LEXINGTON, Massachusetts, United States and SYDNEY, Australia – 3 February 2014 – GI Dynamics, Inc. (ASX: GID), a medical device company developing innovative treatments for type 2 diabetes and obesity, today announced that InEk, the German Institute for the Hospital Remuneration System, has assigned NUB (Neue Untersuchungs- und Behandlungsmethoden) Status 1 for EndoBarrier® Therapy.
The purpose of the NUB process is to introduce new and innovative medical products prior to reimbursement being available. It is also the preferred way to bring the procedure cost of a treatment, such as EndoBarrier, into the German reimbursement (DRG) system. The designation of NUB Status 1 is the highest level available, and entitles participating hospitals to negotiate with insurance companies for additional funding to cover the cost of procedures. Once the negotiation is completed, a hospital will be authorized to perform an agreed upon number of procedures in that year. An NUB decision is valid for one year, at which point hospitals can reapply for NUB status. Historically, subsequent NUB status has been granted for multiple years in order to capture a high volume of treatment cost.
“This favorable decision from InEK represents a significant step forward in our national reimbursement efforts in Germany to establish EndoBarrier Therapy as an accessible treatment option for people who are struggling with type 2 diabetes and obesity,” stated Stuart A. Randle, president and chief executive officer, GI Dynamics, Inc. “After receiving the unique OPS-Code for EndoBarrier, and now the NUB Status 1, we are hopeful we’re on a path that will lead to adequate remuneration of EndoBarrier procedures. This positive momentum is a result of our intensive reimbursement strategy in Germany and the collaborative approach taken by GI Dynamics, influential medical societies, physicians and other key constituents.”
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 http://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.