Bernard Lyons, Ph.D.
President and Chief Executive Officer
Mr. Lyons joined Direct Flow Medical, Inc. in February 2006. He has over 25 years of experience in the medical device field. Prior to Direct Flow, he served as President and CEO of Vasca, Inc. a later-stage, privately-held medical device company focused on subcutaneous vascular access ports for hemodialysis treatment in patients with end stage renal disease. Previously, Mr. Lyons was President and CEO of CardioClasp, Inc., a development-stage start-up medical device company focused on the treatment of congestive heart failure. Mr. Lyons has held several senior-level positions at Boston Scientific Corporation, where he was the Vice President, Sales and Marketing for Interventional Oncology; Vice President, Sales and Marketing of the Meadox Division; Vice President, Corporate Product Development; and President of Boston Scientific operations in Japan. Mr. Lyons is a member of the Board of Directors for Paramit Corp. and was previously a Director at Creganna-Tactx Medical. He also was an Instructor in Surgery at Dartmouth Medical School and Adjunct Assistant Professor at the Thayer School of Engineering at Dartmouth College. Mr. Lyons earned his Ph.D. in Cancer Biology from Stanford University School of Medicine and a B.A. from the University of California, Los Angeles.
Chief Technology Officer and Co-Founder
Mr. Bishop co-founded Direct Flow Medical in June 2004. Mr. Bishop was recruited from California Polytechnic State University to Arterial Vascular Engineering, Inc. (AVE) in 1999 where he led various stent projects, including the Driver™ stent, currently on the market in the US and Europe. The Driver stent introduced interventional cardiology to the cobalt chrome era and its improved visibility, deliverability and radial strength due to the stent’s unique material properties. The Driver stent emerged as the preferred cobalt-based alloy stent in Europe, and is the market-leading bare-metal stent in Japan. In addition to leading the Driver stent Project at AVE, Mr. Bishop served on the ASTM F04 committee alongside agents of the FDA and other industry representatives to establish standards for stent testing and modeling. He also provided the patent litigation team with engineering support, and was responsible for failure analysis of returned goods. Hired as a Senior Engineer at MitraLife, Inc,. Mr. Bishop was a lead engineer on a novel percutaneous approach to lessen mitral regurgitation by implanting a device into the coronary sinus. As the first start-up company in this space, MitraLife spawned many other investments in the field. MitraLife was acquired by ev3, Inc. a Minneapolis-based company. Mr. Bishop has a B.S. degree in Mechanical Engineering from California Polytechnic State.
Charles J. Davidson, M.D., FACC, FAHA, FSCAI
Chief Medical Officer
Dr. Davidson joined Direct Flow Medical, Inc. in May 2012. Dr. Davidson brings a wealth of knowledge to the organization, having spent over 20 years in interventional cardiology. Dr. Davidson is the Clinical Chief of Cardiology and Professor of Medicine at Northwestern University Feinberg School of Medicine and Medical Director of the Bluhm Cardiovascular Institute at Northwestern Memorial Hospital, with specific expertise in valvular heart disease, transcatheter valve therapy, and PCI. After completing medical school at the University of Connecticut, Dr. Davidson completed his internship and residency at Northwestern University. He went on to complete general cardiology and interventional cardiology fellowships at Duke University Medical Center in Durham, N.C. He was an Assistant Professor of Medicine and Associate Director of the Cardiac Catheterization Laboratory at Duke. Dr. Davidson has been the principal investigator for numerous NIH clinical trials and has published over 300 peer-reviewed manuscripts and book chapters. He has authored the chapter on Cardiac Catheterization in the last 5 editions of Braunwald’s Textbook of Heart Disease. He is a fellow of the American College of Cardiology, American Heart Association and the Society of Cardiac Angiography and Interventions. He is board certified in cardiovascular disease, internal medicine, and interventional cardiology.
