SAN CARLOS, Calif., Sept. 5, 2018 /PRNewswire/ -- BioCardia®, Inc. (BCDA), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced that additional data from the open label, roll-in cohort of the ongoing Phase III CardiAMP™ Heart Failure Trial (CardiAMP-HF Trial) are expected to be presented at three upcoming fall cardiovascular congresses. The CardiAMP-HF Trial is a study of the company's autologous, investigational CardiAMP stem cell therapy for the treatment of heart failure developed following a heart attack. Positive six-month outcomes from the first 10 patients were published online in Circulation Research in late August and are expected to be published in print in the September 28, 2018 issue.
Two presentations related to CardiAMP are scheduled at the Transcatheter Cardiovascular Therapeutics (TCT) conference, one of the world's largest and most important educational meetings specializing in interventional cardiovascular medicine. Both presentations are scheduled for Monday, September 24, 2018:
- "The CardiAMP Heart Failure Study: First Results from Unblinded Roll-In Phase," 9:06 am PDT.
- "Performance of Helix Transendocardial Biotherapeutic Delivery System after 300 Cases," 9:18 am PDT.
An invited presentation – "The CardiAMP Heart Failure Trial" – is anticipated at the Texas Heart Institute International Cardiovascular Regenerative Medicine meeting, the leading U.S. conference focused on cardiovascular regenerative medicine, on October 5, 2018.
An abstract has also been accepted for presentation at the American Heart Association (AHA) Scientific Sessions 2018 conference. The presentation – "The CardiAMP Heart Failure Trial: Efficacy Outcomes from Roll-In Phase" – is scheduled for Monday, November 12, 2018 at 10:15 am CST.
The CardiAMP-HF Trial is a 260-patient biotherapeutics study currently enrolling at up to 40 centers in the U.S. as an FDA-approved pivotal study. The Center for Medicare and Medicaid Services (CMS) has approved reimbursement for the trial, which also has grant support from the Maryland Stem Cell Research Fund.
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.
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™ 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, 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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