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 traumatic brain injuries, leased a 9,000 sq. ft. facility in Albuquerque, New Mexico. The company will manufacture a critical component of its proprietary biosensor cartridge.
"We anticipate that our new facility will be fully operational within the next several months," said Sharad Joshi, President & CEO of BioDirection. "The plant is a critical step in our commercialization of the Tbit™ System. We have elected to establish in-house manufacturing to ensure our first product meets all targeted criteria for consistency and reproducible quality. Timing is critical since we anticipate entering the European market in 2020 and the U.S. market by the middle of 2020 following FDA clearance."
"Our cutting-edge technology delivers a test result in 90 seconds from a finger stick of blood, potentially opening the door to a large number of markets including sports and recreation venues, military training and deployment, senior living facilities and hazardous work environments. The Tbit System is a truly disruptive technology,” he added.
The company's Tbit System is based on a proprietary nanotechnology biosensor to rapidly detect and accurately measure protein biomarkers that are released from the brain immediately following a head trauma or jolt to the body. 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. Early diagnosis of a brain injury can support more appropriate treatment decisions while potentially reducing unnecessary head CT scans.