FRISCO, Texas, June
7, 2012 /PRNewswire/ -- SomnoMed Limited (SOM:ASX) is
pleased to announce that it has received a 510(k) from the US Food
and Drug Administration ("FDA") and will now begin marketing its
unique SomnoDent® G2 in the USA.
The SomnoDent® G2 technology (patent pending) has been developed
over several years, after extensive research and development,
following US quality system requirements and the FDA regulatory
process.
SomnoDent® G2 will be launched at the 21st Annual Meeting of the
Academy of Dental Sleep Medicine and 26th Annual Meeting of the
Associated Professional Sleep Society, LLC (APSS) from 7-
13 June 2012 in Boston.
SomnoDent® G2 incorporates modular adjustment parts, which are
uniquely identified and provide instant and accurate advancement of
the G2 splints. This revolutionary design "Click to Fit" will
provide a controlled measurement of a patient's mandible position
to treat OSA. The device's range of motion has also been extended
providing more treatment options. The SomnoDent® G2 includes
SomnoMed's proprietary materials, is metal free and is 20% smaller
than SomnoMed's current range of sleep apnea devices, thereby
increasing patient comfort.
SomnoDent® G2 will be available through qualified SomnoMed
Preferred Dental Network partners only. A newly designed premium
packaging and travel case will also protect the device when not in
use. Accompanied by an adjustment kit, which stores and organizes
the modular adjustment parts, the SomnoDent® G2 represents a new
standard of care for Obstructive Sleep Apnea (OSA) patients.
"With the innovative SomnoDent® G2 and Somnomed MATRx® both now
FDA cleared we are able to offer state-of-the-art oral appliance
treatment and diagnostic solutions for OSA patients never seen
before," says CEO Ralf Barschow.
"These revolutionary, premium product innovations continue our
focus on evidence based, quality clinical outcomes for
patients".
For more information please visit SomnoMed at www.somnomed.com
or contact:
Ralf Barschow
CEO, SomnoMed Inc.
+1 888 447 6673 Ext. 101
Cell +1 972 742 2995
About SomnoMed
SomnoMed is a public company providing diagnostic and
treatment solutions for Sleep-related Breathing Disorders including
obstructive sleep apnea, snoring and bruxism. SomnoMed was
commercialized on the basis of extensive clinical research.
Supporting independent clinical research, continuous innovation and
instituting medical manufacturing standards has resulted in
SomnoDent® becoming the state-of-the-art and clinically proven
medical oral appliance therapy for obstructive sleep apnea.
SomnoDent® is the most comfortable and effective design and
treatment solution for over 100,000 patients in 22 countries.
SOURCE SomnoMed