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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
WASHINGTON, June
19, 2008
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
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, see www.enteromedics.com
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