Recent Business Highlights
CardiAMP® autologous cell therapy in ischemic heart failure of reduced ejection fraction (BCDA-01)
- In February, PMDA provided additional questions for
BioCardia , in line with those addressed and discussed in three preliminary clinical consultations, on the evidence supporting safety and efficacy of CardiAMP Cell Therapy System and scheduled our Formal Clinical Consultation. We addressed these questions in advance of the Formal Clinical Consultation with PMDA. - In March, our CardiAMP HF clinical data presented at the Technology and Heart Failure Therapeutics (THT) late breaking clinical trials session showed the CardiAMP cell therapy positively impacts the lives of patients, particularly those having elevated markers of heart stress. These patients experienced statistically significant improvement in heart function. This aligned with the three tiers of the composite outcome of (1) living longer without heart replacement therapies such as LVAD or transplant, (2) having fewer major adverse events such as heart attacks, strokes, and hospitalizations, and (3) having a better quality of life, which also achieved statistical significance.
- In April, during the Formal Clinical Consultation with PMDA attended by six world class cardiologists, PMDA determined that the clinical safety and efficacy evidence for the CardiAMP®
Cell Therapy in ischemic heart failure is likely sufficient to support market clearance. Alignment was achieved on the acceptability of the foreign clinical data developed inthe United States , the indications for use in patients, the approach for introduction of the therapy inJapan , approaches for defining Appropriate Use Conditions, the need for continued post marketing studies inJapan , and how these post marketing studies are to be developed. - In May, we received the preliminary Advisory Record from PMDA which is in line with expectations. We are preparing answers to outstanding questions and advancing towards Shonin submission, the formal application process for Pre-Market Approval (PMA) required to register the CardiAMP Cell Therapy System in
Japan . - In May, we had our Q-Sub Meeting with
FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). FDA expressed no concerns on safety, agreed the benefits for patients who received therapy in the CardiAMP HF Trial were intriguing, and confirmed that Premarket Approval (PMA) continues to be the appropriate regulatory pathway. The FDA considered advancement of the PMA submission based on the currently available data. FDA recommended continuing the ongoing CardiAMP HF II trial as the confirmatory study to support a successful PMA and pledged ongoing support for the trial. - Throughout the first quarter, patients have also been screened, consented, and randomized at the four active CardiAMP HF II clinical sites:
University of Wisconsin ,Morton Plant Mease Hospital ,Emory University andHenry Ford Health .
CardiAMP autologous cell therapy in chronic myocardial ischemic with refractory angina (BCDA-02)
- Primary results of this cohort have been accepted for oral presentation at Euro PCR, a world-leading course in interventional cardiovascular medicine on
May 20, 2026 .
Helix™ Biotherapeutic Delivery System
- In February, we announced a Pre-Submission to the FDA under its Q-Submission program for the approval of our Helix Transendocardial Delivery Catheter (Helix) for intramyocardial therapeutic and diagnostic agent delivery.
- In May,
BioCardia had this Pre-Submission meeting with FDA. FDA agreed that there are two pathways for Helix marketing clearance and raised no concerns on Helix safety data, device performance, or compatibility with general classes of agents. FDA’s preferred route of Helix approval was simultaneous with the approval of the CardiAMP cell therapy system for the treatment of heart failure. FDA also suggested a follow-on pre-submission incorporating agency advice could enable Helix approval via the DeNovo pathway.
Intellectual Property
The Company’s intellectual property portfolio is robust, with more than 60 patents and patent applications worldwide.
In March, the Company announced that the Japan Patent, “Target Site Selection, Entry, and Update with Automatic Remote Image Annotation.” This patent adds further protection to BioCardia’s proprietary Heart3D™ Fusion Imaging (Heart3D) software intended for treatment planning and real-time navigation during CardiAMP Cell Therapy procedures. The allowed Japanese patent has claims on the use of Heart3D fusion imaging configured for transposing a preoperative three-dimensional image obtained by Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) of the patient’s heart onto two orthogonal two-dimensional images to generate a combined three-dimensional model reconstruction of the heart on a display within or adjacent to a sterile field for navigating delivery systems and recording procedural locations.
