Kumaraguru Raja's questions to BioCardia Inc (BCDA) leadership • Q2 2025
Question
Kumaraguru Raja of Brookline Capital Markets inquired about the type of meeting planned with the FDA for CardiAmp, the current screening and enrollment status for the CardiAmp Heart Failure II trial, and the expected timeline for achieving clarity from both the PMDA and FDA.
Answer
CEO Peter Altman explained that the company is still deciding on the type of FDA meeting, possibly a Sprint discussion due to CardiAmp's Breakthrough Designation. He noted the CardiAmp HF2 trial is actively enrolling at four sites, with a fifth starting soon, but regulatory submissions are the primary priority. Dr. Altman clarified that they expect clarity from Japan's PMDA by the end of Q4, with FDA clarity to follow slightly later, after the de novo 510(k) submission for the Helix system.