BioCardia and CellProthera Enhance Collaboration for Development of ProtheraCytes(TM) for the Treatment of Acute Myocardial Infarction in Europe and Potential Early Access for Patients

BioCardia and CellProthera Enhance Collaboration for Development of ProtheraCytes(TM) for the Treatment of Acute Myocardial Infarction in Europe and Potential Early Access for Patients

Sunnyvale, California, US and Mulhouse, France, February 1, 2023 - BioCardia, Inc. [Nasdaq: BCDA], a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, and CellProthera, a private developer of cell-based therapies to repair ischemic tissues, today announce an amendment to their Clinical Research Supply and Support Agreement. 

The amendment extends the long-term partnership between both organizations. The agreement relates to CellProthera’s use of BioCardia’s Helix(TM) transendocardial biotherapeutic delivery system for its ongoing Phase I/IIb EXCELLENT study of its lead product candidate ProtheraCytes(TM).

CellProthera has developed ProtheraCytes as a one shot minimally invasive autologous ATMP cell therapy to improve the quality of life of post-Acute Myocardial Infarction (AMI) patients who have no therapeutic solution to restore the heart’s function, and to reduce ongoing hospitalizations and invasive medical treatments such as heart transplants. BioCardia’s Helix Biotherapeutic Delivery System is the leading percutaneous catheter delivery system for cardiovascular regenerative medicine. It enables local delivery of cell and gene-based therapies to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders.

CellProthera and BioCardia have extended the agreement to complete the ongoing Phase I/IIb EXCELLENT study. The agreement incorporates the intention for both organizations to work together regarding CellProthera’s next clinical study, potential early access commercialization, which could begin in 2024, and future full commercialization programs. 

“CellProthera’s therapeutic solution meets a high unmet medical need and has considerable commercial potential. We remain optimistic that they will be demonstrating clinically meaningful and statistically significant benefits from their ongoing Phase I/IIb clinical trial for post-AMI patients that have no alternative therapeutic options," said Peter Altman, PhD., Chief Executive Officer, BioCardia. “We also look forward to the potential of early commercial access that may be granted in 2024 for the benefit of patients and continued clinical development together in the European Union and the United Kingdom.”

“BioCardia’s Helix delivery system has enabled CellProthera to enhance the delivery and retention of our cellular product in the heart while maintaining the status of a minimally invasive procedure. The Helix system has performed excellently,” said Matthieu de Kalbermatten CEO, CellProthera. “As we complete enrollment in our Phase I/IIb program, this year, it is strategically important for CellProthera to strengthen its partnership with BioCardia for the ultimate benefit of patients, the physicians that treat them, and both companies’ stakeholders.”

Under the terms of the agreement, CellProthera is not required to partner with BioCardia therapeutic delivery devices for its commercial or subsequent clinical efforts. However should it not, BioCardia would receive low single digit royalty on net sales of CellProthera’s transendocardially delivered ProtheraCytes for its contributions to CellProthera’s development efforts.