Senior Vice President, Clinical, Regulatory and Quality Assurance
Mr. Sheahan joined Direct Flow Medical, Inc. in April 2006. He has more than 25 years of experience in the medical device field. Prior to Direct Flow Medical, he served as Vice President of Regulatory Affairs and Quality Assurance for Boston Scientific Santa Rosa (TriVascular). The focus of his responsibilities included all site submissions, approvals and communications for the ENOVUS (Abdominal Aortic Aneurysm Stent Graft) product line with FDA. In addition, he was responsible for all Boston Scientific site integration activities and corporate compliance. Previously Mr. Sheahan was the Vice President of Clinical/Regulatory Affairs and Quality Assurance with MitraLife, Inc., an early-stage, start-up company. Mr. Sheahan was responsible for all initial human use activities and clinical case support for the MitraLife percutaneous mitral annuloplasty technology. MitraLife was sold to eV3 in 2002. Previously, Mr. Sheahan gained PMA approval of the AneuRx Abdominal Aortic Aneurysm stent graft (the first PMA approval for a AAA stent graft in the U.S.) and maintained market dominance during a period of intense FDA scrutiny. Previously, Mr. Sheahan held the position of Quality Assurance Director from the initial concept to US PMA approval for all Arterial Vascular Engineering stent product sales. Mr. Sheahan held a similar position at PS Medical, which designed and developed neurosurgical implants. Mr. Sheahan initially was hired into industry by Terumo Corporation and initiated the company’s first US-based manufacturing facility. Mr. Sheahan holds a B.S. degree in Biochemistry from Saint Joseph’s University in Philadelphia.
David R. Elizondo
Chief Operating Officer
Mr. Elizondo joined Direct Flow Medical, Inc. in January 2011. He has over 21 years of experience in the medical device field. Prior to Direct Flow, he served in the positions of Vice President, Research and Development; Vice President, Clinical Affairs; and General Manager, Tissue Operations at ATS Medical, Inc. a publicly-owned surgical cardiovascular device company primarily focused on heart valve replacement and repair. ATS Medical, Inc. was acquired by Medtronic, Inc., a Minneapolis-based company. Previously , Mr. Elizondo held several leadership positions at Boston Scientific Corporation, where he was the Director, Catheter Research and Development, and Director of New Business Development for the Cardiovascular Division. In addition, Mr. Elizondo has held Research and Development and Operational leadership positions at CryoLife, Inc. and St. Jude Medical, Inc., including Technical Manager at St. Jude Medical Biocor in Belo Horizonte, Brazil. Mr. Elizondo has a B.S. and M.S. degree in Biomedical Engineering from the Milwaukee School of Engineering and the University of Iowa, respectively.
Vice President of Finance
Mr. Burgess was named Vice President of Finance in May 2011 and previously held the position of Director of Finance. Before joining Direct Flow Medical in December 2006, Mr. Burgess was a senior business consultant for a variety of medical device and technology companies. Prior to working as a consultant, Mr. Burgess held several positions with increasing management responsibility in finance and accounting for Medtronic AVE and its predecessor, Arterial Vascular Engineering, Inc. , beginning in 1996 until 2002. Prior to 1996, Mr. Burgess was a Senior Auditor at Coopers & Lybrand located in San Jose, CA. Mr. Burgess is a CPA, holds an M.B.A. degree from the University of San Francisco and a B.A. Accounting from California Polytechnic State University in San Luis Obispo.
Vice President, Sales and Marketing
Dan Rose was named Vice President of Sales and Marketing in October 2012. Prior to joining Direct Flow Medical, Mr. Rose was Vice President of Commercial Operations of Sequana Medical, a Zurich-based company focused on implantable pump technologies for the management of end-stage liver disease and heart failure. Before Sequana Medical, Mr. Rose spent seven years in a number of leadership positions at Medtronic. Most recently, he was Marketing Director for the Coronary and Peripheral Vascular Division in Western Europe. Prior to that, Mr. Rose was Business Manager of the Vascular Division in the Nordic region. Before joining Medtronic, Mr. Rose co-founded a medical device company focused on continuous glucose monitoring technology and worked in early stage venture capital in London. Dan holds a B.A. and M.A. in Foreign Affairs from the University of Virginia and a M.B.A. from the Darden Business School.
Vice President of Regulatory and Clinical Affairs
Ms Selstrom joined Direct Flow Medical in November 2005 and is responsible for providing global regulatory strategic direction for obtaining approvals for the Direct Flow Medical Transcatheter Aortic Valve System. Ms Selstrom has over 15 years of experience in the medical device industry. This experience includes positions in Regulatory Affairs, Clinical Research and Quality Assurance, primarily focused on Class III cardiovascular devices, including TAVI, endovascular AAA and TAA stent grafts, and coronary stents. Her experience covers all facets of regulatory strategy and submissions for US and OUS clinical and commercial approvals. She is experienced in clinical trials and management with extensive experience in the strategy, design, analysis, and reporting of scientifically sound clinical trials and programs to support early product feasibility, product approval and post-marketing requirements around the globe. Ms Selstrom is now focused on the US pivotal IDE trial. Ms Selstrom holds a Bachelor’s degree from Sonoma State University.