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EnteroMedics Announces
Preliminary Results from Detailed Review of EMPOWER Study
Company to Host Conference Call November 12, 2009 8:00 AM EST
St. Paul, minn,
November 12, 2009
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical
devices using neuroblocking technology to treat obesity and other gastrointestinal
disorders, today announced preliminary findings from its ongoing detailed review
of its EMPOWER(TM) study, a randomized, double-blind, controlled pivotal study
designed to evaluate the safety and efficacy of the Maestro(R) System in the
treatment of obesity. On October 2, 2009, the Company announced that the study
did not meet its primary and secondary efficacy endpoints, as results in the
control and treatment arms were statistically indistinguishable, while achieving
all of its safety endpoints.
The ongoing detailed review suggests that vagal blocking therapy may promote
safe and effective weight loss as an adjunct to behavioral support, diet and
exercise in morbidly obese patients. The review further suggests that these
effects were evident in both the treatment and control arms. The Company is
continuing a comprehensive analysis of all clinical, statistical, and engineering
data to understand this finding. Based on the analysis to date, the control
arm of the trial, which was intended to be inactive, apparently provided a
low-intensity blocking signal that introduced VBLOC Therapy in human subjects.
The Company is informing patients and physicians of the following study findings:
- The EMPOWER study met all of its safety goals, including the finding that
there were no therapy-related serious adverse events reported across the
entire study population;
- Patients who met or exceeded the prescribed nine hours of daily device
use (n=128, 51% of evaluated patients) averaged 10.9 hours of daily use and
experienced an average excess weight loss (EWL) of 23.1% from implant by
BMI method (18.3% from treatment initiation by Met Life method) in the treatment
arm and 22.6% (BMI) from implant, (17.8% from initiation, Met Life) in the
control arm at 12 months;
- Patients that did not meet the prescribed nine hours of daily device use
(n=125) averaged 6.9 hours of daily use and experienced a mean EWL of 10.5%
(BMI) from implant in the treatment arm (6.4% from initiation, Met Life)
and 8.6% (BMI) in the control arm (4.6% from initiation, Met Life) at 12
months;
- For all patients (n=253), the average EWL at 12 months was 16.6% EWL (BMI)
from implant (12.1% from initiation, MetLife) for the treatment arm and 16.4%
EWL (BMI) from implant (12.0% from initiation, MetLife) for the control arm;
and
- For those patients with a diagnosis of hypertension (n=110), a statistically
significant reduction of systolic and diastolic blood pressure from baseline
was observed, a result that will require follow-up study.
As of today, in accord with the study protocol, 252 patients remain in the
EMPOWER study and are receiving VBLOC Therapy. Consistent with the study protocol,
physicians are encouraging their patients to use the Maestro System for a minimum
of the prescribed 9 hours per day.
"The EMPOWER study demonstrated a remarkable level of safety for an implanted
medical device," added James W. Freston, M.D., Ph.D., Professor of Medicine
and Clinical Pharmacology (emeritus),University of Connecticut Health Center
and Chairman of the EMPOWER study Data Safety Monitoring Board.
"Results from the two arms of the EMPOWER study as well as from our previous
VBLOC Therapy trials were consistent with each other, suggesting a pattern
of positive clinical outcome when blocking the vagus nerve," said President
and CEO Mark B. Knudson, Ph.D. "The apparent control arm effect, while
unexpected, may be a scientifically important addition to our understanding
of neuromodulation. We are taking steps to discuss the outcome of this study
with the FDA to determine the appropriate regulatory path forward for the Maestro
System as a treatment for morbid obesity."
The Company will discuss these findings in detail in a conference call and
slide presentation today at 8:00 AM Eastern Standard Time.
Conference Call, Presentation and Webcast Details
EnteroMedics management will host a conference call and
live webcast to discuss the detailed findings of its EMPOWER study November
12, 2009 at 8:00 AM Eastern Standard Time. The conference call may be accessed
by dialing (888) 205-6702 for domestic callers and (913) 312-0665for international
callers and providing passcode9194735. A replay of the call will be available
from November 12, 2009 at 10:00 AM Eastern Time through February 12, 2010 at
11:59 PM Eastern Time by dialing (888) 203-1112 for domestic callers and (719)
457-0820 for international callers and providing passcode 9194735.
The conference call will be accompanied by a slide presentation.
The presentation and call will be webcast live and may be accessed by visiting
EnteroMedics' website at www.enteromedics.com. Investors can access the webcast
under "Press
Room" in the "Investors" section of EnteroMedics' website. Please
connect to EnteroMedics' website several minutes prior to the start of the
broadcast to ensure adequate time for any software download that may be necessary.
A replay of the webcast will also be available immediately after the conclusion
of the presentation.
About VBLOC Therapy
EnteroMedics developed VBLOC(R) 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(R)
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
and other gastrointestinal disorders. EnteroMedics' proprietary neuroblocking
technology, VBLOC(R) vagal blocking therapy, is designed to intermittently
block the vagus nerves using high-frequency, low- energy, electrical impulses.
EnteroMedics is currently conducting a feasibility study examining VBLOC Therapy's
effects on blood glucose levels in diabetic patients outside of the United
States. For more information, visit www.enteromedics.com.
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(R) System for the treatment of
obesity; our preliminary findings from our EMPOWER(TM) pivotal trial; 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(R) 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; potential 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 Company's Form 10-K dated March 12, 2009. We are providing this information
as an update to our October 2, 2009 press release and call 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 U.S. Federal law to investigational
use.
The implantation procedure and usage of the Maestro(R) 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.
SOURCE: EnteroMedics Inc.
About Charter Life Sciences
Charter Life Sciences (“CLS”) is a life sciences venture capital
firm with offices in Palo Alto, California and Cincinnati, Ohio. CLS focuses
on providing the initial venture capital to companies that are developing innovative
products for significant unmet medical needs. The CLS team draws on its extensive
medical, operational and start-up company experience to work collaboratively
with its portfolio companies to develop their clinical, operational and financing
strategies. For additional information on CLS, please visit www.clsvc.com.
CONTACT:
Ted Rossman/Lisa Kelaita
New Venture Communications
(650) 343-2735
trossman@newventurecom.com
lkelaita@newventurecom.com
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