BioCardia to present CardiAMP and Helix updates at H.C. Wainwright conference
CEO Peter Altman will detail regulatory progress in Japan and the US and pipeline milestones at the September conference in New York.
BioCardia, Inc. announced on September 10, 2026 that Peter Altman, Ph.D., President and Chief Executive Officer, will present at the H.C. Wainwright 28th Annual Global Investment Conference, held at the Lotte New York Palace Hotel in New York City from September 14 to 16, 2026.1 Altman is expected to update investors on the company's CardiAMP autologous cell therapy program, including progress toward regulatory approval in Japan and the United States, the ongoing CardiAMP HF II pivotal trial, and the Helix transendocardial delivery and Heart3D fusion imaging platforms, along with business development activity around its delivery technologies.1
On the regulatory front, BioCardia is preparing a Shonin pre-market submission to Japan's Pharmaceutical and Medical Device Agency for CardiAMP Cell Therapy in ischemic heart failure, targeted for the fourth quarter of 2026.1 The company said PMDA's formal Consultation Record of Advice supports the submission based on three completed clinical trials and noted the positive clinical outcomes were considered credible.1 In the US, FDA meeting minutes received in June confirmed that the ongoing randomized, double-blind CardiAMP HF II pivotal trial may support a Premarket Approval application for the therapy in ischemic heart failure with reduced ejection fraction.1 That confirmatory Phase III trial is actively enrolling in the US and is designed to provide additional evidence supporting potential approval.1
On the device side, BioCardia said in August that the FDA had confirmed meeting minutes supporting a follow-on De Novo pre-submission for the Helix Transendocardial Delivery Catheter System, which the company intended to submit incorporating that FDA advice during the third quarter of 20261, a target period that had already concluded by the date of this announcement. Separately, BioCardia is advancing its Heart3D Fusion Imaging platform with partner CART-Tech toward a potential FDA 510(k) submission.1 The company's conference presentation was prerecorded and made available to participants beginning September 11, 2026, with no separate webcast planned.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.