ImThera Medical, Inc. today announced interim results from its OSA European clinical study. For the study, ten patients have been surgically implanted with ImThera's aura6000™ hypoglossal nerve neurostimulation device for treating Obstructive Sleep Apnea (OSA). The target population for ImThera's neurostimulation device is moderate and severe OSA patients who are non-compliant with or cannot tolerate Continuous Positive Airway Pressure (CPAP).
“ImThera's mission is to provide a safe and effective alternative for OSA patients that will not or cannot comply with CPAP”
ImThera is releasing information on data from six patients who have had their calibrations and multiple polysomnography (PSG) studies to date. These patients have used the Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy at home for three months or longer. Four additional patients were implanted in September and their results will be reported at a later date.
The six patients vary in age, body mass index (BMI), and OSA severity. All patients had a baseline apnea hypoponea index (AHI) of 30 or greater (range 32 to 80). Patients' Oxygen Desaturation Index (ODI) had a range of 12 to 76. The primary objectives of the European Clinical Study conducted at the Université Catholique de Louvain were safety, 50% or better reduction in the AHI, and 50% or better improvement in the ODI.
Interim results of the study are clinically significant and very encouraging for short-term data. The interim data indicates that AHI has been reduced by an average of 73% and ODI has improved by an average of 77%. On average, arousals have been reduced by 50%.
"These early results are very promising. We have seen a significant reduction in sleep related disordered breathing (decreases in apneas and hypopneas), resulting in much higher oxygen levels during sleep, and in better sleep characteristics. Patients are using the treatment every night at home, and they seem happy with the daytime effects. We see continuous reduction of their AHI over time. In addition, they appreciate the freedom the system gives them during sleep compared to the constraints of CPAP. We are confidently awaiting final data towards the end of 2010, when we plan to report our findings," said Professor Dr. Daniel Rodenstein of the Université Catholique de Louvain, Belgium; and principal investigator of the European clinical study.
More than 800,000 patients in the U.S. are diagnosed with OSA annually. Industry estimates that as many as 38 million Americans may suffer from OSA and that approximately 20 percent of this population is getting treatment today. While CPAP is the established therapy, studies show that only 46 percent of patients comply with CPAP. The aura6000™ is based on ImThera's proprietary THN Sleep Therapy™, delivering neurostimulation to key muscles of the tongue during sleep.
ImThera's aura6000™ system takes, on average, seventy-five minutes to implant surgically. It offers one of the world's smallest implantable and rechargeable stimulators and does not require additional sensors to function.
"ImThera's mission is to provide a safe and effective alternative for OSA patients that will not or cannot comply with CPAP," said Marcelo G. Lima, Chairman, President and CEO of ImThera Medical. He adds, "After a relatively simple implant procedure, patients are experiencing a substantial reduction of obstructive sleep apnea events, sleeping better and achieving improved quality of life. All patients in the European trial are happy with the therapy and utilizing it every night at home. Physicians are pleased and we are very excited with the early results from these trials and are confident that our scientific, clinical and engineering work will lead to a viable therapy alternative."
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