BioCardia Biotherapeutic Delivery and Morph Access Innovations Business Development Update for Shareholders

SUNNYVALE, Calif., Jan. 03, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. (Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, issues the following letter to shareholders:

Dear Shareholders,

BioCardia completed 2023 with three active clinical programs of its autologous and allogeneic cell therapies to treat heart disease, with a focus on ischemic heart failure of reduced ejection fraction. We expect to report clinical data from each of these programs in 2024. In coming months, we will provide a more detailed update on our therapeutic pipeline including expected timelines for data readouts and regulatory milestones.

Today, I am writing to share a brief update on our business development activities related to our Biotherapeutic Delivery Partnering (BDP) business and our Morph Access Innovations (Morph) business. Our BDP efforts are enhanced by the experience of almost 500 patients treated with the Helix transendocardial biotherapeutic delivery systems in twelve clinical trials. Morph products are used in each of our biotherapeutic delivery procedures, and have been used in thousands of vascular procedures over the years. The BDP and Morph businesses are derived from the experience and technology that we have developed in support of our own autologous and allogeneic cell therapy platforms.

In BDP, our team provides support for pre-clinical and clinical stage programs to enable and enhance our partner’s biotherapeutic development efforts. Efforts include review and preparation of protocols, sharing of strategic and regulatory insights, and providing technical input on strategies for handling and delivering biologic agents. We provide protocols and data collection templates as well as catheter products and technologies that are available today. We perform training for staff and physicians and support procedures using our biotherapeutic delivery systems. We believe that BioCardia having more opportunities to participate meaningfully in new high-value therapies through BDP is in our shareholders’ interests and outweighs concerns with respect to enabling competitive therapeutic programs.