BCDA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-12

• The CardiAMP autologous cell therapy is a minimally processed mononuclear cell therapy containing CD34+ and CD133 cells and is designed to promote microvascular repair through enhanced capillary density and reduced fibrosis. The therapy is delivered during a standard minimally invasive catheter-base…

• Three clinical trials of the CardiAMP cell therapy for delivery have been completed with a fourth study actively enrolling. A fourth trial has been initiated to confirm the results observed in the CardiAMP HF Trial. In all trials, patients are typically discharged after an overnight stay.

• Our Phase 1, Transendocardial Autologous Bone Marrow in Myocardial Infarction Trial (TABMMI), National Clinical Trial (NTC) Identifier NCT-00507468, met its primary safety outcome and provided signals of patient benefit including improved exercise tolerance, improved heart function, reduced mortalit…

• Our Phase 2, Transendocardial Autologous Cells in Heart Failure Trial (TACHFT), NCT00768006, also met its primary safety outcome and provided signals of patient benefit when compared to the dedicated placebo group including improved six-minute walk distance, improved quality of life, and reduced maj…

• Our Phase 3, CardiAMP Heart Failure Trial (CardiAMP HF), NCT02438306, was designed based on the Phase II TAC-HFT study to confirm signals of benefit observed relative to its dedicated placebo groups. The trial included biologically informed patient selection based on cell characteristics, point-of-c…

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• The CardiAMP Heart Failure Trial was a randomized, double-blinded, placebo procedure controlled, multi-center pivotal clinical trial for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The trial assessed the safety and effectiveness of the CardiAMP Cell Therapy System f…

• Clinical data from a 10-patient roll in cohort was published in 2021 in the International Journal of Cardiology. These results concluded that all CardiAMP HF protocol procedures were feasible and well tolerated. Favorable functional, echo and quality of life trends suggest this approach may offer pr…

• Principal results from the trial were presented at the Late-Breaking Clinical Trials symposium at the American College of Cardiology (ACC) Scientific Sessions in March 2025. While the trial did not meet the primary endpoint, two-year results from the trial demonstrated:

• In patients with elevated NTproBNP biomarkers (50% of enrolled patients) compared to patients on optimized heart failure medication regimens alone had:

• 13% fewer heart death equivalents (i.e., all-cause death, heart transplantation, left ventricular assist device implantation); a 47% relative risk reduction in heart death equivalents

Text added vs the prior filing · source: 10-Q · 2026-08-12

• The listing of our common stock on the Nasdaq Capital Market (Nasdaq) is contingent on our compliance with the Nasdaq’s conditions for continued listing. We were previously not in compliance with the Nasdaq listing requirements. Although we have regained compliance, a future failure to maintain comp…

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• The listing of our securities on the Nasdaq Capital Market (Nasdaq) is contingent on our compliance with the Nasdaq’s conditions for continued listing. We are currently not in compliance with Nasdaq listing requirements. On April 10, 2026 we received written notice from the Nasdaq (the Notice) which…

• We intend to submit a plan to Nasdaq to regain compliance with the Nasdaq Listing Rules. In determining whether to accept the plan, Nasdaq will consider such things as the likelihood that the plan will result in compliance with Nasdaq’s continued listing criteria, our past compliance history, the re…

• If we fail to regain compliance, our securities will be subject to delisting by the Nasdaq. In the event our securities are no longer listed for trading on Nasdaq, our trading volume and share price may decrease and we may experience further difficulties in raising capital, which could materially af…