BrainScope Surpasses Primary Endpoints in Multi-Year Department of Defense-Funded Validation Study for New Concussion Assessment Capability

July 25, 2019

BETHESDA, MD. July 25, 2019 — Brain­Scope announced today that it has suc­cess­ful­ly com­plet­ed a near­ly five year, $9.9 mil­lion U.S. Depart­ment of Defense research con­tract sup­port­ing the devel­op­ment and val­i­da­tion of an objec­tive mark­er of the pres­ence and sever­i­ty of con­cus­sion. In a large blind­ed val­i­da­tion study, the sys­tem demon­strat­ed its abil­i­ty to help clin­i­cians assess con­cus­sion at the time of injury, reflect sever­i­ty of injury, and aid in their assess­ment of readi­ness to return to activ­i­ty. Brain­Scope extend­ed the work per­formed under this Depart­ment of Defense con­tract to include ado­les­cents fund­ed through pri­vate invest­ment from Brain­Scope and a sec­ond award from the NFL-GE Head Health Chal­lenge I.

Through the research con­tract, the Brain­Scope “Con­cus­sion Index”, an EEG-based, mul­ti­modal mark­er for con­cus­sion, was devel­oped and then val­i­dat­ed in a blind­ed clin­i­cal study. All pre-spec­i­fied per­for­mance tar­gets were achieved or exceed­ed. These clin­i­cal stud­ies were con­duct­ed from 2015 through 2019 at 52 clin­i­cal sites, and includ­ed near­ly 1,700 patients and healthy con­trols with over 4,000 eval­u­a­tions con­duct­ed at high schools, col­leges and con­cus­sion clin­ics. The research also extend­ed the tar­get pop­u­la­tion from 18–25 years down to 13 years of age.

The pri­ma­ry aim of the blind­ed study was to val­i­date the clin­i­cal util­i­ty of the Con­cus­sion Index for assess­ing the like­li­hood of con­cus­sion with both high sen­si­tiv­i­ty and speci­fici­ty, in patients aged 13–25 who sus­tained a closed head injury. Addi­tion­al end­points sup­port­ed the use of the Con­cus­sion Index as an impor­tant objec­tive com­po­nent of the clin­i­cal assess­ment of the sever­i­ty of con­cus­sive injury, and in the eval­u­a­tion of readi­ness to return to activ­i­ty. “We are extreme­ly pleased with the out­come of this study, demon­strat­ing the promise of the Con­cus­sion Index as an objec­tive mark­er in the clin­i­cal assess­ment of con­cus­sion. Impor­tant­ly, the study tar­get­ed patients of high school and col­lege age who are at great risk for both short and long term con­se­quences of con­cus­sion, as the brain in still devel­op­ing,” stat­ed Dr. Leslie Prichep, Chief Sci­en­tif­ic Offi­cer of Brain­Scope and the Contract’s Prin­ci­pal Inves­ti­ga­tor. Brain­Scope CEO, Susan Hertzberg added, “We are thank­ful to the Depart­ment of Defense for our long-term col­lab­o­ra­tive rela­tion­ship. These impor­tant research out­comes bol­ster our prospects of bring­ing this impor­tant capa­bil­i­ty to both ser­vice mem­bers and civil­ians to help address the nation­al con­cus­sion epidemic.”

The 510(k) sub­mis­sion for this capa­bil­i­ty is cur­rent­ly under review by FDA.

About BrainScope

BrainScope’s mis­sion is to rev­o­lu­tion­ize the rapid and objec­tive assess­ment of brain-relat­ed con­di­tions, start­ing with con­cus­sion and mild trau­mat­ic brain injury, uti­liz­ing mul­ti­ple inte­grat­ed assess­ment capa­bil­i­ties, arti­fi­cial intel­li­gence (AI) and dig­i­ti­za­tion. The com­pa­ny is a two-time win­ner of the GE-NFL Head Health Chal­lenge and has received two nom­i­na­tions for the Prix Galien Best Med­ical Tech­nol­o­gy (in 2017 and 2018), regard­ed as the equiv­a­lent of the Nobel Prize for med­ical devices. The company’s ini­tial prod­uct, Brain­Scope One, is now being used in numer­ous mil­i­tary divi­sions and in health sys­tems, urgent care cen­ters and uni­ver­si­ties. For more infor­ma­tion, please vis­it www​.brain​scope​.com.

This work was com­plet­ed under Con­tract No. W911QY-14-C-0098 enti­tled “Objec­tive Brain Func­tion Assess­ment of mTBI from Ini­tial Injury to Reha­bil­i­ta­tion and Treat­ment Opti­miza­tion” by the U.S. Army Con­tract­ing Com­mand, Aberdeen Prov­ing Ground, Nat­ick Con­tract­ing Divi­sion. Any opin­ions, find­ings and con­clu­sions or rec­om­men­da­tions expressed in this mate­r­i­al are those of the author(s) and do not nec­es­sar­i­ly reflect the views of the US Army Con­tract­ing Com­mand, Aberdeen Prov­ing Ground, Nat­ick Con­tract­ing Division.