FDA clears oral sleep apnea device, as search for CPAP alternatives continues

SomnoMed's DentFlex--Courtesy of SomnoMed

Australia's SomnoMed Limited hopes that its just now 510(k)-cleared devices for obstructive sleep apnea give it an advantage over the predominant therapy due to the products' ease of use. Unlike continuous positive airway pressure (CPAP) devices that require a facemask, SomnoMed's oral SomnoDent Fusion Classic and SomnoDent Fusion Flex are worn like a mouth guard.

"SomnoDent Fusion offers improvements over existing devices and a greater level of patient comfort. Patient comfort is at the center of SomnoMed's mission and product philosophy, as it has a direct impact on compliance. We believe the more comfortable the treatment, the more compliant the patient, which is a precondition for better medical treatment outcome. The high level of compliance is giving COAT (Continuous Open Airway Therapy) a distinct advantage over CPAP for the majority of patients," said SomnoMed CEO Dr. Peter Neustadt in a July 9 release.

The company said the products were introduced in June at the American Academy of Dental Sleep Medicine and American Academy of Sleep Medicine conventions, and received positive feedback. A good portion of the company's sales come from dentists. In fact, SomnoMed runs an online certification course for dentists on sleep apnea.

SomnoMed reported revenue growth of 30% at constant exchange rates in its most recent quarter, or $6.5 million. The company had $3 million in cash as of March 31.

It is not the only company looking to offer alternatives to CPAP devices that are made by fellow Australian rival ResMed and others. In May, Inspire Medical Systems raised $40 million in Series E money to launch its Inspire device, which was approved by the FDA in April and is a nerve stimulation implant targeted to a person's jaw that helps keep the upper airway open during sleep. The device is implanted in the chest.

Also in May, Belgian-Israeli startup Nyxoah picked up €8 million ($10.9 million) in financing to advance its tiny neurostimulation treatment for obstructive sleep apnea. The implant is about 20 mm in diameter and just 2.5 mm thick. After a 15-minute implantation procedure, it has a life expectancy of 12 years. And the SomnoMed clearance comes on the heels of FDA's clearance of the latest version of the WatchPat home sleep diagnostic device.

- read the release

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