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Wearable Compliance Measurement Receives FDA Clearance

Posted on Thursday, June 25, 2015

KANATA, Ontario, June 24, 2015 /PRNewswire/ -- BRAEBON Medical Corporation announces today that the DentiTrac® oral appliance compliance system has passed a substantial regulatory hurdle and is now FDA cleared in the USA for use with the SomnoDent oral device.  BRAEBON congratulates SomnoMed for being the first company in the world to achieve this milestone.

The DentiTrac® system has been developed by BRAEBON.  It is a wearable micro-recorder and web cloud portal combination which defines the new gold standard for the objective measurement of oral appliance compliance measurement for sleep apnea.  DentiTrac® is an integrated wearable micro-recorder embedded inside an oral appliance to reliably and accurately gather detailed information to confirm a patient is following prescribed therapy.  The information is then uploaded to the BRAEBON cloud portal where dental and medical specialists can conveniently and securely review patient information and assess sleep apnea therapy adherence.

"We are very pleased DentiTrac® is launching in the US market.  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 (COAT™) is the number one alternative to CPAP and we anticipate this will contribute to significant overall growth in the burgeoning 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," said Dr. Richard Bonato, CEO and Co-Founder.

"The challenge was to develop a measurement technology which could not be easily deceived. This was vital because new US Federal DOT legislation will impact everyone in the transportation industry including all truck drivers, pilots, bus drivers, etc.  We had to invent a novel and powerful solution which we've secured with IP patent protection.  The level of product sophistication connected with our cloud portal is beyond anything we've done before.  I'm very proud of what our team has accomplished," saidDonald Bradley, CTO and Co-Founder.

BRAEBON has an agreement in place with SomnoMed Limited as the preferred worldwide dorsal fin oral appliance design and for exclusive distribution in the EU and parts of Australasia.  At this time, the BRAEBON DentiTrac compliance system is only available from SomnoMed in the USA.

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