ST. PAUL, Minn., Feb. 9, 2017 /PRNewswire/ -- EnteroMedics
Inc. (NASDAQ:ETRM), the developer of medical devices using
neuroblocking technology to treat obesity, metabolic diseases and
other gastrointestinal disorders, today announced the publication
of three-year data from the Company's VBLOC DM2 Study of
vBloc® Neurometabolic Therapy in obese patients with
Type 2 diabetes. The publication, entitled "Vagal Nerve Block for
Improvements in Glycemic Control in Obese Patients with Type 2
Diabetes Mellitus: Three-Year Results of the VBLOC DM2 Study," was
published in the Journal of Diabetes and Obesity and is
available online here.
"In addition to maintaining weight loss over time, successful
management of comorbid conditions such as diabetes is critical,"
said Charles Billington, M.D.,
Professor, Department of Medicine, University of Minnesota. "The three-year data from the VBLOC
DM2 study continue to demonstrate that vBloc Therapy not only
provides durable improvements in weight loss through three years,
but also improved glycemic control in obese patients with Type 2
diabetes who do not wish to undergo anatomy-altering weight-loss
procedures."
Results from the study demonstrate that after three years, the
average percentage excess weight loss (%EWL) was 21% with
reductions in hemoglobin A1c (HbA1c) of 0.6
percentage points from a baseline of 7.8%. This clinically
meaningful reduction in HbA1c resulted in 39% of
participants either reducing or stopping their diabetes
medications. Additionally, 71% of study participants were at or
below the American Diabetes Association target for HbA1c
for people with diabetes of 7%. Also at three years, mean estimated
fasting plasma glucose was significantly decreased by 18 mg/dL from
151 mg/dL at baseline.
"We are encouraged by the strong three year results seen in the
VBLOC DM2 study, as the data provides additional evidence of the
benefit that vBloc Therapy can offer to patients battling obesity
and Type 2 diabetes," said Dan
Gladney, EnteroMedics President, Chief Executive Officer and
Chairman of the Board. "Obesity and Type 2 diabetes are two of the
most serious societal health concerns throughout the world today,
and innovative treatments like vBloc Therapy have the potential to
stem the tide against these dangerous and debilitating
conditions."
The DM2 Study is an international, open-label, prospective,
multi-center study designed to evaluate the safety and efficacy of
vBloc Therapy in 28 diabetic subjects with obesity by measuring
average percentage excess weight loss (EWL), HbA1c (blood sugar),
fasting plasma glucose (FPG, blood sugar) and blood pressure,
following device activation. No deaths, unanticipated adverse
device effects, or life-threatening complications occurred through
three years.
vBloc Therapy is approved for use in helping with weight loss in
people aged 18 years and older who are obese, with a BMI of 40 to
45 kg/m2, or a BMI of 35 to 39.9 kg/m2 with a
related health condition such as Type 2 diabetes, high blood
pressure, high cholesterol levels or obstructive sleep apnea who
have had a poor response to trying to lose weight under supervision
in the last 5 years.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the
development and commercialization of its neuroscience based
technology to treat obesity and metabolic diseases.
vBloc® Neurometabolic Therapy, delivered by a
pacemaker-like device called the vBloc® System, is
designed to intermittently block the vagus nerves using
high-frequency, low-energy, electrical
impulses. EnteroMedics' vBloc® System has
received U.S. Food and Drug Administration approval and
CE Mark.
Information about the vBloc® System and
vBloc® Neurometabolic Therapy
You should not have an implanted vBloc® System
if you have cirrhosis of the liver, high blood pressure in the
veins of the liver, enlarged veins in your esophagus or a
significant hiatal hernia of the stomach; if you need magnetic
resonance imaging (MRI); if you have a permanently implanted,
electrical medical device; or if you need a diathermy procedure
using heat. The most common related adverse events that were
experienced during clinical study of the vBloc System included
pain, heartburn, nausea, difficulty swallowing, belching, wound
redness or irritation, and constipation.
Talk with your doctor about the full risks and benefits of vBloc
Therapy and vBloc System. For additional prescribing information,
please visit www.enteromedics.com.
If you are interested in learning more about vBloc
Neurometabolic Therapy, please visit www.vbloc.com or call
1-800-MY-VBLOC.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements
about EnteroMedics Inc. Our actual results could differ
materially from those discussed due to known and unknown risks,
uncertainties and other factors including our limited history of
operations; our losses since inception and for the foreseeable
future; our limited commercial sales experience with our
vBloc® System for the treatment of obesity in the
United States or in any foreign market other
than Australia and the European Community; our ability to
regain and then maintain compliance with the Nasdaq continued
listing requirements; our ability to commercialize our
vBloc® System; our dependence on third parties to
initiate and perform our clinical trials; the need to obtain
regulatory approval for any modifications to our vBloc®
System; physician adoption of our vBloc® System and
vBloc® Neurometabolic Therapy; our ability to obtain
third party coding, coverage or payment levels; ongoing regulatory
compliance; our dependence on third party manufacturers and
suppliers; the successful development of our sales and marketing
capabilities; our ability to raise additional capital when needed;
international commercialization and operation; our ability to
attract and retain management and other personnel and to manage our
growth effectively; potential product liability claims; potential
healthcare fraud and abuse claims; healthcare legislative reform;
and our ability to obtain and maintain intellectual property
protection for our technology and products. These and additional
risks and uncertainties are described more fully in the Company's
filings with the Securities and Exchange Commission,
particularly those factors identified as "risk factors" in the
annual report on Form 10-K filed March 28, 2016. We are
providing this information as of the date of this press release and
do not undertake any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or otherwise.
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visit:http://www.prnewswire.com/news-releases/enteromedics-announces-publication-of-three-year-data-from-vbloc-diabetic-patient-study-in-journal-of-diabetes-and-obesity-300404757.html
SOURCE EnteroMedics Inc.
