GI Dynamics, Inc. Appoints Stephen Linhares as Vice President of Clinical and Regulatory Affairs
January 04, 2019 at 03:35 am IST
Share
GI Dynamics Inc. announced the appointment of Stephen Linhares to the position of vice president of clinical and regulatory affairs. Linhares' role with GI Dynamics will focus on the pivotal trial of EndoBarrier in the United States (GID 18-1) and the clinical trial of EndoBarrier in India with Apollo Sugar. He will also lead the company's efforts with its notified body, Intertek, to seek a CE mark for EndoBarrier. Linhares brings over 30 years of experience in development, regulatory, preclinical and clinical operations, quality and resource management with a focus on medical devices. Prior to joining GI Dynamics, Linhares held the positions of vice president of regulatory, clinical affairs and quality assurance at Neograft Technologies Inc. and leadership roles at Insulet Corporation,1 Boston Scientific Corporation Inc. and Phase Forward Inc. as well as vice president roles at PLC Medical Systems. Linhares brings deep knowledge of the diabetes disease space, and the medical device space, where he has led 10 clinical trials, multiple CE mark approvals and numerous 510(k) clearances. Linhares holds nearly 20 United States and international patents and co-author of two peer-reviewed publications.
GI Dynamics, Inc. is a medical device company. The Company designs and applies device and disease management solutions for the treatment of metabolic disease. The Company designs, develops, manufactures and markets medical devices for non-surgical approaches to treat type II diabetes and obesity. The Company's product, EndoBarrier, is an endoscopically-delivered device therapy, which is approved for the treatment of obese type II diabetes with body mass index (BMI) greater than or equal to 30 kilogram/square meter (kg/m2), or obese patients with BMI greater than or equal to 30 kg/m2 with greater than or equal to one comorbidities, or obese patients with BMI over 35 kg/m2. EndoBarrier is an incision-free, non-anatomy altering solution designed to specifically mimic the duodenal-jejunal exclusion created by gastric bypass surgery.