GI Dynamics, Inc. designs, develops, and markets medical devices for non-surgical approaches. EndoBarrier System EndoBarrier System is the incision-free, non-anatomy altering solution designed to specifically mimic the duodenal-jejunal exclusion created by gastric bypass surgery. The company is engaged in market development and commercialization of EndoBarrier System in select countries in Europe, South America, the Asia Pacific region and the Middle East. The EndoBarrier system consists of three components: The implant — Also referred to as the EndoBarrier Gastrointestinal Liner, is a 60 cm long liner made of a thin, flexible, impermeable fluoropolymer, which is implanted non-surgically via endoscopy (through the mouth and without cutting any tissue) during a brief procedure. Once properly positioned in the patient’s upper intestine, just below the stomach, the EndoBarrier device is held in place by a proprietary anchoring mechanism and it remains in the body for up to 12 months until removal by endoscopy. The EndoBarrier device acts as a physical barrier between ingested food and the upper part of the intestine, preventing absorption and interaction of food with digestive enzymes and hormones in the first part of the intestine. Delivery system — The EndoBarrier device is delivered using its proprietary, single-use delivery system. This includes a sterile, custom-made catheter, which is about 300-cm long and is flexible to track through the patient’s mouth, down through the stomach and into the intestine. The EndoBarrier device is packed inside a capsule at the end of the catheter until deployment. Removal system — The EndoBarrier device is removed, typically after 12 months of implant, with its custom-made grasper that passes through a standard gastroscope. The EndoBarrier device is usually retrieved in a brief procedure during which time the patient is either anaesthetized or semi-sedated. Other products in development 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. 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 EndoBarrier system, but has a cover with a small hole to slow emptying of the patient’s stomach and create a feeling of ‘fullness’. Next Generation EndoBarrier — This design accommodates wider indications for use, as well as serial use of EndoBarrier Therapy based on anchoring technique and ease of use. Bariatric Surgery Solutions — These are product designs based on its anchoring and sleeve technology that provide solutions for patients whose bariatric surgery is failing. Sales and Marketing In 2014, the company had approximately 69 active centers in European countries. The company has approval for commercial sales in Israel, Saudi Arabia and the United Arab Emirates. In Israel, the company has five active centers and has received a favorable reimbursement decision by Clalit Health Services. The company has an office in Düsseldorf, Germany that is responsible for developing and supporting its European sales and marketing strategy and also supports activity in the Middle East. In South America, the company received regulatory approval in Chile. In the Asia Pacific region, the company received regulatory approval in Australia in 2011. The company has an office in Australia that is responsible for developing and supporting its Australian sales and marketing activity. Customers The company’s customers include health care providers who treat type 2 diabetes and obesity, such as gastroenterologists, endocrinologists and bariatric surgeons, and distributors of medical devices. In certain countries in Europe, the company sells directly to health care providers. In others, the company distributes its product through local and regional distributors. In the Middle East and South America, the company distributes its products through local and regional distributors. In Australia, the company sells directly to health care providers. Intellectual Property Trademarks: EndoBarrier and various company logos are the trademarks of the company, in the United States and other countries. Patents: As of December 31, 2014, the company’s patent portfolio comprised 120 issued and pending U.S. and non-U.S. patents. The company’s patents and patent applications cover the following areas of its technology: the gastrointestinal liner and anchor; delivery and removal systems; placement of the device; treatment alternatives; and the restrictor device. History GI Dynamics, Inc. was founded in 2003. The company was incorporated in Delaware in 2003.
gi dynamics inc-cdi
(2GD:German Stock Exchange)
25 Hartwell Avenue
Lexington, MA 02421
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