ImThera Medical Completes Enrollment in Multi-center Study of the aura6000™ System for Obstructive Sleep Apnea
THN2 Study Will Expand the Clinical Evidence for this Innovative Neurostimulation Therapy for Moderate to Severe Obstructive Sleep Apnea
September 29, 2013
SAN DIEGO, CA.—ImThera Medical, Inc. a privately held global medical device company, today announced that the final patient has been implanted in its THN2 (Targeted Hypoglossal Neurostimulation #2) study. The THN2 Study is an international, prospective multi-center study that will evaluate the safety and efficacy of the aura6000™ Sleep Therapy System for the treatment of moderate to severe obstructive sleep apnea (OSA). This announcement was made as clinical and surgical leaders convened this week at the American Academy of Otolaryngology AAO-HNSF Meeting in Vancouver.
“We are excited to be the first U.S. center to implant subjects in this landmark clinical study,” said Michael Friedman, M.D., Professor of Otolaryngology and Chairman Sleep Surgery Section at Rush University Medical Center, Chicago IL and a study investigator. “The surgeries were simple to perform and took under 60 minutes. Patient satisfaction with the therapy is high and early results are very promising.”
The study enrolled 57 subjects at 9 medical centers in 5 countries, including the U.S. “There are literally millions of patients who have been diagnosed with OSA who are going untreated or undertreated because they are unable to comply with the rigors of CPAP.” said Ofer Jacobowitz, M.D., PhD FAASM, a study investigator and partner at ENT and Allergy Associates in New York. “We believe that this study will add to the growing body of clinical evidence demonstrating that the aura6000™ System is a viable treatment option for this large, underserved patient population.”
About Obstructive Sleep Apnea
OSA is characterized by repetitive episodes of respiratory arrest despite continuing breathing efforts. More than 800,000 people in the U.S. are diagnosed with OSA annually. As many as 38 million Americans may suffer from OSA and only approximately 20 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 20-80% percent of patients cannot or will not comply with CPAP.
About the aura6000™ Sleep Therapy System
The aura6000™ System is based on ImThera’s proprietary THN Sleep Therapy™ technology. THN Sleep Therapy delivers neurostimulation to the hypoglossal nerve and thereby increases the muscle tone of key tongue muscles, 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.
The system consists of two implantable components, a 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 improving upper airway muscle tone.
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.
About ImThera Medical, Inc.
San Diego-based ImThera Medical is a privately-held company that has developed a neurostimulation device for the treatment of Obstructive Sleep Apnea (OSA). For more information, visit www.ImTheraMedical.com.
CAUTION: The aura6000 System is an investigational device and is limited by United States law to investigational use.
aura6000, THN, Targeted Hypoglossal Neurostimulation and ImThera are trademarks of ImThera Medical, Inc. ©2013 ImThera Medical, Inc. All rights reserved.