BioCardia gets positive regulator signals in Japan and US for CardiAMP and Helix

BioCardia reported second quarter 2026 results on August 12, 2026, highlighting regulatory progress in Japan and the United States. Chief Executive Peter Altman said the company had three important positive meetings with regulatory agencies in Japan and the United States, with Japan's PMDA supporting regulatory submission for CardiAMP Cell Therapy for Ischemic Heart Failure, the FDA saying the CardiAMP HF II trial may be sufficient for approval, and the FDA saying DeNovo approval of Helix is possible.¹

In May, PMDA's Consultation Record of Advice supported Shonin pre-market regulatory submission based on three completed clinical trials, confirming alignment on remaining questions and noting the positive trial outcomes were credible.¹ PMDA requested additional detail on patient eligibility and safety events, and BioCardia is preparing for regulatory submission in Japan in the fourth quarter of 2026.¹

On the US side, BioCardia received FDA minutes from a Q-Sub meeting with CBER in June confirming the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval.¹ The company continues actively enrolling in the CardiAMP HF II trial, with four clinical sites recruiting patients and three additional patients expected to qualify that month.¹

In May, primary results from the refractory angina cohort (BCDA-02) were presented at EuroPCR, showing the CardiAMP procedure was well tolerated with no treatment emergent major adverse cardiac events, and patients showed increased exercise tolerance and reduced angina, improving exercise tolerance by an average of 179 seconds and reducing angina episodes by an average of 82% by six months, sustained to two years.¹

On Helix, FDA advised the company it would receive final meeting minutes soon, and BioCardia anticipates submitting a follow-on pre-submission that could enable approval via the DeNovo pathway.¹

Financially, BioCardia raised about $4.9 million net under its "At the Market" facility during the quarter and ended with $4.1 million in cash, providing anticipated runway into 2027.¹