Jay Lenker, Ph.D., Founder, President and CEO
Jay has consulted for several medical device startup companies including Reverse Medical Corporation, Onset Medical Corporation, Ellipse Medical Technologies, Micro Therapeutics, Inc., and Magellan Spine Corporation. He also served as Vice President of Scientific Affairs for MicroVention, Inc, and co-founded and served as President and COO of TheraCardia, Inc., a venture-backed startup company developing an emergency cardiac assist system for treating patients in cardiac arrest. He has also served as Vice President of Research and Development at Medtronic AneuRx where he established the R&D effort during the period from startup to acquisition by Medtronic. Jay was a co-founder of Advanced Surgical Intervention, Inc. and served in Management positions for Shiley, Inc. and Baxter International. He received B.S., M.S. and Ph.D. degrees in Aerospace Engineering from the Pennsylvania State University and is currently a named inventor on over 100 United States patents.
Eugene Breznock, D.V.M., M.S., Ph.D., Diplomate ACVS, Founder and Chief Medical Officer
Eugene has directed or participated in all research activities of an industrial contract research organization for over 20 years. He is currently Professor Emeritus at the School of Veterinary Medicine, University of California, Davis. Dr. Breznock has also served as Study Director for GLP studies testing for devices such as heart valve prostheses (tissue, mechanical, stented, stentless), aorto-coronary vascular grafts, peripheral vascular grafts and ventricular assist devices. Dr. Breznock is the founder and Director of Research at BioSurg, Inc. and a USDA Institutional Official. Dr. Breznock received his B.S. in Animal Science, his DVM, and his Ph.D. from the Ohio State University College of Veterinary Medicine, and his MS from the University of Georgia College of Veterinary Medicine.
James Carroll, BS, MS, Vice President of Research and Development
James worked as an aerospace engineer for 27 years, first with the Douglas Aircraft Company and later with Northrop Grumman Corporation. His background is in design and test of advanced military projects. He also worked on a program to develop a medical stretcher for stabilizing wounded soldiers on the battlefield. The stretcher had an isolation tent enclosing the patient. James designed and built ventilation systems that provide either a positive or negative pressure atmosphere within the enclosure. He has hands-on experience with machine tools and manufacturing processes. He received both B.S. and M.S. degrees in Aerospace Engineering from the Pennsylvania State University.
Paul Gasser, MBA, Director of Regulatory Affairs and Quality Assurance
Paul has more than 30 years of regulatory affairs experience in the medical device industry. He has been responsible for the supervision or conduct of activities surrounding regulatory affairs, quality assurance, quality control and documentation for several medical device companies. As a Vice President at the start-ups GluMetrics, Inc. and Devax Inc., Paul was responsible for the supervision or conduct of all activities surrounding RA, QA, QC, and documentation for a Class III glucose monitoring, combination device (drug coated sensor) and a Class III implantable, combination, cardiovascular device (drug coated bifurcated stent), respectively. Paul has an MBA from Chapman University and a B.S. in Biology from the University of California Irvine.
Laura Minarsch, RT (R), CVT, CCRP, RCIS, Director of Clinical Affairs
Laura began as a cardiovascular invasive specialist in interventional cardiology in 1982, and as extensive experience in interventional cardiology and novel devices used FIH. She was invited to Clinica Columbus Hospital in Milan with Dr. A Colombo and remained there assisting in research and submissions for FIH. Laura founded a clinical strategic research company in 1995 and operates globally as a consulting service to early stage medical technology companies in the areas of clinical development, clinical strategic planning, case support, data management development, literature review, clinical evaluation development in support of CE mark, clinical operations, study and design development and European access for both trials and commercialization. Her recent activities include first in man studies for percutaneous heart valves, cardiac implants, venous access, coronary devices, peripheral vascular devices, cerebral embolic protection devices and otolaryngology.
Don Kolehmainen, BSME, MBA, Vice President of Operations & Engineering
Don has extensive medical device experience in the areas of Operations & Manufacturing Management, Manufacturing/Industrial Engineering, and Research & Development. Throughout his many years in the work force, he has consulted for several medical device companies including Revision Optics, Alpha Medical Instruments, Visogen, and Edwards Lifesciences. He has also served as Director at A&M Biomedical, Abbott Medical Optics, and Microvention, and Vice President for both Glumetrics and Theracardia Incorporated. These experiences have given him the ability to assist in the development of products and take them through all of the design and manufacturing phases to commercial production. Don, has an MBA from California Lutheran University and a B.S. in Mechanical Engineering from Michigan Technological University. Currently, he is a named inventor on over 30 United States patents.
Peter van der Sluis, MBA, Vice President of Business Development
Peter is a Senior Healthcare Executive with significant, global quantifiable results in the areas of sales, marketing, clinical studies, product development, business development, strategic planning, international distribution and general management. In addition to all his experience, he also has served as Head of Management Exec/Investor of 8 successful exits. Currently, he is lending his many years of experience to lecturing at California Polytechnic State University, teaching advanced courses in Strategic Management, Strategic Marketing and Entrepreneurship.