-selected strains working through complementary mechanisms may offer theoretical advantages over single-strain approaches or generic multi-strain probiotics without metabolic focus.

CFU Count Context and Quality Over Quantity

Consumer confusion often centers on CFU (Colony Forming Unit) counts, with some products advertising 50 billion, 100 billion, or even higher counts. However, research doesn’t support the assumption that higher CFU counts necessarily produce better outcomes.

Studies on Akkermansia, Clostridium butyricum, and Bifidobacterium strains have typically used doses in the millions to low billions range—not the astronomical counts some manufacturers advertise. Industry analysts suggest that CFU inflation beyond research-supported ranges often reflects marketing differentiation rather than evidence-based dosing.

Factors that matter more than raw CFU numbers include: whether strains are research-backed for the intended metabolic purpose, whether bacteria survive manufacturing, storage, and stomach acid to reach the intestines viable, delivery mechanisms such as delayed-release capsules or acid-resistant strains, and storage stability maintaining potency through shelf life.

Products with modest CFU counts (hundreds of millions to low billions) of specifically selected, research-backed strains may offer more value than products with astronomical counts of generic strains lacking metabolic research support.

Synbiotic Design

Probiotic bacteria require fuel to survive and function optimally. Synbiotic formulations combine probiotics with prebiotics—the fiber substrates that beneficial bacteria ferment.

Common prebiotic types include inulin (from chicory root), which is well-researched and preferentially feeds beneficial bacteria including Bifidobacterium species and butyrate-producers; fructooligosaccharides (FOS), which support various beneficial bacteria; resistant starch, which feeds butyrate-producing bacteria; and beta-glucans, which support immune function and beneficial bacteria.

Industry experts note that products combining probiotics with their preferred food sources may offer theoretical advantages over probiotics alone, as they provide both the bacteria and the substrate needed for metabolic byproduct generation. However, prebiotic doses in most probiotic supplements are modest compared to standalone fiber supplements, suggesting dietary fiber intake remains important regardless of supplementation.

Manufacturing Quality and Third-Party Verification

Quality variance is a documented concern in the probiotic supplement category. Independent testing by organizations like ConsumerLab has found that some probiotic supplements contain different strains than labeled or significantly lower CFU counts than advertised.

Key quality markers include: GMP (Good Manufacturing Practices) certification, which represents FDA-mandated quality standards for dietary supplement manufacturing; third-party testing by independent laboratories to verify label claims match actual contents; and transparent disclosure of specific strains (genus, species, and ideally strain designation) rather than proprietary blend language hiding formulation details.

While GMP certification is increasingly standard in the supplement industry, it remains an important baseline quality marker. Third-party testing provides accountability that self-certification alone cannot offer.

Realistic Assessment Windows and Guarantee Alignment

Research on probiotic metabolic interventions typically measures outcomes at 12+ weeks (three months). This timeline allows for stable establishment of probiotic strains, consistent production of bacterial metabolites, time for downstream metabolic effects to potentially emerge, and enough consistency to assess subjective changes in appetite, energy, and wellbeing.

Industry analysts note that guarantee periods should align with realistic assessment timelines. Products offering only 15-30 day guarantees may not provide adequate time for consumers to evaluate whether they experience meaningful benefits. Extended guarantees of 90-180 days better align with research timelines and demonstrate manufacturer confidence in long-term satisfaction.

Transparent and Realistic Positioning

Perhaps the most important criterion for evaluating what constitutes the best GLP-1 supplement is how companies position their products and set consumer expectations.

Red flags that suggest problematic marketing include: claims of pharmaceutical equivalence (“works just like Ozempic”), rapid weight loss promises (dramatic outcomes in short timeframes), proprietary blends without strain disclosure, astronomical CFU counts emphasized over strain quality, and unrealistic guarantee windows preventing adequate assessment.

Conversely, indicators of responsible positioning include: honest acknowledgment that mechanisms differ from pharmaceutical drugs, realistic expectation-setting about gradual metabolic support rather than dramatic transformation, transparent disclosure of all strains and doses, quality manufacturing claims (GMP certification, third-party testing), and guarantee periods aligning with research assessment timelines.

Case Study: Health Journey GLP-1 Booster as Market Example

One example of supplements positioning as accessible GLP-1 support for budget-conscious consumers is Health Journey’s GLP-1 Booster, which industry observers note exemplifies several of the criteria outlined above.

According to Health Journey’s product documentation, the formulation contains three research-backed probiotic strains: Akkermansia muciniphila, studied extensively for metabolic health and GLP-1 pathway associations; Clostridium butyricum, a butyrate-producing strain with documented effects on GLP-1 secretion through short-chain fatty acid production; and Bifidobacterium infantis, which supports overall microbiome balance and gut barrier function.

The product contains 500 Million CFU total, which falls within the lower-to-mid range of research-supported dosing for these specific strains. Studies on Akkermansia have used doses ranging from 100 million to 10 billion CFU, Clostridium butyricum effective doses typically range from 20 million to 2 billion CFU, and Bifidobacterium infantis benefits have been documented with doses from 100 million to 10 billion CFU. The formulation represents research-informed dosing of specifically selected strains rather than arbitrary CFU maximization for marketing purposes.

The product includes 211mg of chicory inulin as prebiotic support. This dose is modest compared to standalone prebiotic supplements, which typically provide 5-20 grams, suggesting the inulin serves a supportive rather than primary role. The synbiotic combination provides both the probiotic bacteria and their preferred food source in a single formulation.

According to the company’s quality documentation, Health Journey GLP-1 Booster is manufactured in GMP-certified facilities and undergoes third-party testing for purity and potency. These quality markers provide baseline assurance that label claims match actual contents, addressing the quality variance concerns documented in the broader probiotic category.

The company offers a 180-day money-back guarantee, which is substantially longer than the industry standard of 30-60 days. This extended guarantee period aligns with the 12+ week research timelines for probiotic metabolic interventions, allowing consumers time to complete a full assessment cycle and still request a refund if the product doesn’t provide perceived value.

According to the company’s published pricing structure, the supplement is available at approximately $49-89 per month depending on package selection. This positions the product at roughly 4-11% of pharmaceutical GLP-1 medication costs. The six-month cost ranges from approximately $294-534, compared to $4,800-7,200 for pharmaceutical interventions over the same period. This price point places the product in the mid-tier of the probiotic GLP-1 category—more accessible than premium products positioned at $150-200 per month while offering research-backed strain selection not typically found in budget options priced at $20-40 per month.

The company’s marketing materials emphasize gut health optimization and metabolic support within the context of comprehensive lifestyle approaches, rather than making pharmaceutical equivalence claims or promising rapid weight loss outcomes. This positioning reflects awareness of the mechanistic differences between probiotic support and pharmaceutical intervention.

The Cost-Benefit Reality Check for Consumers

Understanding the financial tradeoffs helps contextualize what the best GLP-1 supplement might mean for different consumer segments based on budget constraints and health goals.

A six-month comparison illustrates the cost differential:

Pharmaceutical GLP-1 medications (Ozempic, Wegovy, Mounjaro) typically cost $800-1,200 monthly without insurance coverage, resulting in six-month costs of $4,800-7,200. These require prescriptions, ongoing medical supervision, and regular monitoring. Clinical trials document typical outcomes of 15-20% body weight loss over 12-18 months, representing substantial, well-documented metabolic effects.

Mid-tier probiotic GLP-1 supplements typically cost $50-90 monthly, resulting in six-month costs of $300-540. These are available over-the-counter with no prescription requirements or medical supervision needs. Realistic expectations based on ingredient research suggest modest metabolic support rather than pharmaceutical-level weight loss, with effects operating within normal physiological ranges.

Budget-tier probiotic options typically cost $20-40 monthly, resulting in six-month costs of $120-240. These often feature single-strain formulations (Akkermansia only) or generic multi-strain probiotics without metabolic-specific targeting. Quality variance is common in this tier, with less consistent third-party testing and GMP certification.

The cost differential between probiotic supplements and pharmaceutical medications is substantial—probiotic options cost approximately 5-10% of pharmaceutical interventions over six months. However, the magnitude of effect differs proportionally, and consumers must calibrate expectations accordingly.

Financial accessibility makes probiotic GLP-1 support potentially relevant for several consumer segments: individuals without insurance coverage for weight management medications, for whom pharmaceutical options are financially inaccessible regardless of efficacy; consumers with modest metabolic goals seeking 5-10% body weight reduction over 6-12 months rather than the 15-20% documented in pharmaceutical trials; people preferring to exhaust natural approaches before pharmaceutical intervention, viewing supplements as a first step in a progressive strategy; those with injection aversion or needle phobia, for whom the weekly injection requirement of pharmaceutical GLP-1 drugs creates a psychological barrier; and budget-conscious consumers for whom $300-540 over six months is achievable while $4,800-7,200 is not.

Conversely, pharmaceutical GLP-1 medications remain more appropriate for certain situations: medically urgent conditions such as type 2 diabetes with poor control or obesity with serious health complications requiring rapid metabolic improvement; scenarios where the magnitude of effect is critical and 15-20% body weight reduction is medically necessary; situations where adequate medical supervision is available to monitor response and manage potential side effects; and cases where insurance coverage exists or out-of-pocket costs are financially manageable.

For educational resources on probiotic metabolic support, see the company’s informational materials.

Expert Guidance on Realistic Expectations

Nutrition experts and industry analysts emphasize several key points consumers should understand before choosing any product marketed as the best GLP-1 supplement:

The term “GLP-1 supplement” can create misleading expectations if consumers anticipate pharmaceutical-equivalent results. The mechanisms are fundamentally different, producing effects at different scales. Probiotic supplements support natural GLP-1 production within physiological ranges; pharmaceutical drugs achieve supraphysiological activation far beyond natural levels.

Assessment timelines matter significantly. Research on probiotic metabolic interventions typically measures outcomes at 12+ weeks minimum. Consumers should commit to at least 90 days of consistent daily use before evaluating whether subjective benefits—improved satiety patterns, digestive regularity, energy consistency, or general wellbeing—are present. Expecting rapid, dramatic results within days or weeks creates disappointment when probiotic approaches operate on different timescales.

Lifestyle integration is essential for optimal outcomes. Industry analysts note that probiotic metabolic support works best when integrated into comprehensive lifestyle approaches including balanced nutrition with adequate dietary fiber, regular physical activity, sufficient sleep, and stress management. Supplements may enhance good foundations, but they don’t replace them. Expecting a supplement to compensate for poor diet quality, minimal physical activity, inadequate sleep, or unmanaged stress creates unrealistic expectations about what probiotic support can deliver.

Individual variability affects outcomes significantly. Baseline gut microbiome composition, dietary patterns, lifestyle factors, genetic variations, and existing health conditions all influence how individuals respond to probiotic supplementation. What provides meaningful benefits for one person may offer minimal value for another, and there’s no way to predict individual response without trying the product for an adequate assessment period.

Consumers should also watch for red flags indicating problematic products or marketing: companies making pharmaceutical equivalence claims, dramatic before-and-after weight loss promises, proprietary blend language hiding strain disclosure, astronomical CFU counts emphasized without research context, and guarantee windows too short to allow realistic assessment (under 60 days).

The Broader Public Health Context

The question of what constitutes the best GLP-1 supplement for budget-conscious Americans exists within a larger public health challenge: how to address America’s obesity and metabolic health crisis when the most effective treatments remain financially inaccessible to those who need them most.

The healthcare costs associated with obesity—exceeding $173 billion annually according to CDC data—create economic burden extending far beyond individual health outcomes. Yet the individuals most affected by obesity and metabolic dysfunction are disproportionately those with lower incomes and less access to comprehensive health insurance coverage.

Pharmaceutical GLP-1 medications represent genuine scientific breakthroughs, with clinical trial outcomes documenting effectiveness that previous weight loss interventions couldn’t match. However, pricing structures that make these medications accessible primarily to affluent consumers create a troubling two-tier system where metabolic health interventions stratify along economic lines.

The emergence of the probiotic GLP-1 supplement category represents market response to this accessibility gap. While these supplements cannot and do not replicate pharmaceutical outcomes, they provide an option for consumers seeking some form of metabolic support within budget constraints that make pharmaceutical interventions impossible.

Public health experts note that this market dynamic—where expensive but highly effective treatments drive consumer interest in more affordable but less potent alternatives—reflects broader challenges in American healthcare accessibility. The ideal solution would involve making proven pharmaceutical interventions accessible to all who medically need them. In the absence of that accessibility, consumers make pragmatic decisions about what options exist within their financial reality.

Looking Forward: 2026 Market Outlook and Research Directions

Industry observers expect the probiotic GLP-1 supplement category to continue growing throughout 2026 as several factors converge: pharmaceutical GLP-1 pricing remains prohibitive for most Americans without comprehensive insurance coverage; research on gut microbiome-metabolism connections continues advancing, potentially identifying additional beneficial strains or optimal formulation strategies; consumer education improves as understanding of mechanistic differences between probiotic support and pharmaceutical drugs becomes more widespread; and quality manufacturers establish differentiation from opportunistic entrants making exaggerated claims.

Research directions that may inform future probiotic GLP-1 supplement development include: studies examining optimal Akkermansia dosing, delivery mechanisms (live versus pasteurized strains), and colonization strategies; investigation of synergistic strain combinations that may enhance metabolic outcomes beyond single-strain approaches; exploration of individual microbiome profiling to enable personalized probiotic selection based on baseline gut bacteria composition; and long-term outcome studies tracking metabolic changes with sustained probiotic use over 12+ months.

As the category matures, industry analysts anticipate clearer differentiation between responsible manufacturers making evidence-based claims and opportunistic entrants making pharmaceutical equivalence promises that research doesn’t support. Consumer protection may benefit from this differentiation, as informed consumers learn to evaluate products based on research-backed criteria rather than marketing hype.

The fundamental question—what is the best GLP-1 supplement for budget-conscious Americans?—ultimately depends on individual circumstances, health goals, budget constraints, and willingness to commit to gradual metabolic support rather than rapid pharmaceutical intervention. What’s increasingly clear is that the accessibility gap created by pharmaceutical pricing has driven genuine category innovation, and consumers entering 2026 with health improvement goals have supplement options that didn’t exist even two years ago.

For consumers evaluating these options, the research suggests focusing on products with documented strain selection, transparent dosing aligned with research, quality manufacturing standards, realistic positioning about mechanisms and outcomes, and guarantee periods allowing adequate assessment time. The goal is matching individual needs and expectations with products that can realistically deliver value within budget constraints—recognizing that “best” means different things depending on whether the priority is maximum effect (pharmaceutical), optimal cost-benefit balance (mid-tier probiotic), or minimum financial commitment (budget probiotic).

As millions of Americans begin 2026 with renewed health commitments, understanding these options and tradeoffs empowers more informed decision-making about which approach—if any—aligns with individual health situations, financial realities, and realistic outcome expectations.

About Health Journey

Health Journey is a dietary supplement company focused on gut health and metabolic wellness. The company’s GLP-1 Booster combines research-backed probiotic strains (Akkermansia muciniphila, Clostridium butyricum, and Bifidobacterium infantis) with prebiotic support to provide accessible metabolic support for consumers seeking natural approaches to wellness. The product is manufactured in GMP-certified facilities and undergoes third-party testing for purity and potency. Additional information is available on the company website.

Contact Information:

Health Journey Email: care@shophealthjourney.com Phone: 855-293-8566 Website: https://tryglp1booster.com

Contact:

For inquiries contact Health Journey customer service at the email and phone number listed above.

Disclaimer: This article is for informational and educational purposes only and does not constitute medical advice. Consumers should consult qualified healthcare providers before starting any new dietary supplement, particularly if they have existing health conditions, take medications, are pregnant or nursing, or are considering significant changes to their health regimen. Individual results with any supplement vary based on baseline health status, dietary patterns, lifestyle factors, and genetic variables. The research discussed examines individual probiotic strains and metabolic pathways; Health Journey GLP-1 Booster as a finished product has not been independently studied in clinical trials. Probiotic supplements are not intended to diagnose, treat, cure, or prevent any disease. Results are not guaranteed, and dietary supplements should not replace prescribed medical treatment for diagnosed conditions.

Scientific References:

Beneficial Metabolic Effects of a Probiotic via Butyrate-induced GLP-1 Hormone Secretion, Journal of Biological Chemistry: https://www.jbc.org/article/S0021-9258%2820%2949115-X/fulltext

Crosstalk between glucagon-like peptide 1 and gut microbiota in metabolic diseases, ASM Journals: https://journals.asm.org/doi/10.1128/mbio.02032-23

Akkermansia muciniphila and improved metabolic health, Nature Medicine: https://www.nature.com/articles/s41591-019-0495-2

Obesity statistics and healthcare costs, Centers for Disease Control and Prevention: https://www.cdc.gov/obesity/data/adult.html

Diabetes statistics, American Diabetes Association: https://diabetes.org/about-diabetes/statistics/about-diabetes

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###

CONTACT: Health Journey Email: care@shophealthjourney.com 
Phone: 855-293-8566

The 3D-Flow Architecture Breakthrough: A Universal, Scalable Digital Processor for Real-Time Pattern Recognition in High-Rate Data Streams — A Platform to Save Millions of Lives and Billions of Euros

The 3D-Flow Architecture Breakthrough: A Universal, Scalable Digital Processor for Real-Time Pattern Recognition in High-Rate Data Streams — A Platform to Save Millions of Lives and Billions of Euros




The 3D-Flow Architecture Breakthrough: A Universal, Scalable Digital Processor for Real-Time Pattern Recognition in High-Rate Data Streams — A Platform to Save Millions of Lives and Billions of Euros

A Revolutionary ATCA/VME/VXI 3D-Flow Board: 512 Channels, >2,800 Programmable Operations—Scalable to >50,000 Operations on Each Dataset Arriving Every 25 ns with Zero Data Loss at a fraction of the cost of FPGA

DALLAS, Dec. 20, 2025 (GLOBE NEWSWIRE) — In PDF https://bit.ly/437YX7H) The Crosetto Foundation for the Reduction of Cancer Deaths, a registered nonprofit organization, urgently calls on the public to help expose and correct scientific and institutional inconsistencies that any person—with or without a scientific background—can understand through common sense and factual evidence.

