ImThera Medical, a privately held global medical device company, announced that the US Food and Drug Administration (US FDA) has approved an investigational device exemption (IDE) for its THN3 Clinical Study. The THN3 Study will evaluate the safety and effectiveness of the aura6000 System for moderate to severe obstructive sleep apnea (OSA) in individuals who are unable to comply or unwilling to try PAP therapy or other OSA treatments. Data from this pivotal clinical study will be used to support a Pre-Market Approval (PMA) application for the aura6000 System.

“This is the most exciting innovation for the treatment of sleep apnea since CPAP,” said Michael Friedman, M.D., Professor of Otolaryngology and director of Chicago Sleep Center at Rush University Medical Center, Chicago IL and a study investigator. “I have had experience implanting the device during the earlier THN2 study. It is an easy and safe procedure to perform.”

Sponsored by ImThera Medical, the THN3 Study (Targeted Hypoglossal Neurostimulation Study) is a randomised, controlled, prospective, multi-center clinical trial. It is being conducted at leading medical centres in the United States and Europe.

“This is a substantial milestone in the development of this technology,” said Alan Schwartz, M.D. Professor of Medicine and Medical Director, Johns Hopkins Sleep Disorders Center, Baltimore MD, principal investigator of the THN3 study, “We have seen very encouraging results from the earlier studies showing that most patients treated with the aura6000 System experienced significant improvements in their sleep apnea.”

“Millions of Americans are waiting for a solution for their obstructive sleep apnea,” said Marcelo Lima, president and chief executive officer, at ImThera Medical, “The approval of this study brings us one critical step closer to being able to make this novel device available to those patients.”

The aura6000 System is based on ImThera’s proprietary THN Sleep Therapy technology. THN Sleep Therapy delivers neurostimulation to the hypoglossal nerve increasing muscle tone of multiple tongue muscles and preventing the tongue from collapsing into the upper airway during sleep. This innovative technology is designed to address nighttime upper airway blockage, permitting normal and restful sleep for OSA patients. “Essentially, the system keeps the tongue in an awake position while the patient sleeps,” explains Dr. Michael Friedman.

The system consists of two implantable components, a small rechargeable pulse generator placed under the skin near the collarbone, and a multi-electrode lead placed in the upper neck. The electrodes deliver mild pulses to the hypoglossal nerve, stimulating various muscles and thereby increasing upper airway flow during sleep.

In November 2012, the aura6000 System was awarded the Golden Electrode Award for Best New Product. The aura6000 System has received the CE Mark, and is commercially available in select markets outside the United States. Within the United States it is only available to participants in this study.

San Diego-based ImThera Medical is a privately held company and a global leader in neurostimulation for the treatment of Obstructive Sleep Apnea (OSA).

OSA is characterised by repetitive episodes of respiratory arrest despite continuing breathing efforts. More than one million Americans are diagnosed annually with OSA. As many as 28 million Americans may suffer from OSA and only approximately 25 per cent of this population is receiving treatment today.

While OSA is readily treated with continuous positive airway pressure therapy (CPAP), studies show that CPAP is a cumbersome treatment, and between 30-60 per cent of patients cannot or will not comply with CPAP.