BioCardia’s CardiAMP Heart Failure Trial Design to be Presented at Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine
September 15, 2017
HOUSTON and SAN CARLOS, Calif. –BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that the trial design for its pivotal Phase III CardiAMP Heart Failure Trial will be presented tomorrow during the “Heart Failure: The Big Target for CV Regenerative Therapy State of the Field” session at the Texas Heart Institute International Symposium on Cardiovascular Regenerative Medicine in Houston. As an invited faculty member for the meeting, Professor of Cardiovascular Medicine at the University of Florida and Study Co-National Principal Investigator Carl Pepine, MD is presenting the design.
CardiAMP therapy, an investigational product, takes a personalized and minimally-invasive approach to the use of stem cells for treating heart failure from a heart attack, learning from unsuccessful methods that have come before. By screening for patients with a higher likelihood of benefiting from treatment and delivering a high target dose of 200 million of a patient’s own bone marrow cells directly to injured cardiac tissue using a proprietary delivery system, CardiAMP therapy is designed to stimulate the body’s natural healing response.
The CardiAMP Heart Failure Trial is a Phase III, multi-center, randomized, double-blinded, sham-controlled study at 40 centers nationwide of up to 260 patients, 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.
“We have designed the CardiAMP therapy and pivotal trial to study a new approach to using bone marrow stem cells to address heart failure. Recognizing that earlier bone marrow cell therapies have been unsuccessful or inconclusive, we have learned from others’ experience,” said BioCardia Chief Medical Officer Eric Duckers, MD. “CardiAMP therapy incorporates a proprietary biomarker screening test to identify patients at a higher likelihood of benefiting from therapy before delivering it, which is designed to optimize outcomes and improve upon earlier results.”
He continued, “We target a high dose of 200 million stem cells, as a high dosage has been associated with improved heart function in previous studies and may improve the opportunity to impact target tissue. Lastly, by using autologous bone marrow cells rather than donor cells, we may improve the body’s acceptance of the therapy and minimize infection risk and complications.”
The company also announced the launch of a new website designed to support patient recruitment for the CardiAMP Heart Failure Trial. On the site, prospective patients can learn more about heart failure and the CardiAMP cell therapy system, and be screened for participation in the trial. The website can be visited at www.cardiamp.com.
Earlier CardiAMP studies – including the Phase II TAC-HFT-BMC trial – have shown an excellent safety profile with statistically significant improvements in patient quality of life and functional capacity. Delivery of stem cell therapy to the heart using the Helix™ transendocardial delivery system incorporated in CardiAMP therapy has been shown to result in superior cell delivery than either percutaneous intra-coronary infusion or direct injection in an open chest procedure.
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.
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 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 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.
Investors and Media:
David McClung, Vice President Finance & CFO
Cell & Gene
The Big Biz show
CALL US NOW
EMAIL US NOW