BioCardia, with $2.2m in cash, lines up Japan and US regulatory filings
The cell therapy and device group is preparing a Japanese submission for CardiAMP and a US De Novo request for its Helix catheter, while funding is guaranteed only into 2027.
BioCardia reported third-quarter 2026 results on 12 November. The company held $2.2m in cash and said its funding lasts into 2027. That is the same period in which it aims to lodge two regulatory filings, one in Japan and one in the US.
In Japan, the company said it has finished its work with the Pharmaceuticals and Medical Devices Agency on the materials supporting an application for CardiAMP, its autologous cell therapy for ischemic heart failure. It expects to file in either the final quarter of 2026 or the first quarter of 2027. It has not committed to a specific date.
In the US, the FDA accepted an updated pre-submission for the Helix delivery catheter in October. BioCardia expects the agency's response within weeks and plans to file a De Novo request in the first quarter of 2027. Context: De Novo is the FDA route for devices with no comparable product already on the market, where the risk is judged low to moderate.
The information reviewed for this article gives no revenue forecasts, partnering terms or pricing plans for either product.
Why it matters
- The Japan filing window spans two quarters, so confirmation that the submission has actually been made is the milestone to watch.
- The FDA's response on Helix, due within weeks, will inform the content of the planned first-quarter 2027 De Novo request.
- With $2.2m in cash and funding guided only into 2027, the regulatory timelines and the company's finances overlap closely, which matters to prospective partners.
Company's press release (SEC filing): BioCardia, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
BeyondSpring wins FDA Fast Track for plinabulin-docetaxel in post-immunotherapy NSCLC as cash dwindles to $0.6M
Calidi cuts costs and restructures as Q3 loss reaches $3.6M ahead of CLD-401 IND
Beyond Air reports record $2.3M quarterly revenue as FDA reviews second-generation LungFit PH
DataMEDS AI Q3 revenue up 50% to $2.7M on GLP-1 dispensing
Curis reports Q3 loss of $8.1m as emavusertib trials enrol; cash runway reaches only early 2027
