Le Lézard
Classified in: Health
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.

Aurora Concussion Therapy Systems, Inc. Logo

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.

These press releases may also interest you

at 11:49
Eligible producers from participating Land O'Lakes co-ops and direct Land O'Lakes Dairy members in Minnesota and Kansas have less than two weeks to enroll in the Land O'Lakes Cooperative Farmer Member Health Plan. For coverage beginning January 1,...

at 11:45
The "Global Digital Biomarkers Market: Focus on Key Trends, Growth Potential, Competitive Landscape, Components, End Users, Application (Sleep and Movement, Neuro, Respiratory and Cardiological Disorders) and Region - Analysis and Forecast,...

at 11:41
A recent study by the National Institute for Occupational Health and Safety revealed that cancer is currently the leading cause of death among firefighters. Recognizing the need for resources to support the brave men and women who put their lives on...

at 11:40
Internationally renowned pulmonologist Kevin K. Brown, MD, has been named the new Chair of the Department of Medicine at National Jewish Health. Dr. Brown's appointment follows a comprehensive national and international search.  He has served as Vice...

at 11:33
ANYMEDI participated in AI showcase of RSNA 2019 (Radiological Society of North America), held in Chicago, U.S. from December 1st to 6th, exhibiting patient-specific surgical applications based on AI, 3D printing and AR/VR technologies. As a solution...

at 11:28
Point of Care market leader PatientPoint® has named esteemed pharmaceutical and health and wellness industry veteran and POC expert Charlie Greenberg as Senior Vice President of Campaign Quality and Compliance. Greenberg brings more than 35 years of...

News published on 24 september 2019 at 10:15 and distributed by: