LEXINGTON, Massachusetts & SYDNEY, Australia – 1 October 2013 – GI Dynamics, Inc. (ASX: GID) announced today that the German Institute of Medical Documentation and Information (DMDI) has designated preliminary OPS codes (Operationen- and Prozedurenschlussel) to EndoBarrier® Therapy which is indicated for the treatment of type 2 diabetes and/or obesity. Furthermore the Federal Office for Statistics (BFS) in Switzerland has published a unique CHOP code (Schweizerische Operationsklassifikation) for the implantation of the EndoBarrier. The designation and implementation of these codes allow government authorities to track costs and align reimbursement codes for EndoBarrier Therapy. Once data on a sufficient number of EndoBarrier procedures have been accumulated, these will be evaluated and the Company expects that the codes will be mapped to procedure codes and costs consistent with EndoBarrier Therapy.
“These designations represent the next, vital step to achieving appropriate reimbursement at the national level,” stated Stuart A. Randle, president and chief executive officer, GI Dynamics, Inc. “EndoBarrier Therapy continues to gain interest and traction among physicians, patients, health insurers and government agencies, as demonstrated by this recent action by the German and Swiss health authorities. These actions confirm our strategy to invest and commercialize in reimbursed markets, and we look forward to continued growth and activity in these markets.”
In addition to Germany and Switzerland, EndoBarrier Therapy is available in several additional European countries, as well as Australia, Chile and Israel.
EndoBarrier is a thin, flexible, tube-shaped liner that forms a physical barrier between ingested food and a portion of the wall of the intestine. Inserted endoscopically (through the mouth without any cutting or scarring of tissue), the EndoBarrier liner prevents the interaction of food with enzymes and hormones in the proximal intestine. In effect, food bypasses the duodenum, but without surgery or permanent changes to the anatomy. In clinical studies, more than 80% of patients were able to reach healthy blood glucose levels (HbA1c ≤ 7.0%) and achieve weight loss of approximately 15-20 percent within one year.,
About EndoBarrier Therapy
EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment proven to help people living with uncontrolled type 2 diabetes and obesity achieve rapid and dramatic reductions in blood sugar levels, as well as substantial weight loss. EndoBarrier Therapy is a convenient and discreet treatment for people whose diabetes medications are no longer effective, who are at risk for serious health complications and who want to avoid the progression to daily insulin injections. This first-of-its-kind therapy is helping patients around the world fight their battle against type 2 diabetes and obesity while providing a pathway to a healthier lifestyle. For more information, please visit www.endobarrier.com.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer and marketer of EndoBarrier®, a breakthrough device that represents an entirely new class of non-surgical, non-pharmaceutical therapy for the treatment of type 2 diabetes and/or obesity. EndoBarrier is approved and commercially available in multiple countries outside the U.S. EndoBarrier is not approved for sale in the U.S. and is limited by federal law to investigational use only in the United States. GI Dynamics is conducting a pivotal clinical trial of EndoBarrier in the U.S. for the treatment of patients who have uncontrolled type 2 diabetes and are obese. 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 enrollment in or completion of our clinical trials and our associated regulatory submissions and approvals; 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.
1 Moura, GHD, et al, Metabolic Improvements in Obese Type 2 Diabetes Subjects Implanted for 1 Year with an Endoscopically Deployed Duodenal–Jejunal Bypass Liner. Hospital das Clinicas, University of São Paulo, São Paulo, Brazil. DT&T, February 2012, vol 14, no.2:183-189.
2 Escalona, A., et al, “Weight Loss and Metabolic Improvement in Morbidly Obese Subjects Implanted for 1 Year with an Endoscopic Duodenal-Jejunal Bypass Liner.” Department of Digestive Surgery. Faculty of Medicine Pontificia Universidad Católica de Chile. Annals of Surgery, June 2012, Vol 255, Issue 6, p 1080–1085.