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Interim data from the pivotal SUPRA study and eight earlier studies show that the aerSleep II device achieves clinically meaningful reductions in apnea-hypopnea index in over 70% of patients with all levels of disease. The device has demonstrated a favorable safety profile and high patient preference compared to previous treatments. All subjects have exceeded Medicare compliance criteria after six months of home use. Earlier versions received Health Canada clearance and FDA Breakthrough Device designation
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