Biolux Research, Vancouver, Canada, developer of Light Accelerated Orthodontics™ technology and products, has teamed with the Schulman Study Group to beta test the company’s new OrthoPulse™ 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. According to a release, 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.
As part of this exclusive beta evaluation program, a group of 44 Schulman members will evaluate the OrthoPulse product in their practices in both the United States and Canada. Patients will undergo regular orthodontic treatment, combining the OrthoPulse 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 OrthoPulse 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 OrthoPulse 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 OrthoPulse in a clinical setting. Of the several products on the market that accelerate orthodontic treatment, OrthoPulse is noninvasive 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 honored to collaborate with the renowned Schulman Study Group on this OrthoPulse beta evaluation program,” states John Nabors, VP global sales and marketing of Biolux. “We are dedicated to developing and commercializing the best possible OrthoPulse product for patients, orthodontists, and practices. We see the OrthoPulse 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.”