Pulse Therapeutics, Inc. — Department of Health and Human Services SBIR Phase I: 101

Description

Acute ischemic strokeAISis the result of a blood clot in a cerebral arteryCurrentlyAIS remains a leading killer and the leading cause of long term disabilitywhich annually impacts nearlyAmericansBecause brain tissue rapidly diestime to reperfusion is critical in both preventing death and improving neurological outcomesWhile economic burden associated with ischemic stroke are high in the United StatesUSit is projected to increase from $B into $B byIntravenous use of tissue plasminogen activatortPAis the standard of care for AISwith thrombectomy recommended for proximal large vessel occlusion in the anterior circulationThis strategy results in improvements in long term neurological outcomes over tPA aloneHoweverover half of thrombectomy treated patients die or are left moderately to severely disableddespite a majority achieving complete or partiallycomplete blood flow restorationInaccessible distal emboli post thrombectomy are a primary reason for poor outcomeswhich result in incomplete flow in up to half of casesPatients not achieving complete recanalization tend to be hospitalized longershow weaker neurological improvementshave worse long term neurological outcomesand experience more hemorrhageversus those with complete recanalizationNo options currently exist for treating distal emboli given that current tools are too large and intra arterial infusion of thrombolytic agents has shown limited to no success due to distal occlusions creating stagnant columns of blood proximal to the clot which restricts their diffusion to less than a few millimeters per hourPulse TherapeuticsIncPTIhas made a breakthrough discovery using magnetic particles to adjunctively convey thrombolytic agents overX fasterIn vitro and in vivo work confirm that this technology improves thrombolytic agent conveyance and clot lysisIt has also been shown that low doses of tenecteplaseTNKare superior to tPAThis project s aims are to develop the technology for an intra arterial procedure in the treatment of AISFor Phase Ibenchtopin vitroand in vivo work will be conducted to demonstrate proof of concept and optimize TNK and particle dosing and therapy deliveryFDA feedback using Phase I results will be sought to improve Phase II aimsPhase II will assess the system s impact on TNK pharmacokinetics and aggravation of hemorrhageIn additionan angiography suite compatible workstation will be developed and flow studies using neuro phantoms will be repeated under fluoroscopy to assess anticipated clinical workflowEarly FDA engagement indicates that the technology may be evaluated as a device given persuasive mode of action and biocompatibility preliminary studiesImportantlythe PTI technology supports the FDA s mission to reinforce the value of comprehensive stroke centers and promises to improve care for the nearlyAIS victims showing visible clot in the anterior circulationIf successfulthis technology would represent the first drug delivery nanotechnology approved as a medical device in the US The goal of this SBIR FastTrack application is to provide a minimally invasive tool to lyse otherwise untreatable emboli in acute ischemic strokeAISOf theAIS events in the US each yearnearly half are associated with a large vessel occlusion whichwhen a thrombectomy is performedcan create untreatable distal emboliup to half of casesthat result in poorer neurological outcomesBy leveraging Pulse Therapeuticsbreakthrough discovery in which magnetics are used to intra arterially and adjunctively convey tenecteplase overX faster for lysing otherwise impossible to treat emboli in the distal vasculaturea transformational and much needed tool can be provided which promises to improve neurological outcomes for currently untreatable AIS victims