BioCardia to Seek FDA Approval for CardiAMP Cell Therapy in Q3 2025.

BioCardia plans to submit a DeNovo 510(k) application to the FDA for approval of its Helix Transendocardial Delivery System in Q3 2025. The application will be based on the system's safety and performance in 12 cell and gene therapy clinical studies, which have shown a high safety standard with over 4,000 intramyocardial deliveries. The company also intends to submit a regulatory application to the Japan PMDA for its CardiAMP Cell Therapy System in Q4 2025.

BioCardia, Inc. (NASDAQ: BCDA), a global leader in cellular and cell-derived therapeutics, has provided an update on its regulatory activities for the CardiAMP® Cell Therapy System and the Helix™ Transendocardial Delivery Catheter. The company plans to submit a DeNovo 510(k) application to the FDA for approval of the Helix system in Q3 2025. This application will be based on the system's safety and performance in 12 cell and gene therapy clinical studies, which have shown a high safety standard with over 4,000 intramyocardial deliveries [1].

Additionally, BioCardia intends to submit a regulatory application to the Japan PMDA for its CardiAMP Cell Therapy System in Q4 2025. 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 [2].

The regulatory timeline reflects BioCardia's strategic approach to securing approvals for its cardiovascular therapies. The company's clear regulatory roadmap includes critical FDA and PMDA meetings scheduled for late 2025, with significant milestones expected in the second half of the year. The Helix Transendocardial Delivery System's demonstrated superior retention of therapeutic agents in the heart compared to alternative approaches represents a key differentiator [1].

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 status and clinical trial results [2].

References:

[1] https://www.globenewswire.com/news-release/2025/08/04/3126387/0/en/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.html
[2] https://www.stocktitan.net/news/BCDA/bio-cardia-provides-update-on-timing-of-regulatory-activities-u9ohdxnwr19u.html