insitro Appoints R&D Veteran Stephen Hitchcock and AI Visionary Vijay Pande as Scientific Advisors




insitro Appoints R&D Veteran Stephen Hitchcock and AI Visionary Vijay Pande as Scientific Advisors

Former Takeda CSO and a16z Bio + Health Founder to Guide Clinical Translation and Scaling of insitro’s ChemML™ Platform

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–insitro, the AI therapeutics company built on causal biology, today announced the appointment of two scientific advisors: Stephen Hitchcock, Ph.D., a preeminent drug development leader and former Chief Scientific Officer of Takeda, and Vijay Pande, Ph.D., co-founder of VZVC and, previously, founder and General Partner of Andreessen Horowitz’s Bio + Health fund.

Hitchcock and Pande will advise on the continued development and scaling of insitro’s AI-driven ChemML™ platform as it is deployed across insitro’s pipeline and partner programs. Their guidance will focus on translating compelling targets into the medicinal chemistry and preclinical development strategies required to advance therapeutics into clinical trials – connecting computational prediction with the realities of drug development at scale.

“Drug discovery often falters at the gap between biological promise and clinical reality,” said Daphne Koller, Ph.D., founder and CEO of insitro. “ChemML is designed to bridge that divide. By integrating computational prediction with high-throughput medicinal chemistry, we can rapidly create novel molecules that also solve for the complex pharmacological properties that determine a molecule’s success in patients – not just in the lab.”

“Steve brings deep experience navigating the complexities of drug development, while Vijay has been a pioneer in the use of machine learning for biology and chemistry,” Koller added. “Their combined perspective – spanning traditional R&D rigor and computational strategy – is critical as we advance our internal pipeline in metabolic disease and neuroscience, and work with strategic partners such as Bristol Myers Squibb and Eli Lilly.”

• Stephen Hitchcock, Ph.D., is a pharmaceutical R&D executive leader with more than 30 years of experience in biotech and large pharma (Takeda, Eli Lilly, and Amgen). As the former Chief Scientific Officer and Head of Global Research at Takeda, he directed the global research teams responsible for delivering clinical candidates against historically intractable targets across multiple therapeutic areas. He is currently a Venture Partner at 5AM Ventures and the CEO of Implexsys Bioscience.

  “The ChemML platform distinguishes itself by moving beyond binding affinity to solve for the multiparametric pharmacological profile that drives safety and efficacy,” Hitchcock said. “This simultaneous optimization, particularly when applied to novel targets in challenging indications such as ALS – identified through insitro’s collaboration with Bristol Myers Squibb – represents a fundamentally different approach to drug discovery. I believe this technology will enable scientists to drug targets that would otherwise remain intractable, particularly in areas like CNS disorders where pharmacological complexity has historically limited progress.”
  

• Vijay Pande, Ph.D., served as a Stanford University faculty member for 16 years – notably as the Henry Dreyfus Professor of Chemistry, Structural Biology, and Computer Science – where he pioneered the use of computational methods in biology and chemistry. He founded Folding@home, a distributed computing project that helped establish large-scale computation as a practical tool for biological research. Pande subsequently served as a General Partner at Andreessen Horowitz, where he founded the firm’s Bio + Health fund. He co-founded VZVC earlier this year to invest in companies leveraging technology to solve humanity’s biggest problems, including healthcare and care access.

  “AI is transforming every dimension of our lives, yet its most profound potential lies in rewriting the trajectory of human health,” Pande said. “I am delighted to work with Steve and the insitro team as they advance this shift from descriptive science to predictive engineering. insitro has built the first true ‘closed loop’ system where high-quality data generation and model training reinforce one another. This structural advantage allows insitro to solve for clinical relevance at the very start of design, bridging the gap between computational promise and patient impact.”

The appointments follow several recent validation milestones for insitro’s integrated platform. The company expanded its collaboration with Bristol Myers Squibb in October to apply ChemML to a novel ALS target discovered in the partnership’s first phase – a deal with a potential value exceeding $2 billion. In September, insitro announced a partnership with Eli Lilly to build first-in-kind predictive ADMET models using data from 40 years of Lilly chemistry residing in Lilly’s TuneLab and validating ChemML as a core engine for the industry’s most difficult optimization challenges.

“For decades, drug discovery has been trapped in a cycle of elegant biochemistry yielding clinical disappointment,” said Philip Tagari, Chief Scientific Officer of insitro. “R&D teams optimize for binding affinity because it’s measurable, then confront the unmeasured complexity – brain penetration, metabolic stability, selectivity – only after molecules fail in vivo. ChemML inverts this entirely by treating pharmacology as a design constraint from the first iteration, solving simultaneously for the complete profile that determines therapeutic success. As we scale this approach across ALS, metabolic disease, and other intractable indications, Steve and Vijay bring the strategic perspective needed to bridge computational prediction with clinical reality, ensuring we build medicines that work in people, not just in silico.”

About insitro

insitro is the AI therapeutics company built on causal biology. By generating the largest integrated multi-modal corpus of human and cellular data and disentangling it through the lens of AI, we have created a platform that reveals how disease begins, progresses, and can be resolved. Our approach enables us to precisely identify genetic drivers, select the right targets, and use AI to design medicines that treat disease at its root. Focused on metabolic disease and neuroscience, our models create a self-learning loop that accelerates discovery and moves us closer to systematically eradicating grievous illness. insitro is backed by world-class investors and has brought in ~$800M in capital, including ~$150M from non-dilutive pharma partnerships including BMS, Lilly, and Gilead. Learn more at insitro.com.

Contacts

Media Contact
Eric McKeeby

eric@insitro.com

Taiho Oncology Europe announces the launch of Lytgobi®▼ (futibatinib) in the United Kingdom for eligible adult patients with a previously treated subtype of locally advanced or metastatic cholangiocarcinoma1




Taiho Oncology Europe announces the launch of Lytgobi®▼ (futibatinib) in the United Kingdom for eligible adult patients with a previously treated subtype of locally advanced or metastatic cholangiocarcinoma1

Lytgobi (futibatinib) marks the first medicine launched by Taiho Oncology Europe in the UK²

BAAR, Switzerland–(BUSINESS WIRE)–For United Kingdom (UK) Trade and Medical Media Only

Taiho Oncology Europe GmbH announced today the UK launch of Lytgobi^® (futibatinib), an irreversibly binding fibroblast growth factor receptor (FGFR) inhibitor.^1,3 This development follows the conditional marketing authorisation (4 September 2024) and subsequent National Institute for Health and Care Excellence (NICE) recommendation (11 September 2024) for futibatinib monotherapy as an option for the treatment of eligible adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.^1,4

CCA is an aggressive cancer of the bile ducts that carry bile inside the liver and from the liver and gallbladder to the small intestine. In England, approximately 3,110 people were diagnosed with CCA in 2023,^5,6 and the disease is growing in incidence worldwide.⁷ CCA is usually diagnosed at an advanced stage, with a very poor prognosis with less than one in five patients surviving five years, and there is an unmet need for additional treatment options such as futibatinib.^7,8

“Patients with CCA are mostly identified at a late stage of disease and consequently have a poor prognosis. The launch of futibatinib in the UK and positive NICE recommendation for treating locally advanced or metastatic CCA with a FGFR2 fusion or rearrangement that has progressed after at least one prior line of systemic treatment in adults represents a much needed additional treatment option for eligible patients with this aggressive cancer,” said Professor John Bridgewater, Clinical Researcher and Medical Oncologist at University College London Cancer Institute and University College London Hospitals NHS Foundation Trust.

Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy.¹ The medicine is taken orally, once daily, on a continuous basis (treatment should be continued until disease progression or unacceptable toxicity).¹

The conditional marketing authorisation^*, where UK approval is granted for medicines that fulfil an unmet medical need while regulatory data review is ongoing,⁹ is based on findings from the pivotal Phase 2 FOENIX-CCA2^‡ global open-label, single-arm trial evaluating 103 patients with unresectable, locally advanced or metastatic CCA with a FGFR2 fusion or rearrangement.^1,10 The trial showed that futibatinib provided a clinically meaningful benefit, meeting its primary endpoint of objective response (partial or complete response as assessed by independent central review) with a rate of 42% (95% CI, 32–52), and a median duration of response of 9.7 months (95% CI, 7.6–17.0).^10,11 Among the secondary endpoints, the 12-month overall survival rate was 72% (95% CI, 62–80).¹⁰

The most common (≥20%) adverse reactions were hyperphosphatemia (89.7%), nail disorders (44.1%), constipation (37.2%), alopecia (35.2%), diarrhoea (33.8%), dry mouth (31.0%), fatigue (31.0%), nausea (28.3%), dry skin (27.6%), increased AST (26.9%), abdominal pain (24.8%), stomatitis (24.8%), vomiting (23.4%), palmar-plantar erythrodysaesthesia syndrome (22.8%), arthralgia (21.4%), and decreased appetite (20.0%).¹

The results of the FOENIX-CCA2 trial were published in The New England Journal of Medicine in 2023.¹⁰ Within Europe, eligible patients were enrolled in this trial from France, Germany, Italy, the Netherlands, Spain and the United Kingdom.¹⁰

“The launch of futibatinib in the UK is the culmination of extensive and productive collaboration among researchers, healthcare professionals, and patients, all united in their commitment to advance care in cholangiocarcinoma and to improve the lives of eligible patients,” said Dr. Peter Foertig, General Manager of Taiho Oncology Europe. “This marks the first medicine Taiho Oncology has introduced in the UK on our own, signifying our intention to establish a strong presence and reinforcing our ongoing commitment to bringing innovative oral therapies to patients with cancer.”

Futibatinib was developed by Taiho Oncology Europe’s parent company, Taiho Pharmaceutical Co., Ltd., Tokyo. The larger Taiho family of companies continues to investigate its potential in other tumours.¹²

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information.

^* A conditional marketing authorisation is granted for medicines that fulfil an unmet medical need to treat serious diseases, and the benefits of having them available earlier outweigh any risks associated with using the medicines while waiting for further evidence. As part of this authorisation there will be ongoing review of data to ensure the benefit-risk balance remains positive.⁹

^‡ The FOENIX-CCA2 trial is a Phase 1 / 2 Study of TAS-120 in Patients with Advanced Solid Tumors Harboring FGF/FGFR Aberrations: FGFR Oral SElective Novel Inhibitor X [across] tumors.

About Lytgobi (futibatinib) 

Futibatinib is an oral, potent, selective, and irreversible tyrosine kinase inhibitor of FGFR1, 2, 3 and 4. Futibatinib irreversibly binds to the adenosine triphosphate-binding pocket of FGFR1–4 resulting in the inhibition of FGFR-mediated signal transduction pathways, reduced tumour-cell proliferation and increased tumour-cell death in tumours with FGFR1–4 genetic aberrations.^1,3

About Taiho Oncology Europe 

The mission of Taiho Oncology Europe is to improve the lives of patients with cancer, their families, and their caregivers. The company specialises in orally administered anti-cancer agents and has a growing pipeline of selectively targeted anti-cancer agents. Taiho Oncology Europe GmbH (Baar, Switzerland) is the European subsidiary of Taiho Pharmaceutical Co., Ltd. (Tokyo, Japan). For more information, visit www.taihooncology.eu.

Lytgobi is a registered trademark of Taiho Pharmaceutical Co., Ltd.

References:

1. Lytgobi^® (futibatinib): Summary of Product Characteristics. Available at https://www.medicines.org.uk/emc/product/100700/smpc#gref Last accessed: November 2025.
2. Taiho Oncology Europe. Futibatinib in Italy for the treatment of cholangiocarcinoma. Published 12 February 2025. Available at Taiho Oncology Europe Announces Availability of Lytgobi® (futibatinib) in Italy for the Treatment of Cholangiocarcinoma Last accessed: November 2025.
3. Sootome H, Fujita H, Ito K, et al. Futibatinib is a novel irreversible FGFR 1–4 inhibitor that shows selective anti-tumor activity against FGFR-deregulated tumors. Cancer Res. 2020;80:4986-4997. Available at: https://aacrjournals.org/cancerres/article/80/22/4986/645861/Futibatinib-Is-a-Novel-Irreversible-FGFR-1-4 Last accessed: November 2025.
4. NICE. Futibatinib for previously treated advanced cholangiocarcinoma with FGFR2 fusion or rearrangement. Published: 11 September 2024. Available at https://www.nice.org.uk/guidance/ta1005 Last accessed: November 2025.
5. Tataru D, Khan SA, Hill R, et al. Cholangiocarcinoma across England: temporal changes in incidence, survival and routes to diagnosis by region and level of socioeconomic deprivation. JHEP Reports. 2023;6(3):100983. Available at: https://www.jhep-reports.eu/article/S2589-5559(23)00314-2/fulltext Last accessed: November 2025.
6. Office for National Statistics. Population estimates for the UK, England, Wales, Scotland and Northern Ireland: mid-2023. Available at: Population estimates for the UK, England, Wales, Scotland and Northern Ireland – Office for National Statistics Last accessed: November 2025.
7. Banales JM, Marin JJG, Lamarca A, et al. Cholangiocarcinoma 2020: the next horizon in mechanisms and management. Nat Rev Gastroenterol Hepatol. 2020;17:557-588. Available at: https://www.nature.com/articles/s41575-020-0310-z#:~:text=CCA%20is%20a%20rare%20cancer,in%20the%20past%20few%20decades Last accessed: November 2025.
8. Valle JW, Bai LY, Orlova R, et al. Ramucirumab (RAM) or merestinib (MER) or placebo (PL) plus gemcitabine (GEM) and cisplatin (CIS) as first-line treatment for advanced or metastatic biliary tract cancer (BTC): a randomized, double-blind, phase II study. J Clinical Oncol. 2020;38(4):Abstract 477. Available at: https://ascopubs.org/doi/10.1200/JCO.2020.38.4_suppl.477 Last accessed: November 2025.
9. GOV.UK. Conditional marketing authorisations, exceptional circumstances MAs, scientific advice. Available at: https://www.gov.uk/guidance/conditional-marketing-authorisations-exceptional-circumstances-marketing-authorisations-and-national-scientific-advice Last accessed: November 2025.
10. Goyal L, Meric-Bernstam F, Hollebecque A, et al. Futibatinib for FGFR2-rearranged intrahepatic cholangiocarcinoma. N Engl J Med. 2023 Jan 19;388(3):228-239. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa2206834 Last accessed: November 2025.
11. National Library of Medicine. A study of TAS-120 in patients with advanced solid tumors. Available at: https://clinicaltrials.gov/study/NCT02052778 Last accessed: November 2025
12. National Library of Medicine. Futibatinib search results. Available at: https://clinicaltrials.gov/search?term=Futibatinib%20 Last accessed: November 2025

