Biolux today also announced preliminary results of its pilot clinical study utilizing OrthoPulse iO prototypes. This pilot study was single-center and single-operator, with the primary endpoint being the alignment of the anterior teeth of the upper and/or lower arches in patients who had anterior crowding greater than 3 mm (utilizing Little’s Irregularity Index). The study compared an OrthoPulse iO treated group (N = 9) to a control group (N = 11), with all patients treated with same mechanics. Results showed the treated group of patients showed an average rate of resolution of crowding (tooth movement in mm/wk) of 1.40, vs. the control group of 0.32, resulting in a statistically significant (p<0.01) acceleration factor of 4.4x. An analysis of overall treatment time for the alignment phase in the completed patients showed that the average time for the treated group was 41 days (SD = 24) compared to the average for the control group of 115 days (SD = 38).
The new device includes LED light technology embedded within a sealed intraoral mouthguard design made of biocompatible materials. The device is self-enclosed and battery-powered, and is designed for flexibility, comfort, and ease of use. The company has developed significant new intellectual property for the intraoral technology and product designs, and has filed a number of U.S. and Patent Cooperation Treaty patent applications that can be expanded to provide protection for the majority of the worldwide orthodontic market. The company intends to complete development and soft launch the new product into target markets with distribution partners by early 2014.
“We are thrilled to announce this new direction for the company, and we believe that the intraoral approach will be a gamechanger in the orthodontic market,” states Kevin Strange, president and CEO of Biolux. “We have spent significant effort in the last decade developing LED photobiomodulation technology and products, and more recently focusing on accelerating orthodontics with very positive results. The new intraoral approach supports even faster tooth movement and reduced timelines with very short daily treatment sessions. We are convinced that we will achieve our corporate goal of two-thirds reduction in average orthodontic treatment timelines with our Light Accelerated Orthodontics™ technology and products, which will revolutionize the orthodontic market that so eagerly demands faster treatment for patients.”
About Biolux Research
Biolux Research Ltd. 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 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 dentistry in a safe, effective, and noninvasive approach.