ST. PAUL, Minn., Sept. 5, 2017 /PRNewswire/ -- EnteroMedics
Inc. (NASDAQ:ETRM), a developer of minimally invasive medical
devices to treat obesity, metabolic diseases and other
gastrointestinal disorders, today announced the start of its U.S.
FDA post-approval study of the vBloc® System, a medical
device used to treat obesity. The ReNEW Study: Maestro New
Enrollment Post-Approval Study (ReNEW) will evaluate the long-term
safety and effectiveness of the vBloc® System for weight
loss in obese patients in a real-world clinical setting.
The first patient in the company's ReNEW Study was enrolled late
last week at NYU Winthrop Hospital in Mineola, NY, by the site's principal
investigator (PI), Dr. Collin
Brathwaite, MD, FACS, FASMBS; Chairman of Surgery and Chief
of the Division of Minimally Invasive Surgery, Director of the
Bariatric Surgery Program.
"We are so pleased to both participate in the ReNEW Study, as
well as to provide vBloc as a covered benefit for all of our
employees at NYU Winthrop Hospital," said Dr. Brathwaite. "vBloc is
an important innovation in the weight loss care continuum that
provides patients with access to a minimally invasive, non-anatomy
altering solution to obesity that has been shown in clinical trials
to improve patient outcomes."
ReNEW is a five-year, multi-center trial that will provide 200
patients with vBloc® Neurometabolic Therapy at
approximately 10-15 centers across the
United States. All patients will participate in a
weight management program consisting of recommendations regarding
diet, exercise, and behavior modification throughout the study. The
primary safety objective of ReNEW is to demonstrate that the rate
of serious adverse events (SAEs) related to implanting vBloc is
statistically lower than 25% at five years. Primary efficacy
endpoints for ReNEW will examine various measures of excess weight
loss (EWL) and total body weight loss (TBL).
There are currently three centers with IRB approval for the
ReNEW Study. Separately, EnteroMedics is working in collaboration
with Kaiser Permanente on a Type 2 Diabetes Study with vBloc and is
concurrently running its vBloc Now program, which offers commercial
patients access to vBloc Therapy at a reduced-cost with the goal of
collecting additional real-world outcomes data to support
reimbursement.
"With recent focus on real-world evidence by the FDA,
post-approval studies such as ReNEW allow physicians to follow the
safety and efficacy of new treatments in a more complex and diverse
patient population than is typically studied in pre-approval
clinical trials," said Dan Gladney,
Chairman, President and Chief Executive Officer of EnteroMedics.
"Our ability to work with our physician partners to begin this
post-approval study is further evidence of EnteroMedics' commitment
to help the obesity community gain additional insights about the
clinical and economic benefits of vBloc."
The Maestro Rechargeable System was approved by the U.S. Food
and Drug Administration on January 14,
2015.
For more information on EnteroMedics' ReNEW Study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03145636
About vBloc® Therapy
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 that does not alter or remove
any patient anatomy. The vBloc System is designed to give 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.
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.
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.
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 statements regarding our plans
and objectives for the ReNEW Study. 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 Exhibit
99.3 of our current report on Form 8-K filed July 26, 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.