ST. PAUL, Minn., July 25, 2017 /PRNewswire/ -- EnteroMedics
Inc. (NASDAQ:ETRM), a developer of minimally invasive medical
devices to treat obesity, metabolic diseases and other
gastrointestinal disorders, today announced that the Methodist
Dallas Medical Center successfully completed its first implant of
the Company's vBloc® Neurometabolic Therapy through the
Veterans Choice Program. The surgery was performed on July 24, 2017 by Sachin
Kukreja, M.D., a bariatric surgeon in Dallas, Texas.
The federal Veterans Choice Program allows veterans to have the
vBloc procedure within a facility in their local community instead
of at a Department of Veteran's Affairs (VA) hospital,
significantly increasing the accessibility to vBloc for veterans.
According to the VA, in the first quarter of FY2017, they observed
a more than 30 percent increase in authorizations through the
program as compared to the same period in FY2016. The
company's previously announced agreement with Academy Medical
covers the cost of vBloc for qualified veterans in accordance with
their VA health benefits.
"There are over one million veterans battling obesity today, and
it is a privilege for EnteroMedics to be able to facilitate their
access to our life-changing solutions," said Dan Gladney, EnteroMedics' President, Chief
Executive Officer, and Chairman of the Board. "This first VA Choice
implant represents another successful step for EnteroMedics towards
our goal of establishing vBloc Therapy as a standard of care for
patients seeking anatomy-friendly options for weight loss."
vBloc Therapy works to control sensations of hunger using a
pacemaker-like device that is implanted under the skin during a
safe, minimally invasive procedure. The vBloc System gives the
patient a sensation of fullness, empowering them to eat less,
control their appetite, and lose weight. Studies have shown that
vBloc Therapy produces meaningful weight loss while also reducing
comorbidity factors related to obesity.
"It is an honor to help our veterans and their families who have
served this country," said Dr. Kukreja. "With a minimally-invasive,
non-anatomy-altering solution to help fight obesity, vBloc Therapy
offers patients a healthier alternative to other surgical weight
loss solutions."
vBloc Therapy is approved for use 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.
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
Neurometabolic Therapy and the vBloc System. For additional
prescribing information, please visit www.enteromedics.com.
If you are interested in learning more about vBloc Therapy,
please visit www.vbloc.com or call 1-800-MY-VBLOC.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the
development and commercialization of technology to treat obesity
and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by
an FDA-approved pacemaker-like device called the vBloc® System, is
designed to help patients feel full and eat less by intermittently
blocking hunger signals on the vagus nerve. EnteroMedics recently
acquired the Gastric Vest System™ through its acquisition of
BarioSurg, Inc. The Gastric Vest is an investigational, minimally
invasive, laparoscopically implanted medical device being studied
for weight loss in morbidly obese patients. The device wraps around
the stomach, emulating the effect of conventional weight-loss
surgery, and enables gastric volume reduction without permanently
changing patient anatomy.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements generally can be identified
by the use of words such as expect," "plan," "anticipate," "could,"
"may," "intend," "will," "continue," "future," other words of
similar meaning and the use of future dates. Forward-looking
statements in this release include our goal of establishing vBloc
Therapy as a standard of care for patients seeking anatomy-friendly
options for weight loss. These forward-looking statements are based
on the current expectations of our management and involve known and
unknown risks and uncertainties that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Such risks and uncertainties
include, among others: 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; the
competitive industry in which we operate; our ability to 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; the cost and
management time of operating a public company; 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 8, 2017 and
quarterly report on Form 10-Q filed May 15,
2017. 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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SOURCE EnteroMedics Inc.