GI Dynamics, Inc. designs, develops, and markets medical devices for non-surgical approaches for treating type 2 diabetes and obesity. Products The company’s primary product, the EndoBarrier Gastrointestinal Liner (the EndoBarrier), is being sold in select markets in Europe, South America, Australia, and Israel for the treatment of type 2 diabetes and obesity. The EndoBarrier acts as a physical barrier between ingested food and the upper part of the intestine preventing absorbtion and interaction of food with digestive enzymes and hormones in the first part of the intestine. In 2013, the company commenced a clinical trial of the EndoBarrier for the purposes of seeking regulatory approval from the Food and Drug Administration (FDA) to commercialize in the U.S., which it refers to as its pivotal trial. The EndoBarrier system consists of three components: The Implant: Also referred to as the EndoBarrier, is a 60-cm long liner, which is implanted in the proximal intestine, immediately below the stomach. The liner is made of an impermeable fluoropolymer that allows normal functioning of the intestine. Delivery System: The EndoBarrier is delivered using the company’s proprietary, single-use delivery system. This includes a sterile, custom-made catheter, which is approximately 300-cm long and is flexible to track through the patient’s mouth, down through the stomach and into the intestine. The EndoBarrier is packed inside a capsule at the end of the catheter until deployment. Removal System: The EndoBarrier is removed after 12 months of implant, with the company’s custom-made grasper that passes through a standard gastroscope. The grasper is used to pull one of the two drawstrings on the anchor so that it collapses inwards, removing the barbs from the intestinal wall. Its retrieval hood on the end of the gastroscope is then positioned to cover the anchor barbs to allow the implant to be safely removed through the patient’s mouth. Other Products in Development As of December 31, 2013, the company had conducted research and development on the following products: EndoBarrier Liner with EndoBarrier Restrictor: This device combines the company’s EndoBarrier Liner with the EndoBarrier Restrictor. This combination is intended to treat diabetes and create greater weight loss than either device alone. The company conducted a small, 10 patient clinical trial with this device. EndoBarrier Restrictor: This device is targeted for short-term weight loss or weight loss in a patient who is not obese. The device employs the same anchoring technology as the EndoBarrier, and has a cover with a small hole to slow emptying of the patient’s stomach and creates a feeling of ‘fullness’. Strategy The company’s business strategies include targeting commercial launch of its primary product in Europe and South America, as well as in Australia and Israel; seeking local and national reimbursement for EndoBarrier Therapy; building the market for self-pay patients, which has been shown through its success in commercializing EndoBarrier Therapy in Chile and Australia; achieving regulatory approval in the U.S. through a successful U.S. pivotal trial by demonstrating the safety and efficacy of the EndoBarrier; continuing to expand the approved uses of the EndoBarrier; and expanding its manufacturing capacity. Intellectual Property EndoBarrier is a trademark of the company. Its patent portfolio includes 115 issued and pending U.S. and non-U.S. patents. The company has been issued 29 U.S. patents and has 15 pending U.S. patent applications. The company has also sought intellectual property protection outside of the United States and has been issued 49 patents across Australia, Canada, the European Patent Convention region (including Austria, Belgium, France, Germany, Ireland, Italy, the Netherlands, Spain, Sweden, Switzerland, Turkey, and the United Kingdom), Hong Kong, and Japan. It has 22 pending foreign patent applications. Its issued patents expire between 2023 and 2030. Government Regulation The company’s EndoBarrier is classified as a Class III device by the FDA. In Australia, the TGA is responsible for administering the Therapeutic Goods Act with the company’s EndoBarrier falling under the category of an implantable medical device. History GI Dynamics, Inc. was founded in 2003. The company was incorporated in Delaware in 2003.
gi dynamics inc-cdi (2GD:Frankfurt)
25 Hartwell Avenue
Lexington, MA 02421
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