FOR IMMEDIATE RELEASE
BOSTON and SYDNEY — 1 February 2017 — GI Dynamics, Inc., (ASX:GID), a medical device company that has commercialized EndoBarrier in Europe for patients with type 2 diabetes and obesity, announces that InEk, the German Institute for the Hospital Remuneration System, has awarded EndoBarrier NUB Status 1 for 2017.
The NUB process allows for introduction of new and innovative medical devices prior to reaching reimbursement eligibility, and provides for a supplemental payment for new technologies in the German reimbursement system. NUB Status 1 is the highest of four levels, as it allows for full reimbursement for the 143 participating hospitals in 2017. Under NUB Status 1, payers at these hospitals are obligated to cover the gaps in treatment costs for the EndoBarrier procedure.
“The NUB 1 designation is an important step towards full reimbursement for EndoBarrier in Germany, where there is a significant need for additional therapeutic options for patients with type 2 diabetes and obesity,” said Scott Schorer, president and chief executive officer of GI Dynamics. “We look forward to continuing our work with clinical teams in Germany to restore healthy blood sugar levels and achieve weight loss in this patient population.”
EndoBarrier is a minimally invasive, non-pharmaceutical therapy for patients living with uncontrolled type 2 diabetes and obesity. The EndoBarrier liner is a flexible sleeve placed inside the intestine to create a physical barrier between the intestinal wall and ingested food. Clinical data suggest that EndoBarrier works by affecting key hormones involved in insulin sensitivity, glucose metabolism, satiety and food intake. EndoBarrier is currently approved for sale in several countries outside of the United States. For more information, visit www.endobarrier.com.
About GI Dynamics
GI Dynamics, Inc. is the developer of EndoBarrier, the first endoscopically-delivered device therapy approved for the treatment of type 2 diabetes and obesity. EndoBarrier is approved and commercially available in multiple countries outside the United States. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only in the United States. For more information, please visit www.gidynamics.com.
This announcement contains forward-looking statements concerning our development and commercialization plans, potential revenues and revenue growth, costs, excess inventory, profitability and financial performance, ability to obtain reimbursement for our products, clinical trials and associated regulatory submissions and approvals, the number and location of commercial centers offering the EndoBarrier, and our intellectual property position. These forward-looking statements are based on GI Dynamics’ management’s current estimates and expectations of future events as of the date of this announcement. Furthermore, the estimates are subject to several 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 consequences of terminating the ENDO trial and the possibility that future clinical trials will not be successful or confirm earlier results. Further risks are associated with obtaining funding from third parties; the timing and costs of clinical trials; the timing of regulatory submissions; and the timing, receipt and maintenance of regulatory approvals. The timing and amount of other expenses and the timing and extent of third-party reimbursement risks associated with commercial product sales, including product performance, competition, risks related to market acceptance of products, intellectual-property risk; risks related to excess inventory; and risks related to assumptions regarding the size of the available market, the benefits of our products, product pricing, timing of product launches, future financial results and other factors, including those described in our filings with the U.S. Securities and Exchange Commission. Given these uncertainties, one 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 or future events or otherwise, unless we are required to do so by law.
1“NUB”: Neue Untersuchungs- und Behandlungsmethoden“, in German, or: New Diagnostic and Treatment Methods. The correct wording translated from German: “additional payments for new diagnostic and treatment methods (NUB)”.