BrainScope Initiates Teenage and Young Adult Multi-Site Clinical Study for Concussion Assessment Product

May 31, 2018

BETHESDA, MD May 31, 2018 – Brain­Scope, a med­ical neu­rotech­nol­o­gy com­pa­ny focused on con­cus­sion and mild trau­mat­ic brain injury (mTBI) assess­ment, announced today the ini­ti­a­tion of a large, mul­ti-site clin­i­cal research study enrolling sub­jects ages 13–25 years who sus­tained a head injury from a vari­ety of caus­es, includ­ing sports-relat­ed head injuries. Designed as a prospec­tive, obser­va­tion­al inves­ti­ga­tion, eli­gi­ble patients who sus­tained a head injury will be recruit­ed from con­cus­sion clin­ics and high schools sur­round­ing the par­tic­i­pat­ing uni­ver­si­ties con­duct­ing the study. 

The ini­ti­a­tion of this large clin­i­cal study is a sig­nif­i­cant mile­stone in the devel­op­ment of BrainScope’s next-gen­er­a­tion brain injury assess­ment prod­ucts to include teenage patients sus­pect­ed of a con­cus­sion,” said Michael Singer, CEO of Brain­Scope.  “We are aggres­sive­ly pur­su­ing this very large demo­graph­ic with plans to intro­duce a teenage-focused prod­uct in the near-term,” stat­ed Singer. 

There are cur­rent­ly over 44 mil­lion chil­dren par­tic­i­pat­ing in foot­ball, soc­cer, lacrosse and many oth­er sports where head injury occurs each year in the Unit­ed States. It is esti­mat­ed that there are up to 3.8 mil­lion sports- and recre­ation-relat­ed con­cus­sions annu­al­ly in the U.S.  Cur­rent­ly, many of these con­cus­sions are diag­nosed using pure­ly sub­jec­tive, symp­tom-based methods.

About Brain­Scope

Brain­Scope is a neu­rotech­nol­o­gy com­pa­ny using Arti­fi­cial Intel­li­gence (AI) and mul­ti-modal capa­bil­i­ties on hand­held devices to aid rapid and objec­tive assess­ment of neu­ro­log­i­cal con­di­tions, begin­ning with con­cus­sion and mild trau­mat­ic brain injury (mTBI). The company’s first prod­uct intro­duced in 2017, Brain­Scope One, incor­po­rates a mul­ti-modal pan­el of capa­bil­i­ties includ­ing EEG-based tech­nol­o­gy that is non-inva­sive for mild­ly pre­sent­ing patients, 18–85 years old, with­in 3 days after head injury, and is not a replace­ment to CT scan. BrainScope’s tech­nol­o­gy plat­form inte­grates data­bas­es of thou­sands of brain­wave record­ings with AI tech­nol­o­gy and minia­tur­ized hard­ware and dis­pos­able head­set sen­sors, which are all cov­ered by an exten­sive intel­lec­tu­al prop­er­ty port­fo­lio of over 100 issued and pend­ing patents. Brain­Scope has received five FDA clear­ances and ISO 13485:2003 Cer­ti­fi­ca­tion. Brain­Scope has part­nered with the U.S. Depart­ment of Defense for the devel­op­ment of its TBI assess­ment tech­nol­o­gy, and Brain­Scope One is cur­rent­ly being field­ed by the U.S. mil­i­tary. Brain­Scope One is also being uti­lized in a cross-sec­tion of mar­ket seg­ments includ­ing: urgent care and occu­pa­tion­al health clin­ics; con­cus­sion clin­ics; hos­pi­tal emer­gency rooms; uni­ver­si­ty sports and stu­dent health cen­ters; pro­fes­sion­al sports; and phar­ma­ceu­ti­cal clin­i­cal tri­als.  Brain­Scope has been the recip­i­ent of sev­er­al pres­ti­gious awards, includ­ing the Frost & Sul­li­van 2017 Best Prac­tices Award for New Prod­uct Inno­va­tion in the Trau­mat­ic Brain Injury Assess­ment Solu­tions Mar­ket, was a two-time win­ner of the GE-NFL Head Health Chal­lenge, and received a nom­i­na­tion for the Prix Galien Best Med­ical Tech­nol­o­gy, regard­ed as the equiv­a­lent of the Nobel Prize for med­ical devices. For more infor­ma­tion, please vis­it www​.brain​scope​.com.