Medera Inc., a clinical-stage biopharmaceutical company, announced that its wholly owned preclinical subsidiary Novoheart has entered into a transformative partnership with Curi Bio Inc., a leader in preclinical screening technologies. The strategic collaboration integrates Novoheart's industry-leading human Heart-in-a-Jar technology with Curi Bio's advanced Pulse analytics platform, delivering an innovative solution for accelerated, high-content, human-based cardiac drug development.
The partnership reflects a shared focus on the rapidly emerging market of human-based preclinical models for drug development that has been stimulated by the recent passing of the FDA Modernization Act 2.0, which calls for the development of superior human-based alternatives to traditional animal testing.
Proven Track Record in Drug Development
Novoheart's human-based mini-Heart models have demonstrated significant translational power in supporting regulatory applications. The platform has successfully enabled the modeling of diseases traditionally difficult to recapitulate using experimental animals, such as Friedreich's Ataxia and Heart Failure with preserved Ejection Fraction (HFpEF), through collaborations with global pharmaceutical companies including Pfizer and AstraZeneca.
The mini-Heart models have successfully supported Medera and its clinical subsidiary Sardocor to obtain Investigational New Drug (IND) clearance and Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for an ongoing first-in-human gene therapy clinical trial in accordance with the FDA Modernization Act 2.0, validating the platform's translational capabilities.
Advanced Analytics Integration
Curi Bio brings complementary strengths with its Mantarray contractility system, Nautilai calcium imaging system, and Pulse cloud-based analytics. The Pulse platform integrates high-throughput data processing, powerful cloud-based analytics, and intuitive visualization tools to streamline complex biological datasets into actionable insights. With always-on accessibility and real-time updates that enable novel measurements, Pulse ensures researchers have uninterrupted access to powerful analytics for timely and data-driven drug development decisions.
As the first step in their partnership, Curi Bio is adapting Pulse to process the unique pressure-volume data generated by Novoheart's Heart-in-a-Jar. This integration aims to enhance Novoheart's platform by enabling smart, high-content assessment of cardiac pump function, significantly reducing the time and cost required for screening drug candidates.
Dramatic Efficiency Improvements
Together with the newly introduced multi-heart recording technology, the efficiency has been estimated to improve by as much as 100-fold. The integrated solution will initially be made available to select early access customers, representing a significant advancement in human-based cardiac drug screening capabilities.
"This integration underscores Curi Bio's ongoing commitment to delivering innovative solutions for human-relevant drug discovery," said Nicholas Geisse, CEO of Curi Bio. "This partnership with Novoheart exemplifies how complementary collaborations can bring the next generation of human-specific cardiac technologies to the forefront of drug discovery, ultimately benefiting patients worldwide."
Strategic Vision for Drug Development
"Medera believes in strength through collaboration, and partnering with Curi Bio provides a strategic opportunity based on our shared vision for the drug development field," said Ronald Li, CEO and co-Founder of Medera. "By joining forces and leveraging our complementary strengths, this is a first step toward a long-term partnership that will keep both companies at the very forefront of in vitro human-based drug screening, ultimately delivering safer, more effective therapies to patients with maximal efficiency and success."
Kenneth KC Wong, Chairman and CEO of Keen Vision Acquisition Corporation (KVAC), emphasized the collaboration's potential impact on drug safety: "As cardiac safety is critical to all new drug discovery and development, we believe this collaboration can offer a more holistic approach in better determining the safety of new drugs, more accurately assessing new drug dosages, and further enhancing human safety in drug development process."
Company Profiles
Medera operates through two business units: Novoheart for preclinical disease modeling and drug discovery, and Sardocor for clinical development. Novoheart's versatile technology platform provides state-of-the-art automation hardware and software as well as screening services for human-specific disease modeling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization.
Sardocor has received 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 Fast Track Designation, and Duchenne Muscular Dystrophy-induced Cardiomyopathy (DMD-CM) with Orphan Drug Designation.
Curi Bio specializes in unlocking novel workflows and delivering functional human data to inform biopharmaceutical R&D decision-making through an integrated platform featuring advanced 3D tissue models of disease, biosystems enabling clinically relevant functional analyses, and AI/ML-enabled insights.
