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Data to Be Presented at the 24th Annual Scientific Conference of the Obesity and Surgery Society of Australia and New Zealand on April 11, 2012

Tue, 04/03/2012 - 3:45am
The Associated Press

EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices

using neuroblocking technology to treat obesity, metabolic diseases

and other gastrointestinal disorders, today announced 2.5-year

diabetes, hypertension and weight loss data from the Company's DM2

ENABLE Study of VBLOC@ vagal blocking therapy delivered via the

Maestro@ Rechargeable (RC) System. A portion of the data will be

presented at the 24th Annual Scientific Conference of the Obesity and

Surgery Society of Australia and New Zealand being held April 11-13,

2012, in Darwin Australia. The presentation will be delivered by

Professor James Toouli, MBBS, PhD, FRACS, professor of surgery at

Flinders University in Adelaide, Australia, on April 11, 2012.

"Recently published results from large, independent studies about the

effects of weight loss surgery on type 2 diabetes are reflected in

this study of the Maestro RC System, where reduction in glycemic load

and HbA1c, two diabetes indicators, appears independent of weight

loss," said Dr. Toouli. "These results are not only significant, but

durable, lasting out to 30 months, and show an effect on blood

pressure and weight loss, while continuing to demonstrate an excellent

safety profile, including cardiovascular safety. I look forward to

further investigating the potential of VBLOC Therapy in the treatment

of obesity, diabetes and hypertension."

Mark B. Knudson, PhD, EnteroMedics' President and Chief Executive

Officer, said: "Our neuroscience-based approach to the treatment of

obesity and its related co-morbidities could have a significant impact

on the way these diseases are treated in the future. These highly

encouraging results, now at 30 months of follow-up, will support our

plans to add the treatment of diabetes and hypertension to the

existing obesity CE Mark indication."

Updated VBLOC-DM2 ENABLE Study Data

The DM2 Study is an international, open-label, prospective,

multi-center study designed to evaluate the safety and efficacy of

VBLOC@ vagal blocking therapy delivered via the Maestro@ RC System in

28 diabetic subjects with obesity by measuring average percentage

excess weight loss (EWL), HbA1c (blood sugar), fasting plasma glucose

(FPG, blood sugar) and blood pressure, following device activation. To

date, no deaths or unanticipated adverse device effects have been

reported during the VBLOC-DM2 ENABLE Study and the safety profile is

similar to that seen in other VBLOC clinical trials.

The metabolic effects at 2.5 years in diabetes, hypertension and

weight loss were consistent with previous findings and were all

statistically significant. Change for HbA1c, in percentage points, and

fasting plasma glucose, in mg/dl, both type 2 diabetes indicators,

were -0.8 (p0.0492) and -29.0 (p0.0306) from a baseline of 7.7% and

162.8 mg/dl, respectively (n12). Change in mean arterial pressure

(n9) and diastolic blood pressure (n8), indicators of hypertension,

showed sustained improvement, with reductions of 11.5 mmHg (p0.0053)

and 13.2 mmHg (p0.0037) at 30 months from baselines of 99.1 and 85.9,

respectively. Excess weight loss was 22.5% (p < 0.0001) for the 19

subjects who reported for their 30 month visit.

About Maestro@ RC System

The Maestro RC System delivers VBLOC@ 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@ 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. These

electrical impulses are delivered by a neuroregulator, EnteroMedics'

Maestro@ RC System, which is powered by an integrated rechargeable

battery. For more information, visit

www.enteromedics.com(http://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 commercial

regulatory approval for our Maestro@ 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 pivotal trial; 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@ 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 otherwise.

Caution - Investigational device. Limited by Federal (United States)

law to investigational use.

The implantation procedure and usage of the Maestro@ 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.

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