Aug 12, 2026 earnings call — Regulatory progress for CARDIamp and HELIX catheter
PMDA supported Shonin submission for CARDiAmp with an expected initial indication of approximately 20 thousand patients and approval approximately 12 months after submission.
EPS $-0.13 (est $-0.18)
Key quotes
"Our Q Sub meeting with FDA's Center for Biologics Evaluation and Research, The meeting minutes from FDA confirm that the ongoing CardiAmp Heart Failure II trial may support premarket approval for market clearance."
"During the second quarter, BioCardia raised net proceeds of approximately $4.9 million under our at-the-market facility at an average price of $1.22 per share."
Analyst Q&A 3
FDA de novo clarity; Japan market expansion
Q (Joe Pantginis · H. C. Wainwright): He asked which key points remain outstanding in the FDA minutes. He also asked how to expand the initial 20 thousand patient market in Japan, how CardiAmp compares to ReHeart on delivery and reimbursement, and whether Japan approval helps other countries.
A: Management said the FDA’s main issue is approving a novel delivery system via the de novo route and that they expect to need a special approach but have data and experience to support it. They said Japan expansion depends on a successful post-marketing study, good physician experience, and education; CardiAmp is percutaneous and autologous while ReHeart requires surgical implantation and likely chronic immunosuppression. They added that a Japan approval and inspections can help open discussions in other countries.
"The key issue with FDA is they have a very challenging time approving a delivery system for a biologic for a clinical indication, and a route of administration for which no therapeutic has yet been approved." — Peter A. Altman (CEO)
Japan marketing plan and trial enrollment
Q (James Molloy · Allianz Global Investors): He asked how the designated marketing authorization holder (DMAH) relationship will work, whether it is a standard partnership, and whether the partner is guaranteed or close to signing. He also asked how sales and royalties would work in Japan and for an update on CardiAmp HF2 enrollment and number of centers and patients.
A: Management said the DMAH is a contractor that represents regulatory and quality responsibilities for Biocardia in Japan, and Biocardia will pay them while other parties handle GCP audits and dossier work. They said Biocardia plans to sell CardiAmp for the post-marketing study, noting local hospital distributors typically take up to 10% of product value, and that Japan is geographically small so a small team can manage roll-out. On CardiAmp HF2 they said they are not releasing total patient numbers; four centers are actively enrolling and have patients in the queue, and enrollment is steady but not rapid.
"To represent all of the regulatory and quality issues associated with the cardiac cell therapy in Japan." — Peter A. Altman (CEO)
PMDA document work and DMAH costs
Q (Deepankar Roy · Brookline): He asked how much extra work PMDA’s outstanding requests require and whether new source data verification is needed that could push a Q4 2026 Shonin submission. He also asked the expected cost structure for the DMAH and whether having that relationship is required before submission.
A: Management said they already have most of the data PMDA wants and that the main remaining work is chasing documentation on why a few patients were not on guideline directed medical therapy; they noted "out of the 115 patients on the 4 drugs" there are about "8 patients or so or 9 patients" needing clarification. They said the DMAH costs are not significant, the dossier and GCP audit work are underway, they do not expect delays, and that preparing CDISC-formatted data is the longest pole in the tent.
"The nuance here is we feel we have got all of the data that they would like to see pretty readily available to us." — Peter A. Altman (CEO)