A Media Snippet accompanying this announcement is available by clicking on this link.

These inconsistencies have harmed taxpayers, patients, and the advancement of science. They can be fixed with dialogue, transparency, and your support. Please consider contributing $10, $20, $50, or whatever you can via online donation (https://crosettofoundation.org/donate-now/) or if you have Zelle app on your phone/computer, send your donation directly to donate@crosettofoundation.org [1]. If you cannot donate, your voice still matters—read on to learn how to take action by writing to your Member of the Parliament.

Notice to Readers:

The full version of this 60-page scientific article, including complete references, factual data, and detailed calculations, is available in PDF format at: https://bit.ly/437YX7H

Due to platform limits on document length, this abridged version includes the titles and subtitles of all sections, along with selected explanatory paragraphs and references listed at the end.

Only Section 16 (Thirty Years of Missed Opportunities to Fund the Non-Recurring Engineering, NRE) and Section 17 (Final Call to Action) are reproduced in full. Other sections contain only headings and specific paragraphs containing citations. Consequently, these sections may lack the necessary context for full comprehension and require to access the full document.

Readers who require additional technical detail, background explanations, or full documentation are invited to consult the complete PDF version.

This article is divided into three parts.

Part I — Scientific Evidence: The Case for Accountability and Scientific Integrity (Section 1 through 7) documents the facts, public records, and actions revealing a persistent suppression of transparency and scientific accountability that has caused tremendous financial waste and slowed progress in particle physics at CERN and in cancer detection and prevention.

Part II Technical Proofs, Industrial Comparisons, and Specifications (Sect. 8 through 15), presents the technical evidence. It demonstrates the fundamental architectural limits of FPGA-based systems in executing complex algorithms on datasets arriving at ultra-high rates without data loss, and contrasts these limitations with the 3D-Flow architecture. The 3D-Flow architecture was officially recognized in 1993 at Fermilab as a breakthrough invention capable of overcoming these barriers with unprecedented performance and cost-effectiveness, yet it has remained chronically unfunded and continually suppressed. (See the scientific article of 14/4/2025 [2], which supports the two-hour IEEE presentation of 102 slides granted to Crosetto in 2024 at the conference that accepted all six of his papers, and the Press Release in HTML and PDF of 28/8/2025 [3] which describes the missed opportunities that result in the loss of billions of taxpayer euros and millions of lives).

Part III — The Cost of Delay and the Final Imperative (Sect. 16 through 17) analyzes the real-world consequences of the three-decade funding gap, synthesizes the evidence, provides a mandate for immediate action to rescue scientific integrity and protect taxpayer investment and defines the ethical, scientific, and institutional actions required to restore accountability, prevent further waste of public resources, and enable progress that serves science and humanity

Part I: Scientific Evidence: The Case for Accountability and Scientific Integrity

The Genesis, Proven Merit, and Unjust Suppression of the 3D-Flow Architecture: A Three-Decade-Spanning Account of Technical Triumph and Institutional Failure

The speed of light is constant, but the ability of humanity to process the data it reveals is not.

Every major scientific endeavor—from the search for the smallest particles at the Large Hadron Collider (LHC) to the diagnosis of life-threatening diseases using Positron Emission Tomography (PET)—is fundamentally limited by one bottleneck: Real-Time Digital Processing. Data arrives from detectors at rates equivalent to hundreds of thousands of gigabits per second, but traditional computing architectures, reliant on centralized buses and commercial Field-Programmable Gate Arrays (FPGAs), cannot keep pace.

The insistence on these flawed conventional strategies has already cost taxpayers dearly: ignoring the proven 3D-Flow invention in favor of FPGAs has wasted over $4 billion during the past three decades at CERN.

Worse, the most recent CERN implementation of the FPGA-Based Level-1 Trigger planned for the 2026-2036 decade is a 650 kW system containing an incredibly high number of transistor, 20 trillion in all, which would waste over $12 billion [4] if this technically inadequate solution is not scrapped.

It is inadequate at filtering relevant data from 8 billion events per second from the HL-LHC costing $4 million/day to operate, wasting also the salary of thousands of scientists analyzing for several years irrelevant data.

These systems routinely discard over 99% of the raw information they receive, often including the very ‘needle in the haystack’ event scientists are seeking. Chapter 1 defines this crisis, explaining why conventional, multi-billion-dollar processing strategies are not just technically deficient but financially irresponsible when confronted with the 21st-century data deluge.

(See additional Press Releases from June through October 2025 published by over 5,000 NEWS Outlets [5] that have reached a potential of over 800 million readers [6], [7], [8], [9], [10], [11], [12], [13], [14], [15], [16], [17].

1. The Core Scientific Challenge

1.1     Challenge in Real-Time Digital Processing

The challenge of real-time data processing is fundamental to both scientific discovery and clinical diagnostics. Whether Filtering 8 billion events per second from the High-Luminosity Large Hadron Collider (HL-LHC) or processing high-rate radiation data in medical imaging for early-stage cancer detection, the need for a programmable, high-throughput, universal solution is critical.

1.2      Crosetto’s 3D-Flow Invention Solves the Core Challenge and Is Designed to Serve Scientists’ Needs

1.3     Official Recognition and Funding for 3D-Flow

Crosetto’s invention of the 3D-Flow architecture [18] in 1992 was officially recognized in 1993 by a major public scientific review at FERMILAB [19]. In 1995, the U.S. Department of Energy awarded Crosetto a $1 million grant for a feasibility study [20] (See pages 34-44 of [2]).

Figure 1. Isometric view of the 3D-Flow processor also referred as a ‘Logical Unit’ or ‘Processing Element (PE)’, illustrating the various input and output ports (top in figure). The bottom portion of the figure displays the timing diagram of five 3D-Flow pipeline stages (See Figure 24, page 37 of [2].

Figure 2. Sequence of the flow of data in different times in one 3D-Flow electronic channel (See Table V, page 37 of [2].

Figure 3. Example of algorithms executed on the 3D-Flow processor (12 to 18 operations per clock, average 13). (Page 114-116 of [25]).

1.4     Technology-Independent Development Suite

1.5     3D-Flow for Life-Saving Diagnostic Applications

This versatile architecture enables instantaneous, high-throughput processing, essential not only for Level-1 Triggering at the HL-LHC but also for real-time pattern detection for life-saving diagnostics—specifically, the ability to identify tumors at the earliest curable stage [25], [28], [29].

2. Scientific Validation and Proof of Feasibility

2.1     Peer-Reviewed Proof of Feasibility and Architectural Advantage

The positive results of the DOE-funded feasibility study, including the design of two universal analog and digital input boards, were published in a 1999 peer-reviewed 45-page article in Nuclear Instruments and Methods in Physics Research (NIM Sec. A, vol. 436, pp. 341–385). [21].

In this article, Crosetto demonstrated the 3D-Flow design’s capability to execute up to 26 operations in a single cycle (e.g., add, subtract, multiply, compare one value with 24 values, etc.) for a number of cycles longer than the 25 ns dataset-arrival interval.

2.2     Public Demonstration of the Simulation of 3D-Flow for a Complete Level-1 Trigger (2000)

In 2000, at the IEEE-NSS-MIC Conference, Crosetto provided a demonstration of the 3D-Flow simulator for thousands of processors and the application development tools. He also presented two articles [22], [23] and distributed 200 free copies of his book, ‘400+ times improved PET efficiency for lower-dose radiation, lower-cost cancer screening’ [24], detailing the 3D-Flow architecture’s advantages in medical imaging and its potential to save lives through cost-effective early cancer detection. Despite its relevance, Crosetto’s book has not been cited in 25 years, though many have copied the ideas and content Crosetto presented therein.

2.3     Hardware Proofs of 3D-Flow Functionality

2001 (First Proof): Crosetto presented a working hardware [25] proof of concept at the IEEE-NSS-MIC conference.

2003 (Scalability Proof): Crosetto demonstrated the feasibility and scalability of a 144-processor 3D-Flow system (on 36 Altera FPGAs, costing $500 per processor, operating at 20 MHz) for high-energy physics (HEP) and Medical Imaging applications, by building industrialized IBM-PC modular boards at his own expense [26]. Successful inter-board [27] communication proved that a scalable 3D-Flow system could be built for any detector size in High-Energy Physics (HEP) or Medical Imaging, ensuring all relevant information is extracted at the lowest cost per valid signal captured.

3. Fabricability and Missed Technological Opportunities

3.1     Fabricability Proof and the First Missed Opportunity (1997)

3.2     The Missed 120 nm CMOS Opportunity: Capability to Meet LHC Requirements Through 2026

Crosetto’s repeated requests to meet with the DOE to explain the advantages of 3D-Flow over non-programmable ASICs and FPGAs were consistently denied. Instead, the DOE funded a single researcher with over $50 million for a project that did not simulate the entire trigger system. This latter project subsequently attracted over $100 million from European funding agencies to implement the CMS Level-1 trigger using ASICs and FPGAs, and ultimately failed. The 4,000 boards were scrapped in 2016 due to their ineffectiveness, as reported by the system’s own designers [28].

4. Documented Limitations and Failures of FPGA-Based Triggers

4.1     Documented Failures of FPGA-Based Level-1 Triggers to Meet LHC Requirements

Public records clearly shows that for the past 25 years, CERN has repeatedly built inadequate FPGA-based Level-1 Triggers, necessitating multiple rebuilds.

During the Higgs boson discovery announcement on 4 July 2012, only 40 events were detected out of ~100,000 produced by 1,000 trillion LHC collisions over two years.

These 40 events were likely recorded by chance, demonstrating the fundamental unsuitability of FPGA architecture for Level-1 Trigger, a fact Crosetto has demonstrated (pages 46-49 of [2]).

5. Institutional Decisions and the Record of Suppression

5.1     DOE Solicitation and Continued Suppression (2015-2016)

Following the recognized failure in 2015 of the 4,000 CMS FPGA-Based Level-1 Trigger boards that were scrapped the following year as it is publicly documented [22], the Director of the High Energy Physics Office at the U.S. DOE solicited Crosetto to prepare a proposal for a universal Level-1 Trigger.

Crosetto submitted a detailed 274-page proposal [29], supported by 59 quotes from 21 reputable industries, including quotes to port the 1997 synthesis (four 3D-Flow processors/chip, 350 nm CMOS @ 61 MHz) to a more advanced 64 processors/chip, 40 nm CMOS technology @ 400 MHz (estimated cost: NRI + ~$1 per processor).

This proposal was never examined by the DOE, and a requested meeting was never granted.

… CERN has approved and already built a new FPGA version for 2026–2036—yet again relying on a design consuming 650 kW FPGA-Based CMS Level-1 Trigger system, built from 20 trillion transistors [30], [31] and demonstrably unable to meet HL-LHC real-time requirements.

5.2     High-Level Scientific Meetings and Continued Inaction (2016)

After meeting one-on-one at the same conference with CERN Director of Research and explaining the advantages of the 3D-Flow proposal [29] Crosetto requested a public meeting be organized at CERN between himself and the designers of the CERN FPGA-Based Level-1 trigger, which was denied.

Instead, the Director used €17 million from the European H2020 ATTRACT Grant (No. 777222) to fund WPET (Wearable PET), a scientifically implausible and logistically impractical 350+ kg coat for 24-hour cancer screening [32], [33].

5.3    European Parliamentarians Intervene (2017 & 2021)

Parliamentary Question [34] (translated into 24 languages) on the 3D-CBS project [25] (see 11 minute educational video [35]) to the European Commission, demanding transparency regarding the unjustified funding of the impractical WPET project and an explanation for the suppression of the scientifically validated 3D-CBS project (which uses 3D-Flow for early cancer detection).

2021: …Instead of investigating, the European Commission awarded another €28 million [36] to the CERN-ATTRACT consortium that funded the WPET project in 2019.

6. The Continued Suppression of Unrefuted Scientific Evidence (2024-2025)

In October 2024, all six of Crosetto’s scientific papers were approved by the seven Chairs of the IEEE-NSS-MIC-RTSD Conference. He was granted two hours to present his 102-slide presentation [37]. Despite answering all questions, supporting his presentation with an 82-page scientific article [2].

6.1     Overview: Suppression of Transparency and Failure of Scientific accountability

   6.1.1.    November 2024 (IEEE silencing)

Access to Crosetto’s six conference presentations was deliberately made difficult by changing the online URL, and the two-hour video of the presentations was temporarily removed without notification (see Section IX, page 28 of [2]).

   6.1.2.    April 2025 (TechArchiv censured)

Crosetto’s article [3] detailing the 3D-Flow architecture and its advantages compared to FPGA and other approaches was suppressed from the open platform TechArchiv without scientific justification, forcing its publication as a Press Release in order to ensure continued accessibility to the scientific community and the public.

   6.1.3.    May 2025 (Proven Solution Ignored)

Crosetto’s two-page technical abstracts—one summarizing the performance, power consumption, and cost comparison [38] between 3D-Flow and the CERN FPGA-Based CMS Level-1 Trigger, and the other summarizing a revolutionary, universal, scalable 3D-Flow board [39] capable of executing complex Level-2 trigger algorithms at Level-1—were ignored by CERN and suppressed by the 2025 IEEE-NSS-MIC-RTSD Conference without reason.

   6.1.4.    20 June 2025: CERN $12 Billion Mistake

On 20 June 2025, the CERN Council approved [40] funding for major upgrades to the ATLAS and CMS experiments (https://bit.ly/4mDncCi), including a CMS Level-1 Trigger system based on approximately 20 trillion transistors and consuming about 650 kW of power [30], [31], as well as a similar FPGA-based system for ATLAS.

   6.1.5.    July 2025 (IEEE-NSS-MIC-RTSD suppression of the 3D-Flow solution without providing a feedback)

On 3 July 2025, Crosetto received an email from the IEEE-NSS Chairs stating ‘We regret to inform you that your abstracts (#2905 [38] and #2954 [39]) have not been accepted for presentation in the 2025 IEEE NSS MIC RTSD conference… If you would like detailed feedback regarding why your submission was not accepted, please respond to this message.’

Despite multiple follow-up phone calls and emails, no such feedback was ever received. Consequently, on 16 July 2025, Crosetto sent a formal letter [41] to 43 IEEE leaders and other senior figures in the field, explaining the scientific importance of the rejected work and requesting that its content be openly discussed with colleagues.

In the weeks leading up to the conference, Crosetto continued to write respectfully to these 43 leaders, reiterating his willingness to engage in technical dialogue. In parallel, he formally requested permission [42] from the conference organizers and notified Yokohama law enforcement authorities of his intention to distribute 1,200 technical documents to conference participants, in order to ensure peaceful, transparent, and lawful scientific communication.

  6.1.6.    3 November 2025: Suppression of a Question at the IEEE Plenary Session

On 3 November 2025, during the first IEEE-NSS Plenary Session—attended by approximately 800 scientists in person (+ remotely connected)—the IEEE-NSS Chair moderating the session prevented Crosetto from asking a question of the keynote speaker [43].

   6.1.7.    4 November 2025: IEEE-CERN: The Unanswered Questions. A $12+ Billion Waste of Taxpayer Funds

On 4 November 2025, at the IEEE-NSS Session, Crosetto pursued a path of open scientific dialogue by posing two critical, quantifiable questions directly to the CERN-ATLAS and CMS speakers regarding the performance and cost of their FPGA-Based Level-1 Trigger:

Performance:Please provide the number of programmable basic operations the CERN-FPGA-Based Level-1 Trigger can perform on each dataset arriving every 25 nanoseconds without data loss’.

Cost:Please provide the cost per electronic channel’.

Both speakers were unable to answer these fundamental questions. Despite a formal written follow-up sent to the CERN CMS and ATLAS collaboration leadership on 14 November 2025 [44], no response has been received.

Technical Inadequacy

Leadership Accountability

The existence of a superior alternative—the 3D-Flow processor and system architecture—has been known since its formal recognition as a breakthrough in 1993. Key ATLAS and CMS leaders (currently member of the CMS Management and Executive Board) were directly involved in this process (see details at [44]).

The IEEE Presentation Controversy: A Question of Impartiality

A serious question of impartiality surrounds the IEEE-NSS Chairs’ Decision:

According to the official list of IEEE-NSS topics and submission at [45], a total of 592 papers were submitted to the 2025 Conference. Of these, only 12 papers were rejected. As shown in the conference summary graph ([46]), only three rejections occurred in the critical DAQ–Trigger category (the fifth line of topics). Notably, two of those three rejections corresponded to the 3D-Flow papers that explicitly demonstrated a viable solution

Figure 4. Slide presented on 7 November 2025 at the IEEE-NSS Closing Session showing the official NSS Topics (note the fifth line: DAQ, Trigger and Front End Electronics).

Figure 5. Slide presented on 7 November 2025 at the IEEE-NSS Closing Session showing that, among 592 submitted papers, only 12 were rejected; only three rejections occurred in the DAQ Trigger category (fifth topic line), and two of those were the 3D-Flow papers demonstrating a solution to the Level-1 Trigger problem, while FPGA-Based papers that cannot meet LHC requirements were approved.

