BioCardia Anticipates DSMB Feedback on Interim Data

NASDAQ:BCDA   BioCardia, Inc.
1. BioCardia Anticipates DSMB Feedback on Interim Data From Pivotal Phase 3 CardiAMP Heart Failure Trial

BCDA today announces that it anticipates data safety monitoring board (DSMB) verbal feedback by the end of December 15, 2020 on interim data from the Company’s pivotal Phase 3 CardiAMP Heart Failure Trial that is currently enrolling nationwide for infusion of BioCardia’s CardiAMP™ autologous cell therapy to the myocardium. The DSMB is then anticipated to provide its written feedback approximately 24 hours later. BioCardia plans to provide an announcement pre-market on December 17, 2020 summnarizing the feedback and outlining the next resulting steps.

The CardiAMP Heart Failure study has been approved by the FDA to enroll up to 260 patients at up to 40 centers. The purpose of the study is to determine the safety and efficacy of CardiAMP cell therapy in the treatment of patients with ischemic heart failure. The FDA has said that the trial qualifies as a pivotal trial to produce the primary data to support market registration for the CardiAMP cell therapy for this significant unmet clinical need.

2. BioCardia, Inc. Announces $8.5 Million Registered Direct Offering Priced At-The-Market Under Nasdaq Rules

today announced it has entered into definitive agreements with investors for the purchase and sale of 1,789,474 shares of its common stock at a purchase price of $4.75 per share in a registered direct offering priced at-the-market under Nasdaq rules. The closing of the offering is expected to occur on or about December 16, 2020, subject to the satisfaction of customary closing conditions.


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