The Company announces activation of CardiAMP HF II, a randomized controlled pivotal trial of its CardiAMP autologous cell therapy for patients with ischemic heart failure. The study was approved by FDA in Q4 2023 for the treatment of ischemic etiology heart failure of reduced ejection fraction (HFrEF). Study activation includes study-wide
The data supporting the design of CardiAMP HF II is from the interim results of the ongoing CardiAMP Heart Failure autologous cell therapy study (CardiAMP HF), a randomized, double blind, controlled study that enrolled 125 patients with New York Heart Association Class II and III ischemic heart failure. The interim results of the study will be shared at the upcoming Technology and Heart Failure Therapeutics meeting on
The primary endpoint for CardiAMP HF II is a Finkelstein-Schoenfeld composite difference between groups based on all-cause heart death, major adverse cardiac and cerebrovascular events, and quality of life as measured by Minnesota Living with Heart Failure Questionnaire at a minimum of one year and a maximum of two-year follow-up. The FDA approved trial size is 250 patients which has greater than 90 percent power (statistical probability of success).
“Now that the study is activated, we are working with our interventional heart failure network and individual clinical sites to complete the final steps to begin patient enrollment,” said Dr.
About the CardiAMP Autologous Cell Therapy Program
CardiAMP Cell Therapy – FDA designated as a Breakthrough therapy – uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure to potentially stimulate the body’s natural healing response. CardiAMP Cell Therapy incorporates three proprietary elements not previously utilized in investigational cardiac cell therapy: a pre-procedural cell analysis for patient selection, a high target dosage of cells, and a proprietary delivery system that has been shown to be safer than other intramyocardial delivery systems and exponentially more successful in cell retention. The CardiAMP HF trial is supported by the
About
Forward Looking Statements
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, the activation of clinical sites and the enrollment of patients in the CardiAMP II Trial, statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, 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
We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the 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 may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release 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
Media Contact:
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
Email: investors@BioCardia.com
Phone: 650-226-0120
Source:
2024 GlobeNewswire, Inc., source