   6.1.8.    Escaping Accountability: Removal of the Trigger Topic from the 2026 IEEE-NSS in Madrid and its Impact on 90% of CERN’s $3 Billion Annual Budget

… IEEE-NSS-MIC-RTSD General Chair and NSS-Chair for the 2026 Conference in Madrid removed the ‘Trigger’ category from the official NSS Topics. The program now lists only ‘DAQ, front end and electronics,’ [47] as confirmed on the IEEE website: [https://nssmic.ieee.org/2026/program/].

This omission is not a minor organizational adjustment. It represents a significant evasion of scientific and financial accountability affecting 90% of CERN’s $3 Billion Annual Budget.

The Central Role of the Trigger

The Trigger is the central electronic unit upon which the relevance and effectiveness of multiple downstream components depend.

  • Data Acquisition (DAQ) systems exist to capture scientifically valuable data. When the trigger fails to discriminate valuable signals from noise, DAQ systems merely record irrelevant information.
  • Investments in detectors, front-end electronics, and data analysis pipelines become ineffective if the trigger does not ensure that recorded data are meaningful.

The Cost of Failure

The High-Luminosity LHC (HL-LHC) absorbs approximately 90% of CERN’s $3 billion annual budget, as detailed in Section 9.1.3 of [3]. Without an effective Level-1 Trigger capable of executing complex, long algorithms on each dataset arriving every 25 ns—resolving pileup, exchanging data with neighboring channels, and correlating information across sub-detectors—the HL-LHC cannot achieve its scientific objectives.

The Question of Scientific Integrity

What is the rationale for Eliminating ‘Trigger’ from the 2026 conference topics?

Who Must Demand Accountability?

  • All European Member States and associated countries that finance CERN.
  • Oversight authorities responsible for scientific integrity, ethical conduct, and financial accountability.
  • Institutions committed to preventing further waste during the HL-LHC program spanning 2026–2042.

Figure 6. 2026 NSS Topics presented at the IEEE-NSS Closing Session on 7 November 2025 showing that the ‘Trigger’ topic has been removed (also available on the IEEE website: https://nssmic.ieee.org/2026/program/).

7. Public Conduct, Transparency, and Benefit to Humanity

7.1     Crosetto’s Longstanding Respect for Science, Colleagues, and Taxpayers: A Factual Record of Conduct and a Clarification of What Is Truly Disrespectful

(See more about Crosetto’s commitment to science [48]. See also public scientific review at [49].

Respectful Actions vs. Institutional Evasion

The True Disrespect: Harm to Science and Taxpayers

The more serious concern, for institutions and taxpayers, is:

  • Is it respectful to science to suppress evidence instead of refuting it?
  • Is it respectful to colleagues to prevent open dialogue on technical contradictions?
  • Is it respectful to taxpayers to continue publicly funded programs without answering quantifiable scientific questions?

History ultimately judges not personalities, but whether scientific decisions followed evidence or avoided it.

7.2     Unwavering Public Dialogue: Yokohama (2025)

To establish a dialogue based on scientific evidence rather than authority, Crosetto took the significant step of personally distributed from 3 to 7 November 2025, 1,200 two-page flyers and carrying two large posters (1 m x 1.5 m) to the 1,789 scientists attending the IEEE-NSS-MIC-RTSD conference in Yokohama, Japan. Several participants stopped to speak with Crosetto, expressing encouragement, appreciation for his perseverance, and urging him to continue presenting documented scientific evidence.

   7.2.1.    Incontrovertible Scientific Evidence

   7.2.2.    Comprehensive Documentation and Transparency

   7.2.3.    Benefit to Science and Humanity

Part II: Technical Proofs, Industrial Comparisons, and Specifications

Part I established the history of suppression; Part II the technical demonstration of the limitations of FPGA executing complex algorithm on dataset received at ultra-high speed without data loss and 3D-Flow architecture officially recognized at FERMILAB in 1993, but unfunded and continue to be suppressed. To fully appreciate the magnitude of the 3D-Flow advantage, a rigorous and honest appraisal of the incumbent technology is required.

This Part II initiates that technical deep dive by analyzing the actual, field-proven performance of FPGA-based commercial digital processing boards across ten critical industries—from high-speed defense systems to industrial measurement and scientific readout.

The analysis does not just list products; it deconstructs the underlying architectural compromises that constrain these boards:

  1. Limited on-chip routing and I/O bottlenecks.
  2. High power per unit of logic.
  3. Significant cost per unit of processing.

These compromises render FPGAs suitable primarily for applications requiring simple, programmable combinatorial logic, limiting them to solving relatively simple equations. FPGAs are fundamentally inadequate for executing complex pattern-recognition algorithms that require thousands of basic operations while simultaneously sustaining a high input data rate with no data loss, even when parallelism is applied.

Furthermore, the inherent limitations on parallelism in FPGAs are severe, a constraint that the 3D-Flow architecture demonstrates can be vastly exceeded (exceeding 250 parallel circuit copies in the boards designed in this document) due to its superior architectural concept.

By detailing the specifications and limitations of devices from NI, Keysight, ADI, and others, this analysis establishes the current performance ceiling for general-purpose FPGA solutions, providing the necessary, quantifiable benchmark against which the revolutionary efficiency and throughput of the 3D-Flow will be measured

8. Commercial FPGA-Based Digital Processing Systems: Industry Survey

8.1     Comparative Analysis: Detailed Performance Metrics of Commercial Digital Processing Boards Based on FPGAs Across Key Industry Leaders

Following are the ten major companies and categories that manufacture or sell these types of electronic boards and systems:

Major High-Performance & Modular DAQ Manufacturers

These companies offer modular systems, many of which use standard form factors like PCIe, PXIe, or various embedded form factors, often with on-board FPGA processing:

   8.1.1.     National Instruments (NI / Emerson): Evaluating Scalability and Throughput in Industrial Test Systems

   8.1.2.    Keysight Technologies: Assessing High-Speed Data Acquisition and Real-

   8.1.3.    Analog Devices (ADI): Analyzing Integrated Signal Processing and Power Efficiency for Embedded Systems

   8.1.4.    Yokogawa Electric Corporation: Performance in High-Reliability Industrial

   8.1.5.    ADLINK Technology – Taiwan / Global: Examination of Performance in Edge Computing and Communication Platforms

   8.1.6.    UEI (United Electronic Industries) – United States: Reviewing Rugged, Real-Time Data Acquisition in Extreme Environments

   8.1.7.    GaGe (a Vitrek brand) – USA: Detailed Look at Ultra-High-Speed Digitizers and Signal Processing

   8.1.8.    Electro Standards Laboratories (ESL) – USA: The Constraints and Opportunities in Custom FPGA Board Manufacturing

   8.1.9.    CAEN: Performance in Nuclear and Particle Physics Readout Systems

   8.1.10.    XIA: Specialized Analysis in Digital Pulse Processing for Scientific Instruments

9. Algorithm Analysis: Performance Limitations of FPGA-Based Processing

Comparison between the commercial boards and the 3D-Flow boards

9.1     Real-Time Threshold / Edge / Peak Detection Pipeline (fully pipelined at ≥1 GS/s)

This is the most standard real-time sequence used in oscilloscopes, trigger systems, radar front-ends, and digitizers.

Operations performed for each sample (executed every 1 ns):

  • Baseline Estimation
    Bn = alpha * Bn-1 + (1 – alpha) * xn
    Operations: 1 multiply + 1 subtract + 1 add (Total 3 operations)
  • Real-Time FIR Filter (e.g., 7–15 taps) at 1 GS/s
    FIR filtering is one of the canonical real-time FPGA algorithms.
    General equation: y[n] = sum_{k = 0 to M-1} h[k] * x[n – k] (Example 7-tap FIR 7 multiply and 6 add, total 13 operations/ns
  • Matched Filtering at 1 GS/s (correlation with known pattern)
    Matched filter equation: y[n] = sum_{k = 0 to M-1} x[n – k] * p[k]
    If M = 15 taps, identical operations as an FIR filter: 15 multiplies and 14 additions, 29 operations per sample

    Used in: High-energy physics, Particle identification patterns, Radar pulse compression.

9.2     What real-time GS/s FPGA systems cannot do

They cannot (and do not attempt to):

  • Execute hundreds or thousands of operations per dataset at 40 MS/s.
  • Perform complex branching logic or deep computation on every sample.
  • Execute CPU-style sequential algorithms.

They rely on limited pipeline parallelism only.

This is far below the thousands of operations per dataset that 3D-Flow demonstrates (Section 3).

10. Quantitative Comparison: FPGA vs 3D-Flow

10.1  The Core Architectural Challenge: Executing Complex Pattern-Recognition Algorithms at Ultra-High Data Streams Without Data Loss

To execute Level-2 Trigger algorithms—which require thousands of operations—at Level-1, on every dataset arriving every 25 ns at each electronic channel without data loss, conventional designs would need to replicate circuits many times (parallelism).

Today the Level-1 Trigger requires even more operations to cope with pile-up, to exchange data with neighboring channels, and to correlate information across sub-detectors. These tasks are impossible for an FPGA to perform on each dataset arriving every 25 ns.

In contrast, the 3D-Flow architecture can execute such algorithms and enables new capabilities that were previously unthinkable—exactly as recognized in the final report of the 1993 Fermilab scientific review. On page 6, the reviewers stated [18]:

‘…given this feature, experimenters would probably think of clever uses not now possible. Better level one triggering will reduce the data rate into level two. If a large enough reduction could be achieved, level two triggers could be replaced by a processor farm.’

This statement provides a scientifically justified basis for eliminating Level-2 triggers, because the 3D-Flow demonstrates that Level-2 algorithms can be executed at Level-1. Yet decision-makers adopted FPGAs—without demonstrating that they could execute Level-2 algorithms at 40 MHz data streams without data loss.

FPGAs are not suitable for executing complex pattern-recognition algorithms because their architecture cannot sustain long sequential computations. Conversely, CPUs, GPUs, ARM processors, or Hypercube architectures—while capable of long sequences—cannot sustain ultra-high-speed input/output data streams.

Crosetto solved both limitations with the invention of the technology-independent, scalable 3D-Flow processors and system architecture, which makes it possible to build systems with an effectively unlimited number of parallel processors, sustaining any input data rate and executing any complex algorithm.

…Doing so would be unreasonable, analogous to asking HP or Acer to equip their laptops with a 35-billion-transistor, 300-Watt, 250-MHz Xilinx Virtex Ultrascale VU19P FPGA to emulate an Intel i7 processor containing only 3 billion transistors and consuming 25 Watts at 3.9 GHz (see Table VI, page 48 of [2]).

3D-Flow provides optimal results when implemented in the most cost-effective technology, as stated in Crosetto’s 45-page peer-reviewed 1999 article [21]. On page 345 he wrote:

‘…it can be implemented at any time using the technology of the day. This in turn will allow achieving, at any moment in time, the best performance in terms of power dissipation, size, speed and, consequently, cost.’

  • A 120 nm CMOS implementation of the 3D-Flow Integrated Circuit (IC) in 1999 would have met LHC requirements through 2026.
  • A 20 nm CMOS implementation today will satisfy requirements through 2042 and beyond.

After verifying 3D-Flow functionality in FPGA, Crosetto made clear in the same 1999 article that a full 3D-Flow implementation in FPGA is unacceptable. Funding the NRE for the ASIC design, validated in FPGA and compiled by Synopsys in 350 nm CMOS, is long overdue.

10.2     Quantitative Comparison of Level-1 Trigger Architectures: FPGA-Based $1 Billion versus $85,500 3D-Flow for 4,096 Channels and 2,821 Operations per Dataset

   10.2.1.    The unacceptable Scenario: Scaling Cost and Power of an FPGA-Emulated 3D-Flow Architecture (~$1 Billion, ~10 MW)

   10.2.2.    The Viable Solution: Feasible Cost and Efficiency of the Optimized 20 nm CMOS 3D-Flow Architecture (~$85,500, ~3 KW)

   10.2.3.    Conclusions of the Quantitative Comparison of Level-1 Trigger Architectures: FPGA-Based versus 20 nm CMOS 3D-Flow

This quantitative comparison conclusively demonstrates that, while the 3D-Flow architecture is fully capable of executing thousands of operations on each dataset arriving every 25 ns without data loss, achieving such performance using FPGA technology is both technologically and economically infeasible.

In contrast, a 20 nm CMOS implementation of the 3D-Flow, achieves the required performance with vastly superior metrics:

  • Two orders of magnitude fewer processors
  • Four orders of magnitude lower cost
  • Approximately three to four orders of magnitude lower power consumption
  • Minimal volume and infrastructure requirements

This confirms the necessity of funding the Non-Recurring Engineering (NRE) required to fabricate the 3D-Flow processor in a CMOS technology (around 20 nm), where cost, power, volume, and performance are simultaneously optimized.

11. The Paradigm Shift in Real-Time Processing: Summary Table of 3D-Flow vs. Commercial Solutions

The Paradigm Shift in Real-Time Processing: A Comparative Table Detailing the Transformative Advantage of Universal, Scalable 3D-Flow Boards Over Commercial FPGA Solutions

Scientific Comparison Table (Updated With 12,000 and 50,000+ Operations)

Table I. FPGA GS/s Systems vs. 3D-Flow Real-Time Architecture

Metric FPGA Systems (UltraScale/Virtex + digitizers) Crosetto’s 3D-Flow Architecture
Technology 7 nm FINFET 20 nm Low Power CMOS
Clock frequency 200–400 MHz (routing-limited) 620 MHz (1.6 ns cycle)
Power consumption 200 W – 300 W per FPGA IC <5 W per 128 PEs 3D-Flow IC
Latency sensitivity Highly sensitive; deep computation impossible Latency irrelevant as long as throughput sustained
Ops per clock per unit 1 op per DSP slice per 4–5 ns 13 ops/cycle Avg.; 26 max
Ops per Level-1 Trigger dataset at full 40 MHz input rate <100 ops/dataset >12,000 ops/dataset@ 40 MHzon 128-ch ATCA board,
Scalability of parallelism Hits ‘brick wall’ due to routing; cannot scale Linear scalabilitydue to bypass switch
Fanout One driver → many loads (major timing bottleneck) Zero fanout: point-to-point bypass switch
Routing/transistor usage 80–90% wasted on routing & LUT configuration Majority used for arithmetic + control
Board-level performance Limited pipelines; timing failure at scale >50,000 ops/dataset @ 40 MHz on 32-Channels ATCA board
Suitability for Level-1 triggers / real-time pattern recognition Fundamentally mismatched; cannot sustain required ops Purpose-built, deterministic, real-time solution, exceeds requirements
CERN Level-1 Trigger Systems CMS-FPGA-Based ~650 kW 3D-Flow-Bases system ~6 kW

Ultimately, it compares also the 3D-Flow boards with the latest FPGA-Based Level-1 trigger designs developed and built for the 2026–2036 HL-LHC era by the ATLAS and CMS experiments at CERN [30].

12. Defining the Future of Real-Time Systems: Comprehensive Technical Specifications of the Universal, Scalable 3D-Flow Processing Board

The 3D-Flow design is adaptable to multiple industry form factors, including PXI, PXIe, PCIe, CompactDAQ, CompactRIO, 6U VME64, ATCA, 9U VME, and VXI. This versatile architecture provides instantaneous, high-throughput capability essential for applications such as HL-LHC Level-1 Triggering and real-time detection of early-stage tumors.

12.3     Parallelism and Layer Stack Calculations

Stack Layers – these execute the real-time pattern recognition algorithm.

Pyramid layers – these reduce many channels into fewer channels and route results to a single output channel. (See the description of the 3D-Flow pyramid Channel reduction and routing results to a single exit channel on pages 117-121 of [25])

The generic calculation of the layers-stack of boards with different input channels is the following

General formula
To find the number of stack layers for any board:
(128 PEs per IC × number of ICs on the board ÷ number of input channels) − 2 pyramid layers

   12.3.1.    6U-VME Board with 12 ICs

   12.3.2.    VXI/ATCA/9U-VME Board with 66 ICs:

12.4.     Sustained Throughput Capacity Calculations

   12.4.1.    6U-VME Throughput

   12.4.2.    VXI/ATCA/9U-VME Throughput

13. Solving the Grand Challenge in High-Energy Physics: Example Implementation of the 3D-Flow Universal Scalable ATCA/9U-VME/VXI Boards for Critical Level-1 Trigger Systems

13.1     The Comprehensive Design Layout: Integrating the Entire Level-1 Trigger System Architecture for the LHC and Future HL-LHC Experiments

Figure 7. The entire Level-1 programmable system of over 68,000 x 3D-Flow processors at $0.5 each can fit into a single crate. A patch panel PRAI-ATCA receives events from the detectors, synchronizes and formats each event into 4,096 channels datasets and send them to the 3D-Flow system —one every 25 nanoseconds. (Available in PDF at [50]).

13.2     Unmatched Density and Computing Power Sustained at Ultra-High Input Data Rates: Technical Details of the Crate, Connectors, and Cables in a 3D-Flow VXI Crate Achieving 4,096 Channels and >2,800 Operations Per Dataset Arriving Every 25 ns

Figure 8. Overview of the complete 3D-Flow-Based Level-1 Trigger system suitable for multiple experiments (Available in PDF at [51].

13.3      Detailed Design and Placement of 66 3D-Flow ICs on a VXI Board (Achieving 512 Channels, >2,800 Operations Per Dataset, Scalable to >50,000 Operations Per Dataset)

Figure 9. Front view of the component layout on a 512-channel VXI board with 66 ICs (8,448 x 3D-Flow PEs). (Available in PDF at: [52]).

