EnteroMedics Announces Food and Drug Administration Advisory Committee Meeting Date for Review of the Maestro(R) Rechargeable

EnteroMedics Announces Food and Drug Administration Advisory Committee Meeting 
Date for Review of the Maestro(R) Rechargeable
System for the Treatment of Obesity 
Center for Devices and Radiologic Health Advisory Committee Scheduled
for May 29, 2014 
ST. PAUL, MN -- (Marketwired) -- 02/12/14 --  EnteroMedics Inc.
(NASDAQ: ETRM), the developer of medical devices using neuroblocking
technology to treat obesity, metabolic diseases and other
gastrointestinal disorders, today announced that the U.S. Food and
Drug Administration's Office of Device Evaluation has scheduled a
meeting of the Center for Devices and Radiologic Health's (CDRH)
Advisory Committee on Thursday, May 29, 2014 to review the Maestro(R)
System delivering VBLOC(R) vagal blocking therapy as a treatment for
morbid obesity. The CDRH Advisory Committee is an independent panel
of clinical and scientific experts that helps evaluate medical
devices for safety and efficacy and makes recommendations regarding
Benefit-Risk to the FDA. 
EnteroMedics' PMA application for VBLOC Therapy, which was accepted
for review by the FDA in July of 2013, contains data from the
Company's ReCharge Pivotal Study. The ReCharge Pivotal Study is a
randomized, double-blind, sham-controlled, multicenter pivotal
clinical study in 239 randomized patients (233 implanted) at 10 sites
testing the effectiveness and safety of VBLOC Therapy utilizing
EnteroMedics' second generation Maestro System.  
"We are pleased that the FDA has decided to move the PMA application
for our innovative technology forward towards possible approval by
scheduling an Advisory panel meeting to discuss the Maestro System.
We very much look forward to presenting VBLOC Therapy to the panel
members as we work to address the significant and widening gap in
treatment alternatives for obesity and its associated diseases," said
Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive
Officer. "We will continue to focus on thoroughly preparing for panel
with the goal of delivering on the promise of this new treatment
option to the millions of Americans who suffer with obesity." 
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. EnteroMedics' proprietary technology,
VBLOC(R) vagal blocking therapy, delivered by a pacemaker-like device
called the Maestro(R) Rechargeable System, is designed to
intermittently block the vagus nerves using high-frequency,
low-energy, electrical impulses. VBLOC allows people with obesity to
take a positive path towards weight loss, addressing the lifelong
challenge of obesity and its comorbidities without sacrificing
wellbeing or comfort. EnteroMedics' Maestro Rechargeable System has
received CE Mark and is listed on the Australian Register of
Therapeutic Goods.  
About the ReCharge Pivotal Study 
The ReCharge Pivotal Study is a randomized, double-blind,
sham-controlled, multicenter pivotal clinical study in 239 randomized
patients (233 implanted) at 10 sites testing the effectiveness and
safety of VBLOC(R) vagal blocking therapy utilizing EnteroMedics'
second generation Maestro(R) Rechargeable (RC) System. All patients
in the study received an implanted device and were randomized in a
2:1 allocation to treatment or control groups. The control group
received a non-functional device during the study period. In February
2013, EnteroMedics announced that its ReCharge Study demonstrated a
statistically significant and clinically meaningful excess weight
loss (EWL) outcome and excellent safety profile. This included an
average EWL of approximately 25% for VBLOC Therapy-treated patients,
with over 50% of those patients achieving at least a 20% EWL. While
the results demonstrated an excellent safety profile that met the
pre-specified study measures, with both a positive benefit-risk
equation and a medically meaningful and clinically significant effect
over the control group, the results did not meet the study's
predefined super-superiority efficacy endpoints. 
About VBLOC(R) Therapy 
EnteroMedics developed VBLOC(R) vagal blocking therapy to offer
bariatric surgeons and their patients a less invasive alternative to
existing surgical weight loss procedures that may present significant
risks and alter digestive system anatomy, lifestyle and food choices.
VBLOC Therapy is delivered via the Maestro(R) System through
laparoscopically implanted leads to intermittently block the vagus
nerves using high-frequency, low-energy electrical impulses. VBLOC
Therapy is designed to target the multiple digestive functions under
control of the vagus nerves and to affect the perception of hunger
and fullness. 
About Maestro(R) System 
The Maestro(R) System delivers VBLOC(R) vagal blocking therapy via
two small electrodes that are laparoscopically implanted and placed
in contact with the trunks of the vagus nerve just above the junction
between the esophagus and the stomach.  
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 lack of
commercial regulatory approval for our Maestro(R) System for the
treatment of obesity in the United States or in any foreign market
other than Australia and the European Community; our preliminary
findings from our EMPOWER(TM) and ReCharge pivotal studies; our
ability to comply with the Nasdaq continued listing requirements; our
ability to commercialize our Maestro System; our dependence on third
parties to initiate and perform our clinical studies; the need to
obtain regulatory approval for any modifications to our Maestro
System; physician adoption of our Maestro System and VBLOC(R) vagal
blocking 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 7, 2013. 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.  
Caution - Investigational device. Limited by Federal (United States)
law to investigational use.  
The implantation procedure and usage of the Maestro(R) System carry
some risks, such as the risks generally associated with laparoscopic
procedures and those related to treatment as described in the
ReCharge clinical study informed consent.  
Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
ir@enteromedics.com 
 
 
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