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EnteroMedics Announces Presentation of Maestro(R) RC System Clinical Data at the XVI
World Congress of the International Federation for the Surgery of Obesity and Metabolic
Disorders
St. Paul, minn,
September 2, 2011
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using
neuroblocking technology to treat obesity, metabolic diseases, and other gastrointestinal disorders, today announced that data
from the Company's VBLOC-DM2 ENABLE (DM2) trial evaluating the Company's second generation Maestro RC System in the
treatment of obesity, diabetes and hypertension, was presented at the XVI World Congress of the International Federation for
the Surgery of Obesity and Metabolic Disorders (IFSO), held August 31 to September 3 in Hamburg, Germany. The oral
presentation, titled "Treatment of Obesity-Related Co-Morbidities with VBLOC Therapy," was delivered by Miguel Herrera
Hernández, M.D., Instituto Nacional de la Nutrición, Mexico, an investigator in the DM2 trial.
DM2 trial results presented at IFSO reflect statistically significant, sustained improvement in glycemic control and blood
pressure, as well as clinically meaningful weight loss in obese, diabetic patients using the Maestro RC System. The 18-month
data presented at IFSO included: excess weight loss (EWL) of approximately 24.6% (n=22), a mean reduction in HbA1c of 1.2
percentage points from a baseline of 8.1% (n=13), a change in fasting plasma glucose of -38.4 mg/dl from a baseline of 151.4
mg/dl (n=12) and, in hypertensive patients (n=10), a reduction in mean arterial pressure of 13.0 mmHg from a baseline of 99.5
mmHg and a reduction in diastolic blood pressure of 15.9 mmHg from a baseline of 87.2 mmHg (n=10). Through 18 months, no
change in mean arterial pressure was observed in patients that did not present with hypertension (n=10).
Dr. Herrera commented: "VBLOC Therapy has demonstrated clinically meaningful outcomes across a number of key measures,
including a significant effect on weight loss, blood sugar levels and hypertension in obese patients. Importantly, a reduction in
blood pressure was observed only in hypertensive patients, with no effect on normotensive patients, and no treatment related
adverse events were observed. These results show promise in distinguishing VBLOC Therapy from all other available bariatric
surgical procedures."
EnteroMedics also hosted a symposium on September 1, 2011 titled "Emerging Dimensions of Vagus Nerve Function in
Bariatric and Metabolic Treatment" which was co-chaired by Scott Shikora, M.D. and Lillian Kow, Ph.D, MBBS. The symposium
was well attended by global thought leaders in the bariatric surgery community.
Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer, said: "EnteroMedics' presence at the IFSO
World Congress as an exhibitor and presenter along with hosting a symposium, play an important role in highlighting the
significant promise of VBLOC Therapy within the European bariatric community. We continue to make progress toward
commercialization of the Maestro RC System in Europe, having achieved CE Mark certification in March, and have similar
efforts ongoing in other important markets around the world, including Australia and the U.S. We are working diligently to collect
further follow-up data for the DM2 trial and remain on track to achieve full enrollment of our ReCharge pivotal study by year
end."
About the ReCharge Pivotal Trial
The ReCharge Pivotal Trial is a randomized, double-blind, parallel-group, multicenter pivotal clinical trial in approximately 234
patients at up to 12 sites testing the effectiveness and safety of VBLOC® vagal blocking therapy in EnteroMedics' second
generation Maestro® Rechargeable (RC) System. All patients in the study will receive an implanted device and will be
randomized in a 2:1 allocation to treatment or control groups. The control group will receive a non-functional device during the
study period. All patients are expected to participate in a weight management counseling program.
About the Maestro® Rechargeable (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 received CE Mark in March 2011.
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, metabolic diseases, and other gastrointestinal disorders. EnteroMedics' proprietary
neuroblocking technology, VBLOC® vagal blocking therapy, is designed to intermittently block the vagus nerves using highfrequency,
low-energy electrical impulses. These electrical impulses are delivered by a neuroregulator, EnteroMedics'
Maestro® System, which is powered by an integrated rechargeable battery. For more information, visit www.enteromedics.com.
Contact:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
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