Lander Egaña-Gorroño's questions to BioCardia Inc (BCDA) leadership • Q2 2025
Question
Lander Egaña-Gorroño of H.C. Wainwright & Co., LLC inquired about the regulatory expectations for CardiAmp in Japan, specifically the differences in review processes for a point-of-care medical device versus a lab-manufactured therapy, and asked for confirmation on the upcoming Q4 data release for the CardiAmp CMI program.
Answer
CEO Peter Altman explained that the PMDA approval process for a medical device is seen as a lower hurdle, especially since nothing is left behind in the patient. He highlighted Japan's cultural preference for autologous therapies due to low organ transplant rates, positioning CardiAmp favorably. He noted that Japan's PMDA can grant conditional approvals with post-marketing studies. Dr. Altman also confirmed the upcoming Q4 data for the CardiAmp CMI program relates to the six-month primary endpoint results for the rolling cohort.