EnteroMedics Announces First Commercial Implants of the Maestro(R) Rechargeable System
ST. PAUL, MN--(Marketwire - June 05, 2012) - 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/m²), 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 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 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.
Greg S. Lea