Announcement • Jun 05
BioCardia, Inc. Receives FDA Confirmation That CardiAMP HF II May Support Premarket Approval Of CardiAMP Cell Therapy For Ischemic HFrEF BioCardia, Inc. announced receipt of FDA minutes from its 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). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use. FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials. CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Japan Pharmaceutical and Medical Device Agency has indicated that the clinical results from three completed clinical trials for the treatment of ischemic heart failure likely provide sufficient evidence of safety and efficacy to support a successful submission for approval. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION - Limited by United States law to investigational use. Upcoming Catalysts in 2026: CardiAMP HF Manuscript Published, CardiAMP HF Japan PMDA Submission Fourth Quarter 2026. Announcement • May 23
BioCardia Inc Announces CardiAMP Cell Therapy Trial Results For Chronic Myocardial Ischemia BioCardia, Inc. announced the oral presentation of the results of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial (CardiAMP CMI) preliminary open label cohort at EuroPCR, an interventional cardiovascular medicine conference held in Paris. Results presented showed that the minimally invasive CardiAMP Cell Therapy procedure was well tolerated with no treatment emergent major adverse cardiac events and patients demonstrated positive clinical outcomes including increased exercise tolerance and reduced frequency of angina episodes with the autologous cell therapy up through 2 years follow-up. Prior to treatment, all patients were on guideline-directed medical therapy and had received all available percutaneous and/or surgical options as appropriate for their medical condition. Patients experienced increased exercise tolerance, improving by an average of 179 seconds, which persisted for the two-year study follow-up. Angina episodes were reduced by an average of 82% by six-months after treatment. Chronic myocardial ischemia occurs in the setting of coronary artery disease when there is reduced blood flow to the heart. This causes angina, a type of chest pain which is characterized as refractory angina when this pain cannot be controlled by a combination of optimal medical therapy, angioplasty or bypass surgery, and is estimated to impact 600,000 to 1,800,000 patients in the United States. Up to 15% of patients who have ischemia or angina and undergo cardiac catheterization are suboptimal candidates for conventional revascularization. Although prognosis of refractory angina has improved in recent years, patients with refractory angina experience a significantly impaired quality of life with disproportionately high utilization of healthcare services. These observations reflect the great need for new therapies for these patients. CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP cell therapy trials for the indications of both chronic myocardial ischemia and ischemic heart failure are covered by the Center for Medicare and Medicaid for both treatment and control procedures. CAUTION - Limited by United States law to investigational use. New Risk • May 19
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.85m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.5m free cash flow). Negative equity (-US$1.1m). Earnings are forecast to decline by an average of 3.2% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (111% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$9.85m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$9.2m net loss in 2 years).