BioCardia Reveals Plans to Request Meeting With FDA Regarding CardiAMP Heart Failure Cell Therapy

BioCardia has stated that it plans to request a meeting with the FDA to discuss the pathway to approval for its CardiAMP cell therapy system, an investigational autologous cell therapy for the treatment of ischemic heart failure (HF).¹

The company noted that it plans to submit the meeting request by the fourth quarter of this year and that the meeting will focus on the approvability of the product based on available clinical data. CardiAMP is currently being evaluated in the pivotal phase 3 CardiAMP HF clinical trial (NCT02438306). Although the study did not meet its primary end points, BioCardia believes a number of factors may allow a pathway to approval for CardiAMP. The company cited as examples of these factors the breakthrough therapy designation previously granted to CardiAMP by the FDA, longer-term follow-up data from CardiAMP HF, the FDA’s prior 510(k) approval of Marrowstim, a primary component of CardiAMP cell therapy, and the confirmatory phase 3bCardiAMP HF II clinical trial (NCT06258447), which is currently enrolling patients at several sites in the United States. BioCardia also noted that is plans to submit a DeNovo 510(k) application for the Helix Transendocardial Delivery System (Helix) to the FDA in the third quarter of 2025. Helix is also a component of CardiAMP.

In addition to the updates regarding US regulatory activities, BioCardia also announced it expects that a clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), which the company requested in July of this year, will take place in the fourth quarter of 2025. BioCardia pointed out that if it and the agency are aligned during the meeting, it may be able to submit for market approval of CardiAMP in Japan.

“This discussion may be influenced by other sponsor’s applications to PMDA for allogeneic cell therapies to treat the same clinical indication expected to require chronic immunosuppression and open chest surgical delivery of cells,” BioCardia stated in a press release.¹ “Such laboratory manufactured therapies may receive early conditional approval under Japan’s adaptive framework for the approval of regenerative medical products with a post marketing study. The CardiAMP Cell Therapy is regulated as a medical device as the autologous cells are processed at point of care.... The point of care CardiAMP cell processing platform is already approved and in clinical use in Japan for orthopedic applications by Zimmer Biomet Japan under the trade name BioCUE.”

Data from CardiAMP HF were presented earlier this year at the American College of Cardiology 74th Annual Scientific Session & Expo, held March 29 to 31, 2025, in Chicago, IL.² A study-wide increase in survival and decrease in major adverse cardiac and cerebrovascular events (MACCE) was reported, although BioCardia noted that the primary composite efficacy end point did not reach a statistically significant result. Furthermore, the company stated that compared to patients receiving an optimized heart failure medication regimen alone, patients treated with CardiAMP experienced 3.6% fewer heart death equivalents, showed a relative risk reduction in heart death equivalents of 20.9%, had 8.7% fewer nonfatal MACCE, and displayed a relative risk reduction in nonfatal MACCE of 44.6%. A 5.5-point improvement on The Minnesota LIVING WITH HEART FAILURE Questionnaire (MLHFQ), considered clinically meaningful, was also observed for patients treated with CardiAMP.

“This clinical trial was conducted because there remains a large group of heart failure patients today who are insufficiently responsive to optimized heart failure medication,” coprincipal investigator Amish N. Raval, MD, FACC, a professor of medicine at the University of Wisconsin School of Medicine and Public Health, who presented the data, said in a March 2025 statement.² “In this rigorous CardiAMP-HF Trial, patients who received the novel cell therapy adjunctive to medication experienced decreased mortality and MACCE, with improved quality of life, when compared to those on medication alone. These benefits appeared to be greater in patients with elevated NTproBNP - comprising fully half of treated patients - reaching statistical significance in the composite measure of these outcomes. The trial shows us that CardiAMP therapy has the potential to safely and significantly improve survival and quality of life for heart failure patients in distress, encompassing a large group of patients we see in daily practice.”

REFERENCES
1. BioCardia provides update on timing of regulatory activities seeking FDA approval and Japan PMDA approval for CardiAMP® cell therapy for heart failure and Helix™ Transendocardial Delivery Catheter. News release.BioCardia, Inc. August 4, 2025. Accessed August 5, 2025. https://www.biocardia.com/investors/press-releases/id/1037?pressReleaseId=233
2. BioCardia phase 3 CardiAMP-HF trial of novel cardiac cell therapy for ischemic heart failure shows increased survival, decreased cardiac events, and improved quality of life at two years. News release. BioCardia, Inc. March 31, 2025. Accessed August 5, 2025. https://www.biocardia.com/investors/press-releases/id/1037?pressReleaseId=217