The broader impact of this Small Business Innovation Research (SBIR) Phase I project lies in the development of an innovative universal embolization biomaterial for the treatment of aneurysms with the goal of stopping undesired blood flow through vessels anywhere in the body. Recent reports estimate aneurysm incidence of 6 million in the US alone. The mortality rate for aneurysm rupture alone are over 50%; 66% of those who survive a rupture suffer from major disabilities. Current benchmark treatments for aneurysms include coil embolization, in which trained radiologists push long metal wires with a coiled shape into the vessel until they are packed densely to slow and clot blood flow. While treatment options exist, most suffer from difficulty in administration, high treatment failure rate, and high cost. The proposed novel shear-thinning biomaterial (STB) technology offers an easy-to-use, cheaper and safer alternative to treat aneurysms. This approach has the potential to reduce procedure time, decrease radiation exposure, reduce world-wide morbidity and mortality, and provide access to a broad range of hospitals. The proposed project will generate the required data for a development of a robust, minimally invasive, and biocompatible STB product for treatment of aneurysms. In Objective 1, we will demonstrate STB off-the-shelf readiness, including stability over an adequate shelf life in a premixed, ready-to-use formulation, and biocompatibility through the ISO-10993 framework. These studies will demonstrate STB safety. In Objective 2, we will conduct preclinical toxicological and performance testing to demonstrate the durability, safety and efficacy of the STB embolic agent using a canine saccular aneurysm (SA) animal model to demonstrate biocompatibility of optimized STBs and successful delivery. Benchmarks include stoppage of blood flow and absence of recanalization within the aneurysm sac in a 60-day follow up time period. Other parameters to be studied include inflammation rates, proper adhesion, and immobility of the material upon exposure to the blood stream, with the goal of successful (>95%) exclusion from the circulation up to 60-day post embolization with epithelization along the lumen interface.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.
