BCDA — what changed in the latest 10-Q

Text added 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 removed vs the prior filing · source: 10-Q · 2025-11-12

• Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate increased capillary density, reduce tissue fibrosis, and ultimately treat microvascular dysfunction, both of…

• The CardiAMP cell therapy procedure for heart failure has a specific reimbursement code, C9782, which was established by the Centers for Medicare & Medicaid Services (CMS). This code is used by hospitals to bill for the procedure, including both the treatment and control arms of the CardiAMP Heart F…

• CardiAMP HF Trial was a randomized, double-blinded, placebo-procedure controlled study of 115 ischemic heart failure patients with HFrEF enrolled at 18 centers in the United States and Canada. The trial assessed the safety and effectiveness of the CardiAMP Cell Therapy System for the treatment HFrEF…

• We have had a positive preliminary clinical consultation with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the CardiAMP Heart Failure Trial two-year data previously provided to the agency. The meeting was held in preparation for the formal clinical consultation on acceptability of th…

• In the fourth quarter of 2025, we expect to complete submission of the CardiAMP HF data and request a meeting with the FDA to discuss the approvability of CardiAMP Cell Therapy for treatment of ischemic heart failure based on the available clinical data, even as the confirmatory CardiAMP HF II trial…

Text added 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…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• 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…

• Our ability to utilize Form S-3 is temporarily limited without a waiver from the SEC.

• As a result of our inadvertent failure to include certain management certificates in our Quarterly Report on Form 10-Q filed on August 11, 2025, which were subsequently filed in an amendment to such Form 10-Q on October 29, 2025, we are unable to have new registration statements on Form S-3 declared…

• Form S-3 permits eligible issuers to conduct registered offerings using a short form registration statement that allows the issuer to incorporate by reference its past and future filings and reports made under the Exchange Act. In addition, Form S-3 enables eligible issuers to conduct primary offeri…

• Should we not have an effective registration statement on Form S-3, we would not be able to utilize our at-the-market program. Furthermore, if we seek to access the capital markets through a different registered offering during the period of time that we may be unable to use Form S-3, we may be requ…