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BioDirection, Inc. Files Pre-Submission Package 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), today announced that it recently filed a Pre-Submission (“Pre-Sub”) Package with the FDA as a critical step toward commercialization of its proprietary Tbit™ diagnostic platform.

BioDirection’s Pre-Sub meeting with FDA to discuss clinical plans and protocols for the company’s Tbit™ system, which is a necessary precursor to commencement of clinical trials, has been scheduled for November 2016.

“This Pre-Sub filing is a critical milestone in the path to commercialize our game-changing technology,” said Eric Goorno, President & CEO of BioDirection. “Tbit™ is truly a disruptive diagnostic platform which has the potential to revolutionize the detection, diagnosis and management of a concussion. We look forward to commencing our clinical trials and advancing to the final stages of FDA regulatory review and product registration.”

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 performed at the earliest stages of medical diagnosis and intervention. Early objective diagnostic testing of patients who have experienced head trauma allows for more rapid and appropriate treatment decisions, while potentially reducing unnecessary head CT scans.

Brian McGlynn, Founder, Executive Vice President and CTO of BioDirection, expanded on the potential benefits of Tbit™. “We are addressing an enormous, global unmet medical need with a truly amazing technical platform. Tbit™’s ability to quantitatively measure protein biomarkers associated with brain injury at ng/mL concentrations offers the potential to aid in concussion prognosis and unbiased return to play/activity decision making. Tbit™ is the first step in rapid and affordable, real-time data to improve diagnosis and patient safety.”