At the Heart of What Fuels Us - Patient Priority

Ken brings more than 30 years of medical device experience to Foldax, both leading companies and serving on boards. Previously, Ken held board and CEO roles at Compellon, a bioinformatics company that was acquired by Clearsense in 2021, and Reshape Lifesciences, a private medical device company that commercialized minimally-invasive products to treat obesity, acquired by EnteroMedics in 2017. He was President and CEO of MindFrame, Inc. which made devices to treat ischemic strokes. In July 2012, Covidien, the world leader in that market, acquired Mindframe. Earlier, Ken was President and CEO of Orqis Medical, a privately funded company in the congestive heart failure space. Ken raised over $85 million for the company and took it from concept through IDE clinical trials. Before Orqis, Ken spent 16 years in general management positions with Baxter Healthcare Corporation, including President of the Bentley Division and President of New Business Initiatives for the Cardiovascular Surgery Division. He also spent four years in Japan as Managing Director of Baxter Japan Cardiovascular Division. Ken earned his B.S. Mechanical Engineering degree from Cornell University and his M.B.A. from the University of Chicago Booth School of Business and completed the Manufacturing Management Program at General Electric Company.

Frank Maguire has more than 30 years of experience in heart valves, other cardiac surgery products and medical grade polymers. Previously he was CEO of Aortech, a publicly traded UK med tech company with facilities in Australia and the US. Frank was Vice President/General Manager for Edwards Lifesciences Research Medical Division in SLC, UT. Frank came to Utah as an engineer for Symbion, Inc., the developer of the Jarvik Artificial Heart. While working for Symbion he was appointed Vice President/General Manager for its Mitral Medical Division developing and manufacturing the Mitroflow bovine pericardial heart valve in Richmond, BC. Frank earned his B.S. in Economics from SUNY Oneonta and his M.B.A. from Golden Gate University.

Laxmi has over 35 years of experience in the fields of pharmaceuticals and medical devices. He has held prior leadership roles in Edwards Lifesciences, Baxter Healthcare and Glaxo. Laxmi brings with him a wealth of knowledge in commercial operations. After leaving Edwards Lifesciences, he held various leadership positions in startups in cardiovascular, neuro, ortho and robotics markets.

Michele has over 35 years of experience in the medical device industry including consulting and senior management positions in areas of pre-clinical development, regulatory affairs, clinical trial management, quality compliance, and new technology reimbursement. She the President of Lakeshore Medical Device Consulting focusing on assisting early phase medical device startups. Recent experience is in class III cardiovascular and spinal devices, and class II vascular access systems, patient monitoring devices, and electrosurgical instruments. Previously Michele was the Vice President of Regulatory and Clinical Affairs for Applied Spine Technologies where her responsibilities also included serving as the sponsor study director for an international IDE clinical trial for a spine dynamic stabilization device. Michele started her career at US Surgical Corporation (now a division of Covidien). During her 14-year tenure Michele, as Director of Corporate Quality Control, was directly involved in the development and commercialization of hundreds of medical devices including mechanical wound closure products and laparoscopic instruments. Michele received her B.S. degree in biology and chemistry from Western Connecticut State University. She is a member of the Regulatory Affairs Professional Society.

Amy joins Foldax with over 30 years of experience driving commercial strategy in medical device companies. She is a seasoned marketing executive who has played key roles in market development, market expansion, and driving therapies to standard of care. Her track record of success spans across large, small, and start-up companies with a focus on implementing strategies for physician and direct-to-consumer marketing. Amy has a deep background in marketing heart valves, with over 13 years of experience managing the global heart valve portfolio for Baxter/Edwards Lifesciences. She has broad medical device experience with startup device companies in cataract surgery, (WaveTec Vision, acquired by Alcon), non-invasive weight loss (ReShape Medical, acquired by Enteromedics), and lumbar spinal stenosis (Vertos Medical). Prior to joining Foldax, Amy served as Vice President of Marketing and Physician Education for Vertos Medical, where her key opinion leader (KOL) development and commercial strategic leadership helped triple sales in three years during the Covid pandemic. Amy holds a B.S. degree in business from Indiana University, and an M.B.A. from Pepperdine University.

