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 Q1 2026 net loss of $2.259M, narrowing from $2.712M a year earlier, as research and development and selling, general and administrative expenses both declined. Cash and cash equivalents were $951,000 as of March 31, 2026, with total assets of $1.712M and stockholders’ deficit of $1.066M.
The company states that existing cash is not sufficient to fund planned operations beyond June 2026 and discloses substantial doubt about its ability to continue as a going concern without new financing. BioCardia continues to rely on its at-the-market equity program, selling 184,725 shares for gross proceeds of $225,000 in the quarter, and may sell up to about $5.1M more under this facility.
Clinically, the CardiAMP heart failure program generated subgroup data suggesting fewer heart-death equivalents and improved quality of life, supporting regulatory interactions. Japan’s PMDA indicated CardiAMP evidence is likely sufficient to support market clearance and aligned on a path toward Shonin submission, while the U.S. FDA reaffirmed Premarket Approval as the appropriate pathway and recommended continuing the CardiAMP HF II confirmatory trial. The Helix delivery catheter also advanced via an FDA pre-submission, with regulators outlining potential approval pathways.
BioCardia, Inc. describes alignment with FDA on marketing clearance pathways for its Helix Transendocardial Delivery Catheter System. FDA agreed there are two potential routes and raised no concerns about Helix safety data, device performance, or compatibility with general classes of agents.
FDA’s preferred path would link Helix approval to approval of BioCardia’s CardiAMP cell therapy system for treating heart failure. FDA also indicated that a follow-on pre-submission, incorporating its advice, could support Helix clearance through the DeNovo pathway, which could position Helix for broader use with other investigational biologic therapies.
BioCardia, Inc. President and CEO Peter Altman reported an open-market purchase of 5,000 shares of the company’s Common Stock at $1.11 per share on April 29, 2026.
Following this transaction, he directly owns 280,766 shares of BioCardia common stock.
BioCardia, Inc. reported that Japan has allowed a patent titled “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation,” covering its proprietary Heart3D™ Fusion Imaging software. Heart3D is intended for treatment planning and real-time navigation during CardiAMP® Cell Therapy procedures and use with the Helix™ intramyocardial delivery system.
The company noted recent positive consultation with the Japanese Pharmaceutical and Medical Device Agency, and is working to submit CardiAMP Cell Therapy and its Helix delivery system for approval in Japan. The Japanese agency indicated that results from three completed ischemic heart failure trials likely provide sufficient safety and efficacy evidence to support a successful approval submission.
BioCardia, Inc. President and CEO Peter Altman reported open-market purchases of company stock. He bought a total of 1,000 shares of BioCardia common stock in two transactions at a weighted average price of $1.23 per share, increasing his direct holdings to 275,766 shares following these trades.
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.