FDA Clears Winx™ Sleep Therapy System

In short

ApniCure, a medical device company focused on developing and commercialising novel home-use devices for the treatment of obstructive sleep apnea (OSA), has announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its Winx™ Sleep Therapy System in the United States. The Winx system is an innovative device designed to be comfortable and easy to use while allowing users to breathe naturally without a mask.

It’s also a great product name with a rather beautiful and clever website.

Background

OSA is a serious disease that is associated with long-term medical and social consequences. A common sleep-related breathing disorder, OSA is characterised by collapse of the upper airway during sleep. Continuous positive airway pressure (CPAP) therapy, the standard of care for treating moderate and severe OSA, is consistently associated with physical and lifestyle challenges related to its forced air delivery through a mask. These may include skin irritation, nose stuffiness, air leaks around the mask, claustrophobic reactions to the mask, problems with spontaneous intimacy with a bed partner and the noise of the machine.2,3

Winx uses a proprietary platform technology called Oral Pressure Therapy (OPT) to treat OSA. OPT is a light, oral vacuum delivered by a quiet console through a slim tube connected to a soft, flexible mouthpiece. The mouthpiece and vacuum work together to gently pull the soft palate forward and stabilize the tongue, increasing the size of the airway and allowing for natural breathing to occur during sleep.

The FDA clearance of Winx was based in part on clinical data from the ATLAST study, a multi-center, prospective clinical trial of patients with mild, moderate or severe OSA. Study results will be presented as a late-breaking abstract at the upcoming 2012 American Thoracic Society (ATS) Conference in San Francisco on May 21.

Company comments

“The Winx system is a first-of-its kind, patient-friendly treatment option for OSA patients,” said Steve Carlson, president and CEO of ApniCure. “We anticipate a commercial launch of the Winx system in select U.S. markets this year, with broader distribution in 2013.”

Source: ApniCure Inc., Marketwire