Welcome to our dedicated page for Biocardia SEC filings (Ticker: BCDA), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
BioCardia, Inc. SEC filings document a clinical-stage biotechnology and medical-device business focused on cell therapies and related delivery technologies for cardiovascular and pulmonary disease. Recent Form 8-K reports cover Regulation FD disclosures and other events involving CardiAMP clinical data, FDA and PMDA regulatory interactions, the Helix transendocardial delivery catheter, and patent protection for Heart3D Fusion Imaging software.
The company’s filings also record annual operating results, research and development activity, liquidity-related financial disclosures, and Nasdaq continued-listing compliance matters. These documents frame BCDA’s public-company record around product-development programs, regulatory pathways, intellectual property, capital and listing status, risk disclosures, and corporate reporting obligations.
BioCardia, Inc. provides an in-depth overview of its clinical-stage cardiovascular and pulmonary cell therapy business. The company is advancing the autologous CardiAMP platform for ischemic heart failure with reduced ejection fraction and chronic myocardial ischemia, and the allogeneic CardiALLO and PulmALLO MSC platforms for heart failure and acute respiratory distress syndrome.
The CardiAMP heart failure program has completed a Phase III trial that did not meet its primary endpoint but showed clinically meaningful and statistically significant echocardiographic benefits in a prespecified high-risk subgroup, and is now supported by a confirmatory CardiAMP HF II trial with Centers for Medicare & Medicaid Services coverage. CardiAMP has FDA Breakthrough Device Designation, and BioCardia is pursuing regulatory pathways in the United States and Japan, while also seeking separate approval of its Helix transendocardial delivery system and leveraging CMS-backed pivotal trials to reduce development costs.
BioCardia, Inc. reported that the FDA has accepted its pre-submission package for approval of the Helix Transendocardial Delivery Catheter, a device designed to deliver therapeutic and diagnostic agents directly into heart muscle.
The FDA’s Center for Devices and Radiological Health will lead a substantive review, with a meeting scheduled for early Q2 in consultation with the Center for Biologics Evaluation and Research. Management notes that Helix marketing clearance could be meaningful for the business and may also support the approval pathway for the CardiAMP Cell Therapy program.
BioCardia, Inc. reported late-breaking echocardiography results from its Phase III CardiAMP HF trial in ischemic heart failure with reduced ejection fraction. The data, presented at the Technology and Heart Failure Therapeutics conference, focus on how the investigational autologous cell therapy affects heart structure over time.
Patients receiving CardiAMP therapy showed positive evidence of decreased pathological left ventricular remodeling compared to controls, aligning with previously reported reductions in major adverse cardiovascular events and improved quality-of-life measures. In a prespecified subgroup with elevated myocardial stress biomarkers, differences in ventricular volumes were both clinically meaningful and statistically significant, supporting BioCardia’s belief in the therapy’s potential benefit.
BioCardia, Inc. filed an 8-K reporting that it has completed a Pre-Submission to the U.S. Food and Drug Administration under the Q-Submission program for approval of its Helix transendocardial delivery catheter for intramyocardial therapeutic and diagnostic agent delivery.
The Pre-Submission is supported by data from fifteen well-controlled clinical trials in three primary cardiac indications and is made under the CardiAMP Cell Therapy System FDA Breakthrough Designation. BioCardia seeks to align with FDA on the regulatory pathway and timing for approval within the next 45 days, after which an application for market clearance could follow.
The company states this process should support Helix becoming the first approved transendocardial delivery catheter system in the United States and may streamline future approvals of its CardiAMP and CardiALLO cell therapies and potential partners’ cardiovascular cell, gene, and protein programs.
BioCardia, Inc. President and CEO Peter Altman, who is also a director, reported buying additional common stock of the company. On 02/04/2026, he purchased 5,000 shares of BioCardia common stock at a price of $1.13 per share.
Following this transaction, Altman beneficially owned 273,866 shares of BioCardia common stock, held in direct ownership. The filing was made on a Form 4, which reports insider trades by company officers and directors.
BioCardia, Inc. reported that echocardiography data from its CardiAMP Cell Therapy program for the treatment of heart failure has been accepted as a Late Breaking Clinical Trial oral presentation at the Technology and Heart Failure Therapeutics (THT) Meeting. This conference is scheduled for March 2-4, 2026, in Boston, Massachusetts.
The company furnished a press release as an exhibit, which provides additional detail on the CardiAMP heart failure data to be discussed at the meeting. This disclosure is characterized as an informational event rather than a financial or transactional update.
BioCardia, Inc. insider activity: President and CEO Peter Altman reported open‑market purchases of the company’s common stock on two consecutive days in January. On January 20, 2026, he bought 600 shares at a weighted average price of $1.32 per share, in multiple trades executed between $1.31 and $1.33. On January 21, 2026, he purchased an additional 300 shares at a weighted average price of $1.34 per share, in trades executed between $1.34 and $1.35. Following these transactions, he directly owned 268,866 shares of BioCardia common stock.
BioCardia, Inc. filed a registration statement to register 424,509 shares of its common stock for issuance under its Amended and Restated 2016 Equity Incentive Plan. These shares became available for grant and issuance on December 2, 2025, after stockholders approved the Restated Plan at the 2025 Annual Meeting of Stockholders.
The Restated Plan also provides for an automatic annual increase on the first day of each fiscal year equal to 4.0% of the company’s outstanding common stock on the preceding day. The filing also describes standard Delaware law and company provisions for indemnifying directors and officers, and it lists the exhibits related to the plan, opinion of counsel, and consents.
BioCardia, Inc.'s president, CEO and director reported open-market purchases of the company’s common stock. On December 16, 2025, the reporting person bought 200 shares of BioCardia common stock at a weighted average price of $1.37 per share, executed in multiple trades between $1.28 and $1.46 per share. On December 17, 2025, they bought an additional 900 shares at a weighted average price of $1.30 per share, with individual trade prices ranging from $1.23 to $1.38 per share. After these transactions, the reporting person beneficially owned 267,966 shares of BioCardia common stock, held directly.
BioCardia, Inc. reported that Japan’s Pharmaceutical and Medical Device Agency has agreed to let the company move its CardiAMP Cell Therapy for the treatment of heart failure with reduced ejection fraction into a formal clinical consultation process. This follows completion of a third preliminary clinical consultation with the agency. If, in that formal consultation, the PMDA concludes that the available data provide sufficient evidence of safety and efficacy, BioCardia would be able to file for regulatory approval in Japan for this cell therapy.