Rapid Magnetomotive Thrombolysis for Stroke

DESCRIPTION provided by applicant Acute ischemic stroke AIS is the result of a blood clot in a cerebral artery It remains a leading killer and the leading cause of long term disabilit annually impacting over Americans Because brain tissue rapidly dies time to reperfusion is critical in both preventing death and improving neurological outcomes While current annual costs related to ischemic stroke are high in the United States US they are projected to increase from $ B in to $ B by Intravenous IV administration of tissue plasminogen activator tPA remains the standard of care for AIS despite a small chance for a full recovery and a andgt chance of death or severe disability While tPA has been proven to offer statistically significant benefits albeit low in AIS the dose dependent bleeding associated with tPA has resulted in a low administration rate in the US As a result a large majority of stroke victims are greatly underserved despite efforts to improve standards of care Due to poor fluid dynamics the effectiveness of all thrombolytic drugs is because of their inability to rapidly diffuse to a clot in the occluded vessel Pulse Therapeutics Inc andapos s PTIandapos s patented and clinically investigated technology has overcome this limitation in a way that dramatically accelerates tPA delivery to a clot by using non tPA attached magnetite particles controlled by an external magnet This technology is deployed in the emergency department after the baseline CT However by attaching the FDA approved drug tPA to PTIandapos s magnetite particles the technology promises faster clot lysis driving better neurological outcomes at a substantially lower tPA dose allowing expansion to nearly all ischemic strokes PTIandapos s objective is to demonstrate dramatic improvements in thrombolysis by attaching tPA to the companyandapos s magnetic particles In Phase I PTI will attempt to develop optimal magnetite particles with the best performing tPA coating conjugated to the surface collect data on the candidate particleandapos s clot lysis rate and proper dosing in vitro optimize a software algorithm for automated particle collection and conduct a pre submission meeting with the FDA For Phase II PTI will modify an existing PTI magnet system suitable for use in pre clinical animal studies identify the best tPA coated particle from safety and efficacy GLP preclinical studies and assemble a data package in preparation for a subsequent FDA IDE submission The proposed technology has dramatic implications for the treatment of AIS By delivering tPA directly to the clotandapos s surface via attachment to magnetic particles clot lysis willto occur faster and result in better neurological outcomes while drug related toxicity effects may be eliminated thereby expanding thrombolytic therapy from the maximum stroke victims eligible today to potentially all ischemic stroke victims PUBLIC HEALTH RELEVANCE Pulse Therapeutics Inc PTI intends to substantially improve accelerate and expand care for underserved acute ischemic stroke victims by attaching tissue plasminogen activator tPA to its magnetically controlled particles Of the over ischemic strokes seen in the US every year most victims do not receive tPA therapy to destroy the clot primarily due to perceived hemorrhage risks and time delays of the who do only a treatment effect is observed due to tPA therapyandapos s poor performance By extending its patented proven and clinically evaluated technology Pulse Therapeutics hopes to destroy blood clots faster and more reliably while substantially reducing tPA associated hemorrhage risks thereby greatly improving neurological outcomes and expanding care beyond what is possible with the current standards of care