ZHEN-AO GROUP Unveils TRIAL RESULTS: 5′-Nucleotide Reduces DNA Methylation Age by 3.08 Years




ZHEN-AO GROUP Unveils TRIAL RESULTS: 5′-Nucleotide Reduces DNA Methylation Age by 3.08 Years

PARIS–(BUSINESS WIRE)–On August 24, 2025, the 23rd International Congress of Nutrition (ICN) convened in Paris, France, under the theme “Sustainable Food for Global Health.” As the premier platform in nutritional science, the event brought together experts from 120 countries.

At the conference, researcher Mei-Hong Xu from Peking University presented groundbreaking findings from a randomized double-blind human trial (RCT) on nucleotide-based anti-aging. The study demonstrated that 5′-nucleotide supplementation over 19 weeks reduced DNA methylation age—the gold standard for epigenetic aging—by an average of 3.08 years in 60-70-year-old participants, alongside improvements in insulin resistance and visceral fat. The 5′-nucleotides, derived from yeast hydrolysis of eukaryotic cells, were validated in the study published in the prestigious journal Advanced Science.

The research was commissioned by ZhenAo and initiated in 2006. The team pioneered a “four-generation rat” safety trial, confirming 5′-nucleotide safety while observing lifespan extensions of up to 270 days (equivalent to up to 30 human years) in rats receiving lifelong supplementation.

Building on these breakthroughs, the team launched systematic research in 2020 to explore 5′-nucleotide mechanisms in lifespan extension. Multi-level experiments—spanning whole organisms, cells, genomics, and microbiota—revealed that lifelong 5′-nucleotide intervention extended median lifespan in SAMP8 mice by 9.21% to 12.6% (almost equal to 8.76-12.01 human years).

These findings underscore 5′-nucleotide’s potential in anti-aging, offering robust scientific support for prolonging healthspan and contributing a “Chinese solution” to global longevity research.

Contacts

ZHEN-AO GROUP CO., LTD.

Wenxuan Zhang, zjx@zhen-ao.com

Compass Pathways to Participate in Four Investor Conferences in September




Compass Pathways to Participate in Four Investor Conferences in September

LONDON & NEW YORK–(BUSINESS WIRE)–$CMPS #Biotech–Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in the following September investor conferences:

• Cantor Global Healthcare Conference – New York, NY: Fireside chat at 1:35 PM EST on September 3, 2025
• Morgan Stanley 23rd Annual Global Healthcare Conference – New York, NY: Fireside chat at 10:45 AM EST on September 9, 2025
• H.C. Wainwright 27th Annual Global Investment Conference – New York, NY: Fireside chat at 9:00 AM EST on September 9, 2025
• TD Cowen’s 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit: Virtual fireside chat at 10:40 AM EST on September 17, 2025

A live audio webcast of these events will be accessible from the “Events” page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following each event.

About Compass Pathways

Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).

Compass is headquartered in London, UK, with offices in New York in the U.S. We envision a world where mental health means not just the absence of illness but the ability to thrive.

Contacts

Enquiries

Media: Dana Sultan-Rothman, media@compasspathways.com, +1 484 432 0041

Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025




European Commission Approves TEVIMBRA® as Neoadjuvant/Adjuvant NSCLC Treatment Ahead of Late-Breaking Data Presentation at WCLC 2025

Final analysis of RATIONALE-315 demonstrates clear overall survival benefit in perioperative setting in resectable non-small cell lung cancer

Broad EU label with nine approved indications in solid tumors, including five in lung cancer, highlights TEVIMBRA’s therapeutic range and strong clinical profile throughout the care continuum

SAN CARLOS, Calif.–(BUSINESS WIRE)–$ONC #BeOne—BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the European Commission (EC) has approved TEVIMBRA (tislelizumab), in combination with platinum-containing chemotherapy as neoadjuvant treatment followed by TEVIMBRA monotherapy as adjuvant treatment, for adult patients with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence. The EC approval is based on results from the Phase 3 RATIONALE-315 trial. The preplanned final analysis of RATIONALE-315 demonstrates that TEVIMBRA, combined with platinum-based chemotherapy before surgery and continued as monotherapy afterward, showed statistically significant and clinically meaningful benefit in overall survival (OS) compared with chemotherapy combined with placebo. Data from this trial will be presented as a Late-Breaking Abstract (#MA04.08)¹ at the IASLC 2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain, September 6-9, 2025.

