BioCardia Completes Roll-in Cohort in Pivotal Phase III CardiAMP Heart Failure Trial
July 26, 2017
SAN CARLOS, CA –BioCardia®, Inc. (OTC:BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today 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 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, MD, PhD, 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.
BioCardia, Inc., headquartered in San Carlos, CA, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP® and CardiALLO® cell therapies are the company’s biotherapeutic product candidates in clinical development. For more information, visit www.BioCardia.com.
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardia’s business and product development plans and overall market conditions. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 30, 2017, including under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
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