Subject: FDA
Aurora Concussion Therapy Systems, Inc. Receives Breakthrough Device Designation from the FDA
ST. PAUL, Minn., Sept. 24, 2019 /PRNewswire/ -- Aurora Concussion Therapy Systems, Inc. (Aurora - CTS), a Minnesota-based privately held company developing a non-invasive medical device to treat concussions and other brain trauma, today announced that the United States Food and Drug Administration (FDA) has designated its Aurora Light Therapy System device as a Breakthrough Device under FDA's Expedited Access Pathway.
The goal of the FDA's Breakthrough Devices Program is to provide patients and health care providers with timely access to medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization.
Doug Devens, Chief Technology Officer of Aurora - CTS, said, "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 involves applying a non-invasive, near infrared light to energize the brain's metabolic cascade process and accelerate the healing process for concussions and other mild brain trauma. More information is available at www.aurora-cts.com.
Aurora - CTS currently is completing its GLP animal safety trials to support the upcoming initiation of its human clinical trials and intends to commence its first planned clinical trials in the near future to demonstrate safety in humans and to record the clinical effects relating to the recovery time for concussion patients.
"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," said Jeffrey S. Kutcher, MD, Director of The Sports Neurology Clinic in Brighton, MI. "To better serve our patients, we need new non-invasive treatment options."
About Concussions (Mild form of Traumatic Brain Injury)1
The Centers for Disease Control and Prevention reports that over 2.8 million traumatic brain injuries occurred in 2014 and 2.5 million of those injuries were classified as mild traumatic brain injuries. These mild TBIs, or concussions, affect a person's quality of life in numerous ways, including cognitive, behavioral/emotional, and physical effects that impact interpersonal, social and occupational functioning for a period of weeks to months or longer.
1 Centers for Disease Control and Prevention (www.cdc.gov/TraumaticBrainInjury).
SOURCE Aurora Concussion Therapy Systems, Inc.
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