EnteroMedics Announces Preliminary Results from Detailed Review of EMPOWER Study

Company to Host Conference Call November 12, 2009 8:00 AM EST
ST. PAUL, Minn.--(Business Wire)--
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using
neuroblocking technology to treat obesity and other gastrointestinal disorders,
today announced preliminary findings from its ongoing detailed review of its
EMPOWER study, a randomized, double-blind, controlled pivotal study designed to
evaluate the safety and efficacy of the Maestro System in the treatment of
obesity. On October 2, 2009, the Company announced that the study did not meet
its primary and secondary efficacy endpoints, as results in the control and
treatment arms were statistically indistinguishable, while achieving all of its
safety endpoints.

The ongoing detailed review suggests that vagal blocking therapy may promote
safe and effective weight loss as an adjunct to behavioral support, diet and
exercise in morbidly obese patients. The review further suggests that these
effects were evident in both the treatment and control arms. The Company is
continuing a comprehensive analysis of all clinical, statistical, and
engineering data to understand this finding. Based on the analysis to date, the
control arm of the trial, which was intended to be inactive, apparently provided
a low-intensity blocking signal that introduced VBLOC Therapy in human subjects.

The Company is informing patients and physicians of the following study
findings:

* The EMPOWER study met all of its safety goals, including the finding that
there were no therapy-related serious adverse events reported across the entire
study population;
* Patients who met or exceeded the prescribed nine hours of daily device use
(n=128, 51% of evaluated patients) averaged 10.9 hours of daily use and
experienced an average excess weight loss (EWL) of 23.1% from implant by BMI
method (18.3% from treatment initiation by Met Life method) in the treatment arm
and 22.6% (BMI) from implant, (17.8% from initiation, Met Life) in the control
arm at 12 months;
* Patients that did not meet the prescribed nine hours of daily device use
(n=125) averaged 6.9 hours of daily use and experienced a mean EWL of 10.5%
(BMI) from implant in the treatment arm (6.4% from initiation, Met Life) and
8.6% (BMI) in the control arm (4.6% from initiation, Met Life) at 12 months;
* For all patients (n=253), the average EWL at 12 months was 16.6% EWL (BMI)
from implant (12.1% from initiation, MetLife) for the treatment arm and 16.4%
EWL (BMI) from implant (12.0% from initiation, MetLife) for the control arm; and

* For those patients with a diagnosis of hypertension (n=110), a statistically
significant reduction of systolic and diastolic blood pressure from baseline was
observed, a result that will require follow-up study.

As of today, in accord with the study protocol, 252 patients remain in the
EMPOWER study and are receiving VBLOC Therapy. Consistent with the study
protocol, physicians are encouraging their patients to use the Maestro System
for a minimum of the prescribed 9 hours per day.

"The EMPOWER study demonstrated a remarkable level of safety for an implanted
medical device," added James W. Freston, M.D., Ph.D., Professor of Medicine and
Clinical Pharmacology (emeritus),University of Connecticut Health Center and
Chairman of the EMPOWER study Data Safety Monitoring Board.

"Results from the two arms of the EMPOWER study as well as from our previous
VBLOC Therapy trials were consistent with each other, suggesting a pattern of
positive clinical outcome when blocking the vagus nerve," said President and CEO
Mark B. Knudson, Ph.D. "The apparent control arm effect, while unexpected, may
be a scientifically important addition to our understanding of neuromodulation.
We are taking steps to discuss the outcome of this study with the FDA to
determine the appropriate regulatory path forward for the Maestro System as a
treatment for morbid obesity."

The Company will discuss these findings in detail in a conference call and slide
presentation today at 8:00 AM Eastern Standard Time.

Conference Call, Presentation and Webcast Details

EnteroMedics management will host a conference call and live webcast to discuss
the detailed findings of its EMPOWER study November 12, 2009 at 8:00 AM Eastern
Standard Time. The conference call may be accessed by dialing (888) 205-6702 for
domestic callers and (913) 312-0665for international callers and providing
passcode9194735. A replay of the call will be available from November 12, 2009
at 10:00 AM Eastern Time through February 12, 2010 at 11:59 PM Eastern Time by
dialing (888) 203-1112 for domestic callers and (719) 457-0820 for international
callers and providing passcode 9194735.

The conference call will be accompanied by a slide presentation. The
presentation and call will be webcast live and may be accessed by visiting
EnteroMedics' website at www.enteromedics.com. Investors can access the webcast
under "Press Room" 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 VBLOC Therapy

EnteroMedics developed VBLOC 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
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 development stage medical device company focused on the design
and development of devices that use neuroblocking technology to treat obesity
and other gastrointestinal disorders. EnteroMedics' proprietary neuroblocking
technology, VBLOC vagal blocking therapy, is designed to intermittently block
the vagus nerves using high-frequency, low-energy, electrical impulses.
EnteroMedics is currently conducting a feasibility study examining VBLOC
Therapy's effects on blood glucose levels in diabetic patients outside of the
United States. For more information, visit www.enteromedics.com.

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 regulatory approval for our Maestro System for the treatment of obesity; our
preliminary findings from our EMPOWER pivotal trial; 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 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;
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; potential 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 Company's Form
10-K dated March 12, 2009. We are providing this information as an update to our
October 2, 2009 press release and call 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 U.S. Federal law to investigational
use.

The implantation procedure and usage of the Maestro System carry some risks,
such as the risk generally associated with laparoscopic procedures and those
related to treatment as described in the EMPOWER clinical trial informed
consent.

EnteroMedics Inc.
Greg S. Lea, 651-789-2860
ir@enteromedics.com

Copyright Business Wire 2009