BioCardia Advances CardiAMP Toward Japan Approval After Completing PMDA Consultations

• BioCardia completed consultations with Japan's PMDA on application materials for its CardiAMP cell therapy for ischemic heart failure.
• The milestone advances CardiAMP toward a marketing approval application; the therapy remains subject to Japanese regulatory review.
• CardiAMP has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.
• The company targets initial patient treatments in Japan and commercial revenue in 2028.

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