BioCardia Anticipates DSMB Feedback on Interim Data from Pivotal Phase 3 CardiAMP Heart Failure Trial
December 14, 2020
SAN CARLOS, Calif. – BioCardia®, Inc. (Nasdaq: BCDA)(BioCardia or the “Company”) 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.
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Company’s biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit www.BioCardia.com.
Forward Looking Statements
This press release contains forward-looking statements that are subject to risks and uncertainties, including the anticipated timing of the data safety monitoring board feedback and a subsequent announcement summarizing that feedback and planned future actions the Company may make in response. Although we believe that we have a reasonable basis for these forward-looking statements, we caution you that forward-looking statements are not guarantees of future performance. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Michelle McAdam, Chronic Communications, Inc.
David McClung, Chief Financial Officer
Henry Ford Health System
Cell & Gene
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