Figure 10. Back view of the component layout on a 512-channel VXI board with 66 ICs (8,448 x 3D-Flow PEs). (Available in PDF at: [52]).

14. Revolutionizing Medical Imaging: Example Implementation of the 3D-Flow Universal Scalable 6U-VME Board for Extracting All Valuable Biophysiological Data from Radiation in a High-Sensitivity 3D-CBS Device

The ultra-sensitive 3D-CBS [53], [25] (3-D Complete Body Screening) technology PET/CT based on the 3D-Flow invention for particle detection is targeted to significantly reduce cancer deaths and healthcare costs and is the first true paradigm change in biomedical imaging because it offers four advantages no other device can offer simultaneously:

  1. an effective early detection of anomalous biological processes and diseases such as cancer at a highly curable stage, including improved diagnosis, prognosis and effective monitoring of treatments, as it is capable of detecting less than 150 Bq activity in humans;
  2. a radiation dose 2.5% of current PET devices,
  3. a 2-minute effective screening examination covering all organs of the body, and
  4. a very low examination cost, less expensive, and more effective that can replace mammograms, PAP tests, colonoscopies, PSA tests, and others.

It is capable of extracting ALL valuable information from radiation (spatial, time and energy resolution and sensitivity) related to biological processes at the lowest cost per valid signal captured from tumor markers.

Universal Efficacy Test

One way to maximize the reduction of cancer deaths and costs would be to demand that funding agencies using taxpayer and donation money to fight cancer, whether through a new drug, vaccine, medical imaging device, or healthy lifestyle promotion, etc., estimate the reduction of cancer deaths and cost they expect to attain with their project (or combined with other existing techniques) and present a plan to test it on a sample population similar to the ROADMAP Table at reference [54].

For example, test the plan on at least 10,000 people, ages 55-74 taken from a location where the mortality rate has been constant for the past 20 years. A difference or no difference in the mortality rate will quantify the success or failure of the proposed solution. This project plans to test 60,000 people per year and achieve a 33% reduction of cancer death in 6 years and 58% in 10 years.

14.1     Technical Details of the 3D-Flow 6U-VME Crate Configuration: PEs, Connectors and Cables for 2,304 Channels (>2,000 Ops/Dataset), Designed for Cost-Effectively Measuring Photon Energy, Time, and Resolution from Low-Cost Crystal Detectors in High-Sensitivity 3D-CBS

Figure 11. Logical and physical layout of the 3D-Flow 6U-VME Crate Configuration: PEs, Connectors and Cables for 2,304 Channels (>2,000 Ops/Dataset), Designed for Cost-Effectively Measuring Photon Energy, Time, and Resolution from Low-Cost Crystal Detectors in High-Sensitivity 3D-CBS (Available in PDF at: [55]).

…the Foundation urgently calls on the public to support the request to Texas Secretary of State, the Honorable Jane Nelson, to organize a public meeting [8] between the inventor, Italian-American scientist Dario Crosetto, and CPRIT scientists, who are managing $6 billion of public funds that Nelson appropriated to eradicate cancer and of which $3.65 billion has already been spent.

This is where the parallel with High-Energy Physics is crucial.
The heart of early cancer detection lies in the ability to capture and interpret all useful signals from radiation, efficiently and accurately.

14.2      Design and Placement of 12 3D-Flow ICs on a Single 6U-VME Board (Achieving 128 Channels, >2,000 Ops/Dataset, Scalable to >9,000 Ops/Dataset)

Figure 12. Component layout on a 128-channel 6U-VME board with 12 ICs (1,536 x 3D-Flow PEs). (Available in PDF at: [56]).

15. Economic and Performance Advantage of 3D-Flow Board and Crate Configurations

Table II. 3D-Flow Board and Crate Configurations: Performance, Channels, and Cost per Channel

Feature 6U VME64 Board ATCA / 9U VME Board
     
3D-Flow ICs (PEs) 12 ICs (1,536 PEs) 66 ICs (8,448 PEs)
Power Dissipation 60 W 330 W
Cost (Single Board)   $2,000   $7,000
     

Performance &Cost

Number of Programmable Operations on Each Dataset Arriving Every25 nsat Each Channel, with Zero Data Loss Number of Programmable Operations on Each Dataset Arriving Every25 nsat Each Channel, with Zero Data Loss
Board Configuration: # Channels / # Operations /
Cost per Channel
# Channels / # Operations /
Cost per Channel
Option 1 (Highest Chs. Density) 128 ch / 2,015 ops /$15 512 ch / 2,821 ops /$13
Option 2 (Medium Chs.Density) 64 ch / 4,433 ops /$31 256 ch / 6,045 ops /$27
Option 3 (High Performance) 32 ch / 9,269 ops /$62 128 ch / 12,493 ops /$54
Option 4 (Very High Performance) (N/A) 64 ch / 25,389 ops /$109
Option 5 (Ultra High Performance) (N/A) 32 ch / 51,181 ops /$218
     
Crate Configuration 16-Board 6U VME64 Crate 8-Board ATCA/9U Crate
Total PEs / Cost 25,344 PEs /$47,500 68,352 PEs /$85,500
     
Option 1 (Max # Channels / Minimum # Operations) (N/A) 4,096 ch / 2,821 ops
Option 2 (Medium # Channels / Medium # Operations) 2,048 ch / 2,015 ops

2,048 ch / 6,045 ops

Option 3 (Standard # Channels / High # Operations) 1,024 ch / 4,433 ops

1,024 ch / 12,493 ops

Option 4 (Low # Channels / High # Operations) 512 ch / 9,269 ops 512 ch / 25,389 ops

Option 5 (Very Low # Channels / Very High # Operations) (N/A) 256 ch / 51,181 ops

Part III The Cost of Delay and the Final Imperative

16. Thirty Years of Missed Funding Opportunities

16.1     Comprehensive Timeline of Missed Opportunities and Funding Failures (NRE)

Timeline of Missed Funding for the 3D-Flow Integrated Circuit

Summary of Missed Funding and Decision Failures

The six critical missed funding opportunities are summarized below

   16.1.1.    1997 — The Foundational RejectionDOE Failure to Fund the First Tape-Out of a Fabricable 350 nm CMOS IC (4 PE/IC, 61 MHz)

Context: Architecture Validation and Synthesis

The 3D-Flow processor and system architecture were rigorously validated prior to CMOS synthesis. Validation encompassed the simulation of the entire Level-1 Trigger processing chain, from raw detector input datasets to the final single-channel trigger decision.

Each input dataset consists of a packet of bits originating from the fast detectors. This packet contains data fields with various meanings and widths assigned by different experiments, such as 12-bit ADC values, 4-bit tracking data, 2-bit pad information, 8-bit time stamps, and other experiment-specific data. The 3D-Flow processors exchange this data with immediate neighbors in programmable array sizes (e.g., 3×3, 4×4, up to 7×7), enabling localized, real-time computation.

Each experiment (e.g., ATLAS, CMS) applies its own programmable Level-1 Trigger equations to this locally exchanged data, reflecting distinct physics goals and particle-search strategies. This capability—customized local processing with deterministic neighbor communication—makes the 3D-Flow architecture a universal platform capable of serving diverse and evolving high-energy physics experiments.

System-Level Simulation

The complete 3D-Flow architecture was validated using a full system-level C++ simulator covering the entire trigger path.

VHDL-Level Simulation

The 3D-Flow processor design was independently simulated at the VHDL level using tools from three FPGA vendors (ORCA, Altera, and Xilinx), ensuring functional correctness and vendor independence.

Following these validations, the design—integrating four processing elements (PEs) per IC—was successfully synthesized by Synopsys in 350 nm CMOS technology. The resulting IC was specified to operate at 61 MHz, and complete tape-out files were generated for fabrication at the TSMC silicon foundry.

Missed Funding

Although the U.S. DOE had previously funded Crosetto the $1 million feasibility study, it did not provide the NRE required to pay the foundry for fabrication. This funding gap prevented tape-out and blocked essential hardware validation of an already synthesized and validated IC.

   16.1.2.    1999 — Ignoring Future Requirements: Missed Opportunity for a 120 nm CMOS IC Capable of Meeting LHC Requirements Through 2026 (4 PE/IC, 120 MHz)

Context

By porting the validated 3D-Flow design to 120 nm CMOS technology, integrating 16 PEs per IC and operating at 120 MHz, the resulting system could have met the LHC event-processing requirement of approximately 1.2 billion events per second through 2026.

Missed Funding

This opportunity was not funded. Instead, the DOE allocated more than $50 million to a single researcher whose work did not include full end-to-end trigger-system simulation. That project later attracted over $100 million from European funding agencies to implement CMS Level-1 Trigger systems based on ASICs and FPGAs—systems that ultimately failed.

   16.1.3.    2001 — Hardware Proof Dismissed: Ignored Functional Demonstration of an 8-Processor 3D-Flow System (2 Altera FPGAs, 4 PE/FPGA, 20 MHz, $500/PE)

Context

Crosetto demonstrated a fully functional hardware implementation of the 3D-Flow architecture using two large Altera FPGAs (four processors per FPGA) operating at 20 MHz. This proof-of-concept was publicly demonstrated at an IEEE conference booth.

Missed Funding

Despite this physical, operational validation, no NRE funding was provided to complete the final ASIC implementation.

   16.1.4.    The Ignored Path to Scalability: Dismissal of a 144-Processor Modular System Scalable to Detectors of Any Size (36 Altera FPGAs, 4 PE/FPGA, 20 MHz, $500/PE)

Context

Crosetto personally funded and built a 144-processor 3D-Flow system using 36 Altera FPGAs mounted on two industrial-grade modular boards. This system conclusively demonstrated scalability for both high-energy physics detectors and medical imaging applications.

Missed Funding

This successful, self-funded demonstration of scalability and feasibility in hardware was ignored by funding agencies.

   16.1.5.    Repeating History: Failure to Fund a 40 nm CMOS IC Despite Scrapping the FPGA Trigger (64 PE/IC, 400 MHz, ~$1/PE)

Context

After the failure and scrapping of the CMS FPGA-based trigger, the U.S. DOE Director of High-Energy Physics—Crosetto’s former supervisor at the SSC—requested a new proposal. Crosetto submitted a detailed, 274-page proposal [29 supported by 59 quotes from reputable industries, including two independent cost quotations for porting the design from 350 nm to 40 nm CMOS (64 PEs per IC, NRE plus approximately $1 per processor).

Missed Funding

The proposal was never examined, the NRE was not funded, and resources were instead directed to yet another FPGA-based design—the current system incorporating approximately 20 trillion transistors and dissipating ~650 kW—which simulations indicate will also fail.

   16.1.6.    The Current Urgent Imperative: Final Opportunity to Fund the Cost-Optimized 20 nm CMOS IC (128 PE/IC, 620 MHz, ~$0.50/PE)

Context

The current 3D-Flow design is ready for porting to 20 nm CMOS technology, integrating 128 processing elements per IC. This implementation would enable execution of more than 50,000 programmable operations per dataset arriving every 25 ns, with zero data loss—meeting HL-LHC requirements through 2042 and beyond.

Missed Funding / Current Request

This represents the final and urgent opportunity to fund the NRE required to fabricate the validated 3D-Flow IC and capitalize on more than three decades of proven development, before another decade of scientific opportunity and public resources is lost.

17. Final Call to Action: Demanding Accountability, Public Demonstration, and Immediate Funding for the 3D-Flow Technology

17.1     Ending the Three-Decade Inconsistency: A Mandate to Stop the Pattern of Suppression and Fiscal Waste

The detailed timeline of the missed opportunities to fund the NRE for the fabrication of the 3D-Flow Integrated Circuit presented in Section 16 is not merely a record of unfortunate events. It documents a three-decade pattern of systemic inconsistency and decision failures that has actively suppressed a transformative technology from receiving the Non-Recurring Engineering (NRE) funding required for fabrication and experimental validation on a full Level-1 Trigger system and 3D-CBS for a cost-effective early cancer detection.

The consequence is measurable and staggering: billions in taxpayer funds have been committed to more expensive, less scalable, and repeatedly inadequate solutions—most notably the FPGA-based Level-1 Trigger—while a proven, cost-optimized alternative was repeatedly excluded from transparent, quantitative comparison.

This section therefore serves as a mandate to immediately cease this pattern of scientific malpractice.

Continuing to deny funding for the final, cost-optimized $0.50/PE 3D-Flow IC after decades of documented failures and escalating costs is no longer a defensible technical judgment. It is an act of gross fiscal negligence.

Funding agencies and political bodies must require an immediate end to bureaucratic and institutional roadblocks that have consistently prioritized internal, less efficient approaches over demonstrably superior innovation. The time for deliberation has passed. The time for action—to halt systemic waste and restore scientific accountability—is now.

17.2     Demand for Public Transparency: Two Measurable Questions Journalists Must Ask CERN Leadership to Stop Taxpayers Waste of $2.63 Million per Day Since 2010—and $4 Million per Day Under the New HL-LHC

Taxpayers, parliamentarians, and the public deserve direct answers to two precise, measurable, non-political questions that CERN leadership has consistently avoided for decades—questions that go to the heart of performance, cost, and accountability. These answers are essential to halt the massive waste of taxpayer funds, which currently amounts to $2.63 million per operational day for the LHC and will reach $4 million per operational day for the new HL-LHC.

Question 1 — Performance

How many programmable basic operations can CERN’s FPGA-based Level-1 Trigger execute on each dataset arriving every 25 nanoseconds, without data loss?

Question 2 — Cost

What is the cost per electronic channel of the CERN FPGA-based Level-1 Trigger?

This responsibility does not rest with CERN alone. Journalists, parliamentarians, and public administrators who act as stewards of taxpayer money have a duty to compel clear, documented answers to these two questions. When public institutions manage multi-billion-euro scientific infrastructures, transparency on performance and cost is not optional; it is a prerequisite for democratic accountability.

On 4 November 2025, during an IEEE-NSS session in Yokohama attended by 1,789 scientists, Italian-American scientist Dario Crosetto posed these two quantitative questions directly to the CERN ATLAS and CMS speakers responsible for the Level-1 Trigger systems. Neither speaker was able to provide an answer.

Despite a formal written follow-up sent on 14 November 2025 to CERN CMS and ATLAS leadership [44], no response has been received.

Rather than addressing these legitimate questions of public accountability—and rather than comparing their systems with Crosetto’s proven 3D-Flow capability, which executes 2,000 to more than 50,000 operations on each dataset arriving every 25 ns at a cost of $13 to $218 per electronic channel—CERN instead diverted public attention with a misleading promotional announcement.

In its 9 December 2025 statement, CERN reported that:

‘Over the full lifetime of the LHC, the ATLAS and CMS have now each been delivered an integrated luminosity of 500 fb⁻¹, equating to approximately 50 million billion particle collisions.’ [57].

This figure is scientifically irrelevant to the core issue. The relevant scientific questions are:

  1. How many meaningful physics signatures were produced?
  2. How many of those signatures were actually detected by the Level-1 Trigger?

When thousands of operations per dataset are required to identify subtle or rare particles at input rates of 1.2 billion events per second at the LHC—and 8 billion events per second at the HL-LHC—a system capable of executing only a few dozen operations on each dataset arriving every 25 nanoseconds—makes substantial, mathematically unavoidable data loss a certainty.

This situation is analogous to:

  • An emergency room with too few doctors for critical patients; even perfect triage cannot prevent deaths when capacity is insufficient.
  • A fruit harvest with too few workers; most of the crop rots because it cannot be collected in time.

In both cases, failure is caused not by poor organization, but by quantitative inadequacy of processing capacity.

Were the Level-1 Trigger capable of executing thousands of programmable operations per dataset using Crosetto’s 3D-Flow architecture, a significantly larger fraction of relevant events would be captured. Instead, multiple FPGA-based trigger implementations at CERN were built over decades, dismissed due to ineffectiveness, and then rebuilt again with the same technology.

This cycle of failure culminated in 2010–2011, when only 40 Higgs boson events were recorded—most likely by chance—out of 100,000 expected from 1,000 trillion proton-proton collisions over two years.

The economic consequences are staggering:

  • Past waste: More than $4 billion already spent due to inefficient triggering, with daily expenditures running at $2.63 million per LHC operational day.
  • Future waste: More than $12 billion projected to be wasted over the next decade, with daily expenditures reaching $4 million per LHC operational day.

This is no longer a theoretical debate.

It is a matter of measurable performance, documented cost, and public accountability.

Silence is no longer acceptable

17.3     Mandate for a Public Scientific Review: Parliamentarians and Funding Agencies Must Require CERN to Organize a Public Technical Comparison Between CERN’s FPGA-Based Level-1 Trigger Team and Crosetto’s 3D-Flow Architecture

Closed-door decisions can no longer be justified after thirty years. To restore confidence in scientific governance, institutional integrity, and fiscal responsibility, parliamentarians, public administrators responsible for public funds, and directors of funding agencies (e.g., the U.S. Department of Energy and the CERN Council) must issue a formal mandate requiring CERN to organize a live, public scientific and technical review of this matter.

A clear precedent exists. In 1993, the Director of the Superconducting Super Collider—who was also Director of Fermilab, then home to the most powerful particle accelerator in the world—called for a major public scientific review of Crosetto’s 3D-Flow invention [19]. That review was successfully completed, and the technology was formally recognized as a breakthrough enabling the execution of complex Level-2 trigger algorithms at Level-1.

With the same rigor and transparency, funding authorities must now require a public meeting featuring direct, head-to-head presentations and technical interrogation of the following two teams:

  • The CERN FPGA-Based Level-1 Trigger Development Team
  • Crosetto, presenting the 3D-Flow Level-1 Trigger Architecture

The review must focus on quantified, verifiable metrics directly relevant to HL-LHC requirements, including:

  • Computational performance per dataset arriving every 25 ns, without data loss
  • Ability to serve multiple experiments and other applications with a universal architecture
  • Cost per electronic channel
  • Demonstrated scalability and power efficiency

This is the only scientifically valid and ethically defensible method to determine which technology best serves global science and taxpayers.

Complete public documentation of the review—including presentations, numerical comparisons, technical questions, and final conclusions—must be disclosed without restriction. Such a review is not a request; it is an obligation of institutions funded by taxpayers. No credible scientific reason exists to oppose a transparent, collegial, data-driven evaluation. Any refusal to participate, or refusal to provide quantified answers, would itself constitute evidence of systemic avoidance and failure of accountability.

Extension to Medical Applications: Public Review of 3D-Flow in 3D-CBS for Early Disease Detection

The same public-review procedure should be applied to the medical applications of Crosetto’s 3D-Flow invention, specifically its use in 3D-CBS (3-D Complete Body Screening) for detecting minimal abnormal biophysiology, including early cancer markers. These abnormalities can precede clinically manifest disease and, when detected early, are associated with substantially higher survival probabilities.

As a former Texas State Senator, the Honorable Jane Nelson played a key role in allocating $6 billion in public funds through the Cancer Prevention and Research Institute of Texas (CPRIT) to fight cancer. Now, as Texas Secretary of State, she is in a unique position to safeguard transparency, accountability, and measurable outcomes for both taxpayers and patients.

Her commitment to this mission is evident in her own public statements, including a video in which she emphasizes the obligation to ensure that public investment in cancer research produces measurable results [58] (see: https://www.youtube.com/watch?v=v7VJhz7easo).

Secretary Nelson has been aware of Crosetto’s early-cancer-detection invention for more than twenty-five years. It is therefore in the best interest not only of fulfilling her mission, but of serving the public interest, to require the organization of a public scientific comparison between:

  • Crosetto, presenting the 3D-CBS system based on 3D-Flow, and
  • CPRIT-funded scientists and any alternative techniques or devices claimed to offer a more cost-effective solution to detect tumor markers with a lifesaving potential.

This comparison must be conducted openly and rigorously, given that CPRIT manages $6 billion in public funds, of which $3.65 billion has already been spent, originally appropriated to eradicate cancer.

If there are valid reasons to deny taxpayers access to the benefits of the 3D-CBS invention—projected to save more than 260 premature cancer deaths per device per year—then taxpayers deserve to hear those reasons in a transparent, public, evidence-based discussion.

The unrefuted calculation of 260 lives saved per device per year is presented on page 6 of [54]. This calculation is supported by well-established clinical survival statistics for cancers detected at an early, curable stage, including:

  • 98% survival for breast and prostate cancer
  • 91% for colon cancer
  • 50% for lung cancer

17.4     The Path Forward: Crosetto Must Be Immediately Funded the Non-Recurring-Engineering (NRE) to Port the Technology-Independent 350 nm CMOS 4-PE IC to the Cost-Optimized 20 nm CMOS, 128 PE/IC

The path to resolving this decades-long contradiction is straightforward, rapid, and cost-effective.

Crosetto must be immediately funded to complete the Non-Recurring Engineering (NRE) required to port the proven, technology-independent 350 nm CMOS 3D-Flow IC (4 PE/IC) to a cost-optimized 20 nm CMOS implementation integrating 128 processing elements per IC operating at 620 MHz.

This single action would:

  • Provide the first physical demonstration of a universally programmable Level-1 Trigger processor capable of executing complex Level-2 algorithms directly at Level-1.
  • Reduce power consumption from hundreds of kilowatts to a few kilowatts while sustaining full real-time processing without data loss.
  • Prevent more than €12 billion in projected taxpayer waste by replacing the current CERN FPGA-based Level-1 Trigger system—comprising approximately 20 trillion transistors and dissipating ~650 kW—which has repeatedly failed and been rebuilt at public expense, with a scalable, technology-independent 6 kW 3D-Flow architecture capable of meeting the requirements of all LHC experiments through 2042 and beyond.
  • Increase scientific efficiency by enabling more advanced data-selection algorithms earlier in the processing chain, thereby reducing the number of days the accelerator must operate at costs of several million euros per day.
  • Deliver a unified, scalable hardware platform applicable both to high-energy physics and to early cancer detection through medical imaging.
  • Send a clear signal to the scientific community that transparency, innovation, and integrity have been restored to publicly funded decision-making.

The cost of this NRE is negligible compared with the scale of public funds it would protect. A single, informed decision can halt thirty years of recurring waste.

Proven Ability to Deliver with Exceptionally Low Execution Risk

From a taxpayer’s perspective, execution risk matters more than promises.

Crosetto’s record demonstrates an unusually low risk profile for the proposed NRE. He has repeatedly designed, built, and validated complex electronic systems that functioned correctly at first implementation, often under severe resource constraints.

A clear example dates to 1989 at CERN, where Crosetto designed and built a highly compact, state-of-the-art electronic board (FDPP [59]), whose component density left virtually no margin for additional components. After fabrication, he invited a visiting student from Turin, Stefano Buono, to generate software-based test signals. Working shoulder by shoulder in the same office-laboratory environment, they successfully tested the board without external assistance or redesign, relying solely on logical analysis and internal corrections of PAL (Programmable Array Logic).

Crosetto later demonstrated the same capability by independently designing and building a modular 3D-Flow board in FPGA [27], which independent reviewers estimated would normally require a full engineering team and several hundred thousand dollars to develop.

That same student, Stefano Buono, later founded a company that he sold fifteen years later for $3.9 billion. The relevance of this episode is not personal recognition, but risk assessment: it illustrates Crosetto’s proven ability to deliver functioning, high-complexity hardware under real-world conditions.

This pattern—design, build, test, and verify—has consistently characterized Crosetto’s work. His methodology relies on experimental validation and measurable results, not assumptions.

Accordingly, funding the NRE is not a gamble. It is a prudent, final engineering step with a clearly bounded cost, exceptionally low execution risk—already demonstrated by a 144-processor 3D-Flow system [27] built using 36 Altera FPGAs—and the potential to eliminate massive ongoing waste while delivering long-term scientific and medical benefits for taxpayers.

17.5     Protecting Scientific Integrity and Taxpayer Investment: Crosetto’s Ethical Mandate—Disclosure of Technical Drawings, Patent Protection, a Free License to CERN, and an Open Call for Collegial Endorsement Based on Scientific Integrity and Ethics to Secure Funding for the Benefit of Humanity

Crosetto is guided by a vision of science governed by rules, ethics, transparency, and mutual recognition among researchers, in which all stakeholders respect the rule of law to advance knowledge and contribute to the collective well-being of society.

To accelerate scientific progress and ensure that innovation delivers public benefit—not only in high-energy physics (HEP), but also in medical imaging and many other fields—Crosetto has taken the following actions:

  • Patent Protection

    Crosetto has filed patents covering his inventions, including the universal, cost-effective, scalable, and configurable 3D-Flow board. This step is intended to encourage industrial investment and to protect the investment of companies willing to manufacture the technology at scale, thereby accelerating the delivery of its benefits to the public.

  • Free License Offer to CERN

    Having dedicated more than thirty years to experimental fundamental research, Crosetto offers CERN a free license to use his inventions. He is also offering collaboration to build the most powerful tools available for experimental physicists in the discovery of new particles.

Scientific Responsibility, Public Accountability, and the Ethical Obligation to Act

This document has presented a detailed, evidence-based account of more than thirty years of missed opportunities, during which demonstrably inefficient technological choices at CERN resulted in the waste of approximately $4 billion in public funds, with an additional $12 billion projected over the coming decade if the recently deployed CERN FPGA-based Level-1 Triggers—incapable of meeting LHC requirements—are not reconsidered.

At the core of this failure lies neither a lack of innovation nor a lack of validation, but the persistent absence of open, public, data-driven scientific comparisons between competing solutions. In particular, the 3D-Flow processor architecture—formally recognized as a breakthrough in 1993 and never scientifically refuted since—has been systematically excluded from transparent evaluation despite orders-of-magnitude advantages in performance, scalability, and cost.

The consequences extend far beyond high-energy physics.

The fundamental challenge faced by CERN—extracting rare, meaningful signals from overwhelming background radiation in real time—is the same challenge that defines modern medical imaging. Advances in particle-physics trigger systems directly enable advances in early disease detection, where identifying minimal abnormal biological processes can determine whether a disease is cured at an early stage before it becomes fatal. Delays in adopting superior signal-processing architectures therefore translate not only into financial waste, but into lost opportunities to save lives.

Ethical Responsibility of Experts Entrusted with Public Trust

A special responsibility rests with scientists who hold recognized positions of expertise and authority in this field. These experts are routinely entrusted by parliamentarians, funding agencies, and public administrators—many of whom are not technical specialists—to provide honest, independent, and competent scientific judgment in decisions involving vast public resources.

This responsibility is not passive. Scientists with integrity have an affirmative duty to demand full transparency and a mandatory, public, technical audit whenever competing technologies show orders-of-magnitude differences in performance, scalability, and cost. Silence in the face of such disparities does not constitute neutrality; it constitutes abdication of professional responsibility.

When experts are presented with a technology that demonstrates substantial, quantified advantages, and when those advantages remain unrefuted after decades of scrutiny, scientific integrity requires more than informal discussion or private skepticism.

If, after rigorous and good-faith analysis, an expert cannot produce quantitative, reproducible arguments that substantially invalidate the demonstrated superiority and societal benefits of the 3D-Flow architecture and its medical derivative, 3D-CBS, then continued neutrality becomes ethically indefensible.

In such circumstances, scientific honesty and responsibility to the public require one of two actions:

  • To publicly and technically refute the claims with documented evidence; or
  • To formally acknowledge that the technology merits public funding directed to the inventor in order to enable experimental validation of the invention.

Silence, delay, or informal appropriation without acknowledgment misleads non-expert decision-makers, perpetuates waste, and delays technologies with profound societal impact.

Invitation to Formal Endorsement Based on Scientific Integrity

Accordingly, qualified experts who, after examination, find no substantial scientific basis to dismiss the demonstrated superiority and cost-effectiveness of the 3D-Flow and 3D-CBS technologies are explicitly invited—and ethically encouraged—to state this conclusion in writing.

Such letters of endorsement are not acts of personal allegiance. They are instruments of transparency, intended to inform funding agencies and public officials—who must rely on expert guidance—that experimental verification is scientifically justified and ethically necessary.

Similar endorsements have already been provided by respected scientists and technology leaders, including the inventor of the pocket calculator, former CERN Division and Group Leaders, and senior researchers from academia and industry. These statements are publicly available at:

https://crosettofoundation.org/testimonials/

Their purpose is simple: to ensure that decisions affecting billions in public funds and millions of human lives are made on the basis of evidence rather than institutional inertia or unsubstantiated opinions.

Institutional Obligation and Final Call

Parliamentarians and public administrators entrusted with taxpayer resources are not required to resolve technical disputes. They are, however, obligated to demand transparency, public procedures, and measurable accountability. Closed-door evaluations, anonymous rejections, and the absence of public technical comparisons are incompatible with democratic governance when the stakes are this high.

The only legitimate path forward is the organization of public, adversarial scientific reviews—in both particle physics and medical imaging—where competing technologies are compared openly using quantified metrics, and where conclusions and decisions are fully documented and disclosed.

This is not a conflict between individuals or institutions. It is a test of whether science serves truth, humanity, and the public interest.

History will judge this moment not by intentions, but by actions taken when the evidence was already available.

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Why Your Donation Matters
Your contribution empowers transparency in science and supports the acceleration of life-saving innovations.

donation is not just financial support—it is the driving force that enables broader PR campaigns, reaching more journalists, parliamentarians, and citizens who deserve the truth.

Without donations, this vital message [7] risks being silenced. With your support, we can expand awareness through more media outlets—many of which have already exposed harmful scientific inconsistencies (see the partial list of the outlets that have published it [5])—making these issues impossible to ignore and thereby help save lives.

Please consider making a donation today—because the truth must be heard, and together we can ensure it reaches the world.

Spread the Word

  • Share this information with your networks.
  • Forward it to scientists, journalists, policymakers, and advocacy groups.
  • Use social media to call for a public, evidence-based comparison of CERN’s and Crosetto’s technologies.

Write to your representative:

In United States:

In Europe:

A template letter addressed ‘To Whom It May Concern’ is downloadable here [63]. Send it to your representative and/or to the person listed above who holds a position of responsibility for advancements in science for the benefit of humanity and who is committed to eradicate cancer. Send also a copy of your letter to jcolburn@crosettofoundation.org, so that the Foundation can forward it to relevant funding agencies and record your support for transparency in science.

Contact
Jennifer Colburn
Crosetto Foundation for the Reduction of Cancer Deaths
DeSoto, Texas
jcolburn@crosettofoundation.org
https://crosettofoundation.org/
Blog: https://crosettofoundation.org/blog/
Facebook: https://www.facebook.com/profile.php?id=100064846172129
Instagram: https://www.instagram.com/dariocrosetto/
Linkedin: https://www.linkedin.com/in/dario-crosetto-4b69a1227/
X: https://x.com/crosettodario

Puoi supportare la Trasparenza nella Scienza con una Donazione alla Crosetto Foundation.

Per donazioni dall’Italia:

  • Banca: CRS – Cassa di Risparmio di Savigliano
  • Conto intestato a: Associazione Fondazione Crosetto – ODV – ONLUS
  • IBAN: IT53E063054640000050129593
  • BIC: SARCIT2S
  • Puoi contribuire con il 5 per mille indicando il Codice Fiscale: 962079895.

Ogni piccolo contributo ci permette di informare i politici e gli amministratori dei fondi pubblici e accelerare i finanziamenti per invenzioni che rivoluzionano la scienza. Aiutaci a risparmiare miliardi di fondi pubblici e a costruire dispositivi in grado di dimezzare le morti per cancro e i costi relativi alla Sanità.

Callouts:

  1. History judges science by actions taken when evidence was already available
  2. Scientific integrity requires refutation or endorsement—not delay, silence, or copying
  3. Transparency in science is not optional when public money and lives are at stake
  4. Your Taxes, Their Silence: Why is CERN avoiding a head-to-head comparison? Demand fiscal responsibility in global science”
  5. Stop the Waste: Over $4B in public funds spent on inefficient tech at CERN. Demand a transparent, public technical review now”
  6. The 3D-Flow Challenge: A breakthrough architecture recognized in 1993. Why hasn’t it been openly compared to FPGAs at CERN?”
  7. From Physics to Healing: The same tech used to find particles can find cancer early. Why is this life-saving leap being suppressed?”
  8. Detect Cancer Sooner: 98% survival for early-stage breast cancer. We have the tech to find it. We need to fund the inventor to build it.”
  9. “No favoritism on $6B to eradicate cancer, demand Nelson organize a public meeting between inventor Crosetto and CPRIT and let science truth emerge
  10. “Your contribution empowers transparency in science and supports the acceleration of life-saving innovations” 
     

Additional References:
____________________________

[1] Donate: Support the Crosetto Foundation online (https://crosettofoundation.org/donate-now/) or if you have Zelle app on your phone or computer, send your donation directly to donate@crosettofoundation.org.

[2] 04/14/2025. Crosetto’s scientific article, title ‘3D-FLOW OPRA for Level-1 Trigger: A Breakthrough Invention Capable of Extracting ALL Valuable Information from Radiation, Providing a Very Powerful Tool to Discover New Particles, Reduce HEP Costs, Advance Science and Benefit Humanity’ documents and details the content of his 2-hour, 102-slide presentation delivered at the IEEE-NSS-MIC-RTSD conference in Tampa, Florida on 31 October 2024 (https://bit.ly/4oNUOyT), (https://drive.google.com/file/d/1JyAw9Ba9DWRjlKwsSoz8j4KEPGDoiDwR/view?usp=sharing).

[3] 08/28/2025, Press Release English title: ‘Urgent Appeal: Freeze CERN Funding, Fund Innovations Suppressed for 32 Years That Can Save Millions of Lives and Billions of Euros’ which describes the missed opportunities that result in the loss of billions of taxpayer euros and millions of lives, in HTML: https://bit.ly/4p0DneC, in PDF: https://bit.ly/3UCW8XE.

[4] Budget and Waste Analysis: An evaluation of CERN’s cost ranges, daily operating expenditures, and estimated spending for the LHC and HL-LHC. (https://bit.ly/45XONYW), (https://drive.google.com/file/d/1vhlFDBXukvzZIAq93JRohgOOwCAv595x/view?usp=sharing).

[5] 11/10/2025, Links to the Press Releases published by over 5,000 NEWS Outlets (https://bit.ly/3HtisQv) that have reached a potential of over 800 million readers.

[6] 11/07/2025        Press Release English title: ‘Call for Scientific Integrity at CERN: More than $4 billion in taxpayer funds have already been wasted, and over $12 billion more is set to be wasted over the next decade as transparency is suppressed’ HTML: https://bit.ly/43idsFY.

[7] 10/28/2025. Press Release, English, title: ‘Evidence Against Evidence: CERN-IEEE FPGA vs. Crosetto 3D-Flow, a Breakthrough Invention Recognized 32 Years Ago That Could Have, and Can Still, Save Billions of Euros and Millions of Lives’, HTML: https://bit.ly/4qKVar8. in PDF (https://bit.ly/3UCW8XE), (https://drive.google.com/file/d/1ixCMjupsJIDdAhe7-RFIKiKtuKEVqqM1/view?usp=sharing).

