RegulatoryCompany release

BioCardia nears Japan filing for CardiAMP and plans Helix De Novo request in Q1 2027

🇺🇸 BioCardia, Inc. (BCDA) · Thu 12 Nov 2026

The US cell therapy and devices company says it has completed the PMDA process on CardiAMP application materials, while FDA feedback on a revised Helix Pre-Submission is expected within weeks.

BioCardia, Inc. reported its third-quarter 2026 results on 12 November, outlining progress on regulatory filings in Japan and the US. The company said it has completed the Pharmaceuticals and Medical Devices Agency (PMDA) process on application materials for CardiAMP, its autologous cell therapy for ischemic heart failure.

A submission in Japan is expected in the fourth quarter of 2026 or the first quarter of 2027, according to the company.

For its Helix delivery catheter, BioCardia said the US Food and Drug Administration accepted a revised Pre-Submission in October. Feedback from the agency is expected within weeks. The company plans to file a De Novo request for Helix in the first quarter of 2027. As general context, the De Novo pathway is the FDA route for novel low-to-moderate-risk devices that have no legally marketed predicate.

On finances, BioCardia reported cash of $2.2 million and said its runway extends into 2027.

What it means for your team

  • Japan filing timing for CardiAMP remains a window (Q4 2026 or Q1 2027) rather than a fixed date; watch for confirmation of submission.
  • The FDA's response to the revised Helix Pre-Submission, due within weeks, will shape the content of the planned Q1 2027 De Novo request.
  • The company's stated cash position of $2.2 million and runway into 2027 is a factor for partners and observers tracking the timelines.

Company's press release (SEC filing): BioCardia, Inc. ↗

Article written by VigiEye from the official source (BioCardia, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →