Medera Inc., a clinical-stage biopharmaceutical company focused on cardiovascular disease therapies, and its pre-clinical subsidiary Novoheart, specializing in human cardiac tissue engineering, have announced a new collaboration with leading physician-scientists at the University of California San Diego School of Medicine and Mayo Clinic. The partnership aims to develop the first human mini-heart models of hypoplastic left heart syndrome (HLHS) using patient-derived stem cells, with the goal of advancing personalized treatment options for children affected by this severe congenital heart defect.
HLHS is a complex condition where the left side of the heart is underdeveloped, and currently, there is no reliable method to predict which patients will benefit from surgery versus needing a heart transplant. Paul Grossfeld, MD, a pediatric cardiologist and HLHS expert at UC San Diego, highlighted the potential impact of the project: “By generating patient-specific 3D human heart models from a simple blood draw, we aim to uncover the biological mechanisms driving disease in each child—and ultimately tailor treatments that improve their chances of survival.”
The project utilizes Novoheart’s proprietary mini-Heart Platform, a suite of 3D bioengineered cardiac tissues that closely replicate human heart structure and function, surpassing traditional animal models and 2D cell cultures. This technology allows detailed functional screening of heart tissues derived from HLHS patients and their healthy relatives, using automated hardware and software systems.
A critical resource for this effort is the Mayo Clinic’s HLHS biobank, containing samples from over 800 HLHS patients and families collected over 25 years. Timothy Nelson, MD, PhD, director of the Wanek Family Program for HLHS at Mayo Clinic, oversees this extensive repository. While some HLHS cases are linked to specific genetic mutations, most remain poorly understood, posing challenges to current research models.
Novoheart has previously developed models for other congenital heart diseases such as Pulmonary Atresia and Tetralogy of Fallot, demonstrating the ability of their platform to address complex cardiac conditions. Kevin Costa, PhD, Novoheart co-founder, emphasized, “This collaboration allows us to test how well our patient-specific disease models can predict treatment responses in the most complex pediatric heart disease we know. It’s the first step toward bringing personalized cardiac care to children with HLHS.”
Ronald Li, PhD, CEO of Medera and Novoheart, added, “We’re proud to support this effort and confident that our mini-Heart Platform will once again demonstrate its predictive power. By building human-relevant disease models, Medera is accelerating the path to better therapies—without relying on animal testing—and aligning with the latest FDA regulatory science.”
This initiative is supported by the John Dimitri Research Foundation for Congenital Heart Disease and Big Hearts 2 Little Hearts. Additionally, on September 5, 2024, Medera announced a definitive merger agreement with Keen Vision Acquisition Corporation, further positioning the company for growth and innovation in cardiovascular therapeutics.