BioCardia Inc. - BCDA STOCK NEWS

BioCardia, Inc. [NASDAQ:BCDA] will report its 2023 financial results and provide a corporate update on March 27, 2024. The conference call will include a Q&A session, and participants can register online. The call will be accessible via phone and webcast, with replays available.

BioCardia, Inc. (BCDA) and StemCardia, Inc. partner to advance investigational stem cell therapy for heart failure, leveraging BioCardia's biotherapeutic delivery system. The partnership aims to accelerate clinical development and broaden future commercial access to an off-the-shelf heart regeneration treatment.

BioCardia, Inc. (BCDA) receives CMS approval for reimbursement coverage of the CardiAMP Phase III clinical trial for ischemic heart failure treatment. The trial aims to enroll up to 250 patients at 40 clinical centers, focusing on reducing mortality and improving quality of life.

BioCardia, Inc. (Nasdaq: BCDA) announced positive interim results from the Phase III trial of CardiAMP cell therapy in patients with chronic heart failure, showing significant risk reductions in heart death equivalents and non-fatal events. The therapy demonstrated promising outcomes, especially in patients with elevated NTproBNP levels, leading to the launch of a follow-on Phase III trial. The company also reported progress in the safety phase of a Phase I/II study of CardiALLO MSC therapy.

BioCardia, Inc. announces the activation of CardiAMP HF II, a pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by the FDA in Q4 2023 and aims to target heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates. The trial size is 250 patients with a statistical probability of success greater than 90 percent. The interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study will be shared at the upcoming Technology and Heart Failure Therapeutics meeting on March 4, 2024, with final results expected in Q4 2024.

BioCardia, Inc. (Nasdaq: BCDA) is targeting heart failure and chronic myocardial ischemia as potential indications for its biotherapeutic candidates. The company announced that two scientific abstracts on its CardiAMP and CardiALLO clinical stage therapeutic programs have been accepted for presentation at the Technology and Heart Failure Therapeutics Conference. The abstracts will be presented in the Late-Breaking Clinical Science/First-In-Human & Early Feasibility Studies session. The company's CardiAMP Phase 3 autologous cell therapy study showed benefits of reduced all-cause heart death equivalents and reduced major adverse cardiac events without safety concerns, but the study was halted as it was not likely to meet its primary endpoint. The CardiALLO Phase I/II allogeneic mesenchymal stem cell therapy study began enrollment in a 3+3 dose escalation design in December. Both cell therapy candidates are delivered with the company's proprietary minimally invasive Helix transendocardial biotherapeutic delivery system, approved for use in Europe and for investigational use in the United States.

BioCardia, Inc. (Nasdaq: BCDA) completed 2023 with three active clinical programs for cellular and cell-derived therapeutics to treat heart disease, expecting to report clinical data in 2024. The company also provided an update on its Biotherapeutic Delivery Partnering (BDP) and Morph Access Innovations (Morph) businesses, with new partnerships anticipated and recent patent issuances in Japan and the EU.

BioCardia, Inc. (Nasdaq: BCDA) Enrolls First Patient in CardiALLO Allogeneic Mesenchymal Cell Therapy Phase I/II Trial

BioCardia, Inc. [Nasdaq: BCDA] announced that PMDA minutes support the understanding that CardiAMP autologous cell therapy may be approved for ischemic heart failure with reduced ejection fraction based on follow-up data from the CardiAMP Heart Failure Trial. Despite not meeting the primary endpoint, treated patients showed reduced mortality and major adverse cardiovascular events. The FDA approved the CardiAMP Heart Failure II Study protocol, and BioCardia expects to submit for approval in Japan based on the data available in late Q4 2024.