ImThera Medical launches the aura6000 neurostimulation system for treating Obstructive Sleep Apnea

Oct 5 2009

Today, at the American Academy of Otolaryngology-Head and Neck Surgery annual meeting, ImThera Medical, Inc. unveiled its new product, the aura6000™ neurostimulation system for the treatment of Obstructive Sleep Apnea (OSA).

More than 800,000 patients in the US are annually diagnosed with OSA. While Continuous Positive Airway Pressure (CPAP) is the established therapy, studies show that only 54% of patients comply with CPAP. According to the Executive Director of the American Sleep Apnea Association, Edward Grandi, “Providing effective treatment options is important to successfully address the sleep apnea crisis. The more ways there are to successfully treat OSA, the more likely we are to reach the 20 plus million untreated patients.”

The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. The system is comprised of a surgically-placed multi-contact electrode specifically designed for the hypoglossal nerve, and a wire (lead) that connects the electrode to a programmable implantable pulse generator (IPG) that is placed in the anterior chest wall. The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep.

The system is externally programmable, specifically for each patient, and re-chargeable. External components include a patient’s controller/charger and a physician’s notebook PC which includes the aura6000 Clinical Manager THN Sleep Therapy physician software. Targeting multiple tongue muscles to deliver therapy, it operates in open loop, continuous mode during sleep, not requiring complex trigger (closed loop) methods and sensors. The aura6000’s IPG is a multi-current source design and measures just over 11 cubic centimeters in volume.

“We’re very excited to be showcasing our technology at the AAO-HNS in our home town of San Diego. The aura6000 was developed by an outstanding team of engineers, scientists and suppliers in record time and will be in European clinical trials shortly,” said Marcelo G. Lima, Chairman, President and CEO of ImThera Medical.

ImThera is attending this annual event to explore additional European clinical trial sites. The company will at a later date determine interest in the US in participating in US clinical trials once appropriate approvals have been obtained.