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BioCardia Announces Japan PMDA Record Of Advice Supports Regulatory Submission For Approval Of CardiAMP Cell Therapy For Ischemic Heart Failure

BCDA
  • BioCardia received PMDA Consultation Record support for submitting regulatory approval of CardiAMP cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF).
  • The PMDA confirmed alignment on addressing remaining questions regarding patients with elevated NTproBNP biomarkers on stable guideline-directed medical therapy (GDMT).
  • Approximately 20,000 of 300,000 HFrEF patients in Japan are estimated to be initially eligible for this therapy.
  • PMDA requested evidence that enrolled patients were on GDMT, not eligible for revascularization, & detailed reporting on all-cause deaths, heart transplants, or left ventricular assist device implants.
  • The submission requires post-marketing study plans covering patient selection criteria, clinical decision frameworks, & collaboration with Japanese academic societies for training & surveillance.
  • BioCardia plans to submit to the PMDA within seven months using a Designated Marketing Authorization Holder to facilitate commercialization.
  • BioCardia is ISO13485 compliant for cardiovascular medical device design, manufacture, & distribution, including catheters for therapeutic delivery.
  • CardiAMP is an autologous cell therapy granted FDA Breakthrough designation intended to increase capillary density & reduce myocardial tissue fibrosis.
  • The final commercialization certificate in Japan will be issued by the Ministry of Health, Labour & Welfare (MHLW) following PMDA's technical assessment & approval recommendation.
  • Forward-looking statements in the release are subject to risks including liquidity, funding, & clinical trial progression as detailed in BioCardia's SEC filings.