Medera Strengthens Leadership Team with Three Key Executive Appointments

Clinical operations, regulatory affairs, technical expertise, and corporate leadership additions support advancing gene therapy pipeline for cardiovascular diseases

BOSTON, Sept. 30, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ("Medera"), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing next-generation therapeutics, and its clinical development division, Sardocor, today announced the appointments of three senior executives to strengthen its leadership team. The expanded team includes Fubao Wang, Ph.D., as Chief Regulatory Officer and Chief Technical Officer, Sardocor; James Kim as Chief Corporate Officer, Medera; and Niharika (Niha) Kamat, M.S., as Vice President of Clinical Operations, Sardocor.

"These exceptional leaders bring decades of combined experience in gene therapy, clinical operations, regulatory affairs, and corporate finance that will be instrumental as we advance our innovative cardiac gene therapy programs through ongoing clinical trials,” said Ronald Li, Ph.D., CEO and Co-Founder of Medera. “Their proven track records in bringing complex therapies from development through regulatory approval, combined with deep capital markets expertise, align perfectly with our mission to transform treatment for patients with incurable cardiovascular diseases.”

Fubao Wang, Ph.D. – Chief Regulatory Officer and Chief Technical Officer, Sardocor

Dr. Wang brings over 28 years of pharmaceutical and biotech industry experience across multiple prophylactic and therapeutic areas and product modalities including gene editing, cell and gene therapy, RNA therapeutics, biologics, and vaccines. His product development and regulatory experience encompasses CMC, pre-clinical, early-stage, and late-stage clinical development, global regulatory strategy, submission, approval, and post-approval regulatory maintenance. Dr. Wang served most recently as Senior Vice President, Head of Regulatory Affairs at Prime Medicine and AskBio, and previously as Vice President, Head of Regulatory CMC at Sarepta Therapeutics, Associate Vice President, US site head of CMC Dossiers at Sanofi, and Director of Global and Emerging Markets Regulatory Affairs at Merck. Dr. Wang holds a B.S. in Biology and M.S. in Microbiology from Nankai University, China; Ph.D. in Molecular Biology from University of Heidelberg, Germany, and was trained as a Post-Doctoral Fellow in Molecular Biology and Genetics at Stanford University.

James Kim – Chief Corporate Officer, Medera

Mr. Kim brings over 20 years of experience in the biopharmaceutical industry as a senior executive and investment banker. In 2024, Mr. Kim served as Chief Financial Officer at TriArm Therapeutics, a private biotechnology company specializing in CAR-T therapies. Prior to his role at TriArm, Mr. Kim was a Managing Director at Stifel, Raymond James, Cantor Fitzgerald, and Jefferies, focused on biopharmaceutical coverage. He has advised on and executed over 100 transactions, totalling approximately $13 billion in mezzanine, public equity, and debt financings, as well as $12 billion in business development and M&A transactions. Mr. Kim holds a Bachelor of Science in Economics from The Wharton School at the University of Pennsylvania.

Niharika (Niha) Kamat, M.S. – Vice President of Clinical Operations, Sardocor

Ms. Kamat brings nearly 20 years of leadership experience across the medical device, pharmaceutical, and biotechnology sectors, with deep expertise in global Phase 1-3 trials across cardiovascular, liver, hemophilia, and rare disease indications. Prior to joining Sardocor, she served as Head of Clinical Operations at Tenaya Therapeutics, where she led First-in-Human gene therapy trials in cardiovascular disease, implemented dose escalation strategies, and built a high-performing Clinical Operations team. Her earlier roles include leading gene therapy programs for hemophilia at Catalyst Biosciences and nearly a decade at Gilead Sciences managing small molecule trials across all phases in infectious diseases, as well as contributing to cardiovascular medical device development at Abbott Vascular. Ms. Kamat holds a Master’s degree in Bioengineering from the University of Texas at Arlington and a Bachelor’s degree in Biomedical Engineering from Mumbai University.

With these strategic leadership appointments, Medera strengthens its position to advance its pipeline of innovative cardiac gene therapies while building the regulatory, clinical operations, and corporate expertise necessary to bring these potentially transformative treatments to patients with significant unmet medical needs.

About Medera Inc.

Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively.

Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart's versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart's technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor's lead therapeutic candidates that are currently in clinical trials.

Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor's pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases.

For more information, please visit www.medera.bio.

Contacts:

Ally Stubin
Public Relations
ICR Healthcare
Ally.stubin@icrhealthcare.com
646.667.1861

Stephanie Carrington
Investor Relations
ICR Healthcare
Stephanie.carrington@icrhealthcare.com
646.277.1282

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