EndoBarrier® Receives German NUB Reimbursement Status 1 for Type 2 Diabetes and Obesity Therapy
February 01 2017 - 07:50AM
Business Wire
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 NUB1
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.
Forward-Looking Statements
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)”.
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Investor RelationsGI Dynamics, Inc.United States:Monica
Bellevue, +1 781-357-3246
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