“Delivering a statistically significant overall survival benefit – a critical endpoint in oncology studies – alongside the European Commission’s approval of TEVIMBRA in perioperative resectable NSCLC marks a pivotal moment for patients and physicians,” said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeOne. “As only the second PD-1 inhibitor to demonstrate an OS benefit in this setting, TEVIMBRA is poised to reshape lung cancer treatment in Europe.”

Building on the RATIONALE-315 results previously reported at the European Society for Medical Oncology (ESMO) Congress Virtual Plenary in February 2024² and published in The Lancet Respiratory Medicine³, which showed the dual primary endpoints of event-free survival (EFS) and major pathologic response (MPR) were met at the interim analyses, key findings from the final analysis (n=453 patients; randomized 1:1) include:

• With a median trial follow-up of 38.5 months, the TEVIMBRA-based regimen showed a statistically significant and clinically meaningful benefit in OS versus the chemotherapy + placebo arm (HR=0.65 [95% CI: 0.45, 0.93]; one-sided P=0.0093).
• The significant EFS benefit previously reported with TEVIMBRA versus chemotherapy + placebo was sustained in this analysis (HR=0.58 [95% CI: 0.43, 0.79]), and this improvement was consistent across both independent review committee (IRC) and investigator assessments, reinforcing the consistency and robustness of the findings.
• OS and EFS benefits were observed across major sub-groups, regardless of PD-L1 expression, disease stage, and histology.
• As reported at the interim analyses, the trial showed a clinically meaningful and statistically significant improvement in EFS, MPR and pathological complete response (pCR) vs. chemotherapy + placebo.
• The safety profile was consistent with the treatment components and the interim analyses. No new safety signals were identified, and the most common (≥ 10%) Grade 3 or 4 treatment-related adverse events (TRAEs) in both arms were decreased neutrophil count and decreased white blood cell count.

“Patients with resectable non-small cell lung cancer still face alarmingly high recurrence rates,” said Dr. Mariano Provencio, Head of the Medical Oncology Department at Hospital Universitario Puerta de Hierro and Professor at Universidad Autónoma de Madrid. “The RATIONALE-315 results confirm that starting tislelizumab in the neoadjuvant phase, and continuing after surgery, has proven to be a powerful approach to improve outcomes for these patients. Now, with approval in the EU, we have a clinically validated new treatment option in the perioperative setting.”

In lung cancer, TEVIMBRA is already approved in the EU in four indications:

• first-line treatment of patients with squamous NSCLC;
• first-line treatment of patients with non-squamous NSCLC with PD-L1 high expression;
• treatment of patients with locally advanced or metastatic NSCLC after prior platinum-based therapy; and
• first-line treatment for extensive-stage small cell lung cancer (ES-SCLC).

It is also approved in the EU in the following indications:

• first-line treatment for patients with gastric or gastroesophageal junction (G/GEJ) adenocarcinoma;
• first-line treatment for unresectable esophageal squamous cell carcinoma (ESCC);
• second-line treatment in ESCC after prior platinum-based chemotherapy; and
• first-line treatment for patients with nasopharyngeal carcinoma (NPC).

About NSCLC

Lung cancer is the most commonly diagnosed type of cancer and the leading cause of cancer-related death worldwide.⁴ In Europe, lung cancer is the third most frequent cancer, with 484,306 new cases diagnosed in 2022.⁵ NSCLC accounts for 80–90% of all lung cancers⁶, of which resectable NSCLC patients at diagnosis represent around 25–30%⁷.

