BioDirection, Inc. and EU Based Center-TBI Announce Collaboration in the Field of Diagnosis and Management of Traumatic Brain Injury

Ultra-sensitive proprietary nanowire technology positioned to provide global physicians with new tool for diagnosis of traumatic brain injury and inflammatory disease

October 10, 2019

Boston, MA - BioDirection, Inc., a privately held medical device company developing rapid, whole blood based point-of-care products for the diagnosis and management of concussions and other traumatic brain injuries, today announced that the company has signed a multi-phased technical collaboration agreement with the coordinator (Anwerp University Hospital, Belgium) of CENTER-TBI (Collaborative European NeuroTrauma Effectiveness Research in Traumatic Brain Injury (www. center-tbi.eu) for the evaluation and development of the Company's proprietary Tbit™ System.

CENTER-TBI represents a focused European effort, supported by the European Union (FP7 Grant 602150) to advance the care of patients with TBI within the broader international framework of InTBIR (International Traumatic Brain Injury Research initiative: https://intbir.nih.gov/). The project includes a large scale observational study, which initially involved 65 medical centers in 20 EU countries, later supplemented by non-EU based medical centers in China, Australia and India. The CENTER-TBI Core Study collected detailed clinical and neuroimaging data and blood sample from approximately 4,550 patients in Europe and Israel.

Andrew Maas, Co-Chairman of the Center-TBI Management Committee, commented "Although we are an EU supported organization, we have global objectives. First, to improve characterization and classification of TBI with inclusion of emerging technologies, such as biomarkers; and secondly, to identify the most effective clinical care to provide evidence in support of treatment recommendations." Dr. Maas went on further to state that, "Early and rapid diagnosis of TBI is critical. Today, only core laboratory tests exist for use in TBI which often require 3-4 hours or more to complete. BioDirection's rapid point-of-care platform could address this urgent, unmet market need, both in and out of the medical center environment."

Mr. Sharad Joshi, President & CEO of BioDirection, added, "BioDirection is honored to be selected by the Center-TBI as a partner. We share a common goal of improving patient outcomes by providing actionable diagnostic results in less than 90 seconds from a single drop of blood." Mr. Joshi further stated, "The Tbit™ System provides a cost-effective platform readily adaptable to include any biomarker which will provide clinicians with research tools for expanding early diagnosis to effectively address the issues of injury stratification, prognosis and return to activity following recovery."

Approximately 50-60 million people suffer a TBI worldwide each year. TBI is reported to be the 4th largest cause of death world-wide and the #1 cause of death for people under 45 years of age. Each year, approximately 114,000 people die due to traumatic brain injuries in the EU and the U.S. alone.

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.