BioCardia submits heart failure cell therapy for Japan regulatory review

SUNNYVALE, Calif. - BioCardia, Inc. (NASDAQ:BCDA), a micro-cap biotechnology company with a market capitalization of $12.76 million, has submitted its CardiAMP autologous cell therapy for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), the company announced Thursday. According to InvestingPro data, the company’s stock currently trades at $2.34, with analysts setting an ambitious price target of $6.00.

The submission includes comprehensive clinical data from the completed CardiAMP HF trial and the principal clinical portion of the Summary Technical Documentation (STED), which demonstrates the system’s safety and performance requirements.

Japan’s PMDA consultation process will review the therapy’s efficacy and safety data, determine appropriate target patient populations, and assess how the treatment may fit into Japan’s heart failure care continuum. Successful consultation could enable BioCardia to submit for market approval in Japan.

"Consulting with the PMDA on the totality of clinical evidence from our three trials supporting CardiAMP cell therapy for heart failure is a pivotal step in our ongoing discussions with PMDA to bring this heart failure therapy to patients in Japan," said Peter Altman, CEO of BioCardia.

The CardiAMP therapy, which has FDA Breakthrough designation in the United States, uses a patient’s own bone marrow cells delivered to the heart through a minimally invasive catheter procedure. The treatment aims to increase capillary density and reduce tissue fibrosis to address microvascular dysfunction.

Results from the 125-patient randomized CardiAMP HF Trial showed reduction in all-cause death, reduced major adverse cardiac events, and improved quality of life, according to the company’s press release statement.

The therapy is currently being evaluated in the Phase IIIB CardiAMP HF II Trial in the United States, which is actively enrolling patients. For investors interested in deeper analysis, InvestingPro offers comprehensive research reports and 12 additional ProTips about BioCardia’s financial position and market outlook, essential for understanding the company’s development trajectory in this critical phase.

In other recent news, BioCardia Inc. announced its financial results for the first quarter of 2025, revealing a net loss increase to $2.7 million from the previous year. Despite the loss, the company highlighted significant advancements in its clinical trials, which seem to have bolstered investor confidence. In addition, BioCardia has been granted a new U.S. patent for its "Radial and Trans-endocardial Delivery Catheter" technology. This patent covers their minimally invasive catheter systems designed for precise delivery of biologic therapies to specific heart sites. The Helix system, a part of this technology, aims to provide targeted treatment while minimizing off-target effects. These developments reflect BioCardia’s ongoing progress in both clinical and technological arenas.

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