News | Stem Cell Therapies | August 16, 2017

BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial

Multi-center randomized trial will assess ability of CardiAMP stem cell therapy system to improve patient response after heart attack through six-minute walking distance improvement

BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial

August 16, 2017 — BioCardia Inc. recently announced completion of treatment for the 10-patient roll-in cohort for the pivotal Phase III CardiAMP Heart Failure Trial. A pre-specified review of the 30-day outcomes in this cohort by the Data Safety Monitoring Board is anticipated in the third quarter of 2017.

The investigational CardiAMP stem cell therapy system is designed to deliver a high dose of a patient’s own bone marrow cells directly to the region of cardiac dysfunction to stimulate the body’s natural healing mechanism after a heart attack. Patients are selected for the investigational treatment, in part, based on biomarkers in their bone marrow that are anticipated to maximize the potential for patient benefit.

“Leading clinical sites are actively screening patients for the randomized phase of our Phase III trial, and we are onboarding additional clinical sites in the United States,” stated BioCardia Chief Medical Officer Eric Duckers, M.D., Ph.D., FESC. “The company anticipates filing an investigational device exemption (IDE) supplement to add an interim efficacy readout in the fourth quarter of 2018 and expects top line data in the fourth quarter of 2019.”

The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study of up to 260 patients at 40 centers nationwide, which includes a 10-patient roll-in cohort. The trial’s primary endpoint is an improvement in six-minute walking distance at 12 months post-treatment. In addition, the primary endpoint analysis incorporates the impact of major adverse cardiac events and other clinically meaningful events.

The company reaffirms guidance on its IDE submission in calendar year 2017 for a new CardiAMP indication to treat patients post-myocardial infarction. In addition, the company anticipates submitting an investigational new drug (IND) application in calendar year 2018 for CardiALLO cell therapy, which utilizes bone marrow-derived mesenchymal cells from a donor to treat heart failure.

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