COMPANY

Headquartered in San Clemente, California, USGI Medical is committed to the development of incisionless technologies that enable physicians to perform procedures through the body's natural passageways.

USGI Medical

USGI Medical's Incisionless Operating PlatformTM — consisting of the g-CathTM EZ Delivery Catheter with Snowshoe® suture anchors, g-Prox® EZ, g-LixTM and Transport®—reduces the need for external abdominal incisions by providing physicians with specialized tools necessary to perform minimally invasive procedures through a patient's mouth or other natural orifices. Notably, USGI Medical has demonstrated the capability to reliably and durably fixate and plicate gastric tissue without an incision. Use of the body's natural orifices for performing minimally invasive procedures offers promise for less pain, shorter hospital stays, reduced risk of wound infection and no external scars—and is rapidly becoming an option demanded by patients and healthcare providers. USGI Medical provides surgeons and gastroenterologists with the tools they need to offer millions of potential patients less invasive techniques including, the Pose® procedure—the only incisionless, hunger control procedure. All components of the Incisionless Operating Platform have U.S. 510(k) clearance and CE Mark. The g-Cath EZ Delivery Catheter with Snowshoe suture anchors used in the Pose procedure is currently under FDA review as a weight-loss treatment.

Executive Management Team

Carlos joined USGI Medical as President and CEO in 2017. A world-class commercialization expert, Carlos brings more than 25 years of successful leadership experience to USGI, with distinguished performance in both public and private sectors of medical device companies. Previously he served as Vice President of AirSeal® System Commercialization for Conmed Corporation, and Chief Commercialization Officer at SurgiQuest, Inc., a medical company offering surgical devices and equipment for laparoscopic and robotic surgical procedures, prior to being acquired by Conmed. Carlos also served as President, International for Curon, Inc. and Chief Sales and Marketing Officer of the medical segment of Vision Sciences Inc., and held various senior management positions at United States Surgical Corporation prior to its acquisition by Tyco, and subsequently by Medtronic.

Tracy has over 25 years of experience in Engineering and Operations management. Prior to joining USGI Medical, Tracy served as Director of Product Development at Volcano Therapeutics, as Senior Product Development Engineer and Director of Research and Development at EMBOL-X and as Product Development Engineer at ArthroCare. Earlier in his career, Tracy also served in professional and management roles at Guidant. Tracy holds a BSME from GMI Engineering and Management Institute, and is named as sole or co-inventor on over 41 patents in the medical device field.

Mike Thomas is responsible for USGI Medical's global commercialization efforts. He has over 29 years of sales, marketing and business development experience in the biotech, pharmaceutical and device industries, having focused in the surgical device space for the last 20 years. Mike has extensive experience in every aspect of new market development and commercialization, having held positions in sales/sales management, marketing, business development, international/national key accounts, recruiting and training. Prior to joining USGI Medical in October 2008, Mike served in sales, management and market development at Allergan Health, Ethicon Endo-Surgery and SmithKline Beecham. Mike attended Gulf Coast Community College and The University of South Florida where his studies were concentrated in the areas of Business Management and Marketing.

Stephanie has over 30 years of clinical experience in research, quality and regulatory management. Prior to joining USGI Medical, she served as Director of Clinical Research at Hill-Rom providing strategic direction and clinical regulatory oversight for the execution of global research studies. Stephanie has also held positions of increasing responsibility at PAREXEL International, Omnicare Clinical Research, and Ethicon Endo-Surgery in which she designed, executed, and managed large global inpatient and outpatient clinical trials under INDs and IDEs as well as post marketing observational safety trials. In addition, she has served as lecturer at Northeastern University and the University of Oklahoma to teach graduate level Clinical Research and Statistics courses. Stephanie holds a BSN in Nursing from Xavier University, a MSN in Perinatal Health and Genetics and a PhD in Research Methodology and Statistics from the University of Cincinnati.

Kevin brings to USGI Medical over 20 years of global experience in bariatric, endolumenal and laparoscopic procedures. Prior to joining, Kevin led the development of numerous novel technologies and procedures in the endolumenal bariatric, natural orifices, and advanced visualization space while at Medtronic. In addition to his many years as a marketing leader, he has held senior positions with increasing responsibilities in sales, business development, and professional education while at Covidien, Karl Storz, and Circon ACMI (now Olympus).

** USGI Medical has a CE Mark Indication that states: "The design, development and manufacture of preloaded, synthetic, non-absorbable suture delivery catheters (g-Cath) and single use, surgically invasive, flexible endotherapy grasping forceps (g-Lix) used for approximation of soft tissue in minimally invasive gastroenterology procedures, including use in obesity intervention for BMI 30-40.

Those aspects of design, development and manufacture related to securing and mantaining the sterility of non-surgically invasive, multichannel endotherapy guides (Transport) and non-surgically invasive flexible endotherapy grasping forceps (g-Prox)."


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