ST. PAUL, Minn., June 28, 2017 /PRNewswire/ -- EnteroMedics
Inc. (NASDAQ:ETRM), the developer of medical devices to treat
obesity, metabolic diseases, and other obesity-related
comorbidities, announced today the launch of the vBloc Now program.
The program provides qualified patients access to vBloc®
Therapy at a reduced cost in partnership with select bariatric and
weight loss centers across the United
States. vBloc Therapy is designed to help patients feel
full, eat less food, and lose weight, thereby improving their
overall health.
"We've repeatedly stated that our goal remains broad coverage
and reimbursement for vBloc Therapy," said Dan Gladney, EnteroMedics President, Chief
Executive Officer, and Chairman of the Board. "Since receiving FDA
approval in 2015, the largest barrier to adoption for patients who
want vBloc Therapy has been cost. Discussions with interested
payers indicate our final hurdle to insurance coverage is gathering
additional patient data in a commercial setting. The vBloc Now
program is designed to generate commercial vBloc patient outcomes
and support positive coverage decisions."
The vBloc Now program provides qualified patients battling
obesity the opportunity to receive vBloc Therapy including the
device, procedure, and vBloc Achieve follow up program at an
affordable price in exchange for sharing detailed health data with
EnteroMedics. The program is available for a limited time, will
reduce patient total out-of-pocket costs, and compete with leading
covered bariatric surgery procedures as well as other low-cost
weight loss devices.
Hundreds of clinical trial patients with vBloc Therapy have
shown durable excess weight loss at two years, as well as
meaningful improvements in related health conditions such as Type 2
diabetes. The vBloc Now program kicked off at two vBloc Institutes
in the beginning of June. Over thirty patients who applied for the
program are expected to complete the minimally invasive procedure
and start vBloc Therapy before the end of the June. To learn more
about the program call 1-800-MY-VBLOC.
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.
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 to obtain broad
coverage and reimbursement for vBloc Therapy, including our ability
to gather additional patient data in a commercial setting in order
to obtain insurance coverage; the ability of vBloc Now to compete
with leading covered bariatric surgery procedures and other
low-cost weight loss devices; and our expectation that patients
will complete the procedure and start vBloc Therapy before the end
of June. 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® 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.
