BioDirection, 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. – NS Medical Devices