(December 16, 2015, Fierce Medical Devices) Irvine, CA’s Alphaeon gained exclusive worldwide commercialization rights to Zelegent’s in-office procedure to reduce snoring, as devicemakers scramble to develop new methods to combat obstructive sleep apnea.
In return for commercialization rights, the provider of aesthetics became the lead investor in Zelegent, also of Irvine, CA. Zelegent touts its offering, dubbed Elevo, as a 5-minute, minimally invasive procedure.
The company’s procedural tool shortens the length of the soft palate, something which is currently done via an invasive surgery that requires the use of a laser.
Zelegent says about 10% of audible snorers suffer from obstructive sleep apnea, which occurs when a restricted airway during breathing leads to a variety of other symptoms stemming from breathing cessation, including poor tissue oxygenation and impaired cognition. Patient are typically treated using continuous positive airway pressure (CPAP), which requires wearing a bulky mask at night to force air down the windpipe.
Zelegent hopes its less obtrusive alternatives will replace the standard of care.
To that end, it recently presented clinical trial results at the Congress of European Otorhinolaryngology and Head and Neck Surgery, and aims to achieve commercialization next year. The company plans to obtain FDA’s 510(k) clearance to offer the Elevo in the U.S.
“Alphaeon’s success and reach with medical devices used in self-pay procedures, and its social commerce platform ShoutMD, make it an ideal partner to bring Elevo to physicians and patients,” said Zelegent CEO Dr. Alexander Arrow in a statement. “We believe this agreement will make Elevoplasty available to millions of patients who seek relief from the health and social consequences of snoring.”
There are several other players in the market for treating sleep apnea using alternatives to CPAP. Fierce 15 member Inspire Medical Systems offers an implantable neurostimulation device. And Australia’s SomnoDent earlier this year achieved FDA clearance for its wearable device that moves the jaw forward slightly during sleep.
Australia’s ResMed is the leading provider of CPAP devices. Smaller InSleep Health is entering the CPAP arena with its recently cleared device for snorers who don’t have sleep apnea.