LEXINGTON, Massachusetts & SYDNEY, Australia – 7 April 2014 – GI Dynamics, Inc. (ASX: GID) today announced that Clalit Health Services, Israel’s largest and one of the world’s largest health maintenance organization (HMO), has established a reimbursement coverage policy for EndoBarrier® Therapy, an endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity.
This coverage policy entitles participating hospitals in Israel to negotiate with Clalit Health Services on the total charge for EndoBarrier Therapy. Patients with type 2 diabetes and obesity who are insured by Clalit Health Services and enrolled in the Mushlam supplementary insurance plan are eligible to receive reimbursement for at least 50% of the total agreed-upon charge for EndoBarrier Therapy. Approximately 2.7 million people are enrolled in Clalit Mushlam, the biggest, broadest and most comprehensive supplementary health plan in Israel.
Stuart A. Randle, president and CEO of GI Dynamics said, “Achieving this reimbursement in Israel follows our recent preliminary reimbursement code in the Netherlands and NUB Status 1 reimbursement designation in Germany, reinforcing the strategic impact of our foundational approach to reimbursement-driven markets. We are pleased that one of the world’s largest and most progressive HMOs has become the first organization to widely adopt our innovative technology, underscoring the clinical and economic value of EndoBarrier Therapy in treating type 2 diabetes and obesity. We will continue to work closely with Clalit and Medison, our distributor in this region, to make EndoBarrier more broadly available to physicians and patients in Israel.”
According to the Israel Diabetes Association, there are an estimated 600,000 Israeli adults currently living with diabetes, and approximately one-third of these are undiagnosed.
“We are extremely pleased to partner with GI Dynamics to bring people living with uncontrolled diabetes and obesity greater access to what we believe is a highly effective, less invasive procedure to lower blood sugar and reduce weight,” said Meir Jacobsohn, CEO of Medison. “We have already seen a significant demand for EndoBarrier Therapy among Israeli men and women with these conditions. We are pleased with this reimbursement decision from Clalit, which will now make EndoBarrier Therapy a more accessible treatment option for people to improve their health and quality of life.”
More than 1,300 patients worldwide have been treated with EndoBarrier Therapy, the world’s first endoscopically-delivered device therapy for patients with type 2 diabetes and obesity. EndoBarrier received medical device registration approval from the Israeli Ministry of Health in February 2012 for the treatment of type 2 diabetes and obesity for up to 12 months. It is also approved for use in Europe and Australia, as well as by a growing number of countries in South America and the Middle East.
About GI Dynamics
GI Dynamics, Inc. (ASX: GID) is the developer of EndoBarrier®, the first endoscopically-delivered device therapy approved 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.
Medison is Israel’s leading marketing group, representing innovative niche healthcare products from companies such as Biogen Idec, Amgen, Shire and Ipsen. Medison has built and maintained long-standing relations with HMOs, local medical centers and physicians. Backed by three generations of experience in the healthcare industry since 1937, Medison is uniquely qualified to provide the complete spectrum of integrated services for international companies looking to enter or expand their presence in the Israeli. Medison has an office and is very also active in Romania. For more information, please visit www.medisonpharma.com.
This announcement contains forward-looking statements concerning: our development and commercialization plans; our potential revenues, costs, profitability and financial performance; our ability to obtain reimbursement for our products; our clinical trials, and associated regulatory submissions and approvals; the number and location of commercial centres offering the EndoBarrier®; and our intellectual property position. These forward-looking statements are based on the current estimates and expectations of future events by the management of GI Dynamics, Inc. as of the date of this announcement and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those indicated in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the possibility that clinical trials will not be successful or confirm earlier results; risks associated with obtaining funding from third parties; risks relating to the timing and costs of clinical trials, results of clinical trials, the timing of regulatory submissions, the timing and receipt of regulatory approvals, the timing and amount of other expenses; execution risks; competition; risks related to market acceptance of products; intellectual property risks; and assumptions regarding the size of the available market, benefits of our products, product pricing, timing of product launches, future financial results and other factors. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We do not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by law.
 Israel Diabetes Association (http://www.sukeret.co.il/en/enInfo.asp?info_id=26810