LYT-PM-UK-0011

Contacts

Taiho Oncology Europe Media Contact:
Leigh Labrie

+1 609.664.9878

llabrie@taihooncology.com

www.taihooncology.com

Beth Gaffey

+44 7884 318 976

bethan.gaffey@precisionaq.com

Merck Showcases Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at CTAD 2025




Merck Showcases Data for Alzheimer’s Disease Candidates MK-2214 and MK-1167 at CTAD 2025

Merck granted Fast Track Designation by the U.S. FDA for MK-2214 for the treatment of Alzheimer’s disease

RAHWAY, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced plans to present first-in-human data for MK-2214 and MK-1167 at Clinical Trials on Alzheimer’s Disease (CTAD) 2025 in San Diego, California from Dec. 1-4. In addition, the company announced that MK-2214, a novel candidate targeting the abnormal accumulation and aggregation of tau in the brain, has been granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease. Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and address an unmet medical need.

Key data being presented:

• MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau: First presentation of data from three Phase 1 studies evaluating MK-2214. Two studies assessed the safety, tolerability and pharmacokinetics of a single ascending dose of MK-2214 in healthy volunteers, while a third assessed the safety, tolerability and pharmacokinetics of a multiple ascending dose regimen in individuals with mild cognitive impairment and mild-to-moderate Alzheimer’s disease. The results from these studies helped inform an ongoing Phase 2 trial of MK-2214 evaluating safety and efficacy, including its effect on certain changes in the brains of people with early Alzheimer’s disease (NCT07033494).
• MK-1167, an investigational oral positive allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor: First presentation of data from a Phase 1 first-in-human study evaluating MK-1167. The trial assessed the effect of single doses of MK-1167 on glutamate metabolism in the prefrontal cortex of healthy adult male volunteers, as measured by 13C-magnetic resonance spectroscopy. The results from this study helped inform dose selection for an ongoing Phase 2 trial of MK-1167 evaluating safety and efficacy, including its effect on memory and mental activity, in people with mild-to-moderate Alzheimer’s disease dementia taking stable donepezil treatment (NCT06721156).

“Alzheimer’s disease remains one of the greatest neurological challenges of our time and yet new insights are providing important new paths to evaluate potential new therapeutic approaches,” said Dr. Mike Egan, vice president, neuroscience, global clinical development, Merck Research Laboratories. “We are pleased to share data showing progress in our pipeline of candidates targeting Alzheimer’s disease at CTAD 2025.”

Details on Merck abstracts at CTAD 2025:

MK-2214 is being developed through an agreement with Teijin Pharma.

About Alzheimer’s disease

Alzheimer’s disease is a progressive brain disorder and the most common cause of dementia, in which people lose memory, thinking skills and the ability to live independently. Alzheimer’s disease affects approximately seven million people in the U.S., with this number estimated to grow to 14 million by 2060. Recent progress in the area of human genetics in addition to advanced technology and screening tools is helping us better understand pathology in the brain and fueling innovative research in Alzheimer’s.

Merck in Neuroscience

At Merck, we are committed to discovering and developing novel therapeutics for a variety of diseases involving the nervous system, which remain among today’s most significant medical challenges. Our research is focused on investigating the complexities of central and peripheral nervous system disorders to treat, slow progression or prevent disease.

About Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA

This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they 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.

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 health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’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 the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Contacts

Media Contacts:

Julie Cunningham

(617) 519-6264

Katie Fey

(929) 738-2078

Investor Contacts:

Peter Dannenbaum

(732) 594-1579

Steven Graziano

(732) 594-1583

Ronovo Surgical Announces Appointment of Non-Executive Directors to Accelerate Global Growth




Ronovo Surgical Announces Appointment of Non-Executive Directors to Accelerate Global Growth

SHANGHAI–(BUSINESS WIRE)–#MIS–Ronovo Surgical, a global innovator in next-generation surgical robotics, announces today the appointment of Dr. Eduardo Parra-Davila and Jeroen M.M. van Heesewijk as Non-Executive Directors to its Board of Directors.

Dr. Parra-Davila is one of the world’s leading general surgeons with over 25 years of experience and over 5,000 cases of robotic surgery. He currently serves as Chief of General Surgery and Director of Minimally Invasive Colorectal Surgery and Hernia/Abdominal Wall Reconstruction at Good Samaritan Medical Center in West Palm Beach (Florida). As a founding member of the Society of Robotic Surgery (SRS) and the Clinical Robotic Surgery Association (CRSA), Dr. Parra-Davila has trained thousands of surgeons globally in minimally invasive and robotic surgery. He is also a contributing member of American College of Surgeons (ACS), Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), American Hernia Society (AHS) and American Society of Colon and Rectal Surgeons (ASCRS).

Mr. van Heesewijk is a seasoned executive with over 30 years of management experience in the medical devices industry, including professional leadership roles for 7 years in Europe and 15 years in China. He most recently served as SVP of Asia Pacific and Global Distribution at Intuitive. Previously, he served in numerous senior executive roles within Philips, including VP of Strategic Business Development at Philips Medical Systems Asia Pacific, President of Philips Medical Systems Greater China, as well as GM of Philips Balkan, Philips Romania Srl. and Philips Bulgaria Ltd. With an academic background in international law and international relations, Mr. van Heesewijk holds a profound understanding of corporate governance structures.

