BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System (Form 8-K)

BioCardia Announces Japanese Patent for Helix™ Biotherapeutic Delivery System

March 10, 2025

Sunnyvale, Calif. - BioCardia^®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Japan Patent Office has granted Japanese Patent No. 7641330 titled "Radial and Transendocardial Delivery Catheter" with a patent term that will expire on or after September 30, 2034.

"This new patent in Japan adds to our growing patent position with respect to minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart," said Dr. Peter Altman, BioCardia CEO. "Our clinical cell therapy candidates for the treatment of ischemic cardiomyopathies benefit greatly from the performance of these systems, as will current and future biotherapeutic partners supported by our extensive preclinical and clinical experience. Japan is an important initial market for these therapies because of their national commitment to support novel and cost-effective cell therapy solutions for their aging population while also developing the Japanese stem cell industry (1)."

BioCardia's newly issued Japanese Patent No. 7641330 describes minimally invasive interventional biotherapeutic delivery catheters to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal treatment at the sites where needed, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed claims cover BioCardia's helical needle-tipped catheter technology platform, which available data supports is the safest and most efficient approach for biotherapeutic delivery to the heart (2, 3). BioCardia believes its Helix System to be the only catheter-based intramyocardial delivery system in active clinical use.

BioCardia has secured an extensive portfolio of issued patents and pending patent applications around cell, exosome, and microRNA biotherapeutic candidates, minimally invasive biotherapeutic delivery platforms, and advanced cardiac imaging technologies. These inventions have resulted from the pursuit of its ongoing mission to develop new therapies for the patients suffering from cardiovascular disease.

About BioCardia

BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company's biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms.