newsfilter
← Latest News
GlobeNewswire·

BioCardia Completes Clinical Consultation Process with Japan's PMDA for CardiAMP Cell Therapy System, Advancing Toward Submission of Marketing Approval Application

BCDA
  • BioCardia, Inc. completed the consultation process with Japan's Pharmaceuticals and Medical Devices Agency (PMDA) regarding application materials for CardiAMP Cell Therapy System.
  • The consultation positions BioCardia favorably for regulatory review with a potential approval timeline of 12 months following submission.
  • The company targets treating its first patients in Japan & realizing commercial revenues in 2028.
  • CardiAMP is a minimally invasive, catheter-based autologous cell therapy intended for patients with ischemic heart failure.
  • The therapy has been evaluated in three clinical trials involving more than 200 patient procedures, including two randomized, double-blind, placebo-controlled trials.
  • Completion of the consultation process does not constitute regulatory approval, as the system remains subject to PMDA review.
Company
BioCardia, Inc.
Keywords
Nasdaq:BCDA, BioCardia, Inc., $BCDA, #stemcelltherapy, #PMDA, #HelixDeliverySystem, #ischemicheartfailuretreatment, #ischemicheartfailure