FDA approves ImThera Medical's investigational device exemption for pivotal study

ImThera Medical, Inc., a privately held global medical device company, today announced that the U.S. Food and Drug Administration (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 #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 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 CEO 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."

SOURCE ImThera Medical, Inc.





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