About RATIONALE-315

RATIONALE-315 (NCT04379635) is a randomized (1:1), double-blind, placebo-controlled, multicenter, Phase 3 trial, which evaluated TEVIMBRA neoadjuvant/adjuvant treatment in 453 adult patients with previously untreated, resectable, stage II or IIIA NSCLC. The dual primary endpoints are event-free survival (EFS) and major pathologic response (MPR). Key secondary endpoints include overall survival (OS), pathologic complete response (pCR), and disease-free survival (DFS).

About TEVIMBRA (tislelizumab)

TEVIMBRA is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

TEVIMBRA is the foundational asset of BeOne’s solid tumor portfolio and has shown potential across multiple tumor types and disease settings. The global TEVIMBRA clinical development program includes almost 14,000 patients enrolled to date in 35 countries and regions across 70 trials, including more than 20 registration-enabling studies. TEVIMBRA is approved in 47 markets, and more than 1.7 million patients have been treated globally.

Important Safety Information

The current European Summary of Product Characteristics (SmPC) for TEVIMBRA is available from the European Medicines Agency.

The information in this press release is intended for a global audience. Product indications vary by region.

About BeOne Medicines

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit www.beonemedicines.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding the ability of TEVIMBRA to improve patient outcome and potentially alter the course of the disease and to potentially help patients earlier in their treatment journey; the impact of TEVIMBRA on lung cancer treatment in Europe; the ability of BeOne to deliver more comprehensive and effective cancer treatment to more patients; and BeOne’s plans, commitments, aspirations, and goals under the heading “About BeOne Medicines.” Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne’s ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne’s ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne’s ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne’s reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne’s limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and achieve and maintain profitability; and those risks more fully discussed in the section entitled “Risk Factors” in BeOne’s most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne’s subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law.

To access BeOne media resources, please visit our Newsroom site.

Contacts

Investor Contact
Liza Heapes

+1 857-302-5663

ir@beonemed.com

Media Contact
Navneet Miller

+1 857-301-6440

media@beonemed.com

I2Pure and Caracal Announce Expanded Collaboration and Go-To-Market Effort for Novel Iodine Products




I2Pure and Caracal Announce Expanded Collaboration and Go-To-Market Effort for Novel Iodine Products

ASHBURN, Va.–(BUSINESS WIRE)–I2Pure and Caracal Products & Services, through its Caracal Healthcare Products division, today announce an expansion of their relationship. I2Pure’s proprietary iodine formulations and product concepts have received an overwhelmingly favorable response from Caracal’s healthcare customer base. Based on that positive feedback, I2Pure and Caracal have committed joint efforts to accelerate manufacturing and product delivery.

Three offerings make up the initial product entry: a topical iodine soak, a nasal decolonization product, and a topical iodine skin ointment. Additional products in development include surgical scrub, hand sanitizer, and several other topical iodine products.

“Since announcing our collaboration last year, Caracal has been amazed by the appetite of our healthcare customers for novel iodine products. The healthcare community clearly values the antimicrobial capability of iodine, as well as its long history of biosafety and biocompatibility,” said Don Roberts, CEO of Caracal Products & Services. “In a very short time, I2Pure’s technologies and products have become a primary interest within our healthcare customer base. We’re excited to begin marketing and delivering I2Pure products later this year.”

“A lot of hard work by our incredible team has put I2Pure in position to begin making our vision a reality. We’re thrilled to be in production now to start delivering products through Caracal later this year,” said Jeff Jochims, I2Pure CEO. “The world is ready for the next iteration of iodine chemistry. With ever-increasing antibiotic resistance and global pathogen risk, the time is right to harness the incredible antimicrobial broad-spectrum efficacy of molecular iodine, which has a time-proven safety profile and no known resistance development.”

I2Pure’s products will be available to most healthcare customers exclusively through Caracal Products & Services. Product samples will be available in September. Product delivery is expected to begin in the fourth quarter of 2025 and to expand throughout 2026.

