Biocardia Inc SEC Filings

BioCardia, Inc. reported preliminary open-label results from its CardiAMP Cell Therapy trial in chronic myocardial ischemia, presented at the EuroPCR conference. The minimally invasive, autologous cell therapy was well tolerated, with no treatment emergent major adverse cardiac events through two years of follow-up.

Patients had already exhausted guideline-directed medical, percutaneous, and surgical options before treatment. After CardiAMP therapy, average exercise tolerance increased by 179 seconds and this benefit persisted over two years. Angina episodes fell by an average of 82% by six months, suggesting meaningful symptom relief for severely symptomatic refractory angina patients.

BioCardia, Inc. President and CEO Peter Altman reported an open-market purchase of 5,700 shares of Common Stock at a weighted average price of $0.92 per share. Following this transaction, he directly holds 291,566 shares. The trade was executed in multiple lots between $0.89 and $1.02 per share.

BioCardia, Inc. President and CEO Peter Altman reported an open-market purchase of common stock. He bought 5,100 shares at a weighted average price of $1.02 per share. Following this transaction, he directly owns 285,866 shares of BioCardia common stock.

BioCardia, Inc. reported first quarter 2026 results, showing a smaller net loss while its balance sheet weakened. Net loss was 2,259 thousand for the three months ended March 31, 2026, compared with 2,712 thousand a year earlier, and net loss per share improved to $0.21 from $0.59. Total costs and expenses fell to 2,266 thousand from 2,726 thousand, reflecting lower research and development and selling, general and administrative spending. Cash and cash equivalents were 951 thousand as of March 31, 2026, down from 2,496 thousand at December 31, 2025, and total assets declined to 1,712 thousand from 3,413 thousand. Stockholders’ equity turned into a deficit of 1,066 thousand at March 31, 2026, compared with positive equity of 895 thousand at year-end 2025, while current liabilities increased to 2,778 thousand. The company highlighted a robust intellectual property portfolio with more than 60 patents and patent applications worldwide, including a newly allowed Japanese patent covering its Heart3D Fusion Imaging software to support CardiAMP Cell Therapy procedures.

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.