SCIENCEPLUSPLEASE LLC — Department of Health and Human Services SBIR Phase I: 105

Description

This supplemental application for the NIH I Corpsprogram will provide resources and training to conduct customer discovery interviews that will inform production and business development for our predicate Phase I SBIR grant NSentitled andquot Noninvasive scalp detection of cortical spreading depression for brain injuryandquotThis grant provides for the development and validation our proof of concept device for non invasive detection of cortical spreading depolarizationCSDin acute brain injuryincluding strokesubarachnoid hemorrhageand severe traumatic brain injuryThe device will address the unmet need for a noninvasive CSD detection as the only currently accepted method is an invasive procedure involving electrodes placed on the brain surface during medically necessitated neurosurgeryThus only a small fraction of the most critically injured patients are monitoredNoninvasive CSD detection will be used to develop and then monitor treatments of repetitivebrain damaging CSD occurrence in all forms of acute brain injuryin addition to addressing migraine therapies for aura suppression as migraine aura is now known to be the result of CSDsOur proof of concept prototype is composed of a proprietary configuration of direct currentDCcapable electrodessignal collection using commercially available DC coupled bio signal amplifierssignal processing with consideration for the DC potentials created at the skin surfaceand a digital CSD detection algorithmA patent is under final review for the core technology of the deviceOnce non invasive CSD detection is validatedour proof of concept prototype would be the basis for a device to detect CSD for routine Neuro Intensive Care UnitNeuro ICUuseWe aim to explore customer and stakeholder needs for our scalp mountedCSD detection systemOur first spearhead customers are investigators who have performed many clinical studies using the current non invasive CSD detection system and who are part of the CoOperative Study on Brain Injury DepolarisationsCOSBIDhttpwww cosbid orggroupThese Neuro ICU based investigators are convinced that CSD targeted therapies will reduce post injury brain injury expansion and are primed for a device that will greatly expand their ability to evaluate and validate such therapiesOther stakeholders includepharmaceutical companies who would use non invasive CSD monitoring for the objective evaluation of anti aura CSD therapies and anti CSD therapies to reduce CSD based brain injury expansionandmedical device companies interested in a new product for a new marketOur team is composed of the PI of the predicate Phase I SBIR and CEO of the company with detailed knowledge of our prototype devicethe System Engineer of the company as the Scientific Technical Expertwho can directly implement stakeholder concerns into the design of our next generation deviceand an industry expert with a wide ranging experience in product out reach and marketingOur goal is to provide a marketableeasy to use device designed for routine use in the Neuro ICU that will be used to monitor brain saving therapies that will reduce the duration of rehabilitationextend lifeand prevent death PROJECT NARRATIVE Cortical spreading depolarizationa primary feature of acute brain injuryis increasingly implicated as a fundamental mechanism underlying progression of acute brain injuries but cannot be observed optimally with conventional electroencephalographyThis project will explore customer needs for the development of a noninvasivescalp mounted system for detection of these repetitive brain damaging disturbancesSuch a scalpmounted detection device could change the landscape for therapeutic monitoring of acute brain injury in the Neuro Intensive Care Unit by providing direct and non invasive assessmentThe availability of our device will also allow non invasive detection of cortical spreading depolarization events in other conditions that it is known to occursuch as migraine auraand has been hypothesized to occursuch as concussionIn summaryit will allow for the monitoring of therapeutic options in acute brain injury patients based on the negative aspects of cortical spreading depolarization so that patient outcome could be improved