LifeSciences BC > Member Announcements > BIOLUX RESEARCH ANNOUNCES THAT ORTHOPULSE™ RECEIVES REGULATORY APPROVAL IN CANADA

BIOLUX RESEARCH ANNOUNCES THAT ORTHOPULSE™ RECEIVES REGULATORY APPROVAL IN CANADA

November 21, 2014 – Biolux Research Ltd.

VANCOUVER, CANADA / November 21, 2014 – Biolux Research, developer of Light Accelerated Orthodontics™ technology and products, is proud to announce that its innovative new product, the OrthoPulse™, has received a Medical Device License from Health Canada and is now commercially available in Canada. The device was approved as a Class 2 medical device according to the Canadian Medical Device Regulations. In addition, the Company recently updated its ISO 13485 scope of operations to include devices for use in orthodontics.

The OrthoPulse™ is a clinically proven device that utilizes photobiomodulation, or light therapy, to significantly reduce orthodontic treatment time. OrthoPulse™ 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. Biolux’s clinical goal is to reduce average orthodontic treatment timelines by an average of 2/3’s, by focusing on optimizing the biology of tooth movement with photobiomodulation.

The OrthoPulse™ is a self-treatment device which the patient uses at home, and is designed for a daily treatment of only 10 minutes per day. The OrthoPulse™ can be used with any type of orthodontics 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.

“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,” states Kevin Strange President and CEO of Biolux. “Receiving regulatory approval in Canada, an important orthodontic market, 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 timelines to patients. We strongly believe that the entire orthodontic market is hungry for new solutions to reduce treatment timelines and to support patients achieving great smiles faster.”

About Biolux Research
Biolux Research is a world leader in the development of innovative Light Accelerated OrthodonticsTM technology and products for use in orthodontics, implantology, and other dentistry markets. Biolux Research focuses on product development and clinical research, and its proprietary, patent-pending technologies have been developed to enhance clinical outcomes and dramatically reduce treatment timelines in orthodontics and dentistry in a safe, effective and non-invasive approach. www.orthopulse.com www.bioluxresearch.com

For More Information:
John Nabors
VP Global Sales and Marketing
Biolux Research
j.nabors@bioluxresearch.com