In News

October 29, 2019

NEW YORK, Oct. 29, 2019 (GLOBE NEWSWIRE) — Oculogica, Inc., a pioneer in algorithm-based neuro-diagnostics for brain health, announced today that the American Medical Association (AMA) has confirmed the addition of a new Category 3 CPT Code, 0X17T, Eye movement analysis test without spatial calibration, allowing clinicians to appropriately report the services related exclusively to the Oculogica EyeBOX® exam. The approved new code will be published by the AMA CPT Editorial Panel January 1, 2020 and become effective July 1, 2020.

“Obtaining the CPT code is an important achievement and builds on EyeBOX’s position as the first and only FDA-cleared objective, baseline-free aid in diagnosis of concussion. This new CPT code is vital to Oculogica’s goals of broadening access to clinically validated, multi-modal tools for patients and healthcare practitioners to improve the diagnosis of concussion”, said Rosina Samadani, Ph.D., CEO of Oculogica. “The introduction of this code is an important first step in the establishment of widespread insurance coverage and reimbursement for the EyeBOX Test.”

The EyeBOX uses eye-tracking to assist in the evaluation of patients with suspected concussion, and was developed by neurosurgeon Dr. Uzma Samadani, Associate Professor at the University of Minnesota. The under 4-minute test is unique in that it uses non-spatially calibrated eye-tracking, is non-invasive, does not require a baseline test and is authorized by the FDA. The EyeBOX obtained marketing authorization in December 2018 as an aid in the diagnosis of concussion, also known as mild Traumatic Brain Injury (mTBI) and launched in January 2019.

The FDA marketing authorization granted for the EyeBOX was based on the results of Oculogica’s pivotal DETECT multi-site study, in which the EyeBOX results of patients presenting with a suspected head injury were compared against a clinical reference standard for concussion. The study demonstrated the EyeBOX’s high sensitivity to the presence of concussion and ability to provide objective information to aid in the evaluation of patients with suspected mTBI. Since launch of the EyeBOX, Oculogica has initiated studies to assess its applicability in concussion management and treatment while continuing to explore its potential utility in the diagnosis of other neurological conditions, such as elevated intracranial pressure.

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 82% 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.

About Oculogica
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, the first baseline-free, aid in diagnosis of concussion to help physicians objectively evaluate patients with suspected concussions. EyeBOX is a 4-minute test appropriate for ages 5 to 67 years. To learn more about the Company and EyeBOX, visit www.oculogica.com.

Oculogica, EyeBOX, and the respective logos are the trademarks and copyrights of Oculogica, Inc.

References

  1. 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.
  2. 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.
  3. McCrea M. Mild traumatic brain injury and postconcussion syndrome: The new evidence base for diagnosis and treatment. Oxford Workshop Series: Americ; 2008.

http://www.globenewswire.com/news-release/2019/10/29/1936938/0/en/Oculogica-Announces-New-Category-3-CPT-Code-Created-by-American-Medical-Association.html

FDA: The FDA Recommends Only Using Cleared or Approved Medical Devices to Help Assess or Diagnose a Head Injury, Including Concussion: FDA Safety Communication