BCDA;BCDAW 8-K filed 2026

Item 7.01           Regulation FD Disclosure.

On May 28, 2026, BioCardia, Inc. issued a press release reporting the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission for regulatory approval of the CardiAMP® cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF) based on the Company’s three completed clinical trials of this therapy in HFrEF. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT). PMDA noted that the positive outcomes seen in the trial were credible. It is estimated that 20,000 of the 300,000 patients in Japan would initially be eligible for this therapy. PMDA requested BioCardia demonstrate that enrolled patients were on GDMT and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation.

The results presented by Dr. Raval, on behalf of the CardiAMP CMI Investigators, 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 two 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.

A copy of the press release is attached hereto as Exhibit 99.1 to this current report on Form 8-K.

The information furnished pursuant to this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing.
BCDA;BCDAW Biocardia, Inc. - 8-K

Item 7.01 - Regulation FD Disclosure

Item 9.01 - Financial Statements and Exhibits
