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Product Spotlight

Biolux Research Announces that Orthopulse Receives Regulatory Approval in Europe

September 26, 2014
by Biolux Research Ltd.

VANCOUVER, B.C., CANADA –  Biolux Research, developer of Light Accelerated Orthodontics™ technology and products, is proud to announce that its innovative 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 is also pleased to announce the launch of a new product website – www.orthopulse.com – which provides all product, technology, and clinical information, a catalog and shopping cart, plus many new patient and doctor-focused features. 

OrthoPulse™ is a clinically proven device that utilizes photobiomodulation, or light therapy, to significantly reduce orthodontic treatment time, depending upon treatment mechanics, patient compliance, and patient biology.  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 also help prevent decalcification and gingival recession, and may also contribute to greater dental health for orthodontic patients.  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. Product launches are also planned for Canada, upon Health Canada approval anticipated in November 2014, and for the United States, in early 2015, once FDA clearance is obtained.

Kevin Strange, President and CEO of Biolux Research notes, “The entire Biolux team is excited to receive our first regulatory approval and launch OrthoPulse™ in Europe.  We wish to thank the many people involved inside our company and, in particular, our clinical researchers and evaluators who have all contributed to the development of this fantastic new product. This revolutionary product is the first step towards our clinical goal of reducing average orthodontic treatment timelines by an average of two-thirds, which we expect to achieve by focusing on optimizing the biology of tooth movement with photobiomodulation.  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

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