SomnoMed now offering SomnoDent with compliance recorder powered by DentiTrac®

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SomnoMed first in world to receive FDA clearance for insertion of compliance recording technology in oral devices


SomnoDent with Compliance Recorder

"...we know that the more compliant the patient is, the more effective the treatment (of obstructive sleep apnea)." stated Dr. Jagdeep Bijwadia

SomnoMed®, the global leader in COAT™ (Continuous Open Airway Therapy) and manufacturer of oral devices for the treatment of mild to moderate obstructive sleep apnea, now offers compliance micro-recording technology in their wearable devices.

SomnoMed, Inc. (ASX: SOM) is the first and only company to receive FDA 510(k) clearance to offer the compliance micro-recording feature for their oral devices through the new product, SomnoDent with compliance recorder. SomnoMed, Inc. is partnering with Braebon Medical Corp., maker of the DentiTrac technology, to introduce SomnoDent with compliance recorder powered by DentiTrac® in the immediate future.

Sleep apnea is a potentially dangerous condition that often goes undiagnosed. Signs of sleep apnea may include loud snoring and fatigue after waking up from a full night of sleep to waking up gasping for breath. Obstructive sleep apnea occurs when throat muscles relax and collapse, causing an obstruction.

Affecting more than 60 million Americans, many sleep apnea sufferers are seeking treatment beyond the cumbersome CPAP, however, many physicians have prescribed CPAP, in part, for its ability to record whether patients are using their therapy. Offering compliance recording in an oral device indicates a significant advancement in technology and oral device therapy, and is particularly important for transportation workers, many of whom are mandated to record their OSA treatment by their employers.

“The ability to objectively measure patient compliance is an important feature for COAT, when compared to other treatment modalities. Physicians and payers have told us that they want to have evidence that patients are wearing their SomnoDent and receiving treatment as prescribed,” said Dr. Peter Neustadt, SomnoMed's Executive Chairman and CEO.

SomnoDent with compliance recorder is worn during sleep to provide Continuous Open Airway Therapy by moving the jaw slightly forward. This movement tightens the soft tissue and muscles of the upper airway, which prevents a collapse of the airway thus reducing apneas during sleep.

DentiTrac uses patented technology and sophisticated anti-deception algorithms to determine when a patient is wearing their device, with results that can be transmitted to a HIPAA secure cloud portal for remote access by physicians.

“Our patients subjectively report that they use their SomnoDent devices at very high rates of compliance, but this is a way for physicians and dentists to reliably make sure that we are actually reaching those levels of compliance, because we know that the more compliant the patient is, the more effective the treatment.” said Dr. Jagdeep Bijwadia, SomnoMed’s Chief Medical Officer.

SomnoDent with compliance recorder technology allows physicians prescribing flexibility, particularly for patients who are intolerant of their CPAP device.

If you think you or a loved one may be at risk for sleep apnea or are interested in this alternative treatment, visit

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