Caracal and I2Pure expect to begin marketing products at healthcare conferences later this year, including the American Association of Hip and Knee Surgeons annual meeting in October and the National Minority Supplier Development Council’s Annual Conference & Exchange in early November in Miami.

About Caracal Products & Services: Founded in Detroit, Michigan, in 2004, Caracal is a U.S. based company with a focus on creating jobs and value in the healthcare industry through pioneering products and innovative services. As a sourcing solutions provider, Caracal offers a wide range of high-quality products and value-added services to businesses, government agencies, and educational institutions of all sizes. Caracal has cultivated strong, established partnerships in the healthcare, insurance, and financial services industries. Known for its proactive communication and stable, strategic vendor relationships, Caracal prides itself on living up to the Caracal motto each day: Supplying everything but surprises. For more information about Caracal Products & Services please visit https://www.caracalcorp.com or contact Sarah Herschelman at sherschelman@caracalcorp.com.

About I2Pure: I2Pure is an iodine technology company dedicated to advancing health and biosafety through its patented, non-toxic molecular iodine solutions. I2Pure’s mission is to prevent pathogenic threats to the world. Our technology can be utilized for countless applications across healthcare, industrial biosafety, consumer products, and food processing. The platform technology can be delivered directly or through carriers via solutions, nano particles, polymers and coatings. For more information about I2Pure, visit https://www.i2pure.com or contact the company at info@i2pure.com.

Contacts

info@i2pure.com

Acadia Pharmaceuticals to Participate at Upcoming Investor Conferences




Acadia Pharmaceuticals to Participate at Upcoming Investor Conferences

SAN DIEGO–(BUSINESS WIRE)–Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that it will participate at three upcoming investor conferences:

Morgan Stanley 23rd Annual Global Healthcare Conference

Fireside Chat: Monday, September 8, 2025 at 10:45 a.m. Eastern Time in New York, NY

H.C. Wainwright 27th Annual Global Investment Conference

Fireside Chat: Tuesday, September 9, 2025 at 8:00 a.m. Eastern Time in New York, NY

TD Cowen’s 5th Annual Novel Mechanisms in Neuropsychiatry & Epilepsy Summit

Fireside Chat: Thursday, September 18, 2025 at 1:40 p.m. Eastern Time (Virtual)

Live webcasts of each fireside chat will be accessible on the company’s website, acadia.com, under the investors section and an archived recording will be available on the website for approximately one month following each presentation.

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neurological and rare diseases to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Contacts

Investor Contact:
Acadia Pharmaceuticals Inc.

Al Kildani

(858) 261-2872

ir@acadia-pharm.com

Acadia Pharmaceuticals Inc.

Jessica Tieszen

(858) 261-2950

ir@acadia-pharm.com

Savara Announces Participation in Upcoming Investor Healthcare Conferences




Savara Announces Participation in Upcoming Investor Healthcare Conferences

LANGHORNE, Pa.–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA) (the “Company”), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced members of the management team will host 1×1 meetings and present at two upcoming healthcare conferences.

Wells Fargo Securities Healthcare Conference

September 3, 2025, 4:30pm ET/1:30pm PT

H.C. Wainwright Global Healthcare Conference

September 9, 2025, 1:00pm ET/10:00am PT

The live webcasts and subsequent replays will be available on the “Events & Presentations” section of the Company’s corporate website and will be archived for 90 days.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). MOLBREEVI is delivered via an investigational eFlow^® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.

*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.

Contacts

Media and Investor Relations Contact
Savara Inc.

