BioCardia has announced that Mark Schwartz—a 25-year veteran of cardiovascular device development—has joined the company as Vice President of Clinical Affairs. A press release reports that 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 resynchronisation therapy. Previously, he served as senior director of Clinical Affairs for The Sorin Group, leading the US clinical programme for the company’s cardiac rhythm management and heart valve programmes. 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.
BioCardia CEO Peter Altman, says: “Mark’s clinical trial expertise will be an invaluable addition to the team as we continue to enrol the Phase III CardiAMP Heart Failure Trial studying our investigational cell therapy for heart failure resulting from a heart attack. 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 US market.”