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, acquired by Stryker). 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.

Atul brings over 25 years of management experience in the medical device and life science industries to Foldax. He has extensive experience ranging from general management to operations and commercialization. Previously, he was the President of InVitro International, an innovative provider of non-animal based human safety testing for a wide range of industries. At Paramit (purchased by Tecan for $1B) he helped commercialize contract design and manufacturing services globally, to both industry leaders and start-up companies in the medical device and life science space. He managed worldwide OEM partnerships and built a distributor network in India for Masimo (IPO); commercialized innovative blood pressure technology at BMEYE (purchased by Edwards LifeSciences); led marketing efforts for a public diagnostic cardiology company, Quinton (merged with Cardiac Science) and helped commercialize P.E.T. (positron emission tomography) and Nuclear Medicine technologies for ADAC (bought by Philips Medical Systems). He also worked as a management consultant for Booz Allen & Hamilton and as an automotive engineer for Altair Engineering (acquired by Siemens for $10B). Atul holds a B.S. in Mechanical Engineering from Indian Institute to Technology, an M.S. in Mechanical Engineering from The Ohio State University and an M.B.A from the University of Chicago Booth School of Business.

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.

George Wallace is a seasoned entrepreneur and executive with over three decades of experience in building and leading innovative medical device companies. His expertise spans executive leadership, strategic investments, and commercialization of groundbreaking healthcare technologies. Currently serving as Chief Executive Officer at EnCompass Technologies, Inc., George has been at the helm since 2018, driving innovation and growth in the medical technology sector. Prior to this, he spent 20 years as Managing General Partner of Intersect Partners, a firm focused on research and investment in solutions for large, unmet medical needs in healthcare. George co-founded and served as President and CEO of two successful ventures: Sub-Q, Inc., which developed advanced closure technologies for puncture sites, and Micro Therapeutics, Inc., a pioneer in neurovascular intervention acquired by ev3. His leadership was instrumental in developing and marketing transformative products that addressed critical gaps in patient care. Earlier in his career, George held leadership roles at Applied Medical, where he served as General Manager across multiple divisions, gaining extensive operational and sales experience.

Jim Demetriades is the Founder & CEO of Kairos Ventures, a venture capital firm that partners with universities to identify the world’s leading scientific discoveries and commercialize them. Kairos, which Jim founded in 2015, is currently invested in more than 50 portfolio companies that are producing groundbreaking technologies with the potential to disrupt the industries in which they operate. Jim’s fervent belief is that the discoveries Kairos is bringing to life will not only improve lives, but also, ultimately, help restore a sense of hope. Prior to founding Kairos, Jim founded SeeBeyond Technology Corp. in 1989 which he built into the world’s largest organically grown and self-funded integration software company whose technologies were used by thousands of global customers ranging from Fortune 500 companies to large hospitals and healthcare systems. Under Jim’s leadership, SeeBeyond grew to over 1,600 employees with offices in 35 countries. After taking SeeBeyond public, the company was acquired in an all-cash transaction by Sun Microsystems (now part of Oracle) in 2005 for almost $400 million. Jim also founded real estate development and management company, Multiversal, and his own unique children’s internet education media company, Inspero.net. He is currently on the boards of numerous technology companies across a variety of industries and is a Board Member of the Jane Goodall Legacy Foundation. He holds a Bachelor of Science degree in Economics, with a second major in computer science and minors in marketing and mathematics from Loyola Marymount University, Los Angeles.