BioCardia Seeks FDA Approval for CardiAMP and Helix Transendocardial Delivery Catheter

BioCardia is seeking FDA and Japan PMDA approvals for its CardiAMP and Helix systems. The Helix system has undergone 12 clinical studies with more than 4,000 intramyocardial deliveries and demonstrated superior therapeutic agent retention in the heart. BioCardia expects to complete a submission to FDA for CardiAMP Cell Therapy and meet with PMDA in Q4. If successful, this could enable market entry in Japan.

BioCardia, Inc. [Nasdaq: BCDA], a leader in cellular and cell-derived therapeutics for cardiovascular and pulmonary diseases, has outlined its regulatory timeline for seeking approvals of its CardiAMP® Cell Therapy System and Helix™ Transendocardial Delivery Catheter from both the FDA and Japan PMDA. The company plans to submit a DeNovo 510(k) application for the Helix system in Q3 2025, backed by safety data from over 4,000 intramyocardial deliveries. In Q4 2025, BioCardia will request an FDA meeting to discuss CardiAMP Cell Therapy's approval for heart failure treatment, supported by its Breakthrough Designation status and clinical trial results. Simultaneously, the company expects an in-person consultation with Japan's PMDA regarding CardiAMP system approval, potentially benefiting from Japan's adaptive framework for regenerative medical products. If successful, these regulatory approvals could enable market entry in Japan.

The Helix Transendocardial Delivery System has demonstrated superior therapeutic agent retention in the heart compared to alternative approaches, setting a high safety standard. The system has undergone 12 clinical studies, with more than 4,000 intramyocardial deliveries, including studies under CE-mark in Europe. The CardiAMP Cell Therapy System, granted FDA Breakthrough Designation, uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to increase capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction. The Phase IIIB CardiAMP HF II Trial (NCT06258447) is actively enrolling in the United States.

BioCardia's regulatory timeline reveals a strategic approach to secure approvals for its cardiovascular therapies. The company plans to submit a DeNovo 510(k) application for its Helix Transendocardial Delivery System in Q3 2025, leveraging impressive safety data from over 4,000 intramyocardial deliveries across twelve clinical studies. For its flagship CardiAMP Cell Therapy for heart failure, BioCardia is pursuing an interesting regulatory strategy. Despite not meeting primary endpoints in pivotal studies, the company will request an FDA meeting in Q4 2025 to discuss potential approval pathways. They are building their case on the FDA's previous granting of Breakthrough Designation, long-term clinical results, and the status of the primary components of CardiAMP Cell Therapy.

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. PMDA has provided advice to BioCardia that should CardiAMP Cell Therapy be approved with Helix, other developers of biologic therapies in Japan would be enabled to use Helix from a regulatory perspective by reference.

BioCardia's forward-looking statements include references to the Company’s investigational product candidates, future regulatory submissions, future regulatory meetings, and outcomes of these regulatory discussions. These statements are subject to many risks and uncertainties, and the actual results may differ materially from the forward-looking statements. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 26, 2025, under the caption titled “Risk Factors,” and in their subsequently filed Quarterly Reports on Form 10-Q.

References:
[1] https://www.biospace.com/press-releases/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
[2] https://www.stocktitan.net/news/BCDA/bio-cardia-provides-update-on-timing-of-regulatory-activities-u9ohdxnwr19u.html