Positive Data on BioCardia's Investigational CardiAMP Cell Therapy for Heart Failure Presented at Transcatheter Cardiovascular Therapeutics (TCT) Conference
September 24, 2018
CardiAMP Therapy Demonstrated Clinically Meaningful Patient Improvements at Nine Months
Helix Delivery System for CardiAMP Therapy Shown to Have Best Safety Profile Compared to Leading Biotherapeutic Intramyocardial Delivery Approaches in Clinical Trial Use Today
SAN DIEGO and SAN CARLOS, Calif. – BioCardia®, Inc., a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that positive data from two studies of its investigational CardiAMP stem cell therapy were presented today at the Transcatheter Cardiovascular Therapeutics (TCT) conference.
CardiAMP cell therapy uses a patient’s own (autologous) bone marrow cells to potentially stimulate the body’s natural healing response through a minimally-invasive, catheter-based procedure.
Nine month results from the 10-patient roll-in cohort of the CardiAMP Heart Failure Trial, a Phase III pivotal trial, showed clinically meaningful improvements in symptoms, quality of life and exercise capacity, as measured by New York Heart Association class, Minnesota Living with Heart Failure Questionnaire and Six Minute Walk Distance, respectively.
At nine months, clinically meaningful improvements were seen in Six Minute Walk Distance, New York Heart Association Heart Failure Class and Minnesota Living with Heart Failure Questionnaire, which were statistically significant at six months relative to baseline, although not at nine months. This difference was due in part to the lack of nine month follow-up in one patient due to a MACE event which was assigned a score intended to capture the event for comparison to the control arm. The improvements in exercise capacity and quality of life were greater in magnitude than those observed in the previous Phase II randomized placebo-controlled trial of CardiAMP therapy, which reached statistical significance in both endpoints when compared to control.
CardiAMP-HF is the first multicenter clinical trial of a stem cell therapy to prospectively screen for stem cell therapeutic potency. It is currently enrolling at leading cardiovascular centers across the United States. One-year results for the roll-in cohort of the CardiAMP-HF trial will be presented at the American Heart Association Scientific Sessions 2018 conference in November.
Another presentation examined the safety profiles of leading methods of stem cell therapy delivery in clinical use today, including BioCardia’s Helix Biotherapeutic Delivery System, which is used to deliver CardiAMP cell therapy. The study encompassed a review of published articles on clinical trials supplemented by reports from the FDA Manufacturer and User Facility Device Experience of reported adverse events.
The treatment emergent MACE rate was 0.3 percent for the Helix system, and ranged from 1.2 to 5.0 percent for the other systems. In addition, the Helix System showed no deaths, while the mortality rate of the other approaches ranged from 0.39 to 0.83 percent. As a result, the study concluded that the investigational Helix biotherapeutic delivery system appears to have the best safety profile among the leading delivery systems in clinical trial use today, based on currently available data.
In more than 300 clinical cases and over 5,000 deliveries performed by 40 interventional cardiologists in 30 centers globally, no death, myocardial infarction or stroke related to the Helix system has been reported thus far.
“We continue to be encouraged by positive clinical outcomes for CardiAMP cell therapy and the performance of the Helix system in delivering this therapy,” said BioCardia CEO Peter Altman. “We greatly appreciate the commitment of the clinical coordinators and investigators involved in the CardiAMP Heart Failure trial and their enthusiasm for exploring the promise of this new therapy to improve the lives of heart failure patients.”
BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ Biotherapeutic Delivery System and the Morph® steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix systems and clinical support to their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction.
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 intended outcomes of our trials, the efficacy and safety of our products and therapies, 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 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 may differ materially from the forward-looking statements contained in this press release. 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2018, including those under the caption titled “Risk Factors.” BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
David McClung, Chief Financial Officer
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