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

BrainScope
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.