ApniCure has reported additional positive results from the ATLAST trial of its Winx sleep therapy system, designed to treat patients with obstructive sleep apnea (OSA).
The system uses oral pressure therapy, which delivers an oral vacuum by a console through a slim tube connected to a soft mouthpiece.
To gently pull the soft palate forward and stabilise the tongue, the mouthpiece and vacuum work together to increase the size of the airway and allow for natural breathing to occur during sleep, according to the company.
The multicentre, prospective study has enrolled 63 patients (44 men and 19 women) to demonstrate the safety, efficacy and tolerability of winx system.
To determine apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), study participants underwent laboratory polysomnography at baseline with and without Winx treatment and again following 28 nights of treatment with Winx system.
Using American Academy of Sleep Medicine criteria by a blinded scorer, ODI and AHI were calculated, while OSA symptoms were assessed with the Epworth Sleepiness Scale and a modified Functional Outcomes of Sleep Questionnaire.
The results demonstrated that Winx was safe and well tolerated, improved the severity and symptoms of OSA, and was associated with high nightly usage and patient satisfaction.
ApniCure chief technology officer, founder and board chairman, Matt Vaska, said the new results demonstrate the safety, tolerability and efficacy of Winx.
"Continuous positive airway pressure (CPAP), the standard treatment for OSA, can be associated with physical and lifestyle challenges related to its forced air delivery through a mask," Vaska said.
"In contrast, Winx allows users to breathe naturally without a mask, representing a new alternative for the treatment of OSA."
ApniCure president and CEO Steve Carlson said; "We recently received clearance from the U.S. Food and Drug Administration to market the Winx system and are excited to be commercially launching in select U.S. markets this year with broader distribution in 2013."