EnteroMedics, Inc. (ETRM) Tuesday said critical active implantable medical device components of the Maestro System were approved by the Australian Therapeutic Goods Administration. The Maestro System is a first-in-class, sustainable weight loss treatment which is designed to control both hunger and fullness by blocking the primary nerve which regulates the digestive system. The Maestro RC System received CE Mark in March 2011.
The St. Paul, Minnesota-headquartered company is a developer of medical devices using neuroblocking technology to treat obesity, metabolic disease and other gastrointestinal disorders.
The approval was granted for the Maestro Implant Kit, which is comprised of a rechargeable neuroregulator, anterior and posterior leads and a clinician transmit coil, as well as the individual implantable rechargeable neuroregulator component, both of which were active implantable medical device or AIMD applications.
In addition, the Therapeutic Goods Administration or TGA approved the two class I applications for the AC battery charger and the programmer cable. The TGA continues review of the balance of the individual class III components, which include the mobile charger, multiple versions of the patient transmit coil and the clinician programmer.
Mark Knudson, EnteroMedics' president and chief executive officer, said," The Maestro System is the only surgical intervention to individually address each patient's path toward weight loss without compromises in safety, lifestyle or anatomy. We look forward to completion of the review of the balance of the system components and to the opportunity to provide the Australian bariatric care community with a new, safe and sustainable option for addressing the epidemic of obesity in this important market."
According to the Australian Bureau of Statistics, in 2008 sixty-two percent of all adults in Australia were either overweight (BMI > 25) or obese (BMI > 30). It is estimated that by 2025, 7.2 million Australians could be obese. The Australian Federal Minister has declared obesity a national priority, with obesity related costs exceeding $21 billion annually. Approximately 13,900 bariatric surgeries were performed in Australia in 2008.
The Maestro Rechargeable or 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.
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.
ETRM last traded at $2.00 on the Nasdaq. Over the past year, the stock traded in a range of $1.52 - $3.37.
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