On December 16, 2025, BioCardia, Inc announced progress in its CardiAMP Cell Therapy with Japan’s PMDA.
Key Highlights:
Completed third preliminary consultation with Japan’s PMDA.PMDA allows advancement to formal clinical consultation.Potential for regulatory approval if safety and efficacy are confirmed.Therapy targets heart failure with reduced ejection fraction.Supported by positive outcomes from Phase I, II, and III trials.
Original SEC Filing: BioCardia, Inc. [ BCDA ] – 8-K – Dec. 16, 2025
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AloJapan.com