SOURCE: Frost & Sullivan

April 26, 2011 10:45 ET

Frost & Sullivan Recognizes ImThera Medical for Its Breakthrough Neurostimulation Device to Treat Sleep Apnea

The aura6000™ Is One of the Smallest Implantable and Rechargeable Stimulators in the Market

MOUNTAIN VIEW, CA--(Marketwire - Apr 26, 2011) - Based on its recent analysis of the neurostimulation for sleep apnea market, Frost & Sullivan recognizes ImThera Medical, Inc. with the 2011 North American Frost & Sullivan Award for Technology Innovation for its pioneering sleep apnea device, the aura6000™.

Continuous positive airway pressure (CPAP) treatment, the gold standard for treating obstructive sleep apnea (OSA), has poor patient compliance due to the inconvenience involved. ImThera is one of the few companies to have devised a neurostimulation device for treating OSA that targets CPAP non-compliant patients worldwide (at least 46 percent of patients according to market data) and can also be used for others as a second line of therapy for OSA.

ImThera's aura6000™ electrically stimulates the hypoglossal nerve (HGN), a motor nerve that controls six muscle groups of the human tongue. Since the muscles lose tone during sleep, stimulation of the HGN can activate the relevant tongue muscles, which can tone them and prevent or reduce OSA episodes. This requires the implantation of a small device through a minimally invasive procedure, performed by an ENT surgeon and taking between sixty and ninety minutes of surgical time. HGN stimulation also overcomes the side effects associated with the CPAP method and is more cosmetically appealing.

The aura6000™ is an open loop system with a constant current implantable pulse generator (IPG), which causes a continuous current to be applied to parts of the HGN in a patient customized fashion. The device consists of two implantable components, a rechargeable pulse generator placed under the skin in the upper chest region, and a multi-contact electrode placed in the upper neck. The electrode encircles the HGN and delivers electric pulses to the nerve in up to six different spots through its multi-contact design, stimulating multiple muscles in the tongue and targeting specific regions.

The system does not require complex triggers or pressure sensors as required in a closed loop system. The constant current IPG has potential advantages over the normally used voltage controlled devices for targeted stimulation. An external remote like device helps to recharge the battery and program the settings accordingly.

"OSA patients who cannot comply to CPAP will eventually be treated with HGN stimulation therapy," notes Frost & Sullivan research analyst Ruplekha Choudhurie. "Frost & Sullivan firmly believes that the ease of use with ImThera's system combined with its efficacy and safety will strongly influence its adoption."

The aura6000™ has shown excellent early results in clinical trials in patients with moderate to severe OSA and ImThera hopes to get the CE Mark for its device later this year. The IPG is one of the smallest developed to date [11.5 cc].

With an estimated 1.5 million CPAP non-compliant patients in the U.S. alone, ImThera estimates the economic burden of non-compliant CPAP patients at roughly $20 billion a year due to the advancement of the many serious commorbidities. This suggests a large potential market for targeted HGN stimulation.

All these factors provide a significant competitive edge to the aura6000 system and make ImThera the worthy recipient of the 2011 North American Technology Innovation Award in the neurostimulation market for treating and preventing sleep apnea.

Each year, Frost & Sullivan presents this award to the company that has demonstrated uniqueness in developing a technology, which significantly impacts both the functionality and the customer value of new products and applications. The award lauds the relevance of the innovation to the industry.

Frost & Sullivan's Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis and extensive secondary research in order to identify best practices in the industry.

About ImThera Medical, Inc. (www.imtheramedical.com)
Based in San Diego, ImThera Medical is a privately funded company that has developed a neurostimulation medical device for the treatment of Obstructive Sleep Apnea (OSA).

ImThera's Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy delivers neurostimulation to the hypoglossal nerve to control certain muscles of the tongue. Using a multi-contact electrode and a programmable implantable pulse generator (IPG), the system delivers muscle tone to key tongue muscles to prevent the tongue from collapsing into the upper airway during sleep. This innovative technology is designed to increase nighttime upper airway flow, permitting normal and restful sleep for OSA patients.

About Frost & Sullivan

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