BioCardia plans regulatory submission for its CardiAMP therapy in Japan next quarter, targeting approval roughly 12 months later.
BioCardia announced plans to submit its CardiAMP cell therapy for regulatory approval in Japan during Q3 2026. The company expects a decision approximately 12 months after filing, based on recent positive meetings with Japanese regulators.
The submission follows successful discussions with regulatory agencies in Japan and the U.S. regarding the therapy’s approvability. CardiAMP is designed to treat heart failure using a patient’s own bone marrow cells.
No immediate market reaction was disclosed, but the timeline positions potential approval in mid-2027, pending regulatory review.