Biolux Research, Vancouver, Canada, announced that its new product, OrthoPulse™, has received CE mark approval and is now commercially available for all European countries that recognize CE mark. The device was approved as a Class 2A medical device via the Medical Device Directive 93/42/EEC, Annex V by London-based British Standards Institute.
Biolux has also launched of a new product website—orthopulse.com—which provides all product, technology, and clinical information, a catalog and shopping cart, as well as many new patient and doctor-focused features.
The OrthoPulse device uses photobiomodulation, or light therapy, to reduce orthodontic treatment time, depending upon treatment mechanics, patient compliance, and patient biology. According to the company, OrthoPulse uses low levels of near infrared light energy to stimulate the periodontium and alveolar bone surrounding the roots of teeth to significantly increase bone regeneration and turnover, thus accelerating tooth movement and dramatically reducing treatment time for braces or clear aligners. Reduced orthodontic treatment time may help prevent decalcification and gingival recession, and may also contribute to greater dental health for orthodontic patients, the company adds. Studies have also shown that tooth movement accelerated with OrthoPulse™ does not lead to increased root resorption.
OrthoPulse is a self-treatment device designed for a daily treatment of only 10 minutes per day at home. OrthoPulse can be used with any type of orthodontic mechanics, including brackets/wires and clear aligners. The device is battery operated, includes no buttons or wires, and communicates wirelessly to an Apple iOS app to allow both the patient and the doctor to monitor and track device usage, compliance, and orthodontic treatment progress.
OrthoPulse will debut in Zurich and Geneva, Switzerland, this month and, over time, will be introduced to clinicians throughout Europe. The company plans to launch the product in Canada upon approval from Health Canada, which is anticipated for November 2014.
The company plans to launch OrthoPulse in the United States in early 2015, once FDA clearance is obtained.
