EnteroMedics(TM) Announces Nine-Month Clinical Results on Its VBLOC-RF2 Feasibility Study for Obesity Therapy
ST. PAUL, Minn., Jan 08, 2008 (BUSINESS WIRE)
EnteroMedics Inc. (NASDAQ:ETRM), a developer of medical devices using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced interim clinical results for the company's Maestro(TM) RF2 System. The Maestro RF2 System is currently being evaluated in 33 obese patients outside the United States in the VBLOC-RF2 clinical feasibility study of the company's proprietary VBLOC(TM) vagal blocking therapy.
The most recent follow-up of nine RF2 patients,
among the earliest patients implanted in the VBLOC-RF2 trial,
showed an excess weight loss, or EWL, of 29.5% at nine months
of VBLOC Therapy. The most recent results for the prior follow-up
periods demonstrate an EWL of 10.2% in 32 RF2 patients at one
month, an EWL of 17.5% in 26 RF2 patients at three months,
and an EWL of 22.1% in 21 RF2 patients at six months of VBLOC
Therapy.
"We are encouraged by these interim weight loss data and the safety profile of our Maestro RF2 System," commented President and CEO Mark B. Knudson, Ph.D. "The results continue to support VBLOC Therapy as a meaningful choice for physicians and their patients seeking sustainable weight loss."
The Maestro RF2 System is also being used
in the company's EMPOWER clinical study. An Investigational
Device Exemption (IDE) for the EMPOWER study, which is a randomized,
prospective, double-blind clinical study, was approved by the
Food and Drug Administration in June 2007, and the company
is currently enrolling patients for the EMPOWER study in Australia
and the United States.
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 Inc.
Greg S. Lea
651-789-2764
ir@EnteroMedics.com
|
