A non-invasive device to treat brain traumas such as concussion, developed by privately held company Aurora Concussion Therapy Systems (Aurora-CTS; MN, USA), has been designated by the US FDA as a breakthrough device under FDA’s expedited access pathway.
FDA’s breakthrough device program aims to speed up the development assessment and review of medical devices, whilst still maintaining the statutory standards required for premarket approval. Therefore, be able to offer the devices to patients and healthcare providers much earlier.
Chief Technology Officer of Aurora-CTS, Doug Devens commented: "This designation accelerates our goal of bringing to market a solution that may greatly improve the recovery from a concussion. We look forward to continuing to work closely with the FDA through this process."
The Aurora light therapy system device is a helmet that uses infrared light to penetrate the skull and target the cortex to treat diffuse damage caused by concussion. The light can restore cellular metabolism to normal levels, accelerating the recovery process.
Currently, Aurora-CTS are completing good laboratory practice animal safety trials to support the upcoming initiation of human clinical trials, to record the clinical effects of the device on concussion recovery time.
"The Aurora Light Therapy System is a promising therapy for concussion patients. The standard of care today relies on the body's innate recovery, and this system could make the treatment modality more uniform," explained Jeffrey S. Kutcher, Director of The Sports Neurology Clinic (MI, USA). "To better serve our patients, we need new non-invasive treatment options."