Dr. John Ma, Founder, Chairman, and CEO of Ronovo Surgical, commented:

“We are delighted to welcome Dr. Parra-Davila and Mr. van Heesewijk to our Board. Their extensive experience and insights will be invaluable to Ronovo as we execute our long-term strategy. These appointments reflect our commitment to strengthening corporate governance, accelerating international growth, and creating long-term value for stakeholders.”

About Ronovo Surgical and Carina™ Platform

Founded in 2019, Ronovo Surgical is a digital and robotic surgery company built by a world-class team of medtech veterans and robotic surgeons. Dedicated to addressing unmet clinical needs, Ronovo envisions a future where robot-assisted surgery (RAS) is the practical choice for minimally invasive patient care across all surgical specialties. Ronovo is committed to customer-centric innovation and optimizing cost-effectiveness of robotic surgery solutions while simplifying the learning curve and broadening RAS utilization across surgical specialties. In just four years, Ronovo accelerated from conceptual design to commercialization of its Carina™ Platform for robot-assisted laparoscopic surgery. Its proprietary design is protected by more than 200 patent applications globally.

Carina™ received regulatory approval from China’s National Medical Products Administration (NMPA) in March 2025, becoming the first modular robotic surgery system in the country to obtain simultaneous approvals covering the four major specialties of General Surgery, Gynecology, Urology and Thoracic Surgery. With its configurable modular architecture, Carina™ offers flexibility, adaptability and affordability to address adoption challenges posed by legacy robotic surgery systems. In parallel, Ronovo has initiated global expansion, with regulatory submissions underway in Europe and South America. The platform has already received enthusiastic support from international key opinion leaders, validating its differentiated value proposition and ability to meet significant unmet needs across healthcare systems.

For more information, please visit: http://www.ronovosurgical.com/.

Contacts

ZiHan Lin

VP of International Operations

zlin@ronovo.com

Prodalim Continues Its Accelerated Strategic Transformation With the Acquisition of René Laurent, a Leading Beverage Flavours Company Based in Grasse area, France




Prodalim Continues Its Accelerated Strategic Transformation With the Acquisition of René Laurent, a Leading Beverage Flavours Company Based in Grasse area, France

ROTTERDAM, Netherlands–(BUSINESS WIRE)–Prodalim, a global leader in Juice and specialty ingredients solutions, announced today the acquisition of René Laurent, a leading beverage flavours company, from International Flavours & Fragrances Inc. (IFF).

Established in 1885 in Grasse area, the capital of the flavours and fragrances industry in southern France, René Laurent is a century-old, trusted brand specializing in beverage flavours solutions and unique aromatic Ingredients. The company partners with leading multinational customers and local champions in the beverage industry, offering deep expertise in complex, tailor-made flavour development, including syrups, liqueurs, naturals and coffee. Its extensive flavour library and distinctive in-house distillation and extraction capabilities make René Laurent a respected expert in complex and customized formulations.

René Laurent will become part of Prodalim’s Beverage Compounds business unit, strengthening Prodalim’s holistic beverage solutions platform. This integrated platform now spans juice-based compounds, multi-blends, functional compounds and flavour-based solutions, supported by a robust supply chain, advanced product development capabilities, and strong global commercial organization. Together, these capabilities will allow Prodalim to deliver a comprehensive one stop shop tailor-made offering to customers worldwide and further accelerate its profitable growth journey.

The acquisition of René Laurent marks another important milestone in Prodalim‘s accelerated strategic transformation to cement its position as a high-value innovation partner for the Food and Beverage industry.

As part of its transformation, Prodalim has reorganized its operations into three purpose-driven divisions:

• Juice Solutions – legacy business covering a one stop shop solution for juice producers, including sourcing, logistics, formulation and blending
• Specialty Ingredients & Solutions – covering taste ingredients such as essential oils, aromatic fruit-based essences (FTNF) and flavours, as well as beverage compounds solutions and functional ingredients, including citrus fibers and natural colors
• SOLOS – a premium de-alcoholization patent-based solutions servicing the NoLo industry

All divisions are supported by Prodalim’s vertically integrated, regenerative supply chain, anchored in circular economy principles. Through this approach, Prodalim empowers Food and Beverage brands to innovate with sustainability, functionality, and transparency at their core.

About Prodalim

Prodalim is a global leader in juice and specialty ingredients solutions, harnessing nature’s essence to craft healthier creations. With its tree-to-table supply chain and global footprint, the company develops sustainable, innovative solutions for the food and beverage industry, making a meaningful impact for people and planet.

Visit Prodalim at: www.prodalim.com

Contacts

sales@prodalim.com

FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test




FDA Approves IsoPSA® — Cleveland Diagnostics’ Novel Blood-Based Prostate Cancer Test

IsoPSA Test Evaluates Prostate Cancer-Specific Structural Variants of the PSA Protein to Aid in the Diagnosis of High-Grade Prostate Cancer

CLEVELAND–(BUSINESS WIRE)–Cleveland Diagnostics, Inc., a pioneering, commercial-stage precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s IsoPSA® in vitro diagnostic (IVD) kit through the Premarket Approval (PMA) process. IsoPSA is a blood-based test indicated as an aid in the decision for prostate biopsy for men ≥ 50 years of age with elevated PSA levels.

“FDA approval of our IsoPSA kit marks a significant milestone in Cleveland Diagnostics’ mission to help physicians and patients detect cancer early when it is most treatable and survivable,” shared Arnon Chait, PhD, company president and CEO. “We remain focused on executing our commercial strategy and expanding access to IsoPSA, to the benefit of patients nationwide.”

FDA approval of the IsoPSA test was based on clinical evidence from a large-scale, prospective study conducted at 14 sites across the U.S. and data from supporting analytical validation studies.

Prostate cancer is the second most common cancer in American men, with 1 in 8 diagnosed during their lifetime. In the U.S., greater than 1 million men undergo prostate biopsies each year, yet up to 75% of those follow-up tests are negative for high-grade disease. This diagnostic gap subjects millions to invasive, costly procedures that can produce physical risks, emotional stress, and significant healthcare costs. IsoPSA helps close this gap, giving clinicians and patients a more accurate risk assessment and greater confidence in biopsy decision-making.

“As a practicing urologist, I see firsthand how the limitations of current PSA testing can lead to unnecessary procedures and anxiety for patients and appreciate the critical need for early and accurate risk assessment and testing,” added Dr. Aaron Berger, Chief Medical Officer and Director of Clinical Research at Associated Urological Specialists in Chicago. “IsoPSA represents a meaningful advancement, giving physicians a tool that improves risk assessment and helps us make more informed biopsy decisions with greater confidence.”

“FDA approval underscores the value and clinical utility of IsoPSA in distinguishing benign elevations of PSA from those due to high grade cancer,” said Dr. Eric Klein, Emeritus Chair of the Glickman Urological & Kidney Institute at Cleveland Clinic and Distinguished Scientist at GRAIL, Inc.* “I’m very pleased to see this milestone achieved; it represents the culmination of extensive study and test development over the past decade.”

The IsoPSA IVD kit leverages Cleveland Diagnostics’ IsoClear™ platform. This proprietary technology investigates protein biomarkers at a structural level in the blood to provide clinically relevant insights into disease state.

Cleveland Diagnostics has offered IsoPSA as a Laboratory-Developed Test (LDT) since 2020, and Medicare and a growing number of commercial payors now cover the test. IsoPSA is included in leading clinical practice guidelines, including the National Comprehensive Cancer Network (NCCN) Prostate Cancer Early Detection Guideline (2025) and the Early Detection of Prostate Cancer: American Urology Association/Society of Urologic Oncology Guideline (2023).

For more information and company news, visit ClevelandDx.com

About Cleveland Diagnostics, Inc.

Cleveland Diagnostics is a precision oncology company focused on changing the shape of cancer detection. The company has unlocked the diagnostic power of protein structure with its revolutionary IsoClear™ platform that enables novel diagnostics based on a cancer-specific, protein structure-based assessment using easy to execute tests within the clinical lab setting.

Learn more at ClevelandDx.com and IsoPSA.com.

*Dr. Eric Klein who is quoted in this release, is a shareholder of Cleveland Diagnostics, Inc.

Contacts

Media Contact:
Liz Robinson

CG Life

News@ClevelandDx.com

Investor Contact:

Ji-Yon Yi

Gilmartin Group

ir@clevelanddx.com

The Urgency Still Remains for HIV: AHF Poland Marks World AIDS Day




The Urgency Still Remains for HIV: AHF Poland Marks World AIDS Day

LUBLIN, Poland–(BUSINESS WIRE)–#HIVawareness–On the occasion of World AIDS Day 2025, AHF Poland reminds the public that the fight to end the HIV/AIDS epidemic is far from over. Every year, the world records as many as 1.3 million new HIV infections, a clear signal that we cannot afford to become complacent. Now is the time to rebuild public awareness, invest in prevention, ensure universal and easily accessible testing, guarantee stigma-free care, and maintain strong partnerships with people living with HIV/AIDS—both within our communities and beyond. World AIDS Day is observed annually on December 1.

Despite decades of progress against HIV, around 40 million people worldwide are still living with the virus, and women and girls account for more than half of all infections. Stigma and discrimination continue to deprive many of the care they need, and key populations, such as migrants and people experiencing homelessness, face significant barriers in accessing treatment. World AIDS Day observances aim to highlight these challenges and underscore the importance of keeping HIV/AIDS at the center of national and global public-health efforts.

“Europe is at risk of losing ground in the fight against HIV,” said Daniel Reijer, AHF Europe Bureau Chief. “While Western Europe has made steady progress, in Eastern Europe and Central Asia, the epidemic continues to grow. Europe is now the only region that has fallen behind globally. While HIV-related deaths have halved worldwide since 2010, they have risen by a third across the region. We need renewed political will and stronger health systems that prioritize testing, prevention, and care. This World AIDS Day, let’s reignite the urgency to end HIV everywhere in Europe—because HIV/AIDS is not over until that becomes the reality.”

“The lack of universal health education, including sexual health, and the exclusion of disadvantaged groups—such as migrants or people experiencing addiction crises—from prevention, testing, and treatment efforts is a direct path to disaster,” adds Anna Szadkowska-Ciężka, Country Program Manager for AHF Poland. “Public health requires thoughtful strategies that tailor actions to the needs of specific social groups. This is precisely where AHF Poland focuses its work—reaching communities that are the hardest to reach with essential services.”

Additionally, pharma greed continues to block progress for the global HIV/AIDS response. Even with groundbreaking prevention tools like long-acting injectables, high prices keep them out of reach for the people and countries that need them most. True progress demands that pharmaceutical companies put people before profits because innovation doesn’t matter if it isn’t accessible to all.

World AIDS Day serves as a vital platform for HIV/AIDS advocates to acknowledge the progress made, remember those we have lost to AIDS-related illnesses and those who carry on the fight, and call on governments worldwide to commit the necessary resources and political support to end HIV/AIDS. On this World AIDS Day, we’re reminded: It’s Not Over.

AIDS Healthcare Foundation (AHF) is a global non-profit organization providing cutting-edge medicine and advocacy to over 2.7 million people in 50 countries worldwide in Africa, the Americas, the Asia/Pacific Region, and Europe. We are currently the largest non-profit provider of HIV/AIDS medical care in the world. To learn more about AHF, please visit our website: www.aidshealth.org, find us on Facebook: www.facebook.com/aidshealth and follow us on Twitter: @aidshealthcare and Instagram: @aidshealthcare.

Contacts

POLAND MEDIA CONTACT:

Anna Szadkowska-Ciężka

Country Program Manager

AHF Poland

anna.szadkowska@ahf.org

US MEDIA CONTACT:

Ged Kenslea, Senior Director, Communications, AHF

+1 323.308.1833 work +1.323.791.5526 mobile

gedk@aidshealth.org

Denys Nazarov, Director of Global Policy & Communications, AHF

+1 323.308.1829

denys.nazarov@aidshealth.org

L&T Technology Services Transforms Respiratory Diagnostics with NVIDIA AI-Powered Digital Twin Technology




L&T Technology Services Transforms Respiratory Diagnostics with NVIDIA AI-Powered Digital Twin Technology

Collaboration brings together LTTS’ expertise in MedTech and NVIDIA AI infrastructure to deliver precision diagnostics and enhance patient care

CHICAGO–(BUSINESS WIRE)–$LTTS #AI—L&T Technology Services (BSE: 540115, NSE: LTTS), a global leader in AI, Digital & R&D Consulting Services, today announced the development of a next-gen AI-powered digital twin platform for respiratory diagnostics and lung navigation.

Combining LTTS’ expertise in platform engineering, AI-driven diagnostics, connected health systems and advanced imaging and visualization with cutting-edge NVIDIA AI infrastructure, LTTS aims to deliver scalable, low-latency solutions that enhance diagnostic precision and improve accessibility for healthcare providers worldwide.

To be unveiled at the Radiological Society of North America (RSNA) 2025, the LTTS solution integrates with CT imaging and leverages deep learning models to create a 3D digital twin of lung anatomy, providing visualization of airways, blood vessels, lung lobes and lesions. Powered by NVIDIA MONAI for medical image segmentation and NVIDIA TensorRT for optimized AI inference, the biological digital twin enables interactive visualization, precise path planning and navigation support for bronchoscopy, helping clinicians navigate complex procedures with greater efficiency.

