BioDirection, Inc. Announces Manufacturing Facility in Albuquerque, NM

Facility to manufacture key nanosensor component of the Tbit™ System

November 4, 2019

Boston, MA - 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, today announced that the company has leased a 9,000 sq. ft. facility in Albuquerque, New Mexico to manufacture a critical component of its proprietary biosensor cartridge.

"We anticipate that our new facilty 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."

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.

Mr. Joshi further went on to say, "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."

About BioDirection, Inc.

BioDirection is 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 injury (TBI). The company's lead product, the Tbit System, delivers biologically-based results shown to accurately confirm a concussion in less than 90 seconds. BioDirection's platform utilizes a patented nanosensor technology with the potential for use in a wide range of applications in point-of-care diagnostics. To learn more about BioDirection, visit http://www.biodirection.com

Contacts
Anthony Tremaglio
Vice President of Global Marketing
Tel: +1 617.440.4488
Email: ttremaglio@biodirection.com

Sharad Joshi, President & CEO
BioDirection, Inc.
Tel: +1 508.599.2400
Email: sharad@biodirection.com

BioDirection is always searching for new opportunities. Contact us today with any questions or inquiries.