Every material Form 8-K BioCardia, Inc. has filed with the SEC since October 01, 2026, read and summarized by AI: what happened, the key figures, whether it reads positive or negative for shareholders, and how big a deal it is (impact 1-5). Newest first; each brief links to its own page and to the filing on SEC.gov.
BioCardia said it finished its clinical consultation with Japan's PMDA on application materials for the CardiAMP Cell Therapy System for ischemic heart failure, a step toward submitting a marketing approval application. The company states that completing consultations does not constitute regulatory approval, and the product remains subject to PMDA review.
Consultation with Japan's PMDA on application materials completed, announced November 6, 2026
CardiAMP is intended for ischemic heart failure; CEO Peter Altman targets first patient treatments in Japan and commercial revenues in 2028
Completion does not equal regulatory approval; product remains subject to PMDA review
BioCardia said the FDA has accepted its revised De Novo pre-submission package for marketing clearance of its Helix catheter, and it expects FDA substantive review and a meeting this quarter. The filing does not report any financial results, and clearance is not yet granted, so the update is a regulatory milestone rather than a change in reported financial performance.
FDA accepted the revised De Novo pre-submission package, announced October 19, 2026
Company met with FDA in May 2026 and FDA confirmed and accepted the meeting minutes in August 2026
Revised package was re-submitted in September 2026 and BioCardia expects FDA substantive review and a meeting this quarter
Company cites clinical data from fifteen clinical trials including nearly five hundred patients
BioCardia announced that it will present a scientific poster on the design of its CardiAMP HF II trial at the Heart Failure Society of America Annual Scientific Meeting in Phoenix, Arizona, October 9 to 12, 2026. The filing says FDA recently agreed that the ongoing trial may be sufficient to support FDA approval, but it contains no financial results, and the event is a scientific presentation rather than a financial or regulatory decision.
Poster presentation at HFSA Annual Scientific Meeting in Phoenix, Arizona, October 9 to 12, 2026
Presentation covers the design and scientific support for the CardiAMP HF II Study in ischemic heart failure with reduced ejection fraction
FDA recently agreed that the ongoing CardiAMP HF II trial may be sufficient to support FDA approval
The filing reports no revenue, earnings or guidance figures
BioCardia reported it has completed a revised Pre-Submission to the FDA's Center for Devices and Radiological Health for approval of its Helix Catheter, which is used for delivering therapeutic and diagnostic agents to the heart. The filing says FDA agreed in May 2026 that there are two pathways to marketing clearance and raised no concerns about Helix safety data or device performance, so the revised submission is a regulatory step toward a possible market clearance.
Revised pre-submission completed under the Q-Submission program, reported October 1, 2026.
FDA met with the company in May 2026 and said there are two pathways for Helix marketing clearance.
FDA targets an initial acceptance or refusal review within 15 calendar days and written feedback or a meeting within 70 calendar days.
The company cites clinical data from 15 clinical trials including nearly 500 patients.
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