UNANDUP, LLC — Department of Health and Human Services SBIR Phase I: 102

Description

Acute ischemic strokeAISresults from a blood clot in the neurovasculatureAIS is theth leading cause of death in the United StatesUSand is the leading cause of neurological disabilityAIS will strike more thanAmericans inanddespite recent advances in stroke carethere remains achance of death or severe disabilityByit is expected that the AIS economic burden will exceed $B in the US aloneStandard of care AIS therapies include the use of thrombolysis withinhours of stroke onset and thrombectomy for large vessel occlusions as early as possibleHoweverdespite thrombectomy s proven valuepoor access to early thrombectomy for rural populations still results in large disparities in careIn the USthrombectomies are largely performed at one of nearlyComprehensive Stroke CentersCSCsBecause considerable costs are associated with setting up and maintaining a CSCthese centers are concentrated near highly populated urban centerswhich can provide larger patient volumesHoweverthe consequence is that more than half of Americans face transfer times longer than an hourand for rural AIS victimswho represent nearly a quarter of the US populationtransfer delays can exceed two hoursAs a resultneurological outcomes for rural AIS victims tend to be worseWhile neuroprotective agents are a potentially powerful tool in preserving brain during long transfersthey have yet to be proven effective in clinical studiesOne reason for this discrepancy is that the occlusive blood clot results in restrictive hemodynamics which prevent neuroprotectants from effectively reaching the ischemic region near and around the clotIf this hemodynamic limitation were overcomethe benefit to rural populations would be profoundUNandamp UP has invented a novel nanoparticle based mobile health platform which overcomes adverse strokeassociated hemodynamics so that neuroprotective agents are better delivered to the ischemic volumeThe technology conveys iron oxide nanoparticles into the blood flow deprived region of ischemia using a mode of action that is efficacious for conjugated and unconjugated drugsImportantlythe system is affordable and designed to travel with the AIS victim during transferWhile conjugation of the neuroprotectant promises to substantially improve efficacyregulatory discussions support that the technology could be first regulated under the CDRH if therapeutics are unconjugatedThe team reflects magneticsroboticsnanoparticlestrokeand neuroprotection expertswho have demonstrated prior commercial successesThe Phase I effort focuses on proof of concept of the platformThe aims includeprototype workstation constructionprototype coated iron oxide particle formulationin vitro large vessel occlusion phantom efficacy studies using CTA MRA stroke datasetsandin vivo efficacy and safety assessments using a known AIS animal modelPrior to Phase IIan FDA meeting is planned to inform the regulatory pathwayIn Phase IIthe best neuroprotectant agents will be identified and comparedand biocompatibility studies will be conducted Acute ischemic stroke is the fifth leading cause of death and the leading cause of neurological disabilitywith more thanAmericans stricken each yearBecause transfer times to thrombectomy capable stroke centerswhich are located near or in highly populated urban centerscan take more than two hours for rural populationsneurological outcomes are disproportionately worse as compared to urban concentrated populationsFor this Phase I proposalUNandamp UPshort forUnmet Needs and Underserved Populationswill develop a magnetism based mobile health neuroprotection platform that overcomes the restrictive hemodynamics formed as a consequence of the occlusive clot so that neuroprotective agents are better delivered into the ischemic volumetherefore preserving and protecting the brain during long transfers for rural patients