EnteroMedics' ReCharge Trial Demonstrates Statistically Significant Weight Loss in Obesity But Does Not Meet Predefined

EnteroMedics' ReCharge Trial Demonstrates Statistically Significant Weight Loss 
in Obesity But Does Not Meet Predefined Efficacy
Based on Compelling Data, Company Plans Pre-Market Approval (PMA)
Application; Company to Host Conference Call Today, February 7, 2013,
at 5:00 PM ET 
ST. PAUL, MN -- (Marketwire) -- 02/07/13 --  EnteroMedics Inc.
(NASDAQ: ETRM), the developer of medical devices using neuroblocking
technology to treat obesity, metabolic diseases and other
gastrointestinal disorders, today announced results from its
randomized ReCharge Pivotal Trial of VBLOC(R) vagal blocking therapy
for the treatment of obesity. The trial demonstrated a clinically
meaningful and statistically significant excess weight loss (EWL) of
24.4% for VBLOC Therapy-treated patients, with 52.5% of patients
achieving at least 20% EWL. The trial met its primary safety
endpoint, though it did not meet its predefined primary efficacy
As a result of the excellent safety and efficacy profile of VBLOC
Therapy, EnteroMedics plans to move forward with a Pre-Market
Approval (PMA) application with the U.S. Food and Drug Administration
(FDA) in the second quarter of 2013. 
"Even though we did not reach the predefined efficacy thresholds,
data from the ReCharge trial clearly demonstrate VBLOC Therapy's
positive effect on weight loss, while adding to an excellent safety
record," said Mark B. Knudson, Ph.D., EnteroMedics' President and
Chief Executive Officer. "Based on these compelling results, and the
totality of our clinical experience with the Maestro System, which
now includes more than 600 patients worldwide, we believe
EnteroMedics is well positioned to deliver this novel therapy to
people with obesity in the U.S. We are moving forward with a PMA
application to the FDA, in addition to advancing our plans for
pursuing other indications, including obesity-related diabetes and
hypertension, outside the U.S." 
"Coupled with excellent safety results, the weight loss results for
individuals getting VBLOC Therapy in the ReCharge trial demonstrate
an excellent benefit-to-risk equation," said Robin Blackstone, MD,
FACS, FASMBS, surgeon and Medical Director of Scottsdale Healthcare
Bariatric Center at Scottsdale Healthcare in Arizona and Clinical
Associate Profess
or of Surgery at the University Of Arizona College
Of Medicine and investigator for the ReCharge trial. "If approved,
VBLOC will fill a significant gap in the treatment spectrum, offering
a unique approach that supports a healthy lifestyle and addresses the
lifelong challenges associated with obesity and its co-morbidities." 
Results in Detail 
The ReCharge Pivotal Trial of VBLOC Therapy is a prospective
double-blind, sham-controlled clinical trial involving 239 randomized
patients (233 implanted) at ten sites in the United States and
Australia. Patients were surgically implanted with either a fully
functional device with leads to the vagus nerve (treated) or a device
without leads to the vagus nerve (sham control).  
In the primary analysis (intent-to-treat) population (n=239),
treatment patients achieved a 24.4% average EWL compared to 15.9% for
sham control patients. This 8.5% difference demonstrated statistical
superiority over sham control (p=0.002), but not super-superiority at
the pre-specified 10% margin (p=0.705). In total, 52.5% of treatment
patients had 20% or more EWL compared to 32.5% in the control group
(p=0.004), and 38.3% of treatment patients had 25% or more EWL
compared to 23.4% in the sham control group (p=0.02). While the
respective co-primary endpoint targets of 55% and 45% were not met,
the endpoint targets were within the 95% confidence intervals for the
observed rates and therefore the observed rates were not
significantly lower than these pre-specified rates. These efficacy
data demonstrate VBLOC Therapy's positive effect on weight loss. 
In the per protocol group, which included only those patients who
received therapy per the trial design (n=211), the treatment patients
had an average 26.3% EWL compared to 17.3% for the sham control group
(p=0.003). In total, 56.8% of treated patients achieved at least 20%
EWL, which was above the pre-defined threshold of 55%, compared to
35.4% in the sham control group (p=0.004). 41.8% of patients also
achieved at least 25% EWL in this population, which is slightly less
than the predefined threshold of 45%, compared to 26.2% in the sham
control group (p=0.03).  
The rate of device-related serious adverse events was 3.1% for the
treatment arm, significantly lower than the threshold of 15% (p <
0.0001). The safety results also confirmed VBLOC Therapy had no
adverse cardiovascular effect. An overall reduction in blood pressure
and heart rate was also observed in the treatment arm. Approximately
93% of patients reached the 12 month assessment in the trial,
consistent with a rigorously executed trial. 
Conference Call and Webcast 
EnteroMedics will host a conference call and live webcast to discuss
the detailed findings of its ReCharge Pivotal Trial today, February
7, 2013, at 5:00 PM ET. The conference call will be accompanied by a
slide presentation available at www.enteromedics.com. The conference
call may be accessed by dialing (877) 280-7473 for domestic callers
and (707) 287-9370 for international callers and providing conference
ID number 88748024. A replay of the call will be available beginning
February 7, 2013 through May 6, 2013, and may be accessed by dialing
(855) 859-2056 for domestic callers and (404) 537-3406 for
international callers. 
The call will be webcast live and may be accessed by visiting
EnteroMedics' website at www.enteromedics.com. Investors can access
the webcast under "Events" in the "Investors" section of
EnteroMedics' website. Please connect to EnteroMedics' website
several minutes prior to the start of the broadcast to ensure
adequate time for any software download that may be necessary. A
replay of the webcast will also be available immediately after the
conclusion of the presentation. 
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. All
patients are expected to participate in a weight management
counseling program.  
About Maestro Rechargeable (RC) System
 The Maestro 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 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 choi
ces. VBLOC(R) 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(R) 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 15, 2012. 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.