EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices
using neuroblocking technology to treat obesity, metabolic diseases
and other gastrointestinal disorders, today announced the completion
of the first commercial implants of the Maestro@ Rechargeable (RC)
System, delivering VBLOC@ vagal blocking therapy. The implants were
performed at Hadi Hospital in Kuwait City, Kuwait.
Dr. Jarallah, who performed the first commercial implant, said, "It is
an honor to be the first surgeon to implant the commercially-available
Maestro Rechargeable System. VBLOC Therapy is patient-oriented, in
that it does not force punitive, mechanical limits to lifestyle and
diet, or require surgical alteration of the anatomy. As the first
bariatric procedure to offer this positive path to weight loss, it
represents a revolutionary, neuroscience-based approach to the
treatment of obesity."
Dr. Jarallah added, "The surgeries proceeded without incident, and the
patients are all recovering very well."
The Maestro System is distributed by Bader Sultan & Brothers Co. in
the Gulf Coast Countries. Bader Sultan & Brothers Co. is a leading
distributor of medical and diagnostic equipment, headquartered in
Kuwait, with wide coverage throughout the Middle East.
"The first commercial implants of the Maestro RC System marks another
important step forward for EnteroMedics in our evolution as a
commercial organization and, more importantly, for the bariatric
community in the Gulf Coast Countries, who face a daunting obesity and
metabolic disease epidemic," said Mark B. Knudson, Ph.D.,
EnteroMedics' President and Chief Executive Officer. Dr. Knudson
added: "We are thrilled to now offer individuals in the GCC and
Australia the ability to choose a patient-friendly, long-term solution
for treating obesity."
About Maestro@ Rechargeable (RC) System
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. The Maestro 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 has received CE Mark
and has been listed on the Australian Register of Therapeutic Goods.
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@ Rechargeable 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 Obesity in the Gulf Coast Countries
Obesity and metabolic disease is a significant issue in the Middle
East, where an estimated 13% of men and 24.5 % of women are obese,
according to the World Health Organization. Saudi Arabia, Kuwait,
Qatar and the United Arab Emirates each rank in the top 20 for global
prevalence of adult obesity (BMI ? 30 kg/m), with the obese
population ranging from 25-40% of the total population. In addition,
the incidence of diabetes, a co-morbidity of obesity, is epidemic
within the region.
About Bader Sultan & Brothers Co.
Bader Sultan & Brothers Co. is a leading distributor of medical and
diagnostic equipment, headquartered in Kuwait, with wide coverage
throughout the Middle East.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the development
and commercialization of its neuroscience based technology to treat
obesity and metabolic diseases. EnteroMedics' proprietary technology,
VBLOC@ vagal blocking therapy, delivered by a pacemaker-like device
called the Maestro@ Rechargeable System, is designed to intermittently
block the vagus nerves using high-frequency, low-energy, electrical
impulses. VBLOC Therapy allows people with obesity to take a positive
path towards weight loss, addressing the lifelong challenge of obesity
and its comorbidities without sacrificing wellbeing or comfort. The
Maestro Rechargeable System has received CE Mark and is listed on the
Australian Register of Therapeutic Goods. For more information, visit
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 commercial
regulatory approval for our Maestro@ System for the treatment of
obesity in the United States or in any foreign market other than
Australia and the European Community; our preliminary findings from
our EMPOWER? pivotal trial; our ability to comply with the Nasdaq
continued listing requirements; 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@ 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;
international commercialization and operation; 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; 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 annual report on Form 10-K filed March 15, 2012.
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 (United States)
law to investigational use.
The implantation procedure and usage of the Maestro@ System carry some
risks, such as the risks generally associated with laparoscopic
procedures and those related to treatment as described in the ReCharge
clinical trial informed consent.