FDA has granted breakthrough device designation to Aurora Concussion Therapy Systems' brain trauma treatment, the company said Tuesday.
The non-invasive device uses near-infrared light in an attempt to restore cellular metabolism to cut the time it takes people to recover from concussion and other brain traumas.
Aurora is currently testing the safety of the device in animals with a view to starting testing it in humans in "the near future."
There were 2.5 million emergency department visits related to traumatic brain injuries in the U.S. in 2014, according to the Centers for Disease Control and Prevention (CDC). Trends seen in the run up to 2014, the last year on which CDC has published data, suggest the figure may have risen since then.
An earlier CDC report found mild traumatic brain injuries, such as concussions, account for 75% of all cases in the U.S. More severe cases are more dangerous and expensive to treat. However, the large number of mild cases mean such incidents are calculated to cost the healthcare system far more than moderate and severe traumatic brain injuries and cause more disabilities in children.
Aurora thinks its light therapy system can help healthcare professionals better manage people with concussions. The device is a helmet that emits near-infrared light. Aurora thinks the light will penetrate the skull and reverse the impaired cellular metabolism that characterizes concussions.
Investors saw enough potential in the technology to put up money to found a company around the device earlier this year. Aurora has since worked to gather the safety data in animals that it will need to start testing the device in humans.
The breakthrough designation positions Aurora to benefit from additional FDA input as it works to validate the safety and efficacy of its device, plus an expedited review if it reaches the approval filing stage. FDA has repeatedly used the breakthrough status to support the concussion field but earlier decisions about devices from BioDirection, BrainBox Solutions and SyncThink all covered the diagnosis of injuries.
If it works as intended, Aurora's device could potentially complement these breakthrough diagnostics. Equipped with a better test and a validated treatment, physicians could quickly diagnose and treat concussion, rather than relying on the body’s own recovery systems.