BioCardia finishes PMDA consultation process for CardiAMP in Japan

BioCardia, Inc. announced on November 6, 2026 that it had completed the clinical consultation process with Japan's Pharmaceuticals and Medical Devices Agency regarding the application materials needed to pursue regulatory approval in Japan for its CardiAMP Cell Therapy System, aimed at treating ischemic heart failure.¹

The company described Japan as 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.¹

CEO Peter Altman said the completed consultations put the company closer to offering the therapy to Japanese patients, and stated that the extensive work completed with PMDA positions BioCardia to initiate the process toward final regulatory approval review, with the company targeting treatment of its first patients in Japan and commercial revenues starting in 2028.¹

CardiAMP is designed as a minimally invasive, catheter-based autologous cell therapy option for patients with ischemic heart failure.¹ The company noted that this patient population continues to have significant unmet medical needs despite advances in modern medical and device-based therapies.¹ According to the release, the therapy has undergone testing across three clinical trials covering more than 200 patient procedures, two of which were randomized, double-blind, and placebo-controlled.¹

BioCardia cautioned that finishing the consultation process does not amount to regulatory approval, and the CardiAMP system still faces PMDA review along with other applicable Japanese regulatory requirements.¹

The company's broader pipeline includes CardiAMP autologous and CardiALLO allogeneic cell therapy platforms, with three cardiac clinical-stage product candidates in development,¹ supported by its Helix delivery system, Morph vascular navigation platform, and Heart3D fusion imaging platform under development.¹