Dr. Kevin Costa noted that advancements in their human mini-heart platforms could significantly reduce the time and cost of developing new therapies, aligning with FDA guidance on alternatives to animal testing.

Key advancements discussed at the meeting included high-throughput screening, AI-driven drug classification, and patient-specific disease modeling, highlighting the platform's potential to mitigate risks in drug development and enhance clinical translation.

Additional poster presentations featured findings on engineered human tissue models for heart failure, improvements in drug classification through machine learning, and automated high-throughput screening technologies that enhance cardiac contractility testing.

The event featured seven presentations, including a significant oral presentation on a first-in-human gene therapy for heart failure, utilizing the proprietary human mini-heart platform.

Medera aims to tackle the global heart failure pandemic, which affects an estimated 64.3 million people worldwide, with a particular focus on heart failure with preserved ejection fraction (HFpEF), a condition that has seen limited successful interventions.

Medera operates through its two units, Novoheart, which specializes in cardiac tissue engineering, and Sardocor, focused on clinical development, having received IND clearances for several gene therapy trials targeting various cardiac conditions.

The FDA-supported human-based screening platform is recognized as an animal-free alternative in drug development, facilitating IND and Fast Track approvals under the FDA Modernization Act 2.0.

At the ISSCR 2025 Annual Meeting in Hong Kong, Medera Inc. and Novoheart showcased significant advancements in human mini-heart technology and gene therapy.

A key presentation by Dr. Costa highlighted the MUSIC-HFpEF trial, which explores the gene therapy treatment SRD-002 for heart failure with preserved ejection fraction, recently receiving FDA's IND approval and Fast Track designation.

The trial employs a minimally invasive intracoronary infusion method for delivering the gene therapy, demonstrating the potential of innovative human cardiac models to support regulatory decisions.

Ronald Li, CEO and co-founder of Medera and Novoheart, emphasized the increasing regulatory support for human-specific models to replace traditional animal testing in clinical trials.