GI Dynamics Appoints Vice President of Clinical and Regulatory Affairs

GI Dynamics Inc., a medical device company that is developing EndoBarrier for patients with type 2 diabetes and obesity, has appointed Stephen Linhares as 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.

“On behalf of the GI Dynamics board of directors, I am pleased to announce the appointment of Stephen Linhares,” said Scott Schorer, president and CEO of GI Dynamics. “Stephen will join Charles Carter and I on our senior leadership team. Together we are focused on stage 1 of GID 18-1, the clinical trial in India and gaining the EndoBarrier CE mark. Stephen will help lead the company with the necessary expertise, and I am pleased to welcome him to the team.”
 
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 Corp., 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.²
 
“GI Dynamics is preparing to launch clinical studies on a product that could disrupt the conventional approaches for the treatment of type 2 diabetes and obesity, and I am very honored and excited to be involved,” said Linhares.
 
GI Dynamics Inc. is the developer of EndoBarrier, the first endoscopically-delivered device therapy for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale and is limited by federal law to investigational use only. Founded in 2003, GI Dynamics is headquartered in Boston, Mass.

References
¹Insulet Corporation, a medical device company specializing in state-of-the-art insulin delivery devices.
² Z. Drozdowicz, R.I Rudko, S.J. Linhares and B. Lax, “High Gain 4.3 to 4.5 um Optically Pumped CO2 Laser,” IEEE Quantum Electron, vol. QE-17, pp. 574-1580, 1987.
R.I. Rudko, A. Drozdowicz and S.J. Linhares, “High Repetition-Rate, Recirculating Hydrogen Fluoride/Deuterium Fluoride Laser,” Rev. Sci. Instruments, vol. 53, pp. 452-457, 1982.