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Biolux Research Announces That Orthopulse Receives Regulatory Approval In Australia And New Zealand

March 6, 2015
by Biolux Research Ltd.

VANCOUVER, CANADA  – Biolux Research, designer and developer of Light Accelerated Orthodontics™ technology and products, is proud to announce that its premier product, OrthoPulse™, has received two new regulatory approvals. These most recent approvals, in Australia and New Zealand, will enable doctors in those countries to offer this groundbreaking acceleration technology to their orthodontic patients.

The OrthoPulse™ device is used as an easy self-treatment by the patient for a short 10 minutes per day. OrthoPulse™ utilizes low level light therapy, or photobiomodulation, to stimulate the periodontium and alveolar bone surrounding the roots of the teeth to significantly increase tooth movement and dramatically reduce treatment time for braces or clear aligners. Reducing the time required for orthodontic treatment can also help to prevent decalcification and gingival recession.

In Australia, OrthoPulse™ is now approved by the Therapeutic Goods Administration (TGA), Certificate Number: DV-2014-MC- 20559-1, in the product category of Medical Device Class IIa. The TGA safeguards and enhances the health of the Australian community through effective and timely regulation, and by continually monitoring and evaluating the safety and performance of therapeutic products. In New Zealand, OrthoPulse™ was approved by the Medicines and Medical Devices Safety Authority (Medsafe) as a Class IIa product under WAND, Reference Number: 150122-WAND-6J4TXS. Medsafe’s mission is to “enhance the health of New Zealanders by regulating medicines and medical devices to maximize safety and benefit.”

Besides considerably reducing treatment time, OrthoPulse™ patients can experience less discomfort associated with orthodontic treatment. For use in conjunction with either braces or clear aligners, OrthoPulse™ is a one-size-fits-all soft silicone mouth-guard that patients can use at home or anywhere. The patient self-treats for 5 minutes on both the upper and lower arch. OrthoPulse™ also syncs with an iOS app, allowing both the patient and doctor to monitor and track orthodontic treatment progress, through familiar technology, at any time. This makes treatment compliance engaging and fun and differentiates leading orthodontic practices from others.

Kevin Strange, President and CEO of Biolux Research, notes, “We are excited about bringing the benefits of OrthoPulse™ to patients and dental professionals in Australia and New Zealand. OrthoPulse™ has already received regulatory approval in Europe and Canada. We look forward to receiving more approvals in other countries in the near future as we expand the introduction of this revolutionary product to the worldwide orthodontic market. Long orthodontic treatment timelines are one of the top concerns for all orthodontic patients, and we feel that our solution will dramatically change the orthodontic market for patients, doctors, and the industry. ”

About Biolux Research
Biolux Research is a world leader in the development of innovative Light Accelerated Orthodontics™ 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. http://www.bioluxresearch.com.

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