EnteroMedics Announces Eighteen-Month Excess Weight Loss Results from its VBLOC-RF2 Feasibility Study

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Mon Jan 12, 2009 7:30am EST

ST. PAUL, Minn.--(Business Wire)--
EnteroMedics Inc., (NASDAQ: ETRM), the developer of medical devices using
neuroblocking technology to treat obesity, its associated co-morbidities, and
other gastrointestinal disorders, today announced interim clinical results from
the VBLOC-RF2 feasibility study of the Company's VBLOC vagal blocking therapy
device, the Maestro System. 

The study includes 38 implanted subjects and is designed to evaluate the
system`s safety and efficacy. Follow-up data show excess weight loss, or EWL, of
37.6% in 9 patients at 18 months of VBLOC Therapy, 28.1% in 17 patients at 12
months of therapy and 17.9% in 35 patients at six months of therapy. To date, no
deaths or unanticipated adverse device events have been reported. 

In addition, further subgroup analysis of the effect of VBLOC Therapy on two of
the major co-morbidities frequently associated with obesity, type 2 diabetes and
hypertension, showed the following: ten patients with diabetes, showed a
statistically significant reduction of 1.1 percentage points (p=.002) from 8.2%
at baseline to 7.1% at four weeks and fifteen patients with both systolic and
diastolic hypertension, which was either untreated or controlled with drugs,
showed statistically significant reductions of 13.9 mm Hg in systolic pressure
and 10.7 mm Hg in diastolic pressure at four weeks. The improvements in blood
pressure are maintained through six months. 

"VBLOC Therapy is designed to produce weight loss, in part, by controlling the
feelings that lead patients to fail at losing weight, including hunger and a
lack of feeling full," commented President and CEO Mark B. Knudson, Ph.D. "These
results are an encouraging sign that significant weight loss, occurring over a
extended period of time, can take place without the serious side effects and
adverse lifestyle impact seen in other obesity procedures. We continue to look
forward to releasing the results of our randomized pivotal trial in the second
half this year." 

In addition to the VBLOC-RF2 study, the Maestro System is being used in the
Company's pivotal EMPOWER clinical trial, a randomized, prospective,
double-blind, placebo-controlled study being conducted in the United States and
Australia under an Investigational Device Exemption (IDE) approved by the U.S.
Food and Drug Administration. The trial was fully enrolled at 15 Centers of
Excellence with 294 patients in September 2008. The study blind, which remains
in place for 12 months after activation of therapy in the experiment arm, is
expected to lift in the second half of this year. 

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 has met its enrollment goal under an FDA-approved Investigational
Device Exemption (IDE) for the EMPOWER Study using the Maestro System, its
initial product for the treatment of obesity. EnteroMedics is currently
recruiting patients outside of the United States for a feasibility study
examining VBLOC Therapy`s effects on blood glucose levels in diabetic patients.
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
inability to complete our EMPOWER pivotal trial and other clinical trials, or
significant delays in the completion of our clinical trials; our ability to
timely 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; 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 13, 2008. 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 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

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