Announcement • Jun 13
BioCardia, Inc. Provides Update On Compliance With Nasdaq Listing Rule 5550(b)(1) On April 10, 2026, BioCardia, Inc. (the Company) received a notification letter (the Notice) from the Nasdaq Listing Qualifications Staff (the Staff) of The Nasdaq Stock Market LLC (Nasdaq) notifying the Company that its amount of stockholders' equity had fallen below the USD 2.5 million required minimum for continued listing set forth in Nasdaq Listing Rule 5550(b)(1). As noted in the Original 8-K, the Company had until May 25, 2026 to provide Nasdaq with a specific plan to achieve and sustain compliance. The Company submitted its plan to regain compliance on May 25, 2026, and on June 9, 2026, received written notice that, based on review of the compliance plan, the Nasdaq staff granted the Company an extension to October 7, 2026 to regain compliance with the Rule. The Company is filing this Current Report on Form 8-K to provide an update to its compliance with continued listing requirements as set forth in Nasdaq Listing Rule 5550(b)(1). On June 8, 2026, the Company filed an 8-K and issued a press release announcing that the Company sold 3,509,604 shares at an average price of USD 1.279 on June 5, 2026. The shares were sold pursuant to the Company's At The Market offering agreement with H.C. Wainwright & Co. (the Sales Agreement). Under the Sales Agreement, from April 1, 2026 to June 5, 2026, the Company sold an aggregate of 4,004,330 shares of common stock at an average share price of USD 1.27, resulting in net proceeds of USD 4.9 million after deducting fees and expenses. As a result of these transactions, the Company believes it has regained compliance with the minimum USD 2.5 million stockholders' equity requirement for continued listing as set forth in Nasdaq Listing Rule 5550(b)(1). In that regard, the Company believes that as of the date of this Report, stockholders' equity exceeds USD 2.5 million. Nasdaq will continue to monitor the Company's ongoing compliance with the stockholders' equity requirement and, if at the time of its next periodic report the Company does not evidence compliance, it may be subject to delisting. 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.