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BioDirection, Inc. Holds Pre-Submission Meeting with FDA

Boston, MA – BioDirection, a privately held medical device company developing novel and rapid point-of-care products for the objective detection of concussion and other traumatic brain injury (TBI), announced today that the company has successfully completed a meeting with the U. S. Food and Drug Administration (FDA) to review the company’s Tbit™ blood test Pre-Submission Package. During the meeting company representatives reviewed plans for clinical development of the Tbit™ system as a precursor to commencement of a planned pilot trial.

“We are grateful for the opportunity to review the Tbit™ system’s mechanism of action, as well as our plans for clinical research and efforts to position our technology platform in the market place, in a productive conversation with the FDA,” said Eric Goorno, president and CEO of BioDirection. “We left the meeting with a strong consensus on the parameters to be used in our upcoming clinical trials, and we look forward to advancing our development program in the months ahead.”

The Tbit™ blood test 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 technology platform allows for testing to be performed at the earliest stages of a concussion. Early objective diagnostic testing of patients who have experienced head trauma can support more rapid and appropriate treatment decisions while potentially reducing unnecessary head CT scans.

In pre-clinical human sample testing, the Tbit™ blood test has been shown to offer high levels of both sensitivity and accuracy in measurement of biomarkers associated with traumatic injury in blood.

“We believe that our review with the FDA effectively communicated that the Tbit™ is a unique technology with the clear potential to radically improve the way concussions are diagnosed,” said Brian McGlynn, founder and chief technical officer of BioDirection. “Our technology platform is capable of quantitatively measuring protein biomarkers associated with brain injury at ng/mL concentrations and has the potential to aid in a broad spectrum of applications in TBI management.”