ImThera Medical, Inc. today announced that it has concluded its Phase I and Phase II protocols for the European Pilot study of the aura6000, a neurostimulation device for treating Obstructive Sleep Apnea (OSA). Clinical trial results from the study will be announced at the American Thoracic Society's International Conference on May 16, 2011 in Denver, CO.
“This is an important time for the company as we've now completed our Series B funding and we look forward to the upcoming IDE application with the U.S. FDA as well as the planned U.S. clinical trials.”
Principal investigator Dr. Daniel Rodenstein, who helmed the clinical trials, will deliver the results, including significant improvements to patient's Apnea Hypopnea Index (AHI), Oxygen Desaturation Index (ODI), as well as improvements in sleep quality.
"ImThera's Therapy is safe and shows substantial OSA reduction and sleep improvement in a majority of patients," said Dr. Rodenstein. "I am looking forward to the American Thoracic Society's International Conference and the opportunity to share the substantial patient improvements that resulted from the clinical trial."
The Pilot Study, performed at Universite Catholic de Louvain, St. Luc Hospital, was comprised of moderate or severe non-compliant CPAP patients. Ten patients have completed the six-month study with all patients compliant and responding well to ImThera's Targeted Hypoglossal Neurostimulation (THN) therapy, while using the device every night at home.
"We are very happy with the results of our pilot study showing significant improvements of OSA patients when using our aura6000 system. Especially with the very positive comments received from our patients," said Marcelo G. Lima, president and CEO of ImThera. "This is an important time for the company as we've now completed our Series B funding and we look forward to the upcoming IDE application with the U.S. FDA as well as the planned U.S. clinical trials."
More than 800,000 patients in the U.S. are diagnosed with OSA annually. The 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 Targeted Hypoglossal Neurostimulation (THN Sleep Therapy™), delivering stimulation to key muscles of the tongue during sleep.
ImThera's aura6000™ system takes, on average, ninety minutes to implant surgically. It offers one of the world's smallest implantable and rechargeable stimulators and does not require additional sensors to function.
CAUTION: The aura6000 is not for sale in the U.S.A.
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