FDA Grants Marketing Authorization for Use in Children 5 and Older and Adults up to 67 Years of Age.
January 3, 2019 — NEW YORK– Oculogica, Inc., a pioneer in algorithm-based neuro-diagnostics, announced that the U.S. Food and Drug Administration (FDA) granted their De Novo request for the commercialization of the EyeBOX® device, the first non-invasive, baseline-free tool to aid in the diagnosis of concussion on December 28, 2018. Oculogica plans to market the device for use in pediatrics ages 5 and older and adults up to 67 years of age, starting with a pilot launch for select, qualified sites. The EyeBOX device uses eye-tracking to provide objective information to aid in assessment of patients with suspected concussion via an easy to take, 4-minute test. Results of the pivotal DETECT clinical study of 282 patients who presented in the emergency room and concussion clinic with suspected traumatic brain injury (TBI) formed the basis of the Oculogica De Novo application.
“Oculogica’s extensive clinical research and validation have shown we can provide an objective assessment to healthcare providers when evaluating patients with suspected mild traumatic brain injury,” said Rosina Samadani, Ph.D., CEO of Oculogica. “We are thrilled to receive marketing authorization from FDA for the first non-invasive, baseline-free aid in diagnosis of concussion. This field is a challenging one. Several key aspects of a diagnostic have thus far eluded researchers. Before now, concussion assessments have relied on subjective measures or baseline testing. This authorization by FDA is a significant milestone for the company and, more importantly, heralds a new era for concussion diagnosis and management for patients and healthcare practitioners.”
Other diagnostics require a baseline test, typically generated at the beginning of a sport season, pre-injury, and is compared to subsequent test results at the time of a suspected concussion. In many situations, a baseline concussion assessment is not feasible, especially when evaluating trauma patients in the emergency room. Baseline tests can also be “gamed” or memorized so that athletes and military personnel can pass a subsequent test. The EyeBOX test’s unique eye-tracking algorithm enables it to be baseline-free, a major advancement for the field.
“Eye-tracking will change the practice of emergency care for concussion and will greatly assist a large number of patients. The result will be more consistent and objective diagnoses of concussion in the emergency room and clinic, and eventually on the field,” stated Dr. Robert Spinner, Chair of the Department of Neurological surgery at Mayo Clinic.
“This is an important achievement for the field, which has had to work with the lack of objective measures until now. The EyeBOX test as part of an objective, multimodal assessment will eventually be the new state of the art, which will be an important advance for patients,” stated Dr. Christina Master, professor of clinical pediatrics at the University of Pennsylvania and attending physician at the Children’s Hospital of Philadelphia.
The pivotal DETECT study enrolled 282 patients at six independent clinical sites in the United States and compared the EyeBOX results to a clinical reference standard for concussion in patients presenting to emergency departments and sports medicine clinics with suspected head injury. The study showed that the EyeBOX test had high sensitivity to the presence of concussion and that a negative EyeBOX result is consistent with a lack of concussion, thus providing objective data for healthcare providers to aid in the evaluation of patients with suspected TBI.
“Looking beyond this milestone, the EyeBOX device has the potential to aid in the diagnosis of other neurological conditions and may benefit researchers developing therapies for TBI and concussion,” stated John Leddy, MD, Medical Director of the University at Buffalo Concussion Management Clinic. “Development of treatments for concussion is challenging because there are few reliable outcome measures. The EyeBOX test may offer one solution to this challenge, providing researchers with an objective oculomotor assessment tool.”
Oculogica is engaged in additional studies to assess applications in specific, emerging, concussion therapies as well as in diagnosis of other neurological conditions of the brain, such as elevated intracranial pressure. Eye tracking is an area of increasing recent interest in healthcare and consumer technologies. Google purchased the eye tracking company Eyefluence in October 2016. Apple acquired Germany-based SensoMotoric Instruments GmbH in June 2017 and Facebook acquired Copenhagen-based eye-tracking startup The Eye Tribe ApS in December 2017. Samsung has eye tracking capacity on its S4 device. All have expressed interest in the healthcare industry.
Dr. Samadani stated, “We believe concussion patients deserve a higher standard of diagnostic than has been available to them. Our objective is to bring greater clarity to concussion diagnosis for the benefit of patients and the caregivers, healthcare practitioners and researchers that are working in this field.”
About Traumatic Brain Injury and Concussion
The U.S. Center for Disease Control (CDC) estimates there are more than 2.5 million emergency room visits in the United States as a result of head injuries1, and a study by the CDC and Children’s Hospital of Philadelphia showed that 80% of children with concussions report to their primary care doctor rather than the emergency room, suggesting the actual number of concussions occurring in the Unites States each year could potentially be as high as 10 million. Traumatic brain injury is the leading cause of disability and the number one cause of death for young adults2. Automobile accidents, falls, sports-related injuries, and assaults, are common causes of TBI. At least 75% of brain injuries in the United States are considered mild TBI2, representing an economic burden of at least $16.7 billion annually in direct and indirect costs on the healthcare system3.
Oculogica, Inc. is an eye tracking-based neuro-diagnostic company founded by Dr. Uzma Samadani, Associate Professor of Neurosurgery at the University of Minnesota Medical School. The company has developed the EyeBOX device, the first non-invasive, baseline-free, aid in diagnosis of concussion to help physicians objectively evaluate patients with suspected concussions. The EyeBOX test is a 4-minute test appropriate for ages 5 to 67 years. To learn more about the Company and the EyeBOX device, visit www.oculogica.com.
Oculogica, EyeBOX, and the respective logos are the trademarks and copyrights of Oculogica, Inc.
- Taylor CA, Bell JM, Breiding MJ, Xu L. Traumatic Brain Injury-Related Emergency Department Visits, Hospitalizations, and Deaths-United States, 2007 and 2013. MMWR Surveill Summ. 2017;66(9):1-16.
- National Center for Injury Prevention and Control. Report to Congress on Mild Traumatic Brain Injury in the United States: Steps to Prevent a Serious Public Health Problem. In. Atlanta, GA: Centers for Disease Control and Prevention; 2003.
- McCrea M. Mild traumatic brain injury and postconcussion syndrome: The new evidence base for diagnosis and treatment. Oxford Workshop Series: Americ; 2008.