[8] 09/15/2025. Press Release, English, title: ‘Request for Secretary of State of Texas, Jane Nelson, to Organize a Public Meeting Between Crosetto and CPRIT Scientists Who Have Allocated $3.65 Billion of $6 Billion to Cancer Research’. HTML: https://bit.ly/41TMUKF.

[9] 09/06/2025. Press Release, English, title: ‘CERN’s FPGA Failure and the Suppression of 3D-Flow and 3D-CBS: A Call to Save Millions of Lives and Billions of Euros’. HTML: https://bit.ly/3HYBePY.

[10] 07/15/2025. Press Release, English, Title: ‘Urgent Appeal: Freeze CERN Funding—Fund Innovations That Can Save Billions and Millions of Lives’. HTML: https://bit.ly/4m57FKZ.

[11] 07/04/2025. Press Release, French, Title: ‘Seule la transparence et la responsabilité peuvent sauver le CERN : une condition essentielle pour mettre fin au gaspillage de milliards et accélérer les innovations médicales vitales’. HTML: https://bit.ly/4lfjnTe.

[12] 07/04/2025. Press Release, German, Title: ‘Nur Transparenz und Rechenschaftspflicht können das CERN retten: Milliardenverschwendung stoppen, lebensrettende Innovationen ermöglichen’. HTML: https://bit.ly/3TTV0yb.

[13] 07/04/2025. Press Release, Italian, title: ‘Solo la Trasparenza e la Responsabilità Possono Salvare il CERN: una Condizione Essenziale per Porre Fine allo Spreco di Miliardi e Accelerare le Innovazioni che Salvano la Vita’. PDF: https://bit.ly/4loi7go.

[14] 07/03/2025. Press Release, English, title: ‘Only Transparency and Accountability Can Save CERN: Stop Billions in Waste, Unlock Life-Saving Innovations’. HTML: https://bit.ly/44cIbVQ.

[15] 06/30/2025. Press Release English, title: ‘Only Transparency and Accountability Can Save CERN: Looming Crisis, Billions Wasted, Science Stalled, Innovations Blocked from Reaching Cancer Patients’. HTML: https://bit.ly/3TMnDNI

[16] 06/23/2025. Press Release, English, title: ‘Respectful Request to Submit a Parliamentary Question on CERN’s Transparency and Accountability to prevent further Waste of EU Funds’. PDF: https://bit.ly/4era28b.

[17] 06/23/2025. Press Release, Italian, title: ‘Richiesta Rispettosa di Presentare un’Interrogazione Parlamentare sulla Trasparenza e Responsabilità del CERN per Prevenire Ulteriori Sprechi di Fondi UE’. PDF: https://bit.ly/3T7G1R8

[18] Crosetto DB. The 3D-Flow architecture explained in one page https://bit.ly/4hbX8fl

[19] The official report from the Fermilab public scientific review on December 14, 1993. The committee recognized the 3D-Flow invention as a breakthrough that allows a programmable Level-2 pattern recognition algorithm to be executed at Level-1 on datasets arriving every 25 nanoseconds without data loss. The report affirmed the invention’s feasibility and found no major flaws. (https://bit.ly/41i4ace), (https://drive.google.com/file/d/0BxWfo2ViJ6r5amx4ZlN2OTJqMmM/view?usp=sharing&resourcekey=0-oYLJQocSy9BOTGb68vsu9A)

[20] The U.S. Department of Energy (DOE) awarded a $1 million grant to Crosetto to conduct a feasibility study of his 3D-Flow invention (https://bit.ly/3Pszu1y), (https://drive.google.com/file/d/0BxWfo2ViJ6r5anZtOG1rY250dEk/view?usp=sharing&resourcekey=0-GhQN7cqFP2z7kI9XLfrRlQ).

[21] Crosetto, Peer-reviewed 45-page article published on Nuclear Instruments and Methods in Physics Research Sec. A, vol. 436, (1999) pp.341-385. The article is reporting the successful results of the feasibility study from system level to gate and transistor level of Crosetto’s 3D-Flow Architecture that he performed with a $1 million grant received from DOE. (https://bit.ly/45Mw6pM), (https://drive.google.com/file/d/0BxWfo2ViJ6r5NlVSWHhoTl9jZXc/view?usp=sharing&resourcekey=0-NPvfp2wWcJrD0ins-cx4Cw)

[22] Crosetto, DB.: ‘A modular VME or IBM PC based data acquisition system for multi-modality PET/CT scanners of different sizes and detector types.’ Presented at the IEEE Nuclear Science Symposium and Medical Imaging Conference, Lyon, France, 2000, IEEE-2000-563. Short URL (https://bit.ly/3JRlRZZ), (https://drive.google.com/file/d/0BxWfo2ViJ6r5MTBoTVRucF9CREU/view?usp=sharing&resourcekey=0-2ofmkGvM39MMc-R3A8mQjw).

[23] Crosetto, DB.: ‘Real-time, programmable, digital signal-processing electronics for extracting the information from a detector module for multi-modality PET/SPECT/CT scanners.’ Presented at the IEEE Nuclear Science Symposium and Medical Imaging Conference, Lyon, France, 2000, IEEE-2000-567. Short URL ( https://bit.ly/4fZTzZC), Full URL (https://drive.google.com/file/d/0BxWfo2ViJ6r5d1NENTRkSUg2NVU/view?usp=sharing&resourcekey=0-HBFHiHO9nHghdaEHxZoaDQ)

[24] Crosetto DB: ‘400+ time improved PET efficiency for lower-dose radiation, lower cost cancer screening.’ Technical-scientific book of Crosetto’s 3D-CBS (3D Complete Body Screening) invention, presented and distribute 200 copies free-of-charge at the IEEE Nuclear Science Symposium. and Medical Imaging Conference., Lyon, France, 2000: ISBN 0-9702897-0-7. Included in 2000 in the U.S. Library of Congress Catalog-in-Publication Data Card Number: 00-191510A (https://bit.ly/45U2Wqv), ISBN 0-9702897-0-7, (https://drive.google.com/file/d/0BxWfo2ViJ6r5WVFVWnJteENqMWc/view?usp=sharing).

[25] 2001 (First Proof): Crosetto presented a working hardware proof of concept at the IEEE-NSS-MIC conference in San Diego, (CA) (https://bit.ly/4oG9pLG) (https://drive.google.com/file/d/0BxWfo2ViJ6r5anppNndvTmkxWGM/view?usp=sharing&resourcekey=0-G9NU2S2ySj6MqKPAbPO-5g).

[26] Crosetto’s schematics and PCB layouts of the 3D-Flow electronics board he designed and built in 2003, which have a 10 picosecond resolution and a 40 picosecond maximum skew across thousands of boards in many crates. (https://bit.ly/4l64nWP), (https://drive.google.com/file/d/0BxWfo2ViJ6r5Wl82SG0xSC1hakU/view?usp=sharing&resourcekey=0-pd-KaM-vdJmBKgVzHXsRDA).

[27] Crosetto DB article ‘The 3-D Complete Body Screening (3D-CBS) Features and Implementation’ Conf. Rec. IEEE-NSS-MIC, Portland, Oregon, IEEE 2003-M7-129. (https://bit.ly/43Rlk0s), (https://drive.google.com/file/d/0BxWfo2ViJ6r5RDQ2UURPeHBIYnc/view?usp=sharing&resourcekey=0-6MP6-KUT13Y2b8rSCqFtjQ),

[28] CERN-CMS FPGA-Based Level-1 Trigger was dismissed in February 2016 because it was ineffective as stated in the second paragraph of the introduction of the article: ‘The legacy Level-1 trigger system is composed of approximately 4000 data processor boards’ by scientist of the same CMS Collaboration (https://cds.cern.ch/record/2194548/files/CR2016_121.pdf).

[29] A 274-page proposal by Crosetto DB. detailing the 3D-Flow OPRA and 3D-CBS projects. The proposal was submitted to the U.S. Department of Energy on 22 December 2015, after Crosetto was solicited by the Director of the Office of High Energy Physics of the Office of Science of DOE, to design a universal programmable Level-1 Trigger that would meet the requirements of all LHC experiments. (https://bit.ly/4myTwpY) (https://drive.google.com/file/d/0BxWfo2ViJ6r5MlpkbUpjbEIybUk/view?usp=sharing&resourcekey=0-8RpD1TC0IGKAEZ9L5-DrJw )

[30] The 378-page CERN official document, CERN-CMS-TDR-022, titled ‘The Phase-2 Upgrade of the CMS Data Acquisition and High-level Trigger Technical Design Report,’ dated 17 June 2021, on page 46, Table 3.2. list 130 ATCA crates (5kW/crate = 650 kW), 1226 boards, 1,648 FPGAs totaling >20 trillion transistors (https://cds.cern.ch/record/2759072/files/CMS-TDR-022.pdf)

[31] References to CERN-ATLAS and CMS Level-1 Trigger TDR detailing their trigger boards and calculation of the 20 trillion transistors on pages 70 to 73 of (https://bit.ly/4e1uURA) (https://drive.google.com/file/d/1JyAw9Ba9DWRjlKwsSoz8j4KEPGDoiDwR/view?usp=sharing ).

[32] A slide presented at the CERN auditorium on 21 May 2019, describing the WPET (Wearable PET) project. This project, which received funding from the CERN-ATTRACT Consortium and utilized EU taxpayer money, involves an impractical, absurd 350+ kg coat intended for 24-hour cancer screening. (http://bit.ly/2JWsxG2), (https://drive.google.com/file/d/1-CWKfAWi5sTOD2USvVFQOYie_6d-1IdT/view?usp=sharing)

[33] Crosetto DB., provided a paragraph-by-paragraph refutation of the article requesting funding for the €2 million WPET-Jacket project, but he never received a feedback for his review. (https://bit.ly/3iydDp3), (https://drive.google.com/file/d/1mHoX59_lklPHj95JCCpVPLUlsUYFDwjj/view?usp=sharing)

[34] A parliamentary question submitted to the European Parliament on 21 June 2019, by the Honorable Alessandro Panza. The question demanded accountability from CERN regarding its decision to fund the WPET project for cancer screening instead of the 3D-CBS project. (https://bit.ly/3HKjreL), (https://drive.google.com/file/d/1XwNqFk_2XU7Mjvw0tPFBtkzuiaX1g8jL/view?usp=sharing ), (https://www.europarl.europa.eu/doceo/document/E-9-2021-003244_EN.html).

[35] An educational video showing the bypass switch/register analogy to illustrate the conceptual invention of the 3D-Flow architecture at minute 4:28 (https://bit.ly/4oN7Xbx), (https://www.youtube.com/watch?v=HwMnHRuWo4o).

[36] Instead of stopping funding CERN-ATTRACT and requesting CERN accountability by organize a public meeting between the author of the WPET and 3D-CBS for cancer screening, the European Commission awarded an additional €28 million grant to the CERN-ATTRACT program https://cerneu.web.cern.ch/attract-unveils-projects-will-benefit-its-eu28-million-fund-innovation

[37] Crosetto DB., A 102-slide, 2-hour presentation by Crosetto at the IEEE-NSS-RTSD conference on October 31, 2024. The presentation compares the ATLAS/CMS 1992 logic and the 3D-Flow paradigm, including operational examples (https://bit.ly/45uaZtz), (https://drive.google.com/file/d/1X82XVQbOgHjeHF8OpkIJo-Cfz8AuhMec/view?usp=sharing).

[38] Crosetto DB. A two-page technical comparison of performance, power consumption, and costs of the 3D-Flow versus the FPGA Level-1 Trigger systems, submitted to the 2025 IEEE-NSS-MIC-RTSD conference in Yokohama, Japan. (https://bit.ly/45K6BFz) (https://drive.google.com/file/d/1BLB6z0r3W-RYl4jVgv0k8Kdtqs-kz99x/view?usp=sharing)

[39] Crosetto DB., A two-page brief about the modular universal, scalable 3D-Flow board for Level-1 Trigger, detailing its form factors and applications in physics and PET applications, submitted to the 2025 IEEE-NSS-MIC-RTSD conference in Yokohama, Japan. (https://bit.ly/41hKwgk), (https://drive.google.com/file/d/1Ceb2NWaY9TU4_-oGa1olB5VG00r7mLSI/view?usp=sharing).

[40] 20 June 2025 CERN Council approved the Medium-Term Plan for 2026–2030 for Phase 2 upgrades of ATLAS and CMS (https://bit.ly/4oIjSWV) (https://home.cern/news/opinion/cern/news-june-2025-cern-council-session), (https://drive.google.com/file/d/1aTIvwi9ovdZW_RypQLgo3qsAMUYcFrt2/view?usp=sharing).

[41] 16 July 2025. Letter from Crosetto DB., to 43 IEEE and world leaders explaining the importance of his two papers submitted to the 2025 IEEE-NSS-MIC-RTSD conference and requesting a ‘Feedback’ (https://bit.ly/4m57FKZ), (https://drive.google.com/file/d/1gj0tuWBtJcElYAQY_g-1NJ2R51Zk2IPY/view?usp=sharing).

[42] 29 October 2025 Letter from Crosetto to IEEE organizers and leaders in the field and laws enforcement requesting permission to distribute scientific information (https://bit.ly/4awnSGj), (https://drive.google.com/file/d/1HoT6VGPwj1mN8H9WR2tOc4S99VJygV8R/view?usp=sharing).

[43] 3 November 2025. Video of the Plenary Session showing NSS Chair preventing Crosetto from asking a question to the keynote speaker (https://youtu.be/24pr4jRmwcM).

[44] 14 November 2025. Formal request directed to CERN CMS and ATLAS leaders and trigger experts, demanding a response to two critical questions regarding the FPGA-Based Level-1 Triggers built for the 2026–2036 High-Luminosity LHC (HL-LHC) experiments (https://bit.ly/4aBElsN), (https://drive.google.com/file/d/1E7K2oEESYwd-kHfvDjaq8rXvQg4w_0Ep/view?usp=sharing).

[45] 7 November 2025. Slide presented at the IEEE-NSS closing session showing the List of 2025 NSS Topics (https://bit.ly/4pXfT9W), (https://drive.google.com/file/d/1E6IxXSs7oyD4d113GJlEtg_TF5_ZL3Y_/view?usp=sharing)

[46] 7 November 2025. Slide presented at the IEEE-NSS closing session showing the papers rejected at the 2025 IEEE-NSS (https://bit.ly/49XANRz), (https://drive.google.com/file/d/1uV7KI5d06NwaGjYtOf00IrBprevEeiU7/view?usp=sharing)

[47] 7 November 2025. Slide presented at the IEEE-NSS closing session showing the 2026 NSS Topics that removed ‘Trigger’ (https://bit.ly/3MlZs8y) (https://drive.google.com/file/d/1k_VPJBxAp-R3ytZwltGR0_4CwSsu-PxH/view?usp=sharing)

[48] Crosetto DB. Testimonials of his commitment to make the scientific truth emerge for the benefit of humanity (https://bit.ly/4pCXXl2), (https://drive.google.com/file/d/1K57K_jpUnOVR507vmnt8DdDaNedu-jBQ/view?usp=sharing)

[49] 1 July 2003. Report of the public, international scientific reviews of the 3D-CBS innovative technology in Dallas, Texas. The review panel included the inventor of the pocket calculator, Jerry Merryman. See full report at the Short URL https://bit.ly/3i9xCJ9 Full URL https://drive.google.com/file/d/0BxWfo2ViJ6r5eEd4UVlJeU1PX0k/view?usp=sharing.

[50] Crosetto DB. Figure 7 – The entire Level-1 programmable system of over 68,000 x 3D-Flow processors at $0.5 each can fit into a single crate. A patch panel PRAI-ATCA receives events from the detectors, synchronizes and formats each event into 4,096 channels datasets and send them to the 3D-Flow system —one every 25 nanoseconds. (https://bit.ly/4q96k7E), (https://drive.google.com/file/d/1ZL6czut0U7JO4T2DZIYTW2ZnIU5o-g4n/view?usp=sharing).

[51] Crosetto DB. Figure 8 – Overview of the crates of the 4,096 channels complete 3D-Flow-Based Level-1 Trigger system suitable for multiple experiments (https://bit.ly/3M2IpIs), (https://drive.google.com/file/d/1nsA9ItlOlkpUvaMWmmnU7TcvNIr1I8bC/view?usp=sharing).

[52] Crosetto DB., Figures 9 and 10. View of the component layout on a 512-channel VXI board with 66 ICs (8,448 x 3D-Flow PEs). (Available in PDF at: https://bit.ly/48Ufk9J), (https://drive.google.com/file/d/155wjkq3PeVzdbtvCYBM6BLkiohpBKVve/view?usp=sharing).

[53] Crosetto DB. ‘3D-CBS: The first true paradigm change in biomedical imaging invented 20 years ago, confirmed by measured results as able to provide a safe, very early, lifesaving cancer detection…’ A 147-page article on the 3D-CBS technology for measuring bio-physiology. The article was submitted on 6 July 2020 to the Journal of Medical Imaging (JMI) along with a request for JMI to withdraw a previous article by other authors that Crosetto claims was misleading researchers. The Journal of Medical Imaging excluded Crosetto’s article from review without providing a scientific reason and did not withdraw the other article (http://bit.ly/2QdgdTx), (https://drive.google.com/file/d/1jcMBP43bPooy9t94ZxRdHOkFtaN6zsXZ/view?usp=sharing)

[54] Crosetto DB. A roadmap table and supporting data estimating the lives saved and projected revenues over 30 years from using the 3D-CBS device for early cancer detection. (https://bit.ly/47eqiIh), (https://drive.google.com/file/d/1qYC3vzGm2CO37ZVsCUM05Op4Je_zz_GF/view?usp=sharing).

[55] Crosetto DB. Figure 11 – Logical and physical layout of the 3D-Flow 6U-VME Crate Configuration: PEs, Connectors and Cables for 2,304 Channels (>2,000 Ops/Dataset), Designed for Cost-Effectively Measuring Photon Energy, Time, and Resolution from Low-Cost Crystal Detectors in High-Sensitivity 3D-CBS (Available in PDF at: https://bit.ly/48Qthpf), (https://drive.google.com/file/d/1iFUYKjV5XoNiTuNBRRbDrw88CTsxVVRe/view?usp=sharing).

[56] Crosetto DB. Figure 12. Component layout on a 128-channel 6U-VME board with 12 ICs (1,536 x 3D-Flow PEs). (Available in PDF at: https://bit.ly/44t3Mcl), (https://drive.google.com/file/d/19XqMuBLsmFf04vqzaavjZdXgqyci0aUV/view?usp=sharing).

[57] 9 December 2025. CERN article also published on CERN website stating ‘Fifty million billion particle collisions…’ https://bit.ly/4qjwV2h. (https://drive.google.com/file/d/1MC2EziuyazvHyzrKw6_CkR9LDy2G_pkA/view?usp=sharing

[58] Texas Secretary of State Jane Nelson’s video stating her commitment to eradicate cancer with a €6 billion bill for Cancer Research (https://bit.ly/4e7QVPp), (https://www.youtube.com/watch?v=v7VJhz7easo).

[59] Crosetto DB., designed and built the Fast Digital Parallel Processing module FDPP (https://bit.ly/2CX6CfY) modular electronic boards which implemented a parallel-processing architecture suitable for maintaining the focus of the beam of the Super Proton Synchrotron accelerator at CERN. These boards also provided physicists with a powerful tool for executing a programmable Level-2 Trigger to detect unknown particles (https://bit.ly/4s1bkwV), (https://drive.google.com/file/d/0BxWfo2ViJ6r5cTl0OXZYTjVGeFU/view?usp=sharing&resourcekey=0-xauS3e0j985iigcaoFrtLw).

[60] United States Representatives contacts: Write to your representative in U.S.: https://www.house.gov/representatives/find-your-representative  

[61] European States Parliamentarians contacts: Write to your national parliamentarians of all European states: https://secure.ipex.eu/IPEXL-WEB/parliaments/list_parliaments

[62] European Parliamentarians contacts: Write to the 720 members of the European Parliament. https://www.europarl.europa.eu/meps/en/full-list/all

[63] Template letter to assist you in drafting a message to your representative. (https://bit.ly/4j4J74s), (https://drive.google.com/file/d/1zSgLZin69ZaSFcuzc_HjITkbQ8iTe1Pa/view?usp=sharing)

Clemson University and Nordic Wellness Launch Groundbreaking Partnership to Transform the Student Mental Health Crisis

Clemson University and Nordic Wellness Launch Groundbreaking Partnership to Transform the Student Mental Health Crisis




Clemson University and Nordic Wellness Launch Groundbreaking Partnership to Transform the Student Mental Health Crisis

Clemson University and Nordic Wellness have launched a pioneering partnership tackling the student mental health crisis through peer-led cold plunging and breathwork programs. The initiative empowers students and alumni to build resilience and wellbeing, offering an agile, private-sector model for campus mental health solutions.

Clemson University and Nordic Wellness Launch Groundbreaking Partnership to Transform the Student Mental Health CrisisPhoto courtesy of Clemson University

CHARLESTONE, South Carolina, Dec. 19, 2025 (GLOBE NEWSWIRE) — Nordic Wellness today announced a transformational partnership with Clemson University aimed at redefining how universities address student mental health and resilience through peer-taught cold plunging, breathwork, and consistent practice to build mental strength and discipline.

Across the country, the mental health crisis on college campuses continues to deepen. Suicide remains the second leading cause of death among university students, with many feeling overwhelmed, disconnected, and in need of effective tools to manage stress, pressure, and isolation. Universities require solutions that are relevant, actionable, and most importantly, decoupled from long budgetary cycles.

Clemson University and Nordic Wellness are building a new model to meet this urgent need.
Through a first-of-its-kind public-private partnership, Nordic Wellness, a leading health and wellness brand is launching Nordic University, a platform through which Clemson students will be certified to lead cold water exposure and breathwork classes for their peers.

Clemson University alumni will also play a vital role, where donors can support student wellness by purchasing a special-edition Clemson-branded Viking Cold Plunge. Each purchase will help fund the rapid deployment of student-led training, coaching opportunities, and on-campus wellness experiences.

“Student mental health can’t wait for budgets,” says Warner Jenkins, Founder & CEO at Nordic Wellness. “This private-sector model gives Clemson something rarely available in higher education: speed. Immediate action for an urgent issue.”

Together, Clemson University and Nordic Wellness are creating a blueprint for the future: one where resilience is not just a talking point, but a practice. One where alumni play a direct role in strengthening the next generation. And one where universities and private companies work side by side to solve complex problems at the speed students deserve.

Please visit Nordic Wave’s website for more information about the company.

About Nordic Wellness

Nordic Wellness is a Charleston, South Carolina–based health and wellness company encompassing a portfolio of brands, including Nordic Wave, a leading provider of premium cold plunge products.

Contact Details:

Contact person: Cole Jenkins
Position: Chief of Staff
Website: thenordicwave.com
Email: cjenkins@thenordicwave.com 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/bbace0d6-d5f3-41bc-8519-0f85733adeef

Is MEDVi the Best GLP-1 Supplier for 2026? Platform Lists Compounded Semaglutide at $179/Month With No Contract Ahead of Weight Loss Season

Is MEDVi the Best GLP-1 Supplier for 2026? Platform Lists Compounded Semaglutide at $179/Month With No Contract Ahead of Weight Loss Season




Is MEDVi the Best GLP-1 Supplier for 2026? Platform Lists Compounded Semaglutide at $179/Month With No Contract Ahead of Weight Loss Season

Telehealth Platform Offers Compounded GLP-1 Injections and Oral Tablets at $299/Month With No Contract as 100,000+ Patients Seek Affordable Semaglutide Access Heading Into New Year Weight Loss Season

Los Angeles, Dec. 19, 2025 (GLOBE NEWSWIRE) — Important Information for Readers: This article is for informational purposes only and does not constitute medical advice. GLP-1 medications are prescription medications requiring evaluation by a licensed clinician. Always consult a qualified healthcare professional before starting any prescription treatment. Compounded Medication Notice: Compounded medications are not FDA-approved. The FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed. According to FDA guidance, compounding should occur when an FDA-approved medication is unavailable or when a patient has a specific medical need that cannot be met by an FDA-approved drug. Affiliate Disclosure: This article contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the reader. This compensation does not influence the accuracy or integrity of the information presented.

Individuals interested in evaluating whether MEDVi’s platform aligns with their weight loss goals can review current pricing, medication options, and enrollment details here.

Is MEDVi the Best GLP-1 Supplier for 2026 Platform Lists Compounded Semaglutide at $179 per Month With No Contract Ahead of Weight Loss Season

Platform Overview: MEDVi’s Telehealth GLP-1 Weight Loss Model

Heading into the 2026 New Year weight loss season, a growing number of consumers are seeking affordable alternatives to brand-name GLP-1 medications that typically cost $1,300-1,500/month without insurance coverage. MEDVi, LLC operates a telehealth platform addressing this demand by coordinating access to compounded semaglutide starting at $179 for the first month, with refills listed at $299/month according to the company website.

The platform’s approach reflects broader market dynamics: while FDA-approved medications like Wegovy remain out of reach for most consumers due to limited insurance coverage, compounded alternatives have created a more accessible price point. MEDVi references serving “100,000+ patients” in marketing materials as interest in this category continues expanding.

MEDVi’s operational model involves three separate entities: MEDVi, LLC provides technology infrastructure and coordination; OpenLoop Health’s network of licensed medical providers conducts clinical evaluations and prescribing decisions; and partner compounding pharmacies prepare and fulfill medications based on individual prescriptions. Enrollment does not guarantee prescription approval—independent medical providers make final determinations based on individual medical appropriateness.

According to company terms of use: “MEDVi does not provide any Healthcare Services through the Platform and is not licensed to practice medicine.” This legal structure separates platform technology from clinical decision-making authority, which rests with independent licensed medical providers.

The platform operates month-to-month with no contract according to the company website. For broader context on MEDVi’s market positioning, see comprehensive platform analysis.

Understanding the Three-Entity Operational Structure

MEDVi, LLC: Platform Technology

According to company terms, MEDVi provides technology infrastructure for patient intake forms, administrative coordination between patients and medical providers, customer service, and payment processing. The company’s terms explicitly state: “MEDVi does not provide any Healthcare Services through the Platform and is not licensed to practice medicine.”

Questions about shipping, billing, or account management are directed to MEDVi customer service. Medical questions must be directed to the OpenLoop Health provider network.

Physical business address: 131 Continental Dr, Ste 305, Newark, DE 19713 Contact: help@medvi.org | (323) 690-1564

OpenLoop Health: Medical Provider Network

According to company disclosures, OpenLoop Health operates a network of US-licensed physicians who review patient medical histories and determine prescription appropriateness. The terms specify: “OpenLoop Health clinicians retain the decision to prescribe compounded GLP-1s to patients.”

Submitting information and payment does not guarantee prescription approval. Independent licensed medical providers make final determinations based on individual medical appropriateness.

The website features three physicians in marketing materials: Dr. Ana Lisa Carr (St. George’s University, School of Medicine), Dr. David Mansour (Board-Certified Doctor of Osteopathic Medicine), and Dr. Kelly Tenbrink (American Board of Emergency Medicine). Total provider network size and state-by-state licensure details are not specified on the website. Medical provider licenses can be verified through state medical board public databases.

Partner Compounding Pharmacies

According to the website: “We are partnered with multiple USA certified pharmacies to bring the best product and overall experience to our membership. Our team meets regularly with pharmacies to discuss any product shortages, shipping delays, and get updated reports on their medication testing.”

Specific pharmacy names are not provided on the website. Information about which pharmacy will compound medications is available upon request through customer service before enrollment.

Individuals interested in evaluating whether MEDVi’s platform aligns with their weight loss goals can review current pricing, medication options, and enrollment details here.

FDA-Approved vs. Compounded GLP-1 Medications: Regulatory Framework

Understanding the regulatory distinction between FDA-approved medications and compounded formulations is essential for informed decision-making.

FDA-Approved Medications: Regulatory Pathway

FDA-approved GLP-1 receptor agonists for chronic weight management include Wegovy (semaglutide) and Saxenda (liraglutide). Ozempic (semaglutide) is FDA-approved specifically for type 2 diabetes management. According to FDA policy, licensed physicians may prescribe FDA-approved drugs for off-label uses based on medical judgment. When Ozempic is prescribed for weight loss, this constitutes off-label use.

STEP 1 Clinical Trial Data (Wegovy):

  • Study population: 1,961 adults with obesity or overweight plus weight-related conditions
  • Duration: 68 weeks
  • Average weight loss: 14.9% of body weight
  • Results distribution: 86% lost at least 5% body weight; 69% lost at least 10%; 50% lost at least 15%
  • Protocol: All participants followed reduced-calorie diets and increased physical activity

These medications underwent Phase I, II, and III clinical trials before FDA approval. The FDA reviewed comprehensive data on safety, efficacy, manufacturing quality, and labeling. Post-market surveillance continues monitoring safety signals.

Typical retail pricing: FDA-approved GLP-1 medications for weight loss typically range $1,300-1,500/month at retail pharmacies without insurance coverage. Most insurance plans do not cover weight loss medications; Medicare and Medicaid typically do not cover them.

Compounded Medications: Regulatory Framework

According to MEDVi’s terms: “Compounded medications are not reviewed or approved by the FDA as finished products. They are prepared using active ingredients sourced from FDA-registered facilities under the direction of a prescribing clinician.”

FDA’s Official Position on Compounding:

According to FDA guidance, compounded drugs are not FDA-approved. The FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed. Compounding should generally occur when an FDA-approved medication is unavailable or when a patient has a specific medical need that cannot be met by an FDA-approved drug.

Compounding pharmacies operate under different legal pathways than manufacturers of FDA-approved drugs. State-licensed pharmacies compound under Section 503A of the Federal Food, Drug, and Cosmetic Act, while FDA-registered outsourcing facilities operate under Section 503B.

FDA Safety Alert on Dosing Errors:

The FDA has issued warnings regarding dosing errors with compounded semaglutide, particularly related to multi-dose vials where patients may miscalculate doses. Patients should carefully follow dosing instructions provided by their prescribing clinician and compounding pharmacy, and contact their provider immediately if unsure about proper dosing.

MEDVi’s Medication Offerings

According to the website, MEDVi offers:

Compounded GLP-1 Injections (weekly): $179 first month promotional pricing; refills listed at $299/month on the company website as of December 19, 2025.

Compounded GLP-1 Tablets (dissolvable, daily): $249 first month; refill pricing requires verification through customer service. For detailed analysis of oral GLP-1 tablet formulations and how they compare to injectable options, see comprehensive review.

Brand-Name Ozempic: Starting at $1,999/month according to website when quantities are available.

Clinical Evidence Distinction:

FDA-approved semaglutide has extensive clinical trial data from controlled studies involving thousands of participants. Compounded semaglutide formulations use the same active ingredient but have not undergone independent clinical trials as finished products. Dosing protocols often mirror FDA-approved medication guidelines, but quality and consistency may vary between compounding pharmacies.

Pricing Structure and Payment Considerations

Compounded Medication Costs

First month (compounded injections): $179 according to website Included services per website: Physician review, personalized plan, 1:1 guidance, metabolic report, prescription medication, shipping

Refills (compounded injections): $299/month listed on the company website as of December 19, 2025 Annual projection: First year approximately $3,468 ($179 + $299 × 11); subsequent years $3,588 ($299 × 12)

Compounded tablets: $249 first month; refill pricing not specified on website

Brand Ozempic: $1,999/month when available

Cancellation and Refund Policy

According to the company’s published policy, refund eligibility depends on evaluation outcomes and whether medication has already been ordered. Patients should review MEDVi’s full refund and cancellation policy directly before enrollment as individual circumstances vary.

The company website states the program operates “with no contract” on a month-to-month basis.

Insurance and Payment Options

According to company terms: “MEDVi-affiliated medical professional entities are not contracted healthcare providers with any health insurance plans (commercial, government, or otherwise, i.e., ‘out-of-network’ providers).”

Patients are responsible for 100% of costs. Medicare and Medicaid are not accepted. No insurance claims can be submitted for reimbursement.

HSA/FSA Consideration: The website displays “HSA/FSA Approved!” in marketing materials. According to IRS regulations, medical services and prescription medications prescribed by licensed providers are generally eligible expenses. However, HSA/FSA eligibility is determined by individual plan administrators. Patients should verify with their specific plan administrator before using these funds.

For more information on MEDVi’s compounded semaglutide programs starting at $179 for the first month, visit the company website or contact customer service at (323) 690-1564.

GLP-1 Mechanism and Clinical Evidence Context

Biological Mechanism

GLP-1 (glucagon-like peptide-1) is a hormone naturally produced in intestines that regulates appetite and blood sugar. GLP-1 receptor agonist medications like semaglutide are engineered to resist rapid enzymatic breakdown, providing sustained receptor activation through mechanisms including activating hypothalamic appetite-regulating receptors, slowing gastric emptying, and stimulating glucose-dependent insulin release.

Expected Outcomes Based on Clinical Evidence

FDA-approved semaglutide clinical trial data:

The STEP 1 trial demonstrated 14.9% average body weight loss over 68 weeks when combined with reduced-calorie diet and increased physical activity. Results varied significantly among participants—approximately 50% of trial participants did not reach 15% weight loss threshold. STEP 2 trial (participants with type 2 diabetes) showed 9.6% average weight loss.

Compounded formulation context:

Compounded semaglutide formulations have not undergone equivalent independent clinical trials. According to MEDVi’s website disclaimer: “MEDVi patients typically result in 1-2 lbs per week weight loss after 4 weeks, involving a healthy diet and exercise changes.” Individual results vary based on starting weight, adherence to lifestyle modifications, metabolic factors, genetic factors, current medications, and other variables.

Safety Profile and Medical Considerations

GLP-1 medications are prescription-strength pharmaceutical agents. This overview is not exhaustive and does not replace Patient Drug Education or official prescribing information.

Common Adverse Effects

According to pharmaceutical research on semaglutide, gastrointestinal effects are most frequent: nausea (20-44% incidence, usually mild-moderate, improves over time), vomiting (9-24% incidence), diarrhea (20-30% incidence), constipation (20-24% incidence), and abdominal pain (8-20% incidence). Other common effects include fatigue, headaches (6-14% incidence), dizziness, and injection site reactions for injectable formulations.

Patients experiencing persistent or severe side effects should contact their prescribing medical provider for guidance.

Serious Adverse Events (Rare but Clinically Important)

Thyroid tumors: Animal studies showed GLP-1 receptor agonists caused thyroid C-cell tumors in rodents. Unknown if human risk exists. FDA requires black box warning. Contraindicated in patients with personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Acute pancreatitis: Cases reported in patients using GLP-1 medications. Symptoms include severe abdominal pain not resolving, often radiating to back, with nausea and vomiting. Requires immediate discontinuation and medical evaluation.

Gallbladder disease: Rapid weight loss increases gallstone risk. GLP-1 medications associated with cholelithiasis and cholecystitis.

Renal impairment: In patients with existing kidney disease, dehydration from gastrointestinal effects can worsen renal function.

