LEXINGTON, Massachusetts, United States and SYDNEY, Australia – 27 March 2014 – GI Dynamics, Inc. (ASX: GID), a medical device company developing innovative treatments for type 2 diabetes and obesity, today announced that the Dutch Health Care Authority (NZa) has designated a preliminary reimbursement code for EndoBarrier® Therapy as part of a policy rule for new and innovative health care treatments.
Under this ruling, a defined number of EndoBarrier procedures performed between July 2013 – July 2016 at Rijnstate Hospital in Arnhem will be covered by a major regional health insurance fund in the Arnhem area. The designation of this code allows government authorities in the Netherlands to capture sufficient clinical and economic data for EndoBarrier Therapy over a three-year period. These data will then be evaluated in order to determine if EndoBarrier is eligible to receive permanent reimbursement codes with funding commensurate to the cost of the Therapy.
“Following the recent reimbursement milestones in Germany and Switzerland, this formal announcement from the NZa marks another achievement in our efforts to secure national reimbursement for EndoBarrier Therapy in key markets,” stated Stuart A. Randle, president and chief executive officer, GI Dynamics, Inc. “Based on this policy, we believe there is an opportunity for other hospitals in the Netherlands to secure similar coverage with their regional health insurance funds. We will continue to work collaboratively with these physicians, payers and other constituents to make EndoBarrier Therapy a more accessible treatment option for people in the Netherlands who are battling type 2 diabetes and obesity.”
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.
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.