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. reported a positive outcome from a formal clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) regarding its CardiAMP Cell Therapy for ischemic heart failure. PMDA determined that existing clinical safety and efficacy data are likely sufficient to support market clearance in Japan.
The parties reached alignment on using CardiAMP clinical data generated in the United States, the intended patient indications, how to introduce the therapy in Japan, and the need for post-marketing studies there. BioCardia will await PMDA’s written meeting minutes for detailed feedback and a potential filing timeline.
CardiAMP Cell Therapy, which has FDA Breakthrough designation, uses a patient’s own bone marrow cells delivered via a minimally invasive catheter-based procedure to improve myocardial microvascular function. Development is supported by the Maryland Stem Cell Research Fund and reimbursement from the U.S. Centers for Medicare and Medicaid Services.
BioCardia, Inc. reported that Nasdaq notified the company on April 10, 2026 that it no longer meets the Nasdaq Capital Market’s continued listing standard requiring stockholders’ equity of at least $2.5 million. BioCardia’s stockholders’ equity was $895,000 as of December 31, 2025.
The company has until May 25, 2026 to submit a plan to regain compliance and, if Nasdaq accepts the plan, may receive up to 180 calendar days from April 10, 2026 to show it again meets the requirement. BioCardia’s common stock will continue trading on the Nasdaq Capital Market under the symbol BCDA while Nasdaq reviews the situation.
BioCardia, Inc. submitted CardiAMP HF clinical study data to the FDA and requested a meeting to discuss an accelerated approval pathway for the CardiAMP System to treat ischemic chronic heart failure with reduced ejection fraction. The planned meeting is expected during the current quarter under the program’s existing FDA Breakthrough Designation.
BioCardia aims to confirm whether its proposed approval submission is acceptable based on safety from the CardiAMP HF Trial, clinical response data in 125 ischemic HFrEF patients, and a favorable benefit–risk profile in a subgroup with elevated biomarkers of heart stress. In this higher‑risk subgroup, cells delivered showed a 47% relative risk reduction in all‑cause cardiac death, a 37% relative risk reduction in non‑fatal major adverse cardiac events, and meaningful quality‑of‑life improvement with a reported p=0.04.
BioCardia, Inc. President and CEO Peter Altman bought additional company stock in two open‑market transactions. He purchased 600 shares of common stock on March 24, 2026 at an average price of $1.24 per share and 300 shares on March 25, 2026 at an average price of $1.22 per share.
Both trades were executed in multiple lots within disclosed price ranges, with reported prices reflecting weighted averages. Following these purchases, Altman directly owns 274,766 shares of BioCardia common stock.
BioCardia reported full-year 2025 results, highlighting ongoing investment in its cell therapy pipeline while remaining a development-stage company with minimal revenue. Collaboration agreement revenue was $0 in 2025, down from $58,000 in 2024.
Total operating costs and expenses were $8.3M, slightly above $8.1M in 2024, driven by research and development of its CardiAMP, CardiALLO and Helix delivery programs plus selling, general and administrative spending. The company posted a net loss of $8.2M, compared with a $7.9M loss a year earlier, while net loss per share improved to $(1.23) from $(2.90) as the share count increased.
BioCardia ended 2025 with cash and cash equivalents of $2.5M and total assets of $3.4M, against current liabilities of $2.4M and total stockholders’ equity of $0.9M. Management emphasized progress on regulatory discussions and the confirmatory CardiAMP HF II trial, along with additional therapeutic programs and its Morph vascular navigation platform.
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.