BioCardia [OTC: BCDA] today announced that Mark Schwartz, a 25-year veteran of cardiovascular device development, has joined the company as Vice President of Clinical Affairs, effective November 1. Schwartz brings extensive leadership experience in the design and execution of clinical studies for medical devices in the heart leading to regulatory approvals for such industry leaders as Boston Scientific, The Sorin Group and Guidant, among others.
Schwartz comes to BioCardia from EBR Systems, where he served as Vice President of Clinical and Regulatory Affairs for the developer of cardiac resynchronization therapy. Previously, he served as Senior Director of Clinical Affairs for The Sorin Group, leading the U.S. clinical program for the companys cardiac rhythm management and heart valve programs. There, he had oversight for IDE, research and post-market studies for a variety of cardiac devices, and was responsible for developing clinical, regulatory, market access and health economics strategies.
At Boston Scientific as Manager of Emerging Therapies, Schwartz was involved in the discovery, testing and clinical study of a portfolio of research and development projects, and as Manager of Clinical Programs, he successfully executed multiple clinical trials for heart failure, bradycardia and tachycardia product approvals. An engineer by training, his early career included bioengineering roles related to cardiac rhythm management devices for companies such as InControl and Intermedics. He holds a Master of Science in Biomedical Engineering from The University of Texas at Arlington and a Bachelor of Science in Electrical Engineering from North Dakota State University. Schwarz is an innovator on more than 15 issued patents.
Marks clinical trial expertise will be an invaluable addition to the team as we continue to enroll the Phase III CardiAMP Heart Failure Trial studying our investigational cell therapy for heart failure resulting from a heart attack, said BioCardia CEO Peter Altman, PhD. We look forward to benefiting from his robust experience at market leading companies leading cardiac devices from clinical study through regulatory approval and beyond as we work towards the potential of bringing the first cell therapy for heart failure to the U.S. market.
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BioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular disease. CardiAMP and CardiALLO cell therapies are the Companys 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. CardiAMP cell therapy uses a patients own (autologous) bone marrow cells to potentially stimulate the bodys natural healing response through a minimally-invasive, catheter-based procedure.
The Helix Biotherapeutic Delivery System is known as the Helical Infusion Catheter outside of the United States.
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 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 BioCardias 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 BioCardias 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.