Temre Johnson, Executive Director, Corporate Affairs

ir@savarapharma.com

Arcturus Therapeutics to Attend Upcoming Investor Conferences




Arcturus Therapeutics to Attend Upcoming Investor Conferences

SAN DIEGO–(BUSINESS WIRE)–$ARCT #ClinicalTrial–Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicines company focused on the development of liver and respiratory rare disease therapeutics and infectious disease vaccines, today announced that the Company will participate in the following investor conferences:

Citi’s 2025 Biopharma Back to School Conference (Fireside Chat)

• Tuesday, September 2, 2025 (11:15 a.m. ET)

2025 Wells Fargo Healthcare Conference (Fireside Chat)

• Wednesday, September 3, 2025 (8:00 a.m. ET)

Cantor Global Healthcare Conference (Fireside Chat)

• Friday, September 5, 2025 (8:00 a.m. ET)

H.C. Wainwright 27^th Annual Global Investment Conference (Presentation)

• Tuesday, September 9, 2025 (8:30 a.m. ET)

About Arcturus

Founded in 2013 and based in San Diego, California, Arcturus Therapeutics Holdings Inc. (Nasdaq: ARCT) is a commercial mRNA medicines and vaccines company with enabling technologies: (i) LUNAR® lipid-mediated delivery, (ii) STARR® mRNA technology (sa-mRNA) and (iii) mRNA drug substance along with drug product manufacturing expertise. Arcturus developed KOSTAIVE®, the first self-amplifying messenger RNA (sa-mRNA) COVID vaccine in the world to be approved. Arcturus has an ongoing global collaboration for innovative mRNA vaccines with CSL Seqirus, and a joint venture in Japan, ARCALIS, focused on the manufacture of mRNA vaccines and therapeutics. Arcturus’ pipeline includes RNA therapeutic candidates to potentially treat OTC deficiency and cystic fibrosis (CF), along with its partnered mRNA vaccine programs for SARS-CoV-2 (COVID-19) and influenza. Arcturus’ versatile RNA therapeutics platforms can be applied toward multiple types of nucleic acid medicines including messenger RNA, small interfering RNA, circular RNA, antisense RNA, self-amplifying RNA, DNA, and gene editing therapeutics. Arcturus’ technologies are covered by its extensive patent portfolio (over 500 patents and patent applications in the U.S., Europe, Japan, China, and other countries). For more information, visit www.ArcturusRx.com. In addition, please connect with us on X (formerly Twitter) and LinkedIn.

Contacts

Arcturus Therapeutics

Public Relations & Investor Relations

Neda Safarzadeh

VP, Head of IR/PR/Marketing

(858) 900-2682
IR@ArcturusRx.com

Superbug Survivor and Turn Therapeutics CEO Launches Podcast to Spotlight Hidden Scientific Breakthroughs




Superbug Survivor and Turn Therapeutics CEO Launches Podcast to Spotlight Hidden Scientific Breakthroughs

Asking the Tough Question: “The Cures Exist. Why Don’t We Have Them?”

LOS ANGELES–(BUSINESS WIRE)–Breaking Brad: Cures, Unfiltered is a new podcast born from biotech founder Bradley Burnam’s journey as a patient-turned-CEO. A superbug survivor and founder of Turn Therapeutics, Burnam blends lessons from building a company with candid conversations featuring trailblazers reshaping medicine.

“I came to biotech as an outsider, desperate for a cure that didn’t exist,” said Burnam, who hosts Breaking Brad. “I learned to navigate the FDA, raise capital, and build a company — but also saw how much promising science gets stuck because health policies have not kept up with innovation. This podcast is about sharing those lessons and spotlighting others pushing boundaries in healthcare.”

After contracting a drug-resistant infection, Burnam developed his own cure, carried it through FDA clearance on his own, and built Turn Therapeutics into a company with multiple FDA-cleared products. That dual perspective — patient and founder — shapes Breaking Brad to make complex science and policy accessible while asking why so many cures remain out of reach.

Season one has begun streaming on YouTube, Spotify, and Apple, with episodes highlighting breakthroughs in stem cells, ethnobotany, and functional medicine. Guests include world-renowned stem cell therapy pioneer Neil Riordan, Ph.D.; leading ethnobotanist Cassandra Quave, Ph.D.; Vanderbilt University’s infectious disease expert Buddy Creech, M.D.; and functional medicine leader Greer McGuinness. The season also confronts major healthcare topics like autism, drug pricing, and women’s health.

