Aurora Concussion Therapy Systems said this week that it won breakthrough device designation from the FDA for its Aurora Light therapy system for concussion treatment.
The Aurora Light therapy system is designed to apply a non-invasive, near-infrared light to energize the brain’s metabolic cascade process, accelerating the healing process for concussions and other mild brain trauma.
Minnesota-based Aurora CTS said it is completing its Good Laboratory Practices animal safety trials in support of upcoming human trials. The company said it plans to begin its first clinical trials in the near future.
“This designation accelerates our goal of bringing to market a solution that may greatly improve the recovery from a concussion,” chief technology officer Doug Devens said in prepared remarks. “We look forward to continuing to work closely with the FDA through this process.”
“The Aurora Light therapy system is a promising therapy for concussion patients,” added Dr. Jeffrey Kutcher of the Sports Neurology Clinic in Brighton, Mich. “The standard of care today relies on the body’s innate recovery, and this system could make the treatment modality more uniform. To better serve our patients, we need new non-invasive treatment options.”
Original Article: (https://www.massdevice.com/aurora-concussion-therapy-systems-wins-breakthrough-nod-from-fda/)
