BRAINBox Solutions Enrolls 1000th Patient in Pivotal, HeadSMART II Clinical Study of BRAINBox TBI Concussion Diagnostic and Prognostic Test – QNT Press Release


Richmond, Va., Nov. 14, 2022 /PRNewswire/ — BRAINBox Solutions today announced that the company has enrolled the 1,000th patient in the pivotal, HeadSMART II study of its concussion diagnostic and prognostic test, BRAINBox TBI. The multi-national, multi-site, trial is designed to support an application for regulatory clearance by the US FDA.

“We are developing the BRAINBox TBI (Traumatic Brain Injury) test as the first objective test to aid in the diagnosis of concussion and to provide an assessment of the risk of post-concussive symptoms,” said Donna EdmondsBRAINBox Solutions’ CEO. “We are now in the home stretch of this very important study for the field. We believe the test has great potential to change clinical practice in the diagnosis and management of concussion and will define for the first time, objective diagnostic criteria for this condition, termed Acute Traumatic Encephalopathy (ATE). As such, the trial has been rigorously designed in collaboration with leading experts in traumatic brain injury and emergency medicine. The study evaluates patients in multiple settings and includes state of the art expert adjudication panels.”

She added that the current study…

Full story available on Benzinga.com



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