LEXINGTON, Mass.--(BUSINESS WIRE)--GI Dynamics, a medical device company pioneering the development of new approaches to treat obesity and metabolic disorders, today announced that it has received ISO 13485:2003 certification for the company’s Lexington facility. The company has also received European CE mark approval for the EndoBarrier™, its novel, noninvasive device currently in clinical trials to treat obesity and type 2 diabetes. ISO 13485: 2003 is an international standard that specifies a quality management system for medical devices and related services. The CE marking (an acronym for the French "Conformite Europeenne") certifies that a product has met EU requirements for marketing in Europe.
“We are very pleased to announce that we have received both the ISO certification and the CE mark approval, which are important milestones as we continue to develop the EndoBarrier and lay the groundwork for future commercialization of the product,” said Stuart A. Randle, chief executive officer of GI Dynamics. “Promising data continue to emerge from our clinical development programs in both obesity and type 2 diabetes, and we look forward to conducting larger, longer-term trials with the EndoBarrier in the year ahead.”
To date, more than 100 patients have received the EndoBarrier in clinical trials. In September 2008, GI Dynamics announced data from a multi-center, randomized clinical trial of 37 patients suggesting that the EndoBarrier is well-tolerated with promising short-term weight loss results in morbidly obese patients. These data showed that 26 patients treated with the EndoBarrier lost on average, triple the weight of their diet control group (11 patients). Specifically, at just 12 weeks, the device group lost 13.7 kg (30.2 lbs) versus 4.4kg (9.7 lbs) for the control group. Also notable was evidence that a beneficial effect on type 2 diabetes was observed through lower blood glucose levels and/or a reduction in diabetic medication.
Obesity is one of the world’s most serious and widespread health issues, affecting an estimated 400 million people today and an estimated 700 million by 2015, according to the World Health Organization. Obesity is a complex metabolic disorder that is commonly associated with type 2 diabetes, hypertension, coronary heart disease, stroke, gallbladder disease and cancer. Separately, obesity affects approximately 70 million people in the U.S. alone, and 20 million people live with type 2 diabetes. In combination, both obesity and type 2 diabetes affect approximately 13 million people in U.S.
About the EndoBarrier™ Gastrointestinal Liner
GI Dynamics is developing the EndoBarrier Gastrointestinal Liner, a noninvasive, removable device, which is considered investigational and not commercially available outside of the European Community. The EndoBarrier is being studied in clinical trials around the world as a potential short-term treatment for obesity and type 2 diabetes. The EndoBarrier creates a physical barrier between ingested food and the intestinal wall, which physicians believe, may change the metabolic pathway by controlling how food moves through the digestive system. This mechanical bypass of the small intestine is thought to mimic the effects of gastric bypass surgery on a patient's metabolism, potentially resulting in weight loss and remission of type 2 diabetes. The EndoBarrier can be implanted and removed endoscopically (via the mouth) with relative ease and without the need for surgical intervention or alteration of the patient’s anatomy.
About GI Dynamics
GI Dynamics, a clinical-stage medical device company, is pioneering the development of new, noninvasive approaches to treat obesity, type 2 diabetes and related metabolic diseases. The company’s patented EndoBarrier™ technology has the potential to deliver immediate metabolic control by modifying metabolic pathways. GI Dynamics is developing the EndoBarrier™ Gastrointestinal Liner, an orally delivered, removable device that lines a portion of the small intestine, potentially resulting in short-term weight loss and improved glycemic control. Early clinical data have shown that the EndoBarrier provides short-term weight loss and immediate resolution of type 2 diabetes. Additional clinical trials are ongoing to validate the results seen in prior clinical studies and to evaluate longer-term clinical benefits of EndoBarrier for obesity and type 2 diabetes. Based in Lexington, Massachusetts and founded in 2003, GI Dynamics is backed by top-tier investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners. For more information, visit GI Dynamics online at www.gidynamics.com.