An application to market and distribute the AcceleDent System from OrthoAccel Technologies Inc, Houston, was approved by Australia’s Therapeutic Goods Administration (TGA). AcceleDent, described by the company as an acceleration device to enhance orthodontics, is classified as an orthodontic appliance system in Australia. AcceleDent is now on the Australian Register of Therapeutic Goods (ARTG).
“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,” said Brent Tarver, vice president of clinical affairs at OrthoAccel, in an announcement.
AcceleDent is a removable dental device that patients wear in the mouth for 20 minutes daily.It generates a microvibration force designed to modulate the bone tissue remodeling process and accelerate 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).
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,” said Jeremy J. Mao, DDS, PhD, inventor of the core OrthoAccel technology and chairman of the company’s scientific advisory board.