Medera and Novoheart Presented Breakthroughs in Human mini-Heart Platforms and Gene Therapy at ISSCR 2025

Yahoo

13-06-2025

Showcased 7 presentations at ISSCR 2025, including a featured oral presentation on first-in-human gene therapy for heart failure, powered by their proprietary human mini-Heart technology.
FDA-backed human-based screening platform recognized as an animal-free alternative in drug development, supporting IND and Fast Track approvals under the FDA Modernization Act 2.0.
Breakthroughs in high-throughput screening, AI-driven drug classification, and patient-specific disease modelling underscored the platform's potential to de-risk development and accelerate clinical translation.
BOSTON, June 13, 2025 (GLOBE NEWSWIRE) -- Medera Inc. ('Medera'), a clinical-stage biopharmaceutical company focused on targeting cardiovascular diseases by developing a range of next-generation therapeutics, and Novoheart, its wholly owned pre-clinical subsidiary pioneering human-based cardiac tissue engineering for disease modelling and drug screening, today announced the successful presentation of seven scientific abstracts at the 2025 International Society for Stem Cell Research (ISSCR) Annual Meeting, held June 11–14 in Hong Kong.
The annual ISSCR meeting brought together nearly 4,000 of the world's leading stem cell researchers and regenerative medicine experts. Medera's presentations showcased how the company's human mini-Heart technology has informed and accelerated clinical translation of novel gene therapies, including two ongoing first-in-human clinical trials for heart failure.
'Regulatory momentum is clearly building toward human-specific models in place of traditional animal testing,' said Ronald Li, PhD, CEO and co-founder of Medera and Novoheart. 'At ISSCR 2025, we demonstrated that engineered human mini-Hearts not only predict human outcomes better, as well as directly support clinical and regulatory decisions—including trial design and therapeutic validation.'
'The advances in human mini-Heart platforms presented at ISSCR exemplify the translational promise of stem cell technologies,' said Dr. Kevin Costa, co-founder of Novoheart. 'By creating more physiologically relevant human cardiac tissues, we significantly reduce the time and cost of bringing new therapies to patients while aligning with evolving FDA guidance on alternatives to animal testing.'
Featured Oral Presentation
'Gene Therapy Clinical Trial for Heart Failure with Preserved Ejection Fraction (MUSIC-HFpEF) Informed by In Vitro Screening with Stem Cell-Based Bioengineered Mini-Hearts' (Abstract #2036995)Track: Clinical ApplicationsPresenter: Dr. Kevin Costa, co-founder of NovoheartThis presentation showcased how data generated from Novoheart's human mini-Heart platform informed both the FDA's Investigational New Drug (IND) approval and Fast Track Designation of the MUSIC-HFpEF gene therapy trial (NCT06061549). The trial is investigating SRD-002, a one-time gene therapy treatment delivered through proprietary minimally invasive intracoronary infusion methodology. The FDA's recognition of these in vitro human cardiac models reflects a broader regulatory embrace of non-animal technologies to advance safer and more targeted therapies, in line with new federal policy.
Poster Highlights
'Reversal of Contractile Defects in Engineered Human Tissue Models of Heart Failure with Preserved Ejection Fraction (HFpEF) Leads to First-In-Human Gene Therapy Clinical Trial' (Abstract #2035967)Track: Disease Modeling and Drug DiscoveryThis poster described how disease-specific mini-Heart models enabled rational dose selection and mechanistic insight into SERCA2a-targeted AAV gene therapy now in clinical trials for HFpEF.
'Modulation of SERCA2a of Intra-Myocytic Calcium Trafficking in Patients with Heart Failure with Reduced Ejection Fraction (MUSIC-HFrEF) and Stem Cell Models of Heart Failure' (Abstract #2036913)Track: Clinical ApplicationsThis presentation detailed how mini-Heart models supported the ongoing MUSIC-HFrEF trial (NCT04703842) evaluating SRD-001 gene therapy for patients with HFrEF.
'Enhanced Drug Classification Using Machine Learning with Multiplexed Cardiac Contractility Assays' (Abstract #2035910)Track: Disease Modeling and Drug DiscoveryNovel ensemble algorithms trained on contractility and electrophysiology data from human cardiac tissues were demonstrated to outperform conventional approaches for drug classification.
'Automating High-Throughput Screening of Cardiac Contractility by Robotically Controlled Functional Testing of Stem Cell-Derived Micro-Tissues in a 96-Well Plate Format' (Abstract #2036321)Track: Disease Modeling and Drug DiscoveryThis technology was shown to reduce cell use and screening time by over 90%, scaling up human-relevant cardiac safety and efficacy profiling.
'Collagen Matrix Improves Cardiomyocyte Contractility and Maturity Compared to Fibrin in 3D Engineered hiPSC Cardiac Tissue Strips' (Abstract #2036017)Track: Disease Modeling and Drug DiscoveryThe researchers demonstrated how matrix optimization yields more physiologically relevant tissue phenotypes for improved drug screening and disease modeling.
'Transcriptomic Analysis and Bioengineered Tissue Model of Dystrophinopathy with Patient-Derived iPSC-Cardiomyocytes" (Abstract #2035586)Track: Disease Modeling and Drug DiscoveryA personalized medicine platform was presented for understanding and treating rare genetic cardiomyopathies such as Duchenne Muscular Dystrophy-associated cardiomyopathy.
These advances underscore the transformative role of human organoid technologies in bridging the lab-to-clinic gap while helping to realize the vision of ethical, efficient, and precision-driven biomedical innovation.
On September 5, 2024, Medera and Keen Vision Acquisition Corporation ('KVAC') (NASDAQ: KVAC, KVACW), announced they had entered into a definitive merger agreement.
About Heart Failure with Preserved Ejection Fraction (HFpEF)
Heart failure (HF) is a global pandemic with an estimated 64.3 million cases worldwide and a rising prevalence trend. Accounting for 50% or more of the overall HF population, HFpEF is an age-related condition that has become increasingly prevalent in recent years. This surge is partly due to better awareness and identification of the condition and partly due to lifestyle changes affecting cardiac myocytes. Individuals affected by HFpEF experience similar morbidity and mortality to patients with HF with reduced ejection fraction (HFrEF). Despite the growing epidemic of this emerging syndrome, HFpEF-focused interventional trials have had little success, except for the use of sacubitril-valsartan (Entresto™) and the sodium glucose transporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance™) for reducing cardiovascular mortality and heart failure hospitalization. However, these agents are not disease-modifying, highlighting the critical need for therapeutic interventions targeting the physiological mechanisms involved in HFpEF.
About Medera
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.
About Keen Vision Acquisition Corporation
Keen Vision Acquisition Corp ("KVAC"), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance ("ESG") imperatives.
For more information, please visit www.kv-ac.com.
Forward-Looking Statements
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Contacts:
Keen Vision Acquisition CorporationAlex DavidkhanianChief Financial OfficerEmail: [e-mail]
MederaInvestor RelationsStephanie CarringtonICR [e-mail][phone]
Media RelationsSean LeousICR [e-mail][phone]