LTTS’ deep domain engineering expertise in medical imaging and proprietary navigation systems ensures the platform transforms the snapshots taken into living breathing models that evolve with the patient, delivering intuitive, clinically meaningful simulations that mirror real-world anatomy. This helps transform surgical planning and advancing care for serious conditions such as lung cancer, COPD and infectious diseases.

“AI is reshaping what’s possible in diagnostics and medical technology,” said Alind Saxena, Executive Director and President of Mobility and Tech at L&T Technology Services. “Our collaboration with NVIDIA combines LTTS’ expertise in AI-driven diagnostics and predictive analytics, with NVIDIA’s powerful, modeling and visualization platform. This lets us engineer a digital twin platform that not only enhances diagnostic accuracy but also gives clinicians an immersive, real-time planning tool ultimately helping deliver better outcomes for patients around the world.”

“Working with LTTS to accelerate the development of AI-enabled medical technology demonstrates how NVIDIA is empowering the healthcare industry with accelerated computing and AI innovation,” said David Niewolny, Director of Business Development for Healthcare/Medical at NVIDIA. “LTTS is enabling transformative solutions that bring the vision of real-time AI and biological digital twins powered by NVIDIA to clinical practice – delivering interactive, real-time visualization and intelligent guidance to help clinicians provide higher-quality care and achieve better outcomes for patients.”

About L&T Technology Services Ltd

L&T Technology Services (LTTS) is a global leader in AI, Digital & ER&D Consulting Services. A listed subsidiary of Larsen & Toubro (L&T), we offer design, development, testing, and sustenance services across products and processes.

Purposeful. Agile. Innovation. is how we drive growth across the Mobility, Sustainability and Tech segments. Our customer base includes 69 Fortune 500 companies and 57 top ER&D companies across industrial products, medical devices, transportation, telecom & hi-tech, and process industries. Headquartered in India, we have over 23,670 employees across 23 global design centers, 30 global sales offices, and 105 innovation labs, as of September 30, 2025.

For more information, please visit https://www.LTTS.com/

Contacts

Media:
Aniruddha Basu

L&T Technology Services Limited

E: Aniruddha.Basu@LTTS.com

Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe




Samsung Bioepis Announces Launch of Denosumab Biosimilars, OBODENCE™ and XBRYK™, in Europe

• OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial) become available across Europe as of December 2025 and January 2026, respectively
• Marks Samsung Bioepis’ 10^th and 11^th biosimilars launched in Europe and second and third product to be commercialized directly by Samsung Bioepis
• Launch reinforces Samsung Bioepis’ biosimilar leadership in Europe as it expands its portfolio into endocrinology and builds on its growing direct sales efforts

INCHEON, Korea–(BUSINESS WIRE)–#Biosimilar–Samsung Bioepis Co., Ltd. today announced the launch of OBODENCE™ (60 mg pre-filled syringe) and XBRYK™ (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva. The products will be commercially available in Europe in December 2025 and January 2026, respectively.

“We are very thrilled to launch OBODENCE and XBRYK through our direct sales efforts. Osteoporosis remains a major challenge in Europe due to limited treatment options and affordability challenges. And bone-related events resulting from bone metastases significantly impact a patient’s quality of life, leading to death if not treated fast enough. Our biosimilars aim to improve access, enable timely care, and ease the financial burden on healthcare systems.”, said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial Division at Samsung Bioepis. “With our proven track records, we’re confident that OBODENCE and XBRYK will deliver meaningful impact on patients and their communities.”

OBODENCE, referencing Prolia, has been approved for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

XBRYK, referencing Xgeva, has been approved for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

In Europe alone, osteoporosis results in 4.3 million fragility fractures and health care costs reaching €56 billion annually. Due to the limited treatment options and affordability of the medications, less than half of women at high risk of fracture are treated.¹ In addition, skeletal related events (SREs) resulting from bone metastases can lead to severe pain, increased risk of death, increased health care costs and reduced quality of life.²

OBODENCE, the company’s first biosimilar in endocrinology, and XBRYK, the company’s third biosimilar in oncology, mark Samsung Bioepis’ 10^th and 11^th biosimilars available in Europe. They add to the company’s diverse therapeutic portfolio ranging from immunology, oncology, ophthalmology, hematology, and nephrology.

About OBODENCE (denosumab) in the European Union

Obodence 60 mg solution for injection in pre-filled syringe is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women denosumab significantly reduces the risk of vertebral, non-vertebral and hip fractures.

Treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, denosumab significantly reduces the risk of vertebral fractures.

Treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

OBODENCE EU Important Safety Information

The EU Summary of Product Characteristics for OBODENCE includes the following Special warning and Precautions:

• Hypersensitivity
• Hypocalcaemia
• Renal impairment
• Skin infections
• Osteonecrosis of the jaw (ONJ)
• Osteonecrosis of the external auditory canal
• Atypical fractures of the femur
• Long-term antiresorptive treatment
• Concomitant treatment with other denosumab-containing medicinal products
• Hypercalcaemia in paediatric patients

These highlights do not include all the information needed to use OBODENCE safely and effectively. Refer to the Summary of Product Characteristics for OBODENCE’s full safety information.

About XBRYK (denosumab) in the European Union

Xbryk 120 mg solution for injection is indicated for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.

Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

XBRYK EU Important Safety Information

The EU Summary of Product Characteristics for XBRYK includes the following Special warning and Precautions:

• Hypersensitivity
• Hypocalcaemia
• Hypercalcaemia following treatment discontinuation in patients with giant cell tumour of bone and in patients with growing skeletons
• Renal impairment
• Osteonecrosis of the jaw (ONJ)
• Osteonecrosis of the external auditory canal
• Atypical fractures of the femur

These highlights do not include all the information needed to use XBRYK safely and effectively. Refer to the Summary of Product Characteristics for XBRYK’s full safety information.

# # #

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X, LinkedIn.

¹ International Osteoporosis Foundation. SCORECARD FOR OSTEOPOROSIS IN EUROPE: SCOPE 2021 Summary Report. Available at: https://www.osteoporosis.foundation/scope-2021. Accessed January 2025.

² So A, Chin J, Fleshner N, Saad F. Management of skeletal-related events in patients with advanced prostate cancer and bone metastases: Incorporating new agents into clinical practice. Can Urol Assoc J. 2012 Dec;6(6):465-70. doi: 10.5489/cuaj.12149. PMID: 23282666; PMCID: PMC3526633.

Contacts

MEDIA CONTACT
Yoon Kim, yoon1.kim@samsung.com
Anna Nayun Kim, nayun86.kim@samsung.com

GE HealthCare builds on a century of innovation to shape the future of radiology at RSNA 2025




GE HealthCare builds on a century of innovation to shape the future of radiology at RSNA 2025

• The company will showcase a wave of transformative innovations designed to address the most pressing challenges in healthcare, spanning the care journey across smart devices and drugs throughout disease states enabled by cloud and AI solutions.
• GE HealthCare has invested more than $3B in R&D since 2022, delivering an innovation renaissance across disease states to advance precision care.

