LEXINGTON, Mass., & SYDNEY--(BUSINESS WIRE)--GI Dynamics, Inc. (ASX: GID) today announced new data results from two studies that demonstrate the sustained benefits of the EndoBarrier® Gastrointestinal Liner (the EndoBarrier) on glycemic control and weight loss following removal of the device. These data were presented during an oral presentation and poster session on Monday, Oct. 3, 2011, at the 29th Annual Scientific Meeting of The Obesity Society (TOS) in Orlando, Fla.
Sustained Glycemic Control – 12-Month Diabetes Trial
Previously reported results from this trial found that 22 type 2 diabetes patients who were treated with the EndoBarrier for 12 months achieved:
- A mean 2.3% decrease in HbA1c levels (from 8.9% at baseline to 6.6%; p<0.0001)
- Decreased glucose levels from an average of 175.6 at baseline to 137.8 mg/dL (p<0.0001)
- Average total body weight loss of 20.2 kg (44 lbs.; p<0.0001), or 39% excess weight loss (p<0.0001)
Follow-up data from this study were presented by Guilherme Lopes, M.D., study investigator, Hospital das Clinical, University of Sao Paolo, Brazil, during an oral presentation at TOS. These data presented included an analysis of glycemic levels in a subset of patients who were treated with the EndoBarrier for 12 months. These data found that six months after removal of the EndoBarrier, patients experienced only a slight increase in HbA1c levels, from 6.5% to 6.6%.
“The findings from this analysis show that EndoBarrier treatment offers a prolonged effect on HbA1c that allows for improvement in the patients’ overall disease state,” stated Dr. Lopes. “These results continue to demonstrate the clinical benefits of the EndoBarrier treatment for type 2 diabetes, even after removal of the device.”
Sustained Weight Management – 12-Month Obesity Trial
Previously reported results from a study which evaluated the use of the EndoBarrier treatment for 12 months in obese patients demonstrated that EndoBarrier treatment produced an average of 20% total body weight loss (observed weight loss of 22.8 kg/50lbs.), or 46.4% excess weight loss. In addition, data from a subset of six patients with type 2 diabetes achieved a mean reduction in HbA1c of 1.4% (7.9% at baseline to 6.5%) following 12 months of EndoBarrier treatment.
Follow-up analyses from this study were presented by Alex Escalona, M.D., Digestive Surgery, Pontificia Universidad Catolica de Chile, Santiago, Chile. Weight maintenance was assessed in 22 patients who completed 12 months of EndoBarrier treatment. Notably, six months following the removal of the EndoBarrier, patients had maintained as much as 75% of the weight they lost during the treatment period. These results were achieved without the support of a formal health care directed diet and exercise program after the device was removed.
“These results show that patients are able to maintain a substantial portion of the weight loss achieved through EndoBarrier treatment after the device is removed,” said Dr. Escalona. “These data are very encouraging and demonstrate the benefits of treatment with the EndoBarrier alone. These results also suggest that when the EndoBarrier is combined with a formal post-removal lifestyle support program, patients may maintain the benefits of treatment long after the device is removed.”
The EndoBarrier has received CE mark approval in Europe for implant periods of up to 12 months of treatment for type 2 diabetes and obesity, and recently received TGA approval in Australia. The EndoBarrier is currently commercially available in Chile, Germany, the United Kingdom, Austria and the Netherlands, and GI Dynamics has also received an investigational device exemption approval to commence a pilot clinical trial of the EndoBarrier in the U.S. For more information, please visit www.endobarrier.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is pioneering the development and commercialization of effective, non-surgical treatments targeting the large and growing global patient populations with type 2 diabetes and obesity. The company’s flagship product, the EndoBarrier®, is a novel, non-surgical device proven to lower blood glucose levels and promote weight loss in diabetic and obese patients during the implant period. GI Dynamics currently markets the EndoBarrier in select regions in Europe and South America and is planning significant near-term commercial expansion into Australia and additional European countries. Founded in 2003, GI Dynamics is headquartered in Lexington, Massachusetts. For more information, please visit www.gidynamics.com.
This announcement contains or may contain forward-looking statements that are based on management’s beliefs, assumptions and expectations and on information currently available to management. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements, including without limitation our expectations with respect to our ability to commercialize our EndoBarrier® including our estimates of potential revenues, costs, profitability and financial performance; our ability to develop and commercialize new products including our ability to obtain reimbursement for our products; our expectations with respect to our clinical trials, including enrolment in or completion of our clinical trials and our associated regulatory submissions and approvals; and our expectations with respect to the integrity or capabilities of our intellectual property position. Management believes that these forward-looking statements are reasonable as and when made. You should not place undue reliance on forward-looking statements because they speak only as of the date when made. GI Dynamics does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. GI Dynamics may not actually achieve the plans, projections or expectations disclosed in forward-looking statements, and actual results, developments or events could differ materially from those disclosed in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, described in “Risk Factors” in our Prospectus lodged with the Australian Securities & Investments Commission on 3 August 2011.