EnteroMedics(TM) Announces Pivotal Clinical Study of its VBLOC(TM) Therapy for Obesity
EMPOWER Study Will Test Safety and Effectiveness
of Vagal Blocking Therapy at 15 Sites in U.S. and Australia
ST. PAUL, Minn., Jan 07, 2008 (BUSINESS WIRE)
EnteroMedics, Inc. (NASDAQ:ETRM), a developer
of medical devices using neuroblocking technology to treat
obesity and other gastrointestinal disorders, today announced
its EMPOWER pivotal clinical study. The FDA has recently granted
approval for the pivotal clinical study of the company's investigational
VBLOC Therapy using the Maestro(TM) System, its initial product
for the treatment of obesity. The EMPOWER Study will evaluate
the safety and effectiveness of the Company's proprietary VBLOC(TM)
vagal blocking therapy for the treatment of obesity at 15 clinical
sites in the U.S. and Australia.
The EMPOWER study is a randomized,
double-blind, placebo-controlled study and will include up
to 220 patients across 15 clinical sites. The VBLOC Therapy
system is the only neuroblocking device currently under investigation
for the potential treatment of obesity.
Obesity has become a significant public
health threat in the United States and worldwide. Between 1980
and 2004, obesity rates doubled among U.S. adults. According
to the Centers for Disease Control, more than 30 percent of
the adult population, or 65 million American adults, are obese.
According to World Health Organization estimates, as many as
400 million people suffer from obesity worldwide. Obese individuals
are at a higher risk of being diagnosed with heart disease,
high blood pressure, joint problems, and diabetes, among other
health problems. Upon completion of the first year of the trial,
EnteroMedics plans to use data from this study to support a
premarket approval, or PMA, application to the FDA for the
treatment of obesity in the United States. The Maestro System
has not been approved for commercial sale in the United States.
"Bariatric surgeons and the millions of Americans with
obesity are seeking lower risk alternatives to the current
surgical treatments for obesity with their many known side
effects and complications. VBLOC Therapy has the potential
to address these unmet medical needs with an implantable system
designed to empower weight loss by promoting earlier feelings
of fullness and reduced hunger while essentially preserving
the individual's normal anatomy" said Mark B. Knudson,
Ph.D., President and CEO of EnteroMedics. The EMPOWER trial,
whose objective is to evaluate a new and potentially effective,
lower risk option for the treatment of obesity, is being conducted
in partnership with several nationally and internationally
recognized obesity experts and institutions.
About VBLOC Therapy
EnteroMedics developed VBLOC(TM) 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 the EMPOWER Study
The EMPOWER Study
is a randomized, double-blind, placebo-controlled study being
conducted to evaluate the safety and effectiveness of the Company's
investigational VBLOC Therapy after 12 months of use in obese
patients. The study will be conducted at up to 15 sites in
the U.S. and Australia and will include up to 300 patients
with obesity. The company expects to complete enrollment during
the first half of 2008. In order to qualify for the study,
patients must be 18 years of age or older, with a body mass
index (BMI) between 35 and 45.
To learn more about the EMPOWER Study, call
866 97 VBLOC (866-978-2562), or visit: www.EMPOWERstudy.com
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(TM)
vagal blocking therapy, is designed to intermittently block
the vagus nerves using high-frequency, low-energy, electrical
impulses. The Food and Drug Administration recently granted
approval for a pivotal clinical trial of EnteroMedics' investigational
Maestro(TM) System, the company's initial product for the treatment
of obesity, that delivers VBLOC Therapy.
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(TM) 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(TM) 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 Prospectus dated November 14, 2007. 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.
CONTACT ENTEROMEDICS:
EnteroMedics Inc.
Greg S. Lea
651-789-2764
ir@EnteroMedics.com
PUBLIC RELATIONS:
Schwartz Communications
Helen Shik,
781-684-0770
hshik@schwartz-pr.com
INVESTOR
RELATIONS:
Padilla Speer Beardsley
Al Galgano,
612-455-1700
agalgano@psbpr.com
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