BioCardia Completes Clinical Consultation Process with Japan's PMDA for CardiAMP Cell Therapy System, Advancing Toward Submission of Marketing Approval Application
Key Highlights
- ➤PMDA consultation completed for CardiAMP marketing application materials in Japan
- ➤First Japanese patients and commercial revenues targeted for 2028
- ➤CardiAMP remains subject to PMDA review; consultation is not regulatory approval
- ➤CardiAMP evaluated in three trials involving more than 200 patient procedures
Expert Statements
Peter Altman, Chief Executive Officer of BioCardia
“With the completion of consultations with PMDA regarding our application materials, we are closer to the day when we can provide CardiAMP cell therapy to heart failure patients in Japan.”
Peter Altman, Chief Executive Officer of BioCardia
“The extensive work completed with PMDA positions us to initiate the process toward final regulatory approval review.”
Peter Altman, Chief Executive Officer of BioCardia
“We are targeting the treatment of our first patients in Japan and the realization of commercial revenues in 2028.”
SUNNYVALE, Calif., Nov. 06, 2026 (GLOBE NEWSWIRE) -- BioCardia®, Inc. (NASDAQ: BCDA), a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that it has completed the process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) concerning the application materials required to obtain regulatory approval in Japan for its CardiAMP Cell Therapy System ("CardiAMP") for the treatment of ischemic heart failure.
This milestone represents significant progress toward regulatory approval and commercialization of CardiAMP in Japan, one of the world's largest and most sophisticated cardiovascular medical device markets and a country at the forefront of regenerative medicine, including induced pluripotent stem (iPS) cell therapies.
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