SAN CARLOS, Calif.–(BUSINESS WIRE)–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 company’s 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.
“Mark’s 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.”
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. 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.
The Helix Biotherapeutic Delivery System is known as the Helical Infusion Catheter outside of the United States.
Forward Looking Statements
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