May 28, 2014
by Biolux Research Ltd.
VANCOUVER – Biolux Research, developer of Light Accelerated OrthodonticsTM technology and products, is pleased to team up with the Schulman Study Group to beta test the new OrthoPulseTM product. The intraoral device incorporates proprietary photobiomodulation technology and is designed to be used with any form of orthodontic mechanics to significantly reduce patient treatment timelines.
The Schulman Study Group is a nationally recognized association of prominent orthodontic practices. Membership is extended exclusively by invitation to sustain the same high standard of practice performance and to provide access to new technology and opportunities for innovation and insight that orthodontists would not otherwise find. The Schulman Study Group members share a commitment to exceptional patient care, quality of orthodontic experience, and continuing education. www.schulmanstudygroup.com.
As part of this exclusive beta evalution program, a group of 44 Schulman members will evaluate the OrthoPulseTM product in their practices in both the United States and Canada. Patients will undergo regular orthodontic treatment, combining the OrthoPulseTM treatment with either fixed appliances or removable clear aligners, with the orthodontists documenting the case progress. The evaluators will provide both doctor and patient feedback on the use and acceptance of the OrthoPulseTM device.
Biolux Research intends to use this feedback to validate the product in the clinic prior to formal product launch in the United States in 2015. Given anticipated FDA clearance of the OrthoPulseTM product as a class II medical device by early 2015, this beta evaluation program with the Schulman Study Group will be performed under an investigational protocol with independent ethics approval. Biolux Research is also anticipating regulatory approvals for both Canada (Health Canada MDL) and Europe (CE Mark) by mid-2014, followed by a targeted commercial market launch.
Dr. Ron Redmond, CEO of the Schulman Study Group, states: “The Schulman Study Group is pleased to be working with Biolux to test OrthoPulseTM in a clinical setting. Of the several products on the market that accelerate orthodontic treatment, OrthoPulseTM is non-invasive and has impressive clinical trials. The Schulman Study Group welcomes the opportunity to advance a potentially disruptive product for the orthodontic profession.”
“Our entire Biolux Research team is honoured to collaborate with the renowned Schulman Study Group on this OrthoPulseTM beta evaluation program,” states John Nabors, VP Global Sales and Marketing of Biolux. “We are dedicated to developing and commercializing the best possible OrthoPulseTM product for patients, orthodontists, and practices. We see the OrthoPulseTM as a game-changer in the market, with the opportunity for patients to dramatically reduce their treatment times and for orthodontists to differentiate their practice and improve patient care.”
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