Apnex Medical released preliminary data from a clinical study that showed significant improvements in obstructive sleep apnea (OSA) patients who were treated with the company’s Apnex HGNS System. The Apnex HGNS System treats OSA by activating an upper airway muscle during sleep, which opens the airway, allowing patients to breathe and remain asleep.
Three- and 6-month data from the Australian first-in-man study evaluating the safety and efficacy of the HGNS System were presented by Peter Eastwood, PhD, as part of the session, “New Treatment Approaches for Lung Disease: Late Breaking Abstracts,” at the American Thoracic Society (ATS) 2010 International Conference. The findings show the HGNS System reduced the severity of OSA by an average of over 50%, as measured by the apnea-hypopnea index (AHI).
“These results demonstrate the potential benefits the HGNS System could provide to patients who do not tolerate continuous positive airway pressure (CPAP) therapy,” said Eastwood, senior research fellow at the West Australian Sleep Disorders Research Institute, Sir Charles Gairdner Hospital, professor at the School of Anatomy and Human Biology, University of Western Australia, and an investigator with this study. “In most patients, the Apnex HGNS System reduced the severity of their OSA condition, allowing them to sleep better and feel better.”
Patients also experienced significant improvements in symptoms, as measured by multiple quality of life surveys. Patients tolerated the treatment well, with an average of 6.5 hours of use each night. There were no device failures during the study.
“These data give us confidence that the HGNS System works, patients use it, and patients sleep better because of it,” said Robert Atkinson, Apnex Medical president and CEO. “They have improved oxygen levels during sleep and are waking up less, which we believe can lead to better overall health. We are learning a tremendous amount about this new therapy, which we believe will lead to even better outcomes through therapy adjustment and patient selection. We are excited about our ongoing clinical trials in the United States and Australia, the results of which will support future applications for commercial approval.”
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