BioCardia Submits Clinical Trial to FDA for New Indication of Chronic Myocardial Ischemia for CardiAMP Cell Therapy
January 05, 2018
SAN CARLOS, Calif. –BioCardia®, Inc. [OTC: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported filing a second Investigational Device Exemption with the Food and Drug Administration (FDA) for the CardiAMP Chronic Myocardial Ischemia Trial to treat patients with refractory angina.
This second potential indication for CardiAMP investigational cell therapy of chronic myocardial ischemia (CMI) and refractory angina follows the company’s FDA-approved Phase III clinical trial of CardiAMP in ischemic heart failure, which is currently enrolling patients.
Despite improvements in revascularization techniques, there is a growing population of patients with chronic angina not amenable to further revascularization that suffer with severely limiting symptoms. Recent studies suggest that as many as 15 percent of all patients undergoing cardiac catheterization have significant disease that is not amendable to revascularization. These patients suffer from poor perceived health status and psychological distress, have significant impairments in quality of life, and represent a burden to the healthcare system due to significant use of resources. Current therapies have limitations or are associated with minimal reduction in angina.
The CardiAMP investigational therapy takes a personalized and minimally-invasive approach to the use of a patient’s own cells (autologous cells) in the treatment of CMI. The investigational therapy is designed to stimulate the body’s natural healing response.
“This therapeutic approach of focused implantation of the right combination of bone marrow-derived cells delivered intramyocardially for the treatment of refractory angina is supported by significant existing data,” said Eric Duckers, MD, BioCardia Chief Medical Officer. “CardiAMP has pre-procedure selection criteria for patients that enhances the probability that patients receive the same effective dose of CD34+ cells that has shown efficacy in other large, recent trials.”
“The CardiAMP Chronic Myocardial Ischemia Trial is expected to benefit greatly from the experience and capabilities BioCardia has established in the CardiAMP Heart Failure Trial,” said BioCardia CEO Peter Altman. “Should the FDA approve the IDE and CMS grant a category B designation, as they have for the CardiAMP Heart Failure Trial, we anticipate that the first patients could be enrolled in the second half of 2018.”
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. The Company's current products include the Helix™ transendocardial 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, references to the enrollment of our CardiAMP HF Trial, the efficacy and safety of our products and therapies, 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, 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. We may find it difficult to enroll patients in our clinical trials, which could delay or prevent development of our therapeutic candidates. The rate of enrollment will depend upon the number of clinical sites and their ability to recruit patients that fit our trial profiles, and there could be delays beyond our control. 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, 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.
David McClung, Vice President Finance & CFO
The Big Biz show
University of Minnesota
BioWorld Med Tech
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