EnteroMedics Submits PMA Application for FDA Approval of VBLOC Therapy in Obesity

EnteroMedics Submits PMA Application for FDA Approval of VBLOC Therapy in 
ST. PAUL, MN -- (Marketwired) -- 06/25/13 --   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 Company has
submitted a Premarket Approval (PMA) application to the U.S. Food and
Drug Administration (FDA) for approval of the Maestro(R) Rechargeable
System's VBLOC(R) vagal blocking therapy as a treatment for obesity. 
"The Maestro System is a unique, neuroscience-based approach to the
treatment of this epidemic disease, one which offers the potential to
fill a significant gap in the obesity treatment spectrum," said Mark
B. Knudson, Ph.D., EnteroMedics' President and Chief Executive
Officer. "In the hundreds of patients treated to date, in addition to
showing clinically meaningful weight loss, VBLOC Therapy has
demonstrated an excellent benefit-to-risk profile; a criterion
identified by the Agency as central to the review and approvability
of new obesity treatment devices. We look forward to maintaining a
very open and productive dialogue with the FDA throughout the review
In a recently completed pre-PMA meeting, the FDA indicated that,
subject to its acceptance of EnteroMedics' PMA application and
detailed review of the submitted data, the Company can anticipate
presenting the PMA before a future FDA Advisory Committee panel. The
PMA submission includes data from the Company's ReCharge Pivotal
Trial, a prospective, double-blind, sham-controlled clinical trial
involving 239 randomized patients (233 implanted) at ten sites in the
United States and Australia.  
About Maestro Rechargeable (RC) System 
The Maestro(R) RC 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. The Maestro RC System is
powered by an internal, rechargeable battery. The battery is
recharged via an external mobile charger and transmit coil that the
patient uses for a short time each week. The Maestro RC System has
received CE Mark and has been listed on the Australian Register of
Therapeutic Goods. 
About the ReCharge Pivotal Trial  
The ReCharge Pivotal Trial is a randomized, double-blind,
sham-controlled, multicenter pivotal clinical trial 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 trial 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 trial period. In
February, EnteroMedics announced that its ReCharge Trial 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 trial 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 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.  
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 trials; 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 trials; 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
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 trial informed consent. 
Company Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860 
Media Contact:
Sam Brown Inc.
Mike Beyer
(312) 961-2502
Press spacebar to pause and continue. Press esc to stop.