CHICAGO–(BUSINESS WIRE)–At this year’s Radiological Society of North America’s (RSNA) 2025 Annual Meeting, GE HealthCare (Nasdaq: GEHC) will showcase a wave of significant innovations grounded by its legacy and deep, global commitment to advancing precision care. For more than a century, GE HealthCare has stood at the intersection of medicine and technology—helping clinicians see more, understand more, and do more for their patients. What began with some of the world’s earliest technology innovations in medical imaging has evolved into a strong, global focus to advancing precision care.

Solving industry challenges

Radiology departments worldwide are facing unprecedented pressure. In the coming years, healthcare providers are expected to encounter several critical challenges, including a shortage of qualified staff, rising demand for imaging services, rapid technological advancements, and the urgent need to improve operational efficiency across care settings.¹ Amid these challenges, GE HealthCare is developing cloud-based and AI-enabled innovations aimed at helping providers and clinicians turn data into actionable insights, deliver precise diagnoses and treatment plans faster than before, and help hospitals boost their efficiency.

At RSNA 2025, GE HealthCare will showcase more than 40 technology innovations that merge state-of-the-art imaging device technology with advanced digital, computational and AI capabilities and are designed to address these challenges head-on: from AI-enabled imaging systems that are designed to reduce cognitive load and automate routine tasks, to structured reporting tools that can streamline workflows and improve data consistency.

“As we shape the future of care, our commitment remains clear: to deliver transformative technologies that empower clinicians, drive efficiencies, and help improve patient outcomes across multiple care pathways,” said Peter Arduini, CEO of GE HealthCare. “We start by listening to our customers, and work backwards from their challenges, then develop truly differentiated products and solutions to meet their needs today and into the future.”

Key products driving GE HealthCare’s innovation renaissance

GE HealthCare is delivering bold new solutions designed to elevate patient care and enhance the clinician experience. Since 2022, GE HealthCare has invested more than $3 billion in research and development, fueling a wave of innovation across equipment, radiopharmaceuticals and cloud and AI-enabled solutions. This year at RSNA, GE HealthCare will demonstrate new and recently announced innovations, including:

• Photonova™ Spectra² (510(k) pending with the U.S. FDA; not available for sale): The new photon counting CT (PCCT) system with advanced AI algorithms,³ marks a major milestone in the company’s decades-long history in CT innovation. Built on GE HealthCare’s proprietary Deep Silicon detector technology, Photonova Spectra is designed to deliver remarkable spectral and spatial resolution for ultra-high-definition (UHD) imaging with wide coverage, seeking to enable fast acquisition speeds, precise visualization of anatomical structures and enhanced material separation. This system is designed to maximize the vast amounts of data provided, harnessing up to 50 times more data than conventional CT⁴ to enable advanced reconstruction techniques and precise outputs with the aim of supporting enhanced clinical decision-making and smooth workflows.
• Next-gen SIGNA MRI technology (510(k) pending at the U.S FDA; not available for sale): These technologies are designed to enhance precision diagnosis for clinicians. The innovations include:
  • SIGNA™ Bolt⁵ aims to bring to market our most advanced high-field, clinical wide bore 3.0T MRI system and is seeking to combine ultra-high gradient performance, intelligent digital RF architecture, and sustainable design to deliver precision imaging, fast workflows, and seamless clinical-to-research flexibility, all with exceptionally low energy consumption and operational costs.
  • SIGNA™ Sprint with Freelium™⁶ aims to broaden access to sustainable and equitable MRI technology. With less than 1% helium usage compared to conventional magnets, Freelium is designed to provide effortless sustainability without compromising clinical and operational efficiency.
  • Both are powered by SIGNA™ One⁷, an AI-powered workflow platform designed to improve the imaging experience by combining precision with simplicity.
• Pristina™ Recon DL: This solution is GE HealthCare’s advanced 3D mammography reconstruction technology—the first to combine deep learning with iterative reconstruction to provide outstanding digital breast tomosynthesis (DBT) image quality at a low patient radiation dose. Pristina Recon DL is an enhancement to GE HealthCare’s Pristina Via™ system. Pristina Via with Recon DL mammography system offers high clinical confidence and efficient workflows with exceptional patient experience.
• Vivid™ Pioneer: GE HealthCare’s most advanced and adaptive cardiovascular ultrasound platform. With one-click optimization, AI automation tools, simplified user interface and a lighter, compact, battery supported system, Vivid Pioneer is designed for extraordinary imaging, workflow, and comfort.
• Flyrcado™ (flurpiridaz F 18) injection: FDA-approved PET MPI agent for adult patients with known or suspected coronary artery disease to evaluate myocardial ischemia and infarction; higher diagnostic efficacy versus SPECT, exercise-stress PET enabled by a longer half-life, and ready-to-use unit dose to support adoption. Flyrcado is expected to reach a substantial number of cardiac PET centers in the U.S. as adoption continues. CMS traditional pass-through status (effective Apr 1, 2025) supports access in HOPD settings. U.S. audiences only.
• Definium Pace Select ET: An advanced floor-mounted digital X-ray system designed to deliver high-image quality and optimize efficiency in highly demanding environments while enhancing access and affordability. The system solves for many technologist challenges today by automating manual, repetitive steps and helping to reducing physical strain. The system leverages AI to help ensure accurate patient positioning and consistent image quality across various clinical conditions while streamlining the technologist workflow to maximize the patient experience and throughput.

GE HealthCare is at the forefront of developing advanced AI- and cloud-enabled capabilities to help improve workflow efficiency for radiologists. Key highlights this year include:

• Genesis™ Radiology Workspace⁸ anchored by Genesis Viewer (510(k) pending at the U.S FDA; not available for sale):⁹ Software that is designed to be an ultra-fast diagnostic, zero-footprint viewer – streamlining radiology workflows and aiming to enhance patient care while being fully accessible from any location. Genesis Viewer is part of the GE HealthCare’s Genesis™ Radiology Workspace to help radiologists streamline their workflows. The next-generation solution is designed to transform radiology workflows, unify the user experience, and empower radiologists with great efficiency and precision.
• 100 FDA-authorized AI-enabled solutions: GE HealthCare leads the industry in artificial intelligence innovation, topping the FDA’s list for the most AI-enabled device authorizations of any medical device company this year. These solutions are helping to transform clinical workflows, supporting fast and precise decision-making, and expanding access to high-quality care.