“It has been a tremendous quarter, and we are thankful for the extensive interactions with PMDA and FDA in reviewing the CardiAMP HF clinical trial data and for their continued support. CardiAMP Cell Therapy for the treatment of ischemic heart failure is now advancing towards an expected initial regulatory approval in
First Quarter 2026 Financial Results:
- Net cash used in operations in the three months ended
March 2026 was approximately$1.7 million , compared to approximately$1.6 million in the three months endedMarch 2025 , primarily due to the timing of supplier payments. The Company ended the quarter with cash and cash equivalents totaling$951,000 . - Research and development expenses decreased to approximately
$1.2 million in the three months endedMarch 2026 , compared to approximately$1.5 million in the three months endedMarch 2025 , primarily due to closeout of the CardiAMP HF Trial, partially offset by early enrollment in the CardiAMP HF II Trial and regulatory activities to advance CardiAMP inJapan . - Selling, general and administrative expenses decreased to approximately
$1.0 million in the three months endedMarch 2026 compared to approximately$1.2 million in the three months endedMarch 2025 , primarily due to lower professional service fees. - Our net loss was approximately
$2.3 million in the three months endedMarch 2026 , compared to approximately$2.7 million in the three months endedMarch 2025 .
ANTICIPATED UPCOMING MILESTONES AND EVENTS:
- CardiAMP for Chronic Myocardial Ischemia, Oral Presentation at Euro PCR – Q2 2026
- Japan PMDA Shonin Submission for Approval – Q4 2026
Conference call access:
Participants can register for the conference by navigating to https://dpregister.com/sreg/10209272/104069d5d88. Please note that registered participants will receive their dial-in number upon registration. For those who have not registered, to listen to the call by phone, interested parties within the
A webcast replay of the call will be available approximately one hour after the end of the call at the following link: https://services.choruscall.com/ccforms/replay.html. A telephonic replay of the call will be available and may be accessed by calling 1-855-669-9658 (toll free domestic/
About
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment in our clinical trials, the sufficiency of data from our clinical trials, filings and communications with the FDA and Japan’s
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on
| Condensed Consolidated Statements of Operations | |||||||||||
| (Unaudited in thousands, except share and per share amounts) | |||||||||||
| Three Months ended | |||||||||||
| 2026 | 2025 | ||||||||||
| Costs and expenses: | |||||||||||
| Research and development | $ | 1,235 | $ | 1,530 | |||||||
| Selling, general and administrative | 1,031 | 1,196 | |||||||||
| Total costs and expenses | 2,266 | 2,726 | |||||||||
| Operating loss | (2,266 | ) | (2,726 | ) | |||||||
| Other income (expense): | |||||||||||
| Total other income, net | 7 | 14 | |||||||||
| Net loss | $ | (2,259 | ) | $ | (2,712 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.21 | ) | $ | (0.59 | ) | |||||
| Weighted-average shares used in computing | |||||||||||
| net loss per share, basic and diluted | 10,812,419 | 4,635,764 | |||||||||
| Selected Balance Sheet Data | ||||||
| (amounts in thousands) | ||||||
| 2026(1) | 2025(1) | |||||
| Assets: | ||||||
| Cash and cash equivalents | $ | 951 | $ | 2,496 | ||
| Other current assets | 189 | 236 | ||||
| Property, plant and equipment and other noncurrent assets | 572 | 681 | ||||
| Total assets | $ | 1,712 | $ | 3,413 | ||
| Liabilities and Stockholders' Equity (Deficit) | ||||||
| Current liabilities | $ | 2,778 | $ | 2,432 | ||
| Operating lease liability - noncurrent | 86 | |||||
| Total stockholders' equity (deficit) | (1,066 | ) | 895 | |||
| Total liabilities and stockholders' equity (deficit) | $ | 1,712 | $ | 3,413 | ||
| (1) | ||||||
Media Contact:
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
Email: investors@BioCardia.com
Phone: 650-226-0120
