EnteroMedics Announces Updated Data From VBLOC DM2 ENABLE Study and Caloric
Intake Study Results to Be Presented at the 29th Annual Obesity Society Meeting
St. Paul, minn,
October 3, 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
twelve month Caloric Intake Study data and updated clinical results from the Company's VBLOC-DM2 ENABLE (DM2) Study
evaluating the Company's second-generation Maestro RC System in the treatment of obesity, diabetes and hypertension will
be presented at the 29th Annual Meeting of the Obesity Society October 1-5, 2011 in Orlando, Florida.
DM2 Study - HbA1c, FPG and Waist Circumference Data
The Company will present updated data from additional subjects reaching 18 months in the DM2 Study at the Obesity Society
Annual Meeting. These results include change in HbA1c (blood sugar) and fasting plasma glucose (FPG) at 18 months, as well
as new data on change in waist circumference at 12 months:
HbA1c change in percentage points (Baseline HbA1c = 7.8% ± 0.2) (Company updated interim data):
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Visit (post-device activation) % HbA1cchange N P=
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Week 1 -0.3 28 .002
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6 Months -0.9 25 .002
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12 Months -1.0 26 .002
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18 Months -1.1 18 .002
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FPG change (Baseline 151.4 ± 6.5 mg/dl average) (Company updated interim data):
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FPG Change
Visit (post-device activation) (mg/dl) N P=
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Week 1 -20.9 28 .01
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6 Months -28.7 25 .01
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12 Months -27.6 25 .01
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18 Months -32.0 17 .01
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Waist circumference change (Baseline 120 ± 2 cm) (Company updated data):
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Change in Waist
Circumference
Visit (post-device activation) (cm) N P=
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12 Weeks -8 ± 1 23 < .001
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6 Months -9 ± 2 18 < .001
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12 Months -11 ± 2 19 < .001
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The Company recently presented 18-month data for the DM2 Study at the International Federation for the Surgery of Obesity
and Metabolic Diseases (IFSO), including: Excess Weight Loss (EWL) of approximately 24.6% (n=22) 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). No change in mean arterial pressure was observed in
patients that did not present with hypertension (n=10).
Mark B. Knudson, Ph.D., EnteroMedics' President and Chief Executive Officer, said: "The updated data from our DM2 Study
remain highly encouraging and supportive for the Company's ongoing ReCharge Pivotal Study, which also uses the secondgeneration
Maestro RC System. The ReCharge Study remains on track for full enrollment by year end. In parallel, we continue
to make progress toward commercialization of the Maestro RC System in Australia and Europe."
Caloric Intake Sub-study
The Company will also present results from a sub-study, conducted as part of the DM2 Study, evaluating 12-month satiety and
calorie intake in 10 subjects with type 2 diabetes mellitus enrolled in the DM2 Study. Follow-up measures among patients
enrolled in the sub-study included EWL, 7-day diet records assessed by a nutritionist, calorie calculations and visual analogue
scale (VAS) questions to assess satiety by 7-day or 24-hour recall at the following time periods: baseline, 4 and 12 weeks and
6 and 12 months post device initiation. A validated program, Food Works™, was used to determine calorie and nutrition
content. Results include:
- Mean EWL for the study was 33+5% (p < 0.001) at 12 months;
- Calorie intake decreased by 45% (p < .001), 48% (p < .001), 38% (p < .001) and 30% (p=.02), at 4 and 12 weeks, 6
months, and 12 months respectively, from a baseline of 2,062 kcal/day; and
- VAS recall data, using a repeated measures analysis, documented fullness at the beginning of meals (p=.005), less food
consumption (p=.02), and less hunger at the beginning of meal (p=.03) corroborating the reduction in caloric intake.
"The DM2 caloric intake sub-study reveals a durability of effect in several important measures, including reduction in daily
calories, earlier feelings of fullness and reduced feelings of hunger," said Lillian Kow, Ph.D., MBBS and one of the study's
investigators. "These results, which combine with a desirable safety profile, reflect the ideal conditions for safe and effective
weight loss. VBLOC Therapy, which does not rely on the punitive measures of many existing bariatric surgical approaches,
remains a distinct and uniquely promising treatment for obesity and its frequently associated comorbidities of diabetes and
hypertension."
About the DM2 ENABLE Study
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® ReChargeable (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),
blood pressure, calorie intake, appetite and other endpoints at one week and one, three, six, 12 and 18 months 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.
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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