Pulse Therapeutics, Inc. — Department of Health and Human Services SBIR Phase I: 102

Description

Coronary heart diseaseCHDaccounts forof everydeaths in the United StatesUSwith acute incidences ofM annuallyOf theseare ST elevated myocardial infarctionSTEMIwhich result from a blood clotBecause ischemic heart muscle dies rapidlytime to reperfusion is criticalByannual CHD medical costs are projected to rise andgt $Bwhile lost productivity exceeding $BEarly percutaneous coronary interventionPCIis the first line standard of care in the USHoweverbecause PCI centers primarily target urban populationsPCI has shown limited benefit for STEMI patients living in rural communitieswhich are subject to longer transportation times and system wide delaysConsequentlymore thanof transferred STEMI patients do not receive PCI therapy within the recommendedmin from first medical contactresulting in higher mortality and greater patient costsGiven that overM people live in rural communities that are more thanmiles from a PCI centerit is estimated that nearlyk STEMI victims will remain without timely access to PCI each yearWhile clot dissolving drugs have proven to be effectivephysicians remain concerned with their elevated hemorrhage riskHoweverit is generally agreed that the value and reach of PCI centers could be extended to rural populations if a safer fibrinolytic therapy could be more widely employed during transfer to the PCI centerFundamentallythrombolytic drugs are limited in their effectiveness due to an inability to rapidly diffuse to a clotPulse TherapeuticsIncsPTI spatented technology has overcome this limitationIn preliminary workPTI s breakthrough technology has been shown to accelerate unconjugated drugs to a clot by using magnetite particles controlled by a magnet workstationHoweverin vivo studies confirm that attachment of the FDAapproved drug tenecteplaseTNKto PTI s magnetite particles appears to result in superior efficacy at less than one tenth the standard TNK doseThese studies predict that combining TNK loaded particles with a very low systemic TNK dose promises to maximize the recanalization potential of the technologyPTI s objective is to show dramatic improvements in fibrinolysis for STEMI by using TNK loaded magnetic particles administered alongside a low TNK systemic doseThe proposed scope of work follows from FDA and MHRA meetings which successfully argued the preclinical safety of the unconjugated magnetic particles and workstationIn Phase IPTI will conduct in vitro and in vivo studies to assess the efficacy of low TNK systemic doses alongside PTI s TNK loaded particlesA prototype kit will be developed which will allow trouble free loading and administration of the magnetic particles and TNKLastlymaterials will be assembled for an FDA meeting prior to determining Phase II objectives and aimsThe proposed technology has dramatic implications for rural STEMI treatment and will directly address the American Heart Association s concern thatWhere you live should not determine whether you liveProject Narrative Pulse TherapeuticsIncintends to substantially improveaccelerateand expand care at first medical contact for the treatment of ST elevated myocardial infarctionSTEMIin rural populations during transport to percutaneous coronary interventionPCIcentersby using TNK loaded magnetic particles with a low intravenous dose of TNKOf the more thanSTEMI events seen in the US each yearmore thanof transferred rural STEMI patientsoverM people live in communities more thanmiles from a catheterization centerdo not receive emergency catheterization within the recommendedmin from first medical contactresulting in nearlySTEMI victims with delayed accessBy extending its clinicallyapproved technologyPulse Therapeutics hopes to destroy blood clots in the heart earlier and faster while eliminating TNK dose dependent hemorrhage riskthereby offering crucial therapy to rural STEMI victims during lengthy transportation to a PCI center