Biolux Research announced that OrthoPulse has received a medical device license from Health Canada and is now commercially available in Canada. The device was cleared as a class II medical device according to the Canadian Medical Device Regulations.
"Biolux is very proud to achieve our second significant regulatory approval for our OrthoPulse device, after first obtaining the CE Mark in Europe in September," stated Kevin Strange, president and CEO of Biolux, in a press release. "Receiving regulatory approval in Canada allows us to move forward with soft-launch commercialization activities with orthodontists and doctors, and start to deliver this innovative solution to reducing orthodontic treatment."
OrthoPulse utilizes photobiomodulation, or light therapy, to significantly reduce orthodontic treatment time. It uses low levels of near infrared light energy to stimulate the periodontium and alveolar bone surrounding the roots of the teeth to significantly increase bone regeneration and turnover, thus accelerating tooth movement and dramatically reducing treatment time for braces or clear aligners, according to the company.
Biolux's clinical goal is to reduce average orthodontic treatment time lines by an average of two-thirds, by focusing on optimizing the biology of tooth movement with photobiomodulation.
