BioCardia Seeks Japan PMDA Meeting To Review Clinical Data And Discuss Approval Pathway For CardiAMP® Cell Therapy In Ischemic Heart Failure

BioCardia, Inc., a global company specializing in cellular and cell-derived therapies for cardiovascular and pulmonary conditions, has submitted its investigational heart failure therapy, CardiAMP, for clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). This marks an important milestone in the company’s efforts to bring its autologous cell therapy to the Japanese market, which is considered a key region for advanced heart failure treatment options.

The consultation with the PMDA is a critical step in Japan’s regulatory pathway and involves detailed discussions about the safety, efficacy, and clinical positioning of new medical therapies. As part of this submission, BioCardia provided a comprehensive clinical data package. This included the complete results from the CardiAMP Heart Failure (HF) Trial and the clinical section of the Summary Technical Documentation (STED). The STED is a detailed regulatory document that outlines the technical and clinical evidence needed to demonstrate the safety and performance of a medical product.

Peter Altman, PhD, CEO of BioCardia, stated, “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. We look forward to incorporating the agency's insights into our development plans and working towards a successful regulatory submission and review. Success in these efforts could result in our being engaged in a meaningful post marketing study in Japan next year.”

During the consultation, the PMDA will thoroughly review the CardiAMP HF clinical data to assess whether the treatment’s benefits and safety profile are sufficient for heart failure patients in Japan. The agency will also examine the suitability of the therapy for specific patient populations and its potential role within the existing treatment framework for heart failure care in the country.

Reaching agreement with the PMDA on the strength of the data and the appropriate use of the CardiAMP system could pave the way for BioCardia to formally apply for regulatory approval to market the therapy in Japan. As part of its broader mission, BioCardia continues to explore strategic collaborations in Japan and remains focused on developing innovative therapies to address the unmet needs of patients with heart failure.