Hypoglycemia: Primary concern when combining with other diabetes medications (insulin, sulfonylureas).

Severe allergic reactions: Rare serious reactions including anaphylaxis require emergency medical care.

Contraindications

Absolute contraindications: Personal or family history of medullary thyroid carcinoma; Multiple Endocrine Neoplasia syndrome type 2; previous serious hypersensitivity to semaglutide or GLP-1 agonists; pregnancy (discontinue at least 2 months before planned pregnancy); breastfeeding.

Use with extreme caution or avoid: History of pancreatitis; gallbladder disease; severe kidney disease; history of diabetic retinopathy; gastroparesis or severe gastrointestinal motility disorders.

Compounded Medication Additional Considerations

According to company disclaimer: “We encourage all prospective users of compounded medications to speak with their provider about the specific risks and benefits that may come with the use of compounded medication.” Potential variables between compounded formulations include bioavailability differences, compounding methodology variations, storage and handling affecting potency, and batch-to-batch concentration variations.

This safety overview does not replace Patient Drug Education or official prescribing information. Always review complete safety information provided with prescription and consult prescriber or pharmacist with questions.

Compounded GLP-1 Market Context and Competitive Landscape

The compounded GLP-1 category has expanded significantly as consumers seek alternatives to FDA-approved medications. Multiple platforms now operate similar three-entity models, with pricing generally ranging $250-$400/month for refills across the category. MEDVi’s positioning within this competitive landscape reflects broader industry dynamics where affordability and accessibility are primary differentiators.

According to telehealth industry observers, the market shift toward compounded semaglutide has been driven by three key factors: limited insurance coverage for weight loss medications, retail pricing of FDA-approved alternatives remaining largely inaccessible to most consumers, and increasing consumer comfort with telehealth-delivered prescription services following pandemic-era adoption. Platforms in this space typically emphasize month-to-month flexibility, transparent pricing, and streamlined digital intake processes as core value propositions.

The category continues attracting new entrants while facing evolving regulatory scrutiny, creating a dynamic market environment where platform differentiation increasingly centers on pricing structure, medication formulation options, and operational transparency regarding the separation between technology services and medical decision-making.

Patient Suitability Considerations

Understanding whether MEDVi’s specific structure aligns with individual circumstances requires evaluating medical appropriateness, financial capacity, and treatment preferences.

Platform Structure May Align With Individuals Who:

Require affordable GLP-1 access without insurance coverage. For individuals whose insurance plans don’t cover weight loss medications, MEDVi’s listed refill rate of $299/month for compounded injections provides a lower-cost access point compared to brand-name retail pricing typically ranging $1,300-1,500/month.

Are comfortable with compounded medication regulatory framework. Individuals who understand that compounded formulations don’t have FDA pre-market approval as finished products and accept these regulatory trade-offs in exchange for lower cost.

Prefer entirely remote care. Fully telehealth model eliminates in-person clinic visits for individuals with scheduling constraints, transportation limitations, or privacy preferences.

Have straightforward medical histories. Generally healthy individuals aside from being overweight or having weight-related conditions like pre-diabetes or high blood pressure may be appropriate for telehealth medical supervision.

Alternative Options May Be More Appropriate For Individuals Who:

Require FDA-approved medications only. Individuals who want FDA pre-market approval and comprehensive clinical trial backing of finished products.

Have complex medical histories requiring close monitoring. Complicated unstable cardiovascular disease, severe kidney disease, history of recurrent pancreatitis, gastroparesis, or multiple complex medication regimens may need more intensive medical supervision than telehealth provides.

Have low tolerance for gastrointestinal side effects. GLP-1 medications commonly cause nausea, vomiting, and other GI effects requiring tolerance-building period over weeks to months.

Expect rapid results without dietary modifications. Medication facilitates behavior change by reducing appetite but requires concurrent dietary changes and increased physical activity for results.

Telehealth Limitations

Telehealth consultations have limitations compared to in-person medical care. Remote providers cannot perform physical examinations, directly measure vital signs, or respond to emergency situations. According to company terms: “MEDVi is contemplated for specific non-emergency medical conditions and concerns. If you believe you are experiencing a medical emergency, please dial 911 or your local medical provider.”

Platform Legitimacy and Verification

Verifiable Corporate Information

Legal entity: MEDVi, LLC registered as Delaware limited liability company (verifiable through Delaware Division of Corporations)

Physical address: 131 Continental Dr, Ste 305, Newark, DE 19713

Contact information:

Medical Provider Verification

Medical services provided through OpenLoop Health provider network. Patients can verify medical provider licenses through state medical board websites, which maintain public license verification databases.

Payment Processing

Terms specify Stripe handles payment processing. Stripe is an established payment processor with security standards and fraud detection systems.

Compliance Documentation

Terms of use include sections covering HIPAA privacy protections, informed consent requirements for telehealth services, compounded medication regulatory status disclaimers, mandatory arbitration provisions, and limitation of liability clauses.

Those considering compounded GLP-1 treatment can learn more about MEDVi’s three-entity model, pricing structure, and medical provider network here or by calling (323) 690-1564.

Regulatory Context and Industry Oversight

According to company disclaimer: “The telehealth weight loss and prescription compounding industries have been under increased regulatory scrutiny in recent years. Patients should review the most current information about platform compliance and regulatory standing before starting treatment.”

The FDA continues evolving guidance on compounding practices. State pharmacy boards are increasing oversight of compounding operations. Platforms operating within current regulatory frameworks may face changing requirements as regulations evolve. FDA’s drug shortage database should be consulted for current semaglutide shortage status.

Considerations for Individual Decision-Making

Determining whether MEDVi’s platform structure, pricing model, and medication options align with individual circumstances depends on multiple factors:

Medical appropriateness: Do contraindications exist (personal/family thyroid cancer history, MEN 2, pancreatitis history, severe kidney disease)? Are there concurrent medications with interaction potential? Has discussion occurred with primary care physician?

Financial capacity: Is $299/month sustainable for 12+ months of treatment? Is there understanding of refund policy terms?

Lifestyle readiness: Is there preparedness to make dietary changes and increase physical activity alongside medication? Can potential side effects be managed while maintaining work and life responsibilities?

Expectation alignment: Is there understanding of realistic gradual weight loss (1-2 lbs/week) rather than rapid dramatic results? Is there acceptance that individual response varies?

Risk tolerance: Is there comfort with compounded medication regulatory framework (FDA-registered facilities but not FDA-approved finished products)? Can it be accepted that specific formulations haven’t undergone independent clinical trials?

The evaluating clinician determines whether compounded formulations or other treatment approaches are appropriate for specific medical situations based on individual medical history and clinical judgment.

Contact Information

According to MEDVi’s website:

Email:help@medvi.org Phone: (323) 690-1564 Physical Address: 131 Continental Dr, Ste 305, Newark, DE 19713

Additional information available at company website.

With the 2026 New Year weight loss season approaching, consumers seeking information on affordable GLP-1 access can review MEDVi’s current programs and pricing here.

Disclaimers

Content and Medical Disclaimer: This article is for informational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Descriptions of potential benefits are not guarantees and are not substitutes for individualized medical evaluation. GLP-1 medications require evaluation by a licensed clinician. Information provided does not replace professional healthcare judgment.

Professional Medical Disclaimer: This article is educational, not medical advice. GLP-1 medications are not substitutes for prescribed medical treatment. If taking medications, have existing conditions, are pregnant or nursing, or considering health regimen changes, consult physician before starting prescription treatment. Do not change, adjust, or discontinue medications or treatments without physician guidance.

Compounded Medication Notice: MEDVi’s primary offerings are compounded prescription medications prepared by licensed pharmacies based on individual prescriptions. Compounded medications are not reviewed or approved by FDA as finished products. They use active ingredients from FDA-registered facilities under clinician direction. The FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed. Compounded medications are prepared by pharmacies under federal and state compounding rules.

Results May Vary: Individual results vary based on age, baseline condition, starting weight, medication consistency, diet and exercise adherence, genetic factors, current medications, metabolic health, and other variables. According to company disclaimer, patients typically experience “1-2 lbs per week weight loss after 4 weeks, involving a healthy diet and exercise changes.” Results are not guaranteed.

FTC Affiliate Disclosure: This article contains affiliate links. If a purchase is made through these links, a commission may be earned at no additional cost to the reader. This compensation does not influence the accuracy, neutrality, or integrity of the information presented. All opinions and descriptions are based on published research, company disclosures, and publicly available information.

Pricing Disclaimer: Prices, offers, and program terms mentioned were observed on the company website on December 19, 2025, but are subject to change without notice. Patients should verify current pricing and terms on official website before enrollment.

Publisher Responsibility: The publisher made every effort ensuring accuracy at publication based on company disclosures and publicly available information. The publisher does not accept responsibility for errors, omissions, or outcomes from information use. Readers are encouraged to verify details directly with MEDVi and healthcare providers before decisions.

Insurance Coverage Note: According to terms, MEDVi providers are not contracted with insurance plans including Medicare and Medicaid. They operate out-of-network; patients are responsible for all costs. While website displays “HSA/FSA Approved” in marketing materials, HSA/FSA eligibility is determined by individual plan administrators. According to IRS regulations, medical services and prescription medications prescribed by licensed providers are generally eligible expenses, but patients should verify with their specific plan administrator before using these funds.

Regulatory Scrutiny Acknowledgment: Telehealth weight loss and prescription compounding industries have been under increased regulatory scrutiny. Patients should review most current information about platform compliance and regulatory standing before treatment. FDA periodically issues compounding guidance; regulations affecting compounded GLP-1 availability may change.

This analysis is based on pricing and policies observed on MEDVi’s official website on December 19, 2025. Company terms were last updated January 1, 2024 according to the website. Terms and policies are subject to change. Always verify current information directly with MEDVi before enrollment.

CONTACT: Email: help@medvi.org
Phone: (323) 690-1564

Vireo Growth Inc. to Acquire Additional Outstanding Senior Secured Convertible Notes of Schwazze

Vireo Growth Inc. to Acquire Additional Outstanding Senior Secured Convertible Notes of Schwazze




Vireo Growth Inc. to Acquire Additional Outstanding Senior Secured Convertible Notes of Schwazze

MINNEAPOLIS, Dec. 19, 2025 (GLOBE NEWSWIRE) — Vireo Growth Inc. (“Vireo”) (CSE: VREO; OTCQX: VREOF) (“Vireo” or the “Company”) today announced that it plans to acquire additional outstanding senior secured convertible notes (the “Notes”) of Medicine Man Technologies Inc. (dba “Schwazze”) from third-party noteholders. Total outstanding principal plus accrued interest of the acquired Notes is approximately $2.6 million, but the Notes will be acquired at a substantial discount to par value for total consideration of approximately $1.6 million payable in subordinate voting shares of the Company at closing at a price per share of $0.54.

Upon closing of the transaction, which is expected to occur later this month, Vireo will have acquired approximately 89% of the outstanding senior secured convertible notes of Schwazze. Completion of the transaction is subject to customary conditions, including receipt of necessary approvals. The share consideration will be subject to customary resale restrictions under Canadian securities law and hold period under the rules of the Canadian Securities Exchange.

About Vireo Growth Inc.

Vireo was founded in 2014 as a pioneering medical cannabis company. Vireo is building a disciplined, strategically aligned, and execution-focused platform in the industry. This strategy drives our intense local market focus while leveraging the strength of a national portfolio. We are committed to hiring industry leaders and deploying capital and talent where we believe it will drive the most value. Vireo operates with a long-term mindset, a bias for action, and an unapologetic commitment to its customers, employees, shareholders, industry collaborators, and the communities it serves. For more information about Vireo, visit www.vireogrowth.com.

Contact Information

Joe Duxbury
Chief Accounting Officer
investor@vireogrowth.com
612-314-8995

Forward-Looking Statement Disclosure

This press release contains “forward-looking information” within the meaning of applicable United States and Canadian securities legislation. To the extent any forward-looking information in this press release constitutes “financial outlooks” within the meaning of applicable United States or Canadian securities laws, this information is being provided as preliminary financial results; the reader is cautioned that this information may not be appropriate for any other purpose and the reader should not place undue reliance on such financial outlooks. Forward-looking information contained in this press release may be identified by the use of words such as “should,” “believe,” “estimate,” “would,” “looking forward,” “may,” “continue,” “expect,” “expected,” “will,” “likely,” “subject to,” and variations of such words and phrases, or any statements or clauses containing verbs in any future tense and includes statements regarding the expected decrease in annualized interest expense as a result of the completion of the refinancing of senior secured debt; the Company’s future M&A strategy and optimization of all areas of the Company’s business; the expected benefits of the Company’s expansion into the adult-use cannabis market, including expected future revenues and growth associated therewith; expectations around the proposed transactions involving Schwazze and its assets; and the Company’s expectations around integration of the operations of its recent acquisitions at timing thereof. These statements should not be read as guarantees of future performance or results. Forward-looking information includes both known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company or its subsidiaries to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements or information contained in this press release. Financial outlooks, as with forward-looking information generally, are, without limitation, based on the assumptions and subject to various risks as set out herein and in our Annual Report on Form 10 K and our Quarterly Reports on Form 10 Q filed with the Securities Exchange Commission. Our actual financial position and results of operations may differ materially from management’s current expectations and, as a result, our revenue, EBITDA, Adjusted EBITDA, and cash on hand may differ materially from the values provided in this press release. Forward-looking information is based upon a number of estimates and assumptions of management, believed but not certain to be reasonable, in light of management’s experience and perception of trends, current conditions, and expected developments, as well as other factors relevant in the circumstances, including assumptions in respect of current and future market conditions, the current and future regulatory environment, and the availability of licenses, approvals and permits.

Although the Company believes that the expectations and assumptions on which such forward-looking information is based are reasonable, the reader should not place undue reliance on the forward-looking information because the Company can give no assurance that they will prove to be correct. Actual results and developments may differ materially from those contemplated by these statements. Forward-looking information is subject to a variety of risks and uncertainties that could cause actual events or results to differ materially from those projected in the forward-looking information. Such risks and uncertainties include, but are not limited to: risks related to the timing and content of adult-use legislation in markets where the Company currently operates; current and future market conditions, including the market price of the subordinate voting shares of the Company; risks related to epidemics and pandemics; federal, state, local, and foreign government laws, rules, and regulations, including federal and state laws and regulations in the United States relating to cannabis operations in the United States and any changes to such laws or regulations; operational, regulatory and other risks; execution of business strategy; management of growth; difficulties inherent in forecasting future events; conflicts of interest; risks inherent in an agricultural business; risks inherent in a manufacturing business; liquidity and the ability of the Company to raise additional financing to continue as a going concern; the Company’s ability to meet the demand for flower in its various markets; our ability to dispose of our assets held for sale at an acceptable price or at all; and risk factors set out in the Company’s Annual Reports on Form 10 K and Quarterly Reports on Form 10 Q, which are available on EDGAR with the U.S. Securities and Exchange Commission and filed with the Canadian securities regulators and available under the Company’s profile on SEDAR+ at www.sedarplus.com.

The statements in this press release are made as of the date of this release. Except as required by law, we undertake no obligation to update any forward-looking statements or forward-looking information to reflect events or circumstances after the date of such statements.

AEON Biopharma Reports Inducement Grants Under NYSE American LLC Company Guide Section 711

AEON Biopharma Reports Inducement Grants Under NYSE American LLC Company Guide Section 711




AEON Biopharma Reports Inducement Grants Under NYSE American LLC Company Guide Section 711

IRVINE, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) — AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company seeking accelerated and full-label U.S. market entry by developing ABP-450 (prabotulinumtoxinA) as a BOTOX (onabotulinumtoxinA) biosimilar, today reported the grants in December totaling 392,158 restricted stock units (RSUs) of the Company’s common stock to newly hired non-executive employees of the Company. The awards were approved by the Company’s Board of Directors under the Company’s 2025 Inducement Incentive Plan, with a grant date of December 11, 2025 and vesting commencement dates in December 2025.

The RSUs vest over four years, 25% on each annual anniversary of the vesting commencement date. The awards are subject to the terms and conditions of the Inducement Plan and the terms and conditions of the RSU agreement covering the grant. The awards are being granted as inducement material to new employees entering into employment with the Company in accordance with Section 711 of NYSE American LLC Company Guide.

About the U.S. Biosimilar Pathway

The U.S. Food and Drug Administration (“FDA”) regulates biosimilars under the Public Health Service Act’s 351(k) pathway, which require developers to demonstrate that a proposed product is highly similar to an approved reference biologic with no clinically meaningful differences in safety, purity, or potency. Analytical similarity is the scientific foundation of this process, representing the most critical and data-intensive phase of development. Once analytical comparability across key quality attributes is established, subsequent FDA interactions focus on confirming whether any residual uncertainty requires limited clinical evaluation.

About AEON Biopharma

AEON Biopharma is a biopharmaceutical company seeking accelerated and full-label access to the U.S. therapeutic neurotoxin market via biosimilarity to BOTOX. The U.S. therapeutic neurotoxin market exceeds $3.0 billion annually, representing a major opportunity for biosimilar entry. The Company’s lead asset is ABP-450 for debilitating medical conditions. ABP-450 is the same botulinum toxin complex currently approved and marketed for cosmetic indications by Evolus, Inc. under the name Jeuveau®. ABP-450 is manufactured by Daewoong Pharmaceutical in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada, and European Medicines Agency. The product is approved as a biosimilar in India, Mexico, and the Philippines. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. To learn more about AEON, visit www.aeonbiopharma.com.

Contacts

Investor Contact:
Laurence Watts
New Street Investor Relations
+1 619 916 7620
laurence@newstreetir.com

Source: AEON Biopharma