BioCardia says FDA finalized minutes on Helix catheter pre-submission meeting

BioCardia, Inc. announced on August 24, 2026 that the FDA reviewed and accepted the meeting minutes the company had provided in May 2026, and those minutes are now considered final.¹ The company said this confirms the understanding it had described in its May 8, 2026 press release and 8-K filing.¹

Chief Executive Officer Peter Altman said the company plans to file a follow-on pre-submission this quarter that would incorporate the agency's feedback, and that doing so could open a path to approval of Helix through the De Novo review process. He added that a successful, independent clearance for Helix could help the company form partnerships around delivery of cell, gene, and protein therapies, according to the release.

The Helix system is described as a minimally invasive platform for targeted delivery of therapeutic and diagnostic agents directly into heart muscle tissue.¹ The company said the device can deliver agents precisely within the heart with better retention than other delivery methods, reaching areas that alternative approaches cannot access.¹ It uses a small helical needle at its tip designed to anchor into heart tissue and hold steady during the heartbeat while an agent is delivered.

The release lists several upcoming milestones, including a Q3 2026 FDA Pre-Sub Amendment for Helix, a Q4 2026 peer-reviewed manuscript and Japan PMDA submission for CardiAMP Cell Therapy, and additional CardiAMP and Heart3D imaging milestones extending into 2027 through 2029, as stated in the release.

The company cautioned that forward-looking statements are not guarantees of future performance, and actual results may differ due to factors such as the company's liquidity position, its ability to raise additional funds, and its ability to progress clinical trials successfully.¹