FDA Clears Sleep Apnea Treatment Device From SomnoMed (Includes video)

DentiTrac is now on track to commercialization.

The oral appliance for treating sleep apnea has received U.S. Food and Drug Administration (FDA) clearance, its Australian developer reported. The product, which features an embedded wireless compliance sensor, was created by Sydney, Australia-based SomnoMed and the tracker is from Braebon Medical Corporation, a company based in Ontario, Canada.

Dubbed DentiTrac, the product can be embedded in a number of different oral appliances to track compliance with continuous open airway therapy (COAT), an up-and-coming alternative to continuous positive airway pressure (CPAP) for treating sleep apnea. SomnoMed’s SomnoDent device is the first partner device to receive FDA clearance, which means SomnoMed will, for the moment at least, have exclusive U.S. distribution for the technology.

“We are very pleased DentiTrac is launching in the U.S. market,” Richard Bonato, Ph.D., CEO and co-founder of Braebon said in a statement. “Accurate oral appliance compliance measurement is needed to level the playing field with traditional sleep apnea treatment called CPAP. In addition, the ability to reliably measure sleep apnea treatment adherence is a vital requirement for insurance payers. Continuous open airway therapy is the number one alternative to CPAP and we anticipate this will contribute to significant overall growth in the field of dental sleep medicine and the use of oral appliance therapy for sleep apnea. The DentiTrac is the final realization of our ‘Test Treat Trac’ strategy which empowers clinicians across multiple disciplines to efficiently and collaboratively work together to more effectively manage the sleep apnea patient.”

DentiTrac tracks the time the device is worn, in order to keep clinicians informed about patient compliance. It also tracks a bevy of other metrics including temperature and three-dimensional rotation, according to SomnoMed. Each morning when the patient takes out the device, data is sent through infrared to a base station, which then uploads it to a secure cloud. From there, healthcare providers can keep tabs on patients during their therapy. The device has a battery life of five years, and a data storage capacity of about six months.

Quantifiable compliance to sleep apnea therapy is important to doctors making the decision between COAT and CPAP, insurers who want to see results before deciding to reimburse the device, and to the transportation industry, where commercial drivers with sleep apnea have to prove the condition is being “effectively treated” in order to be medically certified, SomnoMed bigwigs noted.

“Early compliance control tests conducted by SomnoMed in Australia during the last few months indicate that the SomnoDent device achieves an 84 percent objective compliance rate on an ‘all night/every night’ basis,” SomnoMed Executive Chairman Peter Neustadt, Ph.D., said in a statement. “Further, it was shown that where SomnoDent was tested using the standard definition of compliance used for CPAP (based on only 21 nights in a month, for a minimum of only four hours per night) an objective compliance rate of 95 percent was achieved. This exceptional rate of compliance compares very favorably with that of CPAP, which is usually stated to be around 60-70 percent.”

SomnoMed develops obstructive sleep apnea treatment technology.

Watch the video below to learn more about the company: