BrainScope One Demonstrated the Potential to Reduce Head CT Scans By One-​​Third in Emergency Department Use

BusinessWire
April 30, 2018

BETHESDA, Md.–(BUSINESS WIRE)–Brain­Scope announced today the release of a white paper authored by physi­cians at Wash­ing­ton Uni­ver­sity Barnes Jew­ish Med­ical Cen­ter in St. Louis, which demon­strated that the FDA-​​cleared Brain­Scope One had the poten­tial to reduce the use of unnec­es­sary head CT scans by one-​​third in a hos­pi­tal Emer­gency Depart­ment setting.

Today most patients seen in the emer­gency room with a sus­pected head injury receive a com­puted tomog­ra­phy (CT) scan of the head to detect brain tis­sue dam­age, or intracra­nial lesions, that may require treat­ment; how­ever, the vast major­ity of these patients do not have detectable intracra­nial lesions vis­i­ble on the CT scan. The avail­abil­ity of Brain­Scope One can help health care pro­fes­sion­als deter­mine the need for a CT scan and help pre­vent unnec­es­sary neu­roimag­ing and asso­ci­ated radi­a­tion expo­sure to patients.

Using data entered in BrainScope’s national Reg­istry, the white paper authors com­pared 64 patients who were referred for CT scan fol­low­ing the tra­di­tional site refer­ral path­way ver­sus using the Brain­Scope One “Struc­tural Injury Clas­si­fier” deter­mi­na­tion in guid­ing refer­ral for CT scan. These patients were mildly-​​presenting (aver­age GCS of 15), between the ages of 18 and 74 (an aver­age age of 43 years), and assessed within three days of injury. The authors demon­strated that in a real-​​world Emer­gency Depart­ment set­ting, use of the Brain­Scope One device could have led to a sig­nif­i­cant reduc­tion in head CT scan­ning of 33% in this patient group with­out incur­ring any false neg­a­tive cases (100% sen­si­tiv­ity). These ini­tial results in the hos­pi­tal Emer­gency Depart­ment set­ting matched the over­all CT refer­ral rate reduc­tion reported for the BrainScope’s FDA val­i­da­tion trial.

The paper’s lead author, Dr. Rosanne Naun­heim, stated, “The use of such rapidly obtained, objec­tive infor­ma­tion has the poten­tial to reas­sure ED physi­cians in mak­ing con­fi­dent clin­i­cal deci­sions that their patients do not need a CT, and will go a long way toward decreas­ing unnec­es­sary radi­a­tion and decreas­ing the cost of care.”

The white paper enti­tled “Poten­tial Sig­nif­i­cant Reduc­tion in Unnec­es­sary CT Scans in Emer­gency Depart­ments Using an FDA Cleared Med­ical Device for Brain Injury Assess­ment” can be found here: http://​brain​scope​.com/​m​e​d​i​a​/​2​0​1​8​/​4​/​2​9​/​w​a​s​h​i​n​g​t​o​n​-​u​n​i​v​e​r​s​i​t​y​-​e​m​e​r​g​e​n​c​y​-​d​e​p​a​r​t​m​e​n​t​-​w​h​i​t​e​-​p​a​per.

For more infor­ma­tion about the Brain­Scope tech­nol­ogy, visit www​.brain​scope​.com/​p​r​o​d​u​cts.

About Brain­Scope

Brain­Scope Com­pany, Inc. (“Brain­Scope”) is a med­ical neu­rotech­nol­ogy com­pany that is devel­op­ing a new gen­er­a­tion of hand­held, easy-​​to-​​use, non-​​invasive devices designed to aid med­ical pro­fes­sion­als in rapidly and objec­tively assess­ing var­i­ous neu­ro­log­i­cal con­di­tions, begin­ning with trau­matic brain injury (TBI), includ­ing con­cus­sion. The company’s first prod­uct intro­duced in 2017, Brain­Scope One (FDA cleared as Ahead 300), uses EEG-​​based tech­nol­ogy that is non-​​invasive for mildly pre­sent­ing patients 18–85 years old and 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 advanced dig­i­tal sig­nal pro­cess­ing, sophis­ti­cated algo­rithms, 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 four 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 was named both an orig­i­nal recip­i­ent and final awardee of the GE-​​NFL Head Health Chal­lenge I. For more infor­ma­tion, please visit www​.brain​scope​.com.

Con­tacts

Brain­Scope Com­pany, Inc.
Lau­rie Sil­ver, 240–752-7680
Laurie.​silver@​brainscope.​com