Health Canada Gives OrthoAccel Technologies, Inc.'s Approval for OrthoAccel
AcceleDent is the first FDA-cleared clinical approach to safely accelerate orthodontic tooth movement by applying gentle micropulses as a complement to existing orthodontic treatment.
The news from Canada comes less than a year since AcceleDent began distribution in the United States , following the 2011 clearance from the U.S. Food and Drug Administration as a Class II medical device. AcceleDent is also currently marketed in the United Kingdom , across the European Union, Australia and South Korea .
"We're delighted with the decision of Health Canada ," says OrthoAccel CEO Mike Lowe . "It's the Canadian equivalent of our FDA, and their approval means we can now bring the benefits of AcceleDent to Canadian orthodontists and their patients. We're also very gratified that demand for the product was demonstrated with the nearly immediate placement of orders from Canada ."
This sentiment is supported by Dr. Paul Korne , Assistant Professor at McGill University, former President of the Canadian Association of Orthodontists and an expert in the field of orthodontic biomechanics. "Ever since I became aware of AcceleDent, read the results of clinical trials and discussed the device with colleagues in other nations who are able to offer AcceleDent to their patients, I've been convinced that it's a vast improvement over other currently available technologies designed to accelerate tooth movement. Accordingly, I petitioned the Canadian government to approve AcceleDent. Their positive response is extremely gratifying and promises great benefits to orthodontic patients across Canada ."
Credit goes to the staff of the U.S. Commercial Service at the U.S. Embassy in Ottawa for help in securing approval to proceed in Canada . Minister-Counselor Richard Steffens observed, "It is always great to be able to assist a cutting-edge firm like OrthoAccel. Canada is an exciting and dynamic market, where new technologies and techniques are always welcomed."
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.
OrthoAccel® developed and sells AcceleDent®, the first FDA-cleared clinical approach to safely accelerate orthodontic tooth movement by applying gentle micropulses, SoftPulse Technology™, as a complement to existing orthodontic treatment. More information can be found at www.acceledent.com and www.acceledent.co.uk or requested via info@orthoaccel.com.
SOURCE: OrthoAccel Technologies, Inc.
Contact:
Kathleen Malaspina, +1-832-769-4630
http://www.acceledent.com