“For more than 125 years, GE HealthCare has pioneered technologies that transform patient care. And while we celebrate our heritage, we remain focused on what lies ahead: a future where care is more personalized, connected, and intelligent than ever before,” said Roland Rott, CEO and President of Imaging at GE HealthCare. “This year at RSNA, our new innovations continue that tradition, empowering clinicians and advancing the boundaries of what’s possible in healthcare.”

A legacy rooted in discovery

GE HealthCare has been shaping the future of healthcare for more than a century. From the invention of the first x-ray tube still in use in modern day imaging equipment to today’s innovation renaissance, its led advances that redefine diagnostic imaging and how clinicians treat and care for patients. The company’s presence at every RSNA since its inception in 1914 reflects an enduring commitment to advance radiology and support the imaging community.

This year, GE HealthCare commemorates a series of transformative achievements that have shaped the landscape of medical imaging and patient care:

• Sixty years of mammography: Since 1965, GE HealthCare has led mammography innovation—from developing the first dedicated X-ray machine to digital, 3D, and AI-powered technologies that enable early accurate diagnoses. This ongoing commitment to women’s health empowers clinicians and aims to improve outcomes worldwide.
• Twenty-five years of PET/CT: Since introducing the world’s first commercially available PET/CT system in 2001—an innovation that would redefine diagnostic imaging and help transform patient care—GE HealthCare has expanded access and helped elevate precision medicine across care pathways. By combining functional and anatomical imaging, PET/CT has become an essential tool for clinicians, helping them detect, stage, and monitor cancer with greater accuracy and confidence.
• A legacy of industry firsts: GE HealthCare’s history is marked by groundbreaking achievements, including the development of the first full body CT scanner, the commercialization of magnetic resonance imaging (MR), the introduction of the first color pocket-size handheld ultrasound, Vscan, in 2010, and Flyrcado in 2024, a first-of-its kind PET molecular imaging agent for diagnosing and assessing coronary artery disease, a significant game-changing innovation for nuclear cardiology. Each innovation is designed to set new standards for patient care and clinical excellence.

Strategic collaborations driving innovation

GE HealthCare’s commitment to advancing patient care goes beyond research and development—it’s strengthened by strategic collaborations and acquisitions that accelerate innovation. In the past year, the company has strengthened its portfolio to include:

• MIM Software, which enhances GE HealthCare’s ability to provide advanced imaging analytics, visualization, and workflow solutions
• Spectronic Medical, delivering innovations that aim to enhance radiation oncology planning
• icometrix, which further expands GE HealthCare’s leadership in AI-enabled precision imaging, facilitating neurological disorder diagnosis and monitoring of disease progression

For more information on GE HealthCare and these innovative solutions at RSNA, visit booth 7334, explore the press kit, or the RSNA 2025 events page.

Important Safety Information and Usage of Flyrcado™ (flurpiridaz F 18) injection

Indications and Usage

FLYRCADO is a radioactive diagnostic drug indicated for positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress (pharmacologic or exercise) in adult patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.

Contraindications

None

Warnings and Precautions

• Risk associated with exercise or pharmacologic stress: Patients evaluated with exercise or pharmacologic stress may experience serious adverse reactions such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction, stroke, and seizure. Perform stress testing in the setting where cardiac resuscitation equipment and trained staff are readily available. When pharmacologic stress is selected as an alternative to exercise, perform the procedure in accordance with the pharmacologic stress agent’s prescribing information.
• Radiation risks: FLYRCADO contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to minimize radiation exposure to patients and health care providers. Advise patients to hydrate before and after administration and to void.

Adverse Reactions

• Most common adverse reactions occurring during FLYRCADO PET MPI under rest and stress (pharmacologic or exercise) (incidence ≥ 2%) are dyspnea, headache, angina pectoris, chest pain, fatigue, ST segment changes, flushing, nausea, abdominal pain, dizziness, and arrhythmia.

Use in Specific Populations

• Pregnancy
  • There are no data on use of flurpiridaz F 18 in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from flurpiridaz F 18 and the gestational timing of exposure.
  • FLYRCADO contains ethanol (a maximum daily dose of 337 mg anhydrous ethanol). If considering FLYRCADO administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes associated with ethanol exposure during pregnancy.
• Lactation
  • Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for at least 8 hours after FLYRCADO administration.
• Pediatric Use
  • Safety and effectiveness of FLYRCADO in pediatric patients have not been established.

To report SUSPECTED ADVERSE REACTIONS, contact GE HealthCare at 800-654-0118 (option 2 then option 1) or by email at GPV.drugsafety@gehealthcare.com or FDA at 800-FDA-1088 or www.fda.gov/medwatch

For full prescribing information, click here. For important safety information, please click here.

About GE HealthCare Technologies Inc.

GE HealthCare is a trusted partner and leading global healthcare solutions provider, innovating medical technology, pharmaceutical diagnostics, and integrated, cloud-first AI-enabled solutions, services and data analytics. We aim to make hospitals and health systems more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 125 years, GE HealthCare is advancing personalized, connected and compassionate care, while simplifying the patient’s journey across care pathways. Together, our Imaging, Advanced Visualization Solutions, Patient Care Solutions and Pharmaceutical Diagnostics businesses help improve patient care from screening and diagnosis to therapy and monitoring. We are a $19.7 billion business with approximately 53,000 colleagues working to create a world where healthcare has no limits.

GE HealthCare is proud to be among 2025 Fortune World’s Most Admired Companies™.

Follow us on LinkedIn, X, Facebook, Instagram, and Insights for the latest news, or visit our website https://www.gehealthcare.com for more information.

¹ Elizabeth H. Dibble et al. “Workforce Shortage and Strategies for Mitigation: Results from the 2022 ACR/Radiology Business Management Association Workforce Survey.” Journal of the American College of Radiology 22, no. 5 (2025): 573–576. https://doi.org/10.1016/j.jacr.2025.01.xxx.

² Photonova Spectra is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region.

³ Enhanced Boundary for PCCT is 510(k)-pending with the U.S. FDA. Not CE Marked. Not available for sale in the United States, Europe, Canada, or any other region.

⁴ When compared to Revolution Apex Elite.

⁵ SIGNA Bolt is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.

⁶ SIGNA Sprint with Freelium is a sealed configuration of SIGNA Sprint Select. SIGNA Sprint Select is 510(k) pending at U.S. FDA. Not CE marked. Not available for sale.

⁷ SIGNA One is 510(k) pending with the U.S. FDA. Not CE marked. Not available for sale.

⁸ Genesis Radiology Workspace consists of Genesis View, Enterprise Archive, Workflow Manager and App Orchestrator.

⁹ Genesis Viewer is 510(k) Pending at the U.S. FDA; not available for sale.

Contacts

Media Contact:
Catherine Carter

Senior Communications Manager

GE HealthCare

+1 414 396-1439

Catherine.Carter@gehealthcare.com