OrthoAccel Technologies, Inc., developers of the AcceleDent System, which is an acceleration device to enhance orthodontics, announced that its application to market and distribute the product for sale was approved by Australia’s Therapeutic Goods Administration (TGA). AcceleDent is classified as an, “orthodontic appliance system,” in Australia.
AcceleDent System from OrthoAccel Technologies, Inc. Secures Medical Device Regulatory Clearance to Market in Australia
OrthoAccel Technologies, Inc., developers of the AcceleDent System, which is an acceleration device to enhance orthodontics, announced that its application to market and distribute the product for sale was approved by Australia’s Therapeutic Goods Administration (TGA). AcceleDent is classified as an, “orthodontic appliance system,” in Australia.
AcceleDent is a simple, removable dental device that patients wear in the mouth for twenty minutes daily. It generates a light microvibration force which modulates the bone tissue remodeling process and accelerates orthodontic tooth movement. The device is hands-free and allows the user flexibility to carry out most routine tasks during the twenty-minute use session. The first case in private practice was initiated last month in the United Kingdom, OrthoAccel’s first commercial market.
Brent Tarver, VP Clinical Affairs at OrthoAccel, remarked, “We consider this regulatory clearance to be an important part of our strategic plans, particularly as we begin focusing on the conclusion of the pivotal trial next year for FDA clearance here in the United States.” AcceleDent has been added to the Australian Register of Therapeutic Goods (ARTG). Mike Kaufman, VP Business Development at OrthoAccel, added, “We will be attending the World Federation of Orthodontists 7th International Orthodontic Congress in February next year in Sydney. Australia is a progressive orthodontic market that is very open to credible and meaningful new technologies.”
Results from the initial clinical trial demonstrated an overall tooth movement rate of 2.1 mm per month, which is 30% to 50% faster than what is reported in the literature. This same study further demonstrated the safety of the AcceleDent System through a detailed measurement and statistical analysis of root resorption, yielding mean values of below 0.5 mm. It should be noted that 0.5 mm is well below the level of 2 mm, or one-third of the root length, considered clinically significant by researchers.
Jeremy J. Mao, DDS, PhD is the original inventor of the core OrthoAccel technology and also currently serves as the Chairman of the Company’s Scientific Advisory Board. He commented, “The Phase I Human Clinical Trial conducted at the University of Texas Dental Branch in Houston validates our previously published animal data that serves as the foundation for the concept that orthodontic treatment can be safely accelerated.” Dr. Mao also serves as the Director of the Tissue Engineering & Regenerative Medicine Laboratory and Professor at the Columbia University College of Dental Medicine in New York.
OrthoAccel is presently controlling availability of AcceleDent in the United Kingdom to a select group of orthodontic specialists before a broader release in October 2010. The Company reports plans to take a similar approach with the Australian market.
About OrthoAccel Technologies, Inc.
Based in Houston, Texas, OrthoAccel Technologies, Inc. is a privately owned medical device company currently engaged in the development, manufacturing, and marketing of products to enhance dental care and orthodontic treatment.
About the AcceleDent System
AcceleDent represents the first clinical approach to safely accelerate orthodontic tooth movement via modulating biology. The device has been studied clinically and applies gentle pulsing forces in combination with standard orthodontics to move teeth faster through accelerated bone remodeling. Importantly, the device works complementary with all existing orthodontic technologies. AcceleDent is neither FDA cleared nor FDA approved; it is currently investigational only in the United States. More information can be found at www.acceledent.com or requested via info@orthoaccel.com
