Foldax, Inc. is taking the lead in the development of heart valves with the goal of improving hemodynamic performance similar to natural human valves. Driven by a passion to help patients, we collaborate with leading clinicians and researchers to design and manufacture heart valves intended to provide sustainable quality of life improvement for people with aortic, mitral or tricuspid valve disease.
For more information on current clinical investigations, please go to ClinicalTrials.gov.
Ken Charhut, Executive Chairman
Ken brings more than thirty years of medical device experience to Foldax. Currently, he leads two medical device and technology companies. He is executive chairman of the board at Foldax and chairman of the board for Compellon, a bioinformatics company. Previously, Ken held board and CEO roles at Reshape Medical a private device company which commercialized products to treat obesity that was acquired by EnteroMedics in 2017. He was President and CEO of MindFrame, Inc. which makes devices to treat ischemic strokes. In July 2012, Covidien, the world leader in that market, acquired MindFrame. Earlier, Ken was CEO and President of Orqis Medical, privately funded company in the congestive heart failure space. Ken raised over $85 million for the company and took if from concept through IDE clinical trials. Prior to Orqis, Ken spent 16 years in general management position 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.ME 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, Chief Executive Officer
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.
Jason Beith, Vice President, R&D
Jason has over 20 years of experience in the medical device industry, Jason is major contributor to the invention of the Tria™ aortic and mitral surgical valve platforms and lead the development of the novel manufacturing and production system. He has worked previously as a Senior Principal Engineer in R&D with Medtronic where he was the technical lead and inventor of the Avalus pericardial tissue valve. Earlier, Jason was Vice President of R&D with AorTech where he worked on polymer heart valves as well as other medical devices based on their family of polymeric materials. Before that Jason was a Principal Engineer within Edwards Advanced Heart Valve R&D, where he led their efforts on polymer heart valve design and development. Prior to this Jason worked as a Consultant Structural Engineer for 10 years on various capital project around the globe. Jason has 8 issued US patents and numerous applications worldwide.
Jason earned his B.Eng and Ph.D from the University of Glasgow and his M.Sc & DIC from the Imperial College, University of London. He is a Chartered Physicist, member of the Institute of Physics, and a past member of the Institution of Structural Engineering and Earthquake Engineering Field Investigation Team (EEFIT).
Paul Hammond, Vice President, Operations
Paul has over 25 years in the medical device industry covering a variety of product types. Prior to Foldax he was Vice President of Operations at Domain Surgical, a Salt Lake based start-up in the electrosurgical market. Prior to that Paul was Operations Manager for ZEVEX Int. (now MOOG), a contract manufacturer of a variety of fluid delivery systems. His team automated the production of the Infinity Enteral feeding pump that is considered the gold standard in its class. Paul’s career has also included positions at InnerDyne (now part of US Surgical), Bard Access and Merit Medical. He has held a variety of positions spanning the Operations spectrum.
Paul holds a B.S. in Aeronautical Science from Embry-Riddle as well as an M.B.A. from the University of Phoenix.
Michael Numamoto, Vice President, Marketing
Mike brings over thirty years of medical device experience to Foldax. He has a deep background in heart valve marketing with over 15 years managing the global heart valve portfolio for Baxter/Edwards Lifesciences. He has broad device experience with startup device companies in the venous vascular (VenPro), interventional pulmonology (Uptake Medical) and breast cancer (Cianna Medical) spaces. At his last startup venture, Cianna Medical, he led the clinical development and commercialization of the market leading SCOUT wire-free breast tumor localization system. Cianna Medical was acquired by Merit Medical in 2018.
Mike holds a B.S. degree in biological sciences from the University of California, Irvine and an M.B.A. in marketing from Northwestern’s Kellogg School of Management.
Michele Lucey, Vice President, Regulatory & Quality
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 100’s 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.
SCIENTIFIC ADVISORY BOARD
Robert Grubbs, Ph.D.
Dr. Grubbs is currently the Victor and Elizabeth Atkins Professor of Chemistry at the California Institute of Technology in Pasadena, California, where he has been a faculty member since 1978. In 2005, he was a co-recipient of the Nobel Prize in Chemistry (with R. R. Schrock and Y. Chauvin) for his contributions to the field of olefin metathesis. His main research interests are in organometallic chemistry and synthetic chemistry, particularly the development of novel catalysts for olefin metathesis. In olefin metathesis, a catalyst is used to break the bonds of carbon molecules, which can then re-form to create chemical bonds in new ways, producing new compounds with unique properties. The basic technique can be used for creation of polymers, pharmaceuticals and petrochemicals and has broad applications in areas including pharmaceuticals, biotechnology, agriculture and plastics.
Dr. Grubbs received his B.S. and M.S. in Chemistry from the University of Florida, Ph.D. in Chemistry from Columbia University and NIH Postdoctoral Fellow in Chemistry from Stanford University.
David Grainger, Ph.D.
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. He earned his 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.
James Runt, Ph.D.
Dr. James Runt is a 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.
Simon McCarthy, Ph.D.
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.
Thilak Gunatillake, Ph.D.
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.
Ajit Yoganathan, Ph.D.
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 engineering from University College, University of London and Ph.D. in chemical engineering the California Institute of Technology.
Chris Jenney, Ph.D.
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.
MEDICAL ADVISORY BOARD
Frank Shannon, M.D., Chair, Medical Advisory Board
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).
Steven Yakubov, M.D., MSCAI, FACC
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.
Ray Matthews, M.D.
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.
Geoffrey A. Answini, M.D.
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.