OrthoAccel Technologies, Inc. is creating a large orthodontic device market with a technology that significantly reduces the amount of time that it takes an orthodontist to straighten teeth with braces. The device, AcceleDent, includes a Mouthpiece and an Activator that delivers pulsing, vibratory forces that enhance the constant forces being applied by the traditional braces. The patient simply bites down on the device for twenty minutes daily; and the patented technology is compatible with all forms of current orthodontic treatment including Invisalign. Clinical results have been observed in a pilot study. The Company is currently shipping product commercially to the United Kingdom, and has plans to enter Australia next, having recently secured TGA (Therapeutic Goods Administration) clearance. A pivotal trial is in field and should conclude later in 2010. Upon its completion, a 510(k) submission will be made to FDA and US clearance is anticipated in early 2011.
