The proposed Phase I research to be conducted by the applicant firm will continue forward with the development of retroperfusion technology for cerebral applications. The applicant firm has designed and previously tested a system for cardiac retroperfusion. The initial device under Phase I will be modified for the cerebral application. In addition, primate studies started at a major university medical center for the cerebral retroperfusion device will continue during Phase I to confirm the device's safety and efficacy for cerebral retroperfusion. The primate studies will be conducted to show that this novel technique actually reduces the morbidity of stroke victims, in addition to reversing the ECG abnormalities resulting from ischemic stroke. The primate studies will address this by waking the subjects following the treatment and measure morbidity by motor function, paralysis and by pathologic analysis of the treated and untreated ischemic cerebral tissues six days post-treatment. Phase II will build upon the feasibility study by completing the prototype device and beginning clinical trials.