Avi has more than 20 years of experience in the medical device industry. He is a well-established leader with a track record of taking concepts to clinical and ultimately leading to successful global commercial approvals of the technology. Avi has previously worked in leadership positions at Medtronic Cardiovascular, Edwards Lifesciences, Accelerant and Endologix. He has directly led multiple global clinical programs to successful market approvals in US, Canada, EU, Japan and countries in Asia. His passion for clinical research comes from the belief that everyone should have rapid access to safe and effective innovative technologies.

Ryan has more than 20 years of experience in the medical device industry, with expertise in active implantables, surgical tools, device hemocompatibility, patient transport, fluid systems, artificial intelligence and computer vision applications, and robotics and automation. Prior to medical devices, Ryan worked for a decade in the field of composite materials, developing and producing advanced recreation, automotive, and aerospace equipment and processes. He has worked in technical leadership and consultant positions with several companies taking concepts to market and acquisition. A Utah native, Ryan earned B.S., M.S., and Ph.D. degrees in Mechanical Engineering and a B.A. degree in Japanese from the University of Utah.

Greg has a 40-year track record of success in the medical technology arena, leading and growing both private and public companies, from clinical through commercial phases, and from fundraising through acquisition. As President and CEO of Access Closure, General Surgical Innovations, Orquest, and XTNT he led all four companies to successful exits via acquisitions by, respectively, Cardinal Health, U.S. Surgical (now Medtronic), Johnson and Johnson (J&J), and Biosensors International. His experience also includes serving as President and CEO for Cardiac Dimensions, and executive and management roles at Guidant’s Devices for Vascular Intervention division and North American Instrument Corp. Currently, he serves on the board of directors for Colospan, Cytokind, Tulavi Therapeutics and KL Acquisition Corp., and has held board roles with AngioDynamics, Apama Medical, Dextera Surgical, Kerberos Proximal Solutions, and QT Vascular. He has also served as strategic advisor for RenalPro.

Dr. Grainger is a University Distinguished Professor and Department Chair of Biomedical Engineering, and Distinguished Professor of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah.  His research expertise is focused on improving implanted medical device performance, drug delivery of therapeutic molecules, biotechnology agents, and live vaccines, nanomaterials interactions with human tissues, antimicrobial biomaterials, and innovating diagnostic devices based on DNA and protein biomarker capture.  Additionally, he is an expert in applications of surface analytical methods to biomedical interfaces, including analytical methods development for difficult organic surface patterns and nanomaterials, and also internationally recognized as an expert of perfluorinated thin films and biomaterials.  He has several successful experiences producing innovative, marketed medical technology.  Dr. Grainger received his B.A. in engineering and chemistry from Dartmouth College, Ph.D. in Pharmaceutical Chemistry from the University of Utah and performed postdoctoral research in interfacial chemistry and biophysics at the University of Mainz, Germany.

Dr. Padsalgikar is a widely known and well-respected expert in the field of long term implantable medical polymers. His areas of expertise include polymer reaction engineering, chemistry, structure and property and processing. He is named in 25+ publications and recently authored the textbook Applications of Polyurethanes in Medical Devices, May 2022 as part of the PDL Plastics Design Library series. He is a named inventor on 12 patents which include silicone urethane compositions. Dr. Padsalgikar has held Chief Scientific Officer and Principal Scientist positions at AorTech, St. Jude Medical/Abbott and DSM. In these roles has interacted with FDA on long term stability of polymers. Dr. Padsalgikar did his B. Eng. at Maharashtra Institute of Technology and his Ph.D. in Polymer Science at Clemson University.

Chris Jenney is an applied materials and biomaterials expert, having over 20 years of experience in the implantable medical device field.  Chris was instrumental in the development and testing of the first commercially released, implantable, cardiac stimulation leads designed with silicone-polyurethane insulation.  Chris is an expert in material selection, processing methods, and material characterization, including physical, chemical, thermal, and imaging methods.  Chris’ industry experience includes drug eluting combination devices, implantable pacing and defibrillation leads, neuromodulation systems, and microelectronics.  Chris brings practical expertise in the areas of biocompatibility, mechanisms of implantable device failure, and material degradation pathways. Chris received his B.S. in Materials Engineering from California Polytechnic State University, San Luis Obispo and Ph.D. in Biomedical Engineering from Case Western Reserve University.