“What began as me trying to understand the system for my own survival has become a mission to move that same system forward,” Burnam added. “This podcast is about sharing what I’ve learned — and giving a platform to others who are doing work the world needs but rarely sees.”

For more information or to request an interview with Turn Therapeutics CEO and Breaking Brad host Bradley Burnam, please contact Ellie Pickel at (202) 816-4555 or ellie@keybridge.biz. For advertising inquiries: advertising@breakingbradshow.com.

About Follow Up Media

Follow Up Media is a full-service production, distribution, and marketing agency dedicated to helping brands create, launch, and scale content across every platform. From high-quality podcast studios and video storytelling to sonic branding and AI-powered solutions, the firm brings creativity, technical excellence, and results-driven execution to every project. Under the leadership of Founder and CEO Khristian Lee, Follow Up Media’s team of award-winning producers, engineers, and creatives transforms ideas into engaging, impactful media.

Contacts

Media Contact:
Follow Up Media — Khristian Lee, CEO

Email: klee@manfuzed.com | Phone: 678-437-0645

Follow Up Media: https://followupmedia.com

Fresenius Leads New EASYGEN Consortium Aimed at Decentralizing CAR-T Cell Therapy and Improving Hospital Workflows




Fresenius Leads New EASYGEN Consortium Aimed at Decentralizing CAR-T Cell Therapy and Improving Hospital Workflows

• Physicians, researchers, and partner institutions across Europe aim to deliver innovative, personalized therapies more quickly
• Development project focused on a hospital-based modular platform, based on technology initially developed by Fresenius Kabi
• The EASYGEN project is a public-private partnership, with €8 million backed by EU funding through the Innovative Health Initiative
• Important step in #FutureFresenius program

BAD HOMBURG, Germany–(BUSINESS WIRE)–#CommittedToLife–The global healthcare company Fresenius is collaborating with other companies and academic institutions with the goals of accelerating the manufacturing of CAR-T cell therapy, making it more cost-effective, and improving patient access across Europe. Led by Fresenius, the newly launched EASYGEN (Easy workflow integration for gene therapy) consortium will focus on efforts to develop a modular, hospital-based platform capable of manufacturing personalized cell therapies in just a few days, rather than weeks. The project is a public-private partnership, with €8 million in funding provided by the EU through the Innovative Health Initiative (IHI). It leverages technology originally developed by the Cell and Gene Therapy team of Fresenius Kabi, part of Fresenius.

Dr. Christian Hauer, President MedTech at Fresenius Kabi, said: “This project contributes to expanding our MedTech platform, making it an important step on our path to #FutureFresenius. The aim is not only to develop cutting-edge medical technologies, but also to make them available quickly, safely, and close to the patient. In this way, we are actively working to shape the healthcare of tomorrow.”

“EASYGEN brings together physicians, researchers, and partner institutions from across Europe with the goal of collaboratively advancing innovative, personalized therapies such as CAR-T cells for cancer treatment. Automation can help reduce production complexity of these therapies, with the aim of making it easier to scale these life-saving treatments and improve patient access,” added Prof. Dr. med. Ralf Kuhlen, Chief Medical Officer at Fresenius.

CAR-T therapy is a breakthrough treatment that involves genetically modifying a patient’s T cells to target cancer. It requires complex, time-intensive production in specialized facilities often far from patients. Limited manufacturing capacity and supply chain delays can potentially prevent timely patient access. Despite clinical eligibility, access to CAR-T cell therapy remains limited for patients across Europe. This is particularly evident in diffuse large B-cell lymphoma (LBCL), a type of cancer that is one of the most common indications: Across five European countries, the average treatment rate is below 20%. While approximately 30% of eligible patients receive CAR-T therapy in France, the figure drops to just 11% in Italy.¹

Fresenius is actively involved in cell and gene therapy. Fresenius Kabi provides medical technology for these therapies, including automated cell processing systems such as Lovo and Cue. Fresenius Helios, for example, at its Helios Hospital Berlin-Buch, has been offering CAR-T cell therapy as a standard treatment for relapsed cases since 2019. The clinic is also conducting clinical trials to further explore the potential of CAR-T therapies. Quirónsalud, Fresenius’ Spanish hospital business, has established specialized oncology units that offer CAR-T cell therapy as part of their advanced cancer treatment portfolio, particularly for hematologic malignancies.

