EnteroMedics Announces First Implant in ReCharge Pivotal Trial for Obesity
St. Paul, minn,
May 18, 2011
EnteroMedics Inc., (NASDAQ: ETRM), the only developer of medical devices
using neuroblocking technology to treat obesity and other gastrointestinal disorders, today announced that the first patient has
been implanted in the Company's ReCharge pivotal trial for obesity. The ReCharge trial is a randomized, double-blind, parallelgroup,
multicenter pivotal study testing the effectiveness and safety of VBLOC Therapy, delivered via EnteroMedics' second
generation Maestro Rechargeable (RC) System, in the treatment of obesity. The study is expected to enroll 234 patients at up
to 12 sites in the U.S. and Australia. The Maestro RC System is the first obesity treatment to use neuroblocking technology and
represents a less invasive alternative to existing surgical weight loss procedures, which alter digestive system anatomy, lifestyle
and food choices and may present significant risks.
All patients in the ReCharge trial will receive an implanted device and be randomized in a 2:1 allocation to treatment or control
groups. The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during
the blinded study period. All patients are expected to participate in a weight management counseling program.
"The Maestro System is the only surgical weight loss option to affect the physiology of hunger and fullness. With this device,
the patient can achieve weight loss without imposing the compromises in safety, diet and lifestyle that are associated with
existing surgical procedures for obesity," said Michael Sarr, M.D., Vice Chair of Research in the Department of Surgery at Mayo
Clinic, and national principal investigator of the ReCharge trial. "The ReCharge study will be an important measure of the
safety and efficacy of the Maestro RC System in a large study population, and builds off of clinically meaningful results seen in
earlier feasibility studies."
"First implant in our pivotal ReCharge study is an important milestone for EnteroMedics as we work to deliver the first-ever
patient-oriented surgical obesity treatment to markets where obesity has become an epidemic," said President and Chief
Executive Officer Mark B. Knudson, Ph.D. "At this early stage, our projections to have the trial completely enrolled and
implanted by year-end remain on track. EnteroMedics also continues to make substantial progress in our effort to
commercialize the Maestro System in Australia, where we plan to file an application for approval and listing with the Australian
Therapeutic Goods Administration. Our exploration of potential commercialization opportunities in select markets in Europe also
continues to be encouraging."
For additional information on the ReCharge study, please visit www.RechargeStudy.com.
About Maestro RC System
The Maestro® Rechargeable (RC) System is powered by an internal, rechargeable battery. The battery is recharged via an
external mobile charger and transmit coil that the patient uses for a short time each week. The Maestro RC System delivers
VBLOC® vagal blocking therapy via two small electrodes that are laparoscopically implanted and placed in contact with the
trunks of the vagus nerve just above the junction between the esophagus and the stomach.
About VBLOC Therapy
EnteroMedics developed VBLOC® 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® vagal blocking therapy, is designed to intermittently block the vagus nerves using high-frequency, lowenergy,
electrical impulses. These electrical impulses are delivered by a neuroregulator, EnteroMedics' Maestro RC System,
which is powered by an integrated rechargeable battery. For more information, visit www.enteromedics.com.
CONTACT:
EnteroMedics Inc.
Greg S. Lea
(651) 789-2860
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