ImThera Medical Receives FDA Approval for Study of Obstructive Sleep Apnea Device

The U.S. Food and Drug Administration (FDA) has approved an investigational device exemption (IDE) for an obstructive sleep apnea study spearheaded by ImThera Medical Inc.

The company’s THN3 clinical study will evaluate the safety and effectiveness of ImThera’s 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 clinical study will be used to support a Pre-Market Approval application for the aura6000 System.

Sponsored by ImThera Medical, the THN3 Study (Targeted Hypoglossal Neurostimulation Study #3) is a randomized, controlled, prospective, multi-center clinical trial. It is being conducted at leading medical centers in the United States and Europe.

“This is a milestone in the development of this technology,” said Alan Schwartz, M.D., professor of Medicine and medical director at Johns Hopkins Sleep Disorders Center in 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.”

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. The 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,” one doctor explained.

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.

The aura6000 System has received the CE Mark, and is commercially available in select markets outside the United States.

OSA is characterized by repetitive episodes of respiratory arrest despite continuing breathing efforts. More than 1 million Americans are diagnosed annually with OSA. As many as 28 million Americans may suffer from OSA and only approximately 25 percent 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 percent and 60 percent of patients cannot or will not comply with CPAP.

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

San Diego, Calif.-based ImThera Medical is a privately held company that develops neurostimulation technology for the treatment of obstructive sleep apnea.