Brain trauma treatment developer BioDirection announced that it leased a facility in Albuquerque, N.M., for manufacturing a critical component of its proprietary biosensor cartridge.
The new 9,000 square-foot facility in Albuquerque is slated to house manufacturing of the Tbit system’s biosensor cartridge. The Tbit system is designed to use the proprietary biosensor technology to rapidly detect and accurately measure protein biomarkers that are released from the brain following a head trauma.
“We anticipate that our new facility will be fully operational within the next several months,” BioDirection president & CEO Sharad Joshi said in a news release. “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.”
Tbit won FDA breakthrough device designation in February of this year. The company said the system allows for initial testing in the emergency department and, following further FDA clearances, at the point of injury.
“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,” Joshi added. “The Tbit System is a truly disruptive technology.”
Last month, the Southborough, Mass.-based company announced that it leased a 5,000 square-foot facility to move its corporate headquarters from Tucson, Ariz., to Southborough.