EASYGEN is led by Fresenius and academically co-led by Fraunhofer Institute, IZI, Leipzig – one of Europe’s foremost immunotherapy research centers in collaboration with Prof. Dr. Michael Hudecek, a leader in CAR-T cell engineering and Prof. Dr. Ulrike Köhl, a pioneer in translational cellular immunotherapies.

Consortium partners – 18 organizations across 8 countries

Industry & clinical leaders: Fresenius (Coordinator, Germany), Helios Hospital Berlin-Buch (Germany), Quirónsalud (Spain), Fenwal Inc. (USA), Cellix Ltd. (Ireland), Charles River (Germany), Pro-Liance Global Solutions (Germany), TQ Therapeutics (Germany), Philips Electronics Nederland B.V. (Netherlands).

Academic & research institutions: Fraunhofer IESE (Germany), Fraunhofer IZI (Germany), Helmholtz-Zentrum Dresden-Rossendorf (Germany), Technical University of Denmark (Denmark), Frankfurt School of Finance & Management (Germany), European Society for Blood & Marrow Transplantation (Netherlands), Bar-Ilan University (Israel), University of Glasgow (UK), University of Navarra (Spain).

Learn more about CAR-T cell therapy: Interview Prof. Bertram Glaß, Chief Physician for Hematology and Cell Therapy at Helios Hospital Berlin-Buch: https://www.fresenius.com/car-t-cell-therapy

About Fresenius

Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2024 fiscal year, Fresenius generated €21.5 billion in annual revenue. Fresenius currently counts over 176,000 employees. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as an investment in Fresenius Medical Care. With around 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients every year. Fresenius Kabi’s product portfolio touches the lives of 450 million patients annually and includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and intravenous generic drugs and fluids. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner-Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects.

For more information visit the Company’s website at http://www.fresenius.com

Follow us on social media: http://www.fresenius.com/socialmedia

About EASYGEN

EASYGEN is a five-year research project supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement No 101194710. The JU receives support from the European Union’s Horizon Europe research and innovation programme and COCIR, EFPIA, Europa Bío, MedTech Europe, Vaccines Europe and industry partners. Selected under the IHI call “User-centric technologies and optimized hospital workflows for a sustainable healthcare workforce,” the project aims to develop an integrated, automated platform that enables point-of-care CAR-T cell manufacturing—cutting production time, reducing costs, and expanding access to next-generation immunotherapies.

Disclaimer: Funded by the European Union, the private members, and those contributing partners of the IHI JU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the aforementioned parties. Neither of the aforementioned parties can be held responsible for them.

Contacts

Press Contact
Timo Lindemann

Corporate Communications

Fresenius SE & Co. KGaA

Else-Kröner-Straße 1

61352 Bad Homburg

Germany

T +49 (0) 151 15515324

timo.lindemann@fresenius.com
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ICUS Urges CMS to Update CEUS Reimbursement, Citing Clinical Benefits for Patients and Healthcare Systems




ICUS Urges CMS to Update CEUS Reimbursement, Citing Clinical Benefits for Patients and Healthcare Systems

CHICAGO–(BUSINESS WIRE)–#CEUS–The International Contrast Ultrasound Society (ICUS) today urged the Centers for Medicare and Medicaid Services (CMS) to update reimbursement for certain contrast-enhanced ultrasound (CEUS) imaging procedures, citing important clinical benefits for patients and healthcare systems.

“CEUS is a safe, cost-effective, noninvasive, radiation-free imaging modality” that often reduces the need for downstream testing and procedures, speeds up diagnosis, lowers overall imaging costs, streamlines workflows, improves patient outcomes and save lives – even in the sickest patients, according to a letter submitted to CMS by the ICUS Board of Directors.

