Medera Inc. 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 a groundbreaking collaboration with physician-scientists at the University of California San Diego School of Medicine and Mayo Clinic. The goal of the partnership is to develop the first human mini-heart models of hypoplastic left heart syndrome (HLHS) using stem cells from real patients and improve the understanding of this disease with the goal of developing more personalized treatment strategies for children born with this devastating condition.

“There is currently no reliable way to predict which HLHS patients will benefit from surgery versus needing a transplant,” said Paul Grossfeld, MD, Clinical Professor of Pediatrics at University of California San Diego School of Medicine, pediatric cardiologist at Rady’s Children’s Hospital-San Diego, and a leading expert on HLHS. “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 leverages Novoheart’s proprietary mini-Heart Platform, a suite of 3D bioengineered cardiac tissues and chambers that replicate human heart structure and function more faithfully than animal models or traditional cell cultures. In combination with customized hardware- and software-based automated screening, the team will evaluate heart function using mini-Heart models derived from patient stem cells from HLHS patients and their healthy relatives.

Key to this initiative is Mayo Clinic’s HLHS biobank, comprised of samples from more than 800 HLHS patients and family members and developed over the past 25 years under Timothy Nelson, MD, PhD, Director of the Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome. While a minority of HLHS cases can be traced to specific genetic mutations, the majority remain poorly understood. Current models fall short: animal hearts differ significantly from human hearts, and flat (2D) cultures of patient cells or a simpler conventional heart-on-a-chip cannot reproduce the 3D complexity of heart chambers. Novoheart’s technology, which has previously created congenital heart disease (CHD) models such as Pulmonary Atresia, Tetralogy of Fallot, DiGeorge Syndrome, and Hypoplastic Right Heart Syndrome, addresses these challenges.

“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,” said Kevin Costa, PhD, co-founder of Novoheart. “It’s the first step toward bringing personalized cardiac care to children with HLHS—especially those without known genetic mutations.”

Ronald Li, PhD, CEO and co-founder 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 project has also been made possible by the generous support of the John Dimitri Research Foundation for Congenital Heart Disease and Big Hearts 2 Little Hearts.

On September 5, 2024, Medera and Keen Vision Acquisition Corporation (“KVAC”) (NASDAQ: KVAC, KVACW), announced they had entered into a definitive merger agreement.

Source: globenewswire.com