EnteroMedics Announces Planned Expansion of EMPOWER Pivotal Study for Obesity to 300 Patients
Expected Enrollment Completion Remains
First Half of 2008
ST. PAUL, Minn., Feb 26, 2008 (BUSINESS WIRE)
EnteroMedics Inc., (NASDAQ:ETRM), the developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that the Food and Drug Administration (FDA) has granted approval for the expansion of its pivotal clinical trial, known as the EMPOWER Study, from 220 patients to 300 patients. Full enrollment in the EMPOWER Study is expected in the first half of 2008, consistent with previous projections, despite expansion of the study.
The EMPOWER Study, which is currently enrolling
patients at 10 of its projected 15 clinical sites, is a randomized,
double-blind, placebo-controlled study being conducted to evaluate
the safety and effectiveness of investigational VBLOC(TM) vagal
blocking therapy using the Maestro(TM) System in obese patients.
VBLOC Therapy is designed to empower weight loss by promoting
earlier feelings of fullness and reduced hunger while minimizing
the side effects and complications associated with existing
surgical options and preserving the individual's normal anatomy.
"In obesity trials, the problem is generally not finding patients for recruitment, but supporting our clinical centers in managing the number of patients with obesity seeking help. Because of this, we are able to expand the EMPOWER Study, making its endpoint results more robust, while keeping to our original enrollment timeline," said Mark B. Knudson, Ph.D., President and CEO of EnteroMedics. "Our recruitment and screening systems, which include a registered nurse call center and informational meetings, are in place and have already handled the screening of thousands of potential candidates."
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.
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.
Greg S. Lea