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
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
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.