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ProSomnus® Sleep Technologies Receives FDA Clearance for Compliance Sensor, Completes a 6 month Controlled Launch and is Now Offering the Sensor in their ProSomnus [IA] Device

San Francisco, CA, August 1, 2017 – ProSomnus Sleep Technologies, featuring the award-winning ProSomnus® [IA] and ProSomnus® MicrO2® Sleep and Snore Devices, received FDA clearance in November 2016 for using the DentiTrac® Compliance Sensor partnering with dentists to treat the rapidly growing number of patients with Obstructive Sleep Apnea. ProSomnus was the second device manufacturer to receive this designation. The company has completed a controlled launch and is prepared to offer this new technology to their customers. Unlike manual cold cured acrylic manufacturing, the milled pocket in the Control Cured PMMA material provides a more stable environment and puts less stress on the sensor. They are seeing fantastic results and the longevity and survivability of the sensors been unbelievable.

This is an exciting opportunity for our valued customers who desire this feature on the ProSomnus [IA] platform.  Train engineers, truck drivers, pilots, law enforcement, military and many other professions have been moving towards a sleep quality verification protocol like that available for the CPAP. The inclusion of the DentiTrac Compliance Sensor allows for that.

“The recorder can be downloaded monthly and keeps the data for 6 months. The report is easy to read and is similar to a CPAP download,” reported Dr. Erika Mason, Diplomate ABDSM and ACSDD. “In time, I think, we will be able to utilize this for verifying CDL licensure as well as for Pilots and other Department of Transportation verification standards. This appliance with the sensor, is smaller, so it is easier for patients to get used to it.”

Obstructive Sleep Apnea (OSA) is a Sleep Breathing Disorder affecting an estimated 20 million adults in the United States. OSA has been linked with an increased risk of stroke, cardiovascular problems, motor vehicle accidents, depression, memory loss and snoring. The economic impact of OSA is estimated to be between $65 and $165 Billion per year.

“As recent scientific and clinical reports have demonstrated, compliance is an essential ingredient for effective therapy,” noted Len Liptak, CEO of ProSomnus Sleep Technologies. “The ProSomnus [IA] Sleep and Snore Device with the DentiTrac Compliance Tracking Sensor now offers dentists, and their extended treatment team, an option for objectively measuring compliance with oral appliance therapy.” Lead Faculty for Clinical Education Dr. Mark T. Murphy, DDS noted, “the lack of objective compliance data has been a frequent complaint of physicians. Two papers presentetd at the AADSM demonstrated 89% compliance and over 7 hours per night! Not only should that help with acceptance of OAT, the mean disease alleviation should be much better than CPAP as well. And one of them was a physician! What and exciting time for Dental Sleep Medicine.”

 

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