Oramic, LLC — Department of Health and Human Services SBIR Phase I: DESCRIPTION (provided by applicant): The long-term goal of the proposed research is the de

Description

DESCRIPTION (provided by applicant): The long-term goal of the proposed research is the design and construction of a medical device that will treat ischemic stroke by virtue of breaking-down endovascular occlusions using Oramic's proprietary Electro-Fluidic Thrombolysis (EFTTM) technology. The effect utilizes low-energy electrical pulses to efficiently emulsify clot into sub capillary particles. The overall system will consist of a low-cost pulsed voltage supply, and a disposable microcatheter capable of navigating the tortuous neurovasculature. EFT is expected to recanalize the occluded neurovasculature within 10 minutes from the onset of operation. When it comes to stroke time of treatment is brain. Currently available therapies to Interventional Neuro Radiologists (INRs) offer low performance as they take hours to complete the treatment. In the case of clot- busting drugs, the added contraindications limit their use to less than 4% of the population. Approximately 20% of those who suffer a stroke die shortly after the initial attack, while most survivors require full or part- time care. The expected speed and effectiveness of EFT will offer improved patient outcomes, and reduced costs; since in the case of stroke, lack of effective therapies are associated with enormous costs for rehabilitation and long term care. The main Phase I goal of the proposed work is to prove the feasibility of the EFT effect with in-vitro experiments that will (a) demonstrate the efficient emulsification of clot into subcapillaryparticles and (b) establish the optimum operating parameters of the pulsed voltage generator for the most efficacious manifestation of the effect (fastest rate of emulsification of clot material). To achieve that, prototype catheter tips will be constructed that contain a multitude of microelectrodes to be addressed by a switched, pulsed, power-supply. Benchtop emulsification experiments will be repeated to establish optimum operation of the overall effect by monitoring and maximizing the rate (weight of clot per unit time) of emulsification of a given set of experimental conditions. In a future Phase II study, the experiments will be extended into animal trials for the development of pre- clinical products (disposable microcatheter as well as low cost pulsed voltage generators) for the onset of a human clinical study, future FDA approval of the device, and its eventual commercialization. PUBLIC HEALTH RELEVANCE: Currently, the only FDA approved modality for an ischemic stroke indication is intravenous tPA; a clot- dissolving enzyme. Unfortunately due to severe contraindications, less than 4% of all ischemic stroke patients in the U.S. receive treatment with such drug; Cerebrovascular obstructions ( brain attacks ) remain largely untreated. It is clearthat alternative strategies for an ischemic stroke treatment be sought. To address this emerging public health issue, Oramic will develop a robust and disposable microcatheter used in conjunction with an inexpensive pulsed voltage power supply to addressendovascular occlusions in the brain within minutes from the onset of treatment.