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BioDirection Receives Breakthrough Device Designation from FDA for Tbit™ System

Boston, MA – (PRNewswire) – BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other acquired traumatic brain injuries, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s Tbit™ System for the prediction of positive computerized tomography (CT) scans following Traumatic Brain Injury (TBI).

According to the FDA, the goal of the Breakthrough Devices Program (BDP) is to provide patients and health care providers with timely access to designated medical devices by speeding up their development, assessment and review.

“We are pleased to receive this FDA designation and believe it is a clear recognition of the potential advantages of the Tbit System over currently available technology,” said James Wylie, executive chairman  of BioDirection. “The Tbit System is designed to measure the body’s response to trauma and provide a rapid point-of-care test result in less than 2 minutes from a single drop of blood, while current technology may run 3-4 hours or more and require serum testing in a central laboratory.”

The Tbit System uses a patented nanotechnology biosensor to rapidly detect and accurately measure protein biomarkers that are released from the brain immediately following a head trauma. The portable system allows for testing to be initially performed in the emergency department and eventually, after receipt of further FDA clearances, at the point-of-injury. Earlier diagnosis of a brain injury can support more appropriate treatment decisions while potentially reducing unnecessary head CT scans.

“Blunt trauma injuries that impact the head and brain require the rapid identification of comorbidities to rule out or confirm the potential of intracranial hemorrhage that may require some form of surgical intervention,” said Brian McGlynn, founder and chief technical officer of BioDirection. “The Tbit System has the potential to deliver actionable information to the physician where minutes matter. Longer term, our technology has the potential to support a full continuum of care ranging from stratification of injury, prognosis and return to play and activity.”