Dr. Ajit Yoganathan is the Wallace H. Coulter Distinguished Chair in Biomedical Engineering & Regents’ Professor in the Department of Biomedical Engineering at the Georgia Institute of Technology and Emory University, and a member of prestigious U.S. National Academy of Engineering. He has been a pioneer in basic and translational cardiovascular research in fluid mechanics as they pertain to artificial heart valves, the whole heart, and congenital heart diseases. His work utilizes optical techniques (laser Doppler velocimetry & digital particle image velocimetry), as well as clinical tools (cardiac U/S & MRI to non-invasively study and quantify blood flow patterns and parameters in the cardiovascular system, both on the bench and in vivo. Over the last 45 years, Dr. Yoganathan’s contributions to the improvements of the biomechanics of prosthetic heart valves and heart valve repairs have been profound – since 1975, all prosthetic heart valves for use in the U.S. have been evaluated his lab. He received his B.S. in chemical engineer from University College, University of London and Ph.D. in chemical engineering the California Institute of Technology.

Dr. McCarthy is the Chief Scientific Officer at Tricol Biomedical. He brings over 25 years of research experience in chemistry and holds multiple worldwide patents in the chemistry and medical device field. He joined HemCon in 2001 as one of the primary founders and inventors of the underlying technology utilized in the lifesaving HemCon wound care solutions. Simon was named by the US Army as a Top Ten Invention Award recipient in 2005 for invention & development of the HemCon Chitosan Bandage. He further won the Tibbets Award in 2007 for the HemCon Bandage and was the finalist in Australia Eureka Awards 2012 for development of the novel co-polyurethane-siloxane Elast-Eon. Dr. McCarthy received his B.S. in mathematics, computer science and chemistry and Ph.D. in physical & polymer chemistry from Monash University.

Dr. Gunatillake was a Chief Research Scientist and currently a Fellow at the Commonwealth Scientific and Industrial Research Organisation (CSIRO), Melbourne, Australia.  He is a leading biomaterial scientist with world-wide reputation in the field of polyurethanes. His research has been and continues to be design and synthesis of polymers for biomedical applications. He has successfully made the transition from basic discovery research through the entire product development pipeline and helped delivery of commercial products into the medical device marketplace. He has received international recognition through technology innovations and valuable literature contributions to the understanding of structure-property relationships of polyurethanes and their effect on biostability/biodegradability. Dr. Gunatillake received his B.S. in chemistry from the University of Ceylon, M.Phil. in chemistry and Ph.D. in polymer chemistry from City University of New York.

James Runt is Professor Emeritus of Polymer Science in the MatSE Department at Penn State University. His research interests focus on the relationship between polymer dynamics and nanoscale phase separation, and how these influence macroscopic properties and performance of multiphase polymer systems. He is a Fellow of the American Physical Society and the American Institute of Medical and Biological Engineers. He was a co-editor of an ACS Symposium Series book: Polymers for Energy Storage and Delivery: Polyelectrolytes for Batteries and Fuel Cells, and an editor of the ACS Professional Reference Series book: Dielectric Spectroscopy of Polymeric Materials: Fundamentals and Applications. Dr. Runt received his B.S. in Materials Science and Engineering and Ph.D. in Solid State Science with a concentration in polymeric materials from Pennsylvania State University.

Dr. Shannon is the Chief of Cardiovascular Surgery, Research and Quality Programs at Beaumont Health, Royal Oak, Michigan. He is a member of the Society of Thoracic Surgery (STS) national Quality Committee and a reviewer for the Annals of Thoracic Surgery and has served on The Data and Safety Monitoring Board for Medtronic’s newly FDA-approved bovine pericardial aortic valve. Dr. Shannon has a special interest in the development of innovative heart valve devices. He is the co-PI of three transcatheter valve trials — Partner II, REPRISE II and III and SUMMIT as well as the EVEREST Percutaneous Mitral Leaflet Repair Trials. He has worked on the development of mitral rings that are adjustable during and after implant. Additionally, he has a special interest in the “big data” dimension of cardiac surgery and has developed an “analogue” analytical tool (POCMA™) for identifying the root cause of surgical mortalities, which has been adopted by the Michigan Quality Collaborative, Johns Hopkins and the Cleveland Clinic to guide their quality improvement programs in cardiac surgery. Dr. Shannon received his bachelor’s degree in biology from the University of San Francisco and medical degree from Mount Sinai School of Medicine. He completed his general surgery residency at the University of Colorado and was Chief Resident in Cardiothoracic Surgery at New York University. Recently, he pursued formal training in machine learning and artificial intelligence which led to his completion of a master’s degree program in Data Science at the University of California, Berkeley this year (2020).

Dr. Answini is the Chief, Division of Cardiothoracic Surgery and Co-Director of Cardiovascular Service Line at The Christ Hospital in Cincinnati, Ohio. He is a board-certified cardiothoracic surgeon and one of the few cardiac surgeons in the Greater Cincinnati area who performs complex open and endovascular aortic surgery. His clinical specialty is minimally invasive surgery, including valves, LVADS, and endovascular surgery (including EVAR, TEVAR, and TAVR). He has participated in more than 40 clinical trials and has authored several articles in peer-reviewed medical journals. He has presented his work at conferences and symposia including the annual meetings of the American College of Surgeons and the World Surgical Congress of Endoscopic Surgery. After graduating magna cum laude from Auburn University, AL, where he was an All-American swimmer, Dr. Answini earned his medical degree at Temple University School of Medicine, Philadelphia, PA. He completed a surgical residency at Carolinas Medical Center, Charlotte, NC, followed by a cardiothoracic surgery residency with extensive exposure to endovascular therapies at St. Louis University Hospital, MO. He joined the Ohio Heart and Vascular Center at The Christ Hospital in 2003.

Dr. Leon is Professor of Medicine at Columbia University Irving Medical Center (CUIMC). Dr. Leon is also Director of Columbia Interventional Cardiovascular Care, Director of the Cardiac Catheterization Laboratories, and is on the Executive Board of the Columbia Structural Heart & Valve Center. He is a practicing interventional cardiologist at New York-Presbyterian Hospital in New York City. Dr. Leon is also the Founder and Chairman Emeritus of the Cardiovascular Research Foundation. Dr. Leon has served as principal investigator for over 50 clinical trials that have helped shape the field of interventional cardiovascular medicine. Dr. Leon has co-authored over 1550 publications, has performed over 10,000 interventional procedures, and has had a major impact as a thought-leader and innovator in the expanding sub-specialty of interventional cardiovascular device and drug therapies. He is the Director and Founder of Transcatheter Cardiovascular Therapeutics (TCT), the world’s premier interventional cardiovascular meeting. Dr. Leon has also served as Director or Co-Director of more than 100 international educational programs in areas of interventional cardiology. Dr. Leon completed a fellowship in Cardiology at the Yale-New Haven Hospital. He completed medical school at the Yale School of Medicine, and his internship and residency in internal medicine at the Yale-New Haven Hospital.

Dr. Yakubov is the John H. McConnell Chair of Advanced Structural Heart Disease, System Medial Chief, Advanced Structural Heart Disease of OhioHealth and Medical Director of Cardiovascular Studies for the OhioHealth Research Institute at Riverside Methodist Hospital, Columbus, Ohio. He has been involved in numerous clinical trials to advance treatment options for cardiovascular disease and structural heart disease. He is a speaker at several annual major cardiovascular conferences and has numerous publications in major medical journals and book chapters. He has been instrumental in the development of new technology for the treatment of structural heart disease. Dr. Yakubov received his medical degree from the Northeast Ohio Medical University NEOMED (formerly known as NEOUCOM), completed his Internal Medicine residency at Riverside Methodist Hospital and completed his cardiology fellowship at the University of Michigan.

Dr. Matthew is the Director of the Cardiac Catheterization Laboratory at Keck Medical Center of the University of Southern California and Professor of Clinical Medicine at the University of Southern California. He is widely known as a leader in interventional cardiology and has served as principal investigator for more than 50 clinical trials researching new devices. He is also a pioneer in many interventional procedures that are now commonplace in the catheterization lab. Dr. Matthews received his bachelor’s degree in biochemistry from University of Wyoming and medical degree from Creighton University, completed his internal medicine residency at the Mayo Clinic. He later completed a general cardiology fellowship at Harbor-UCLA Medical Center and an interventional cardiology fellowship at Good Samaritan Hospital in Los Angeles.