BioCardia and CellProthera Extend Collaboration for Development of ProtheraCytes to Treat AMI in Europe

February 1, 2023—BioCardia, Inc. and CellProthera announced an extension of their long-term partnership through an amendment to their Clinical Research Supply and Support Agreement. The agreement relates to CellProthera’s use of BioCardia’s Helix transendocardial biotherapeutic delivery system for CellProthera’s phase I/IIb EXCELLENT study of ProtheraCytes product.

BioCardia is a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases.

CellProthera is developer of cell-based therapies to repair ischemic tissues.

According to the companies, CellProthera’s ProtheraCytes is a one-shot minimally invasive autologous ATMP (advanced therapy medicinal product) 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 is a biotherapeutic 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.

The extension of the agreement allows the completion of the ongoing 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.

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.

BioCardia’s CEO Peter Altman, PhD, commented in the companies’ press release, “CellProthera’s therapeutic solution meets a high unmet medical need and has considerable commercial potential.”

Dr. Altman continued, “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. 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.”

Matthieu de Kalbermatten, CEO of CellProthera, added, “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. 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.”