GI Dynamics (ASX:GID) said today it inked a contract manufacturing partnership deal with Proven Process Medical Devices. Through the deal, Proven Process will manufacture Boston-based GI Dynamic’s EndoBarrier device at its Mansfield, Mass.-based facilities. Read the whole story on our sister site, Medical Design & Outsourcing
GI Dynamics
GI Dynamics raises $5m in convertible note offering
GI Dynamics (ASX:GID) said today it raised $5 million in a convertible note offering, giving the company working capital necessary for the remainder of 2017. The financing came from major shareholder Crystal Amber Fund Limited, the Boston-based company said. “We are pleased to announce this bridge financing and appreciate the support and confidence from the Crystal Amber […]
GI Dynamics touts no complications, lowered insulin in EndoBarrier reimplantation trial
GI Dynamics (ASX:GID) today released data from an investigator-initiated study examining the safety and efficacy of its EndoBarrier after reimplantation for treatment for patients with type 2 diabetes and obesity, touting no complications and reduced insulin use. The study followed 5 patients which all completed an initial course of EndoBarrier treatment for 12 months, after which the devices […]
GI Dynamics touts weight loss, lowered HbA1c in EndoBarrier meta-analysis
GI Dynamics (ASX:GID) yesterday released data from a meta-analysis of its EndoBarrier device, touting improved glycemic control in patients with type 2 diabetes and obesity. Data from the meta-analysis study was presented at the Digestive Disease Week meeting in Chicago. The EndoBarrier device from the Lexington, Mass.-based company is a plastic gut sleeve designed to prevent the absorption of […]
CE Mark suspended for GI Dynamics EndoBarrier
GI Dynamics (ASX:GID) said yesterday that the CE Mark approval for its EndoBarrier device was suspended for “nonconformances” in its quality management system under European Union regulations. GI Dynamics president & CEO Scott Schorer told MassDevice.com today during a telephone interview that the suspension is not a recall and does not involve the safety or efficacy […]
GI Dynamics eyes London Stock Exchange listing
GI Dynamics (ASX:GID) said today it is considering listing on the London Stock Exchange’s AIM market. The Lexington, Mass.-based company said it has engaged Allenby Capital Limited as it explores options to seek admission onto the exchange. Allenby Capital is a London-based nominated advisor and broker for the exchange’s AIM market. “We look forward to working […]
GI Dynamics touts preliminary Endobarrier data in adolescent prediabetes treatment
GI Dynamics (ASX:GID) today released preliminary findings from the 1st clinical trial evaluating the use of its EndoBarrier treatment for obesity in adolescents, touting a 10% decrease in BMI with no serious adverse events. The EndoBarrier device from the Lexington, Mass.-based company is a plastic gut sleeve designed to prevent the absorption of nutrients from food as it […]
GI Dynamics notches German reimbursement win
GI Dynamics (ASX:GID) said today that its EndoBarrier device won NUB 1 reimbursement status from the German Institute for the Hospital Remuneration System. This status is the highest of 4 levels, which will bring in full reimbursement for the Lexington, Mass.-based company at the 143 participating hospitals. Payers at these hospitals will be required to cover […]
GI Dynamics raises $1.1m in private placement
GI Dynamics (ASX:GID) said today it raised approximately $1.1 million (AU $1.5 million) and announced an upcoming security purchase plan looking to raise an additional $732,006 (AU $987,910). The Lexington, Mass.-based company raised funds through the sale of 69.9 million Chess depository interests, representing approximately 1.4 million shares of stock at 16¢ (AU 22¢) per share […]
GI Dynamics updates on Australian market removal, release of Q4 earnings
GI Dynamics (ASX:GID) today updated on the status of its EndoBarrier device in Australia, saying it has no plans to appeal in the country. The company also said it is in talks with the FDA as it seeks a regulatory pathway for approval in the U.S., and is continuing to work towards winning reimbursement for its […]
Australia pulls GI Dynamics EndoBarrier from the market
GI Dynamics (ASX:GID) said today that Australia’s Therapeutics Goods Administration removed the EndoBarrier weight loss device from the Register of Therapeutic Goods, effectively stopping commercialization of the device in the region. 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 […]