GI Dynamics (ASX:GID) said it received notice from the Australian Therapeutic Goods Administration that it’s pulling the EndoBarrier device off the market Down Under effective Oct. 12. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and enters the intestinal tract to treat Type II diabetes and obesity. GI […]
GI Dynamics
GI Dynamics looks to next year for 2nd bite at FDA apple for EndoBarrier
GI Dynamics (ASX:GID) is hoping to make another run at FDA approval for its flagship EndoBarrier treatment for obesity and diabetes after its 1st try failed last year. In a presentation accompanying the release of its 2nd-quarter numbers, the Lexington, Mass.-based medical device company said it’s busy repairing its relationship with the FDA and plans to […]
GI Dynamics releases final data from EndoBarrier trial
GI Dynamics (ASX:GID) today released the results of the pivotal clinical Endo trial of its EndoBarrier device designed for weight loss, touting meaningful losses in HbA1c and weight, while acknowledging a higher-than-expected rate of hepatic abscesses. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the […]
Insulet touts new data showing reduced A1c levels with Omnipod system | American Diabetes Assn. 2016 Scientific Sessions
Insulet (NSDQ:PODD) last week touted the publication of new data supporting the benefits of its Omnipod insulin management system, with data supporting the systems’ efficacy at controlling blood glucose levels in patients switching from daily injections or tubed insulin pumps. Data from the company’s multi-center retrospective study was used in 2 online publications in the Journal […]
New GI Dynamics CEO Schorer looks to reboot EndoBarrier
New GI Dynamics (ASX:GID) CEO Scott Schorer is looking to reboot the company’s flagship EndoBarrier weight loss device, after a higher-than-expected rate of liver abscesses forced the halt of a clinical trial last year. The EndoBarrier device is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it exits the stomach and […]
Medtronic patent exec Ruschke nominated to lead PTAB | Personnel Moves May 11, 2016
Medtronic patent exec Ruschke nominated to lead PTAB Former Medtronic (NYSE:MDT) patent executive David Ruschke has been appointed as the new Chief Judge for the Patent Trial and Appeal Board. Rushke is slated to take up the new position on May 23. As chief patent counsel at Medtronic, Rushke managed numerous patent appeals, interferences, post grant […]
GI Dynamics plans 30% workforce cut by end of June
GI Dynamics (ASX:GID) said today that it plans to reduce its workforce by approximately 30% as part of restructuring efforts as it tries to extend its “cash runway.” The Lexington, Mass.-based company said that following the reduction, it expects to have approximately 19 employees total. The reduction in personnel is expected to incur aggregate charges of approximately […]
GI Dynamics touts new safety, efficacy data for EndoBarrier
GI Dynamics (ASX:GID) today touted new safety and efficacy data on its EndoBarrier device designed for weight loss, claiming meaningful improvements in hemoglobin A1c levels and weight reduction in study participants. The trial avoided previous issues involving liver abscesses that forced the halt of a U.S. clinical trial for the EndoBarrier device in July last year. […]
GI Dynamics taps medtech vet Schorer for CEO | Personnel Moves March 25, 2016
GI Dynamics taps medtech vet Schorer for CEO Troubled GI Dynamics (ASX:GID) said this week that it named a veteran medical device executive, Scott Schorer, to be its new president & CEO effective immediately. Schorer spent the last 6 years as a consultant, advising and helping run companies including stealthy Auris Robotics and Neograft Technologies, and […]
GI Dynamics to press on despite missed trial endpoints
GI Dynamics (ASX:GID) said today that it still plans to pursue FDA approval for its EndoBarrier weight loss device, despite missing safety and efficacy endpoints in a pivotal U.S. trial of the gut liner. Lexington, Mass.-based GI Dynamics shut down the trial last July after the FDA ordered it to cease enrolling patients due to a […]
GI Dynamics, in the red, says it has enough gas for 2016
GI Dynamics (ASX:GID) reported it has enough assets to continue through 2016 after reporting a rough fiscal year 2015, seeing sales shrink over 50% while net losses and losses per share trimmed down. GI Dynamics reported losses of $35 million, or $3.71 per share, on revenue of $1.3 million. That amounts to a 27% drop […]