ANVISA Regulatory Submission Filed
LEXINGTON, Massachusetts, SYDNEY, Australia & GOIÂNIA, Brazil – 6 March 2013 – GI Dynamics, Inc. (ASX: GID) today announced that it has entered into an agreement with CMS Medical (CMS), headquartered in Goiânia, Brazil, to distribute its lead product, EndoBarrier®, a breakthrough therapy for type 2 diabetes and/or obesity. Under the agreement, CMS will be the exclusive distributor of EndoBarrier Therapy in Brazil, following regulatory approval of the product in that country.
This agreement follows the recent submission for registration with the Agência Nacional de Vigilância Sanitária (ANVISA) for approval to market EndoBarrier in Brazil. GI Dynamics is working closely with SciTech Produtos Medicos Ltda. (SciTech), a sister company of CMS, to help manage the regulatory process.
“We are very pleased to establish this partnership with SciTech and CMS, with the combined entity being recognized as a premier distributor and manufacturer of minimally-invasive medical products in Brazil,” stated Mark C. Twyman, chief commercial officer of GI Dynamics. “Their proven track record of bringing innovative healthcare solutions to physicians throughout Brazil, coupled with their knowledge and understanding of the ANVISA registration process will be invaluable as we work toward regulatory approval and commercialization in this market. If all goes well, we expect to launch EndoBarrier Therapy in Brazil in early 2014.”
“We are excited to be working with GI Dynamics and look forward to leading the commercialization of EndoBarrier Therapy following ANVISA approval,” said Melchiades da Cunha Neto, co-founder of SciTech. “Our mission is to work with and bring to market the most advanced healthcare technologies and treatments. EndoBarrier Therapy is a novel, non-surgical treatment for type 2 diabetes and obesity, and we look forward to making it broadly available to physicians and patients in Brazil who are struggling to manage these diseases.”
Delivered endoscopically (through the mouth) during a brief, non-surgical procedure, the EndoBarrier device acts as a physical barrier between food and the intestinal wall. Once in place, it begins working immediately and has been shown to lower HbA1c (blood glucose) to healthy levels and achieve weight loss of approximately 20 percent within one year.
EndoBarrier Therapy is currently available in select countries in Europe, as well as Australia, Chile and most recently, Israel. In January, GI Dynamics announced it had initiated its pivotal clinical trial of EndoBarrier in the United States, the ENDO Trial, for the treatment of patients who have uncontrolled type 2 diabetes and are obese.
About EndoBarrier Therapy
EndoBarrier Therapy is a revolutionary, non-surgical, non-pharmaceutical treatment proven to help people living with uncontrolled type 2 diabetes and weight problems 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. An innovative, reversible medical device, EndoBarrier Therapy also enables
patients to avoid the lifestyle changes and frequent post-surgical interventions associated with irreversible bypass surgery and gastric banding. 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.; and 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.