EnteroMedics' Data from VBLOC-RF2 Feasibility Study and VBLOC-RC Study Presented...
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EnteroMedics' Data from VBLOC-RF2 Feasibility Study and VBLOC-RC Study Presented Today at the American Society for Metabolic and Bariatric Surgery Meeting
Company to Host Conference Call Today at 4:30 p.m. Eastern
Daylight Time to Discuss Study Results and to Provide an Update on
EMPOWER Trial Enrollment
WASHINGTON--(Business Wire)--
EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices
using neuroblocking technology to treat obesity and other
gastrointestinal disorders, announced that interim clinical results
for the company's VBLOC(TM) vagal blocking therapy device, the
Maestro(TM) RF2 System, were presented today at the 25th annual
meeting of the American Society for Metabolic and Bariatric Surgery,
being held June 15-20 in Washington, D.C.
James Toouli, M.D., Professor of Surgery at Flinders University in
Adelaide, Australia, presented 12-month follow up from the VBLOC-RF2
clinical feasibility study on behalf of EnteroMedics and the
investigators in the VBLOC-RF2 clinical feasibility study conducted
outside the U.S. The feasibility study of 38 implanted subjects is
evaluating the safety and efficacy of VBLOC Therapy. The weight-loss
results reported today indicate that VBLOC Therapy may provide durable
and ongoing weight-loss for people with obesity. Specifically, the
follow-up data show excess weight loss, or EWL, of 29.1% in 12
patients at 12 months of VBLOC Therapy, 27.4% in 17 patients at nine
months of therapy and 21.4% in 28 patients at six months of therapy.
Importantly, there have been no device-related serious adverse events
and no deaths using the RF2 system.
The RF2 System is also being used in the Company's EMPOWER
clinical trial, a randomized, prospective, double-blind,
placebo-controlled study being conducted in the United States and
Australia under an Investigational Device Exemption (IDE) approved by
the U.S. Food and Drug Administration. The Company remains on track to
achieve its enrollment goal for the EMPOWER trial by the end of June,
which is consistent with the Company's projected target date of
mid-2009 for completion of EMPOWER's 12-month endpoint. EnteroMedics
will further update enrollment and implant numbers in its second
quarter financial release.
Dr. Toouli also discussed the initial clinical experience with
EnteroMedics' VBLOC-RC (rechargeable) proof of concept study. The
device, which integrates a rechargeable battery into the implanted
component of the device, has been successfully implanted in 13
patients. Early excess weight loss results are consistent with the
results seen in the RF2 device. Similarly, no device-related serious
adverse events or deaths have been reported with the RC system.
"We are encouraged by these data, which reinforce our belief that
VBLOC Therapy may become the first option to offer significant weight
loss, a favorable safety profile and the preservation of anatomy to
people with obesity," commented President and CEO Mark B. Knudson,
Ph.D. "With our enrollment objectives on track, we look forward to
reporting results of our pivotal study in mid-2009. Our plan is to
submit a Pre Market Approval application to the Food and Drug
Administration shortly thereafter."
Conference Call and Webcast
The Company will host a conference call and live webcast at 4:30
PM EDT today, June 19, 2008, to discuss findings from the data
presented at the meeting. To listen to the conference call, dial (877)
614-4258 (United States and Canada) or (816) 650-0779 (international),
and use participant code (48663172) approximately 10 minutes prior to
the start time. An audio replay of the conference call can be accessed
by calling (800) 642-1687 or (706) 645-9291. The replay will be
available for two weeks. To access the live Webcast, visit the
investor relations section of EnteroMedics' Web site at
www.enteromedics.com. A replay of the Webcast will be available
immediately after the conference call.
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 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 nerve
using high-frequency, low-energy, electrical impulses. EnteroMedics
recently received an investigational device exemption (IDE)
application approval from FDA for the pivotal trial of its initial
product for the treatment of obesity, the Maestro(TM) System. 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(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 Form 10-K dated March 13, 2008. 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(TM) 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.
EnteroMedics Inc.
Greg S. Lea, 651-789-2860
ir@enteromedics.com
Copyright Business Wire 2008
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