Altman Peter purchased $2K of BCDA

BioCardia (BCDA) submitted a revised De Novo pre-submission package to the FDA for its Helix catheter, following feedback. The FDA accepted the submission and expects review, feedback, and a meeting in Q4 2026. The catheter is designed for delivering therapeutic agents to heart muscle and has clinical safety data from 15 trials. FDA clearance could expand partnership opportunities for BCDA.

BioCardia's FDA pre-submission for Helix catheter was accepted, with substantive review and a meeting expected this quarter. The FDA raised no concerns about safety or performance. The company has clinical data from 15 trials supporting potential clearance, which could expand partnerships. According to the company, marketing clearance could enhance opportunities with cardiac biologics developers.

BioCardia Inc. (BCDA) announced the FDA accepted its pre-submission for the Helix catheter, a device for heart agent delivery. The FDA indicated two pathways for clearance and raised no safety concerns. BioCardia expects substantive review and feedback this quarter. The Helix catheter is supported by clinical data from 15 trials with nearly 500 patients.

BioCardia, Inc. (BCDA) filed an SEC Form 8-K — Other Events. Exhibit 99.1 BioCardia Announces FDA Acceptance of De Novo Pre-Submission Package for Helix TM Catheter Marketing Clearance FDA Substantive Review and Meeting Expected this Quarter October 19, 2026, Sunnyvale, Calif. BioCardia, Inc. [NASDAQ: BCDA] , a global leader in cellular an

BioCardia, Inc. (BCDA) announced the FDA accepted its revised De Novo pre-submission for the Helix catheter, with a substantive review and feedback expected this quarter. According to the company, this follows earlier FDA interactions and revisions to the De Novo package.

BioCardia (BCDA) announced FDA acceptance of its pre-submission package for the Helix catheter, used for heart treatments. The package includes data from 15 trials with nearly 500 patients. FDA agreed on two pathways for marketing clearance and raised no safety concerns. BioCardia expects substantive review and feedback this quarter.