The letter asks CMS to reassign CPT Code 76978 and CPT Code 76979, both covering non-cardiac CEUS scans, to APC 5572 (Level 2 Imaging with Contrast). ICUS is not seeking a change in reimbursement for cardiac CEUS.

CEUS is used worldwide to assess blood flow in real time, allowing physicians to pinpoint and characterize tumors throughout the body, stratify a patient’s risk of heart attack and stroke, monitor chronic gastro-intestinal diseases and other serious medical conditions, and evaluate whether cancer and other therapies are working.

CEUS utilizes commercially available ultrasound contrast agents (UCAs) that are administered intravenously during an ultrasound exam. UCAs do not contain iodine or gadolinium and are not nephrotoxic.

“UCAs are among the safest of all contrast media,” ICUS said.

“CEUS offers a dynamic and highly reliable method of imaging all soft tissue tumors in the abdomen and pelvis, in real time – with sensitivity and specificity comparable to and sometimes better than contrast-enhanced CT and MRI,” said Dr. Richard G. Barr, a professor of radiology at Northeast Ohio Medical University and an officer of ICUS. Dr. Barr also is editor-in-chief of the Journal of Ultrasound in Medicine.

ICUS stated that contrast-enhanced CT and MRI procedures are already signed to APC 5572, so reassignment of CEUS would establish “clinical coherency that does not exist under the current APC assignment for CPT 76978.”

ICUS said it is seeking updated coding for non-cardiac CEUS in order to align reimbursement with the proven clinical and economic benefits.

“Unfortunately, despite the very successful and widespread use of CEUS outside the United States, under-reimbursement in the United States may impede the appropriate use of CEUS, as described in clinical guidelines, potentially to the detriment of patients,” according to Dr. Andrej Lyshchik, a professor of radiology at Thomas Jefferson University in Philadelphia. Dr. Lyshchik currently chairs the ACR LI-RADS CEUS Working Group and is a member of both the LI-RADS Steering Committee and the board of directors of ICUS.

According to Dr. Barr, CEUS allows physicians to identify, characterize and stage tumors of the liver, kidney, prostate, breast and other organ systems.

He said CEUS may be the only advanced imaging tool suitable for patients with renal failure when contrast enhanced CT or MRI cannot be used. And, CEUS may be an ideal option for pregnant patients because UCAs do not cross the placental barrier and because CEUS avoids exposure to ionizing radiation and iodinated contrast.

CEUS can also improve clinical workflows and avoid delays associated with CT and MRI, in part because ultrasound systems are more readily available in many medical centers.

“CEUS offers almost immediate results, so patients can get a speedy diagnosis and quicker access to appropriate therapy,” said Dr. Yuko Kono, a clinical professor of hepatology and radiology at University of California, San Diego and member of the ICUS Board.

ICUS is a non-profit medical society focused on the safe and appropriate utilization of CEUS where medically indicated in order to improve patient care and outcomes. ICUS members include radiologists, oncologists, hepatologists, cardiologists and other physicians, nurses, sonographers and ultrasound imaging professionals.

ICUS offers free membership and free CME-accredited educational webinars and resources, all accessible on the organization’s website: www.ICUS-Society.Org.

ABOUT ICUS:

The International Contrast Ultrasound Society (ICUS) is a nonprofit medical society dedicated to advancing the safe and medically appropriate use of contrast enhanced ultrasound (CEUS) to improve patient care globally. Membership in ICUS is free of charge and there is no fee for ICUS educational programs, CME credits, newsletters or other resources.

To join ICUS and learn more about CEUS, visit www.icus-society.org and download ICUS CONNECT, the free ICUS mobile app.

Contacts

International Contrast Ultrasound Society
Linda Maiman Feinstein, Advisor — 847-624-1844 or 312-876-2563, Linda.Feinstein@Dentons.com
Robin J. Adams, Director of Communication — 202-408-3946, Robin.Adams@Dentons.com