The broader impact/commercial potential of this Small Business Innovation Research Program (SBIR) Phase I project will be a safe endovascular detoxification device for treatment of numerous acute and chronic pathologies. The proposed device could aid in the treatment of severe autoimmune disease patients and organ transplant patients, and furthermore, would clear up a path for safe use of viral gene therapy in the general population. It has the potential to decrease mortality and reduce the burden on the global healthcare expenditure for the widespread antibody-mediated pathological conditions. There is a societal need for a safe, cost-effective, fast-acting, widely-accessible, and easy-to-use system capable of rapid blood detoxification for treatment of pathological conditions. The markets targeted by the proposed device include the multibillion-dollar autoimmune disease, organ transplant rejection, and viral gene therapy markets, with the largest market opportunity being the global autoimmune disease therapeutics market that is expected to reach $153.3 billion by 2025.This Small Business Innovation Research Program (SBIR) Phase I project supports the development an endovascular blood IgG detoxification platform for rapid elimination of IgG antibodies for treatment of IgG-driven pathological conditions. Antibody-mediated immune response has been a key factor responsible for numerous acute and chronic pathological conditions including autoimmune diseases, transplant rejections, immune-mediated rejection in viral gene therapy. Currently, therapeutic apheresis and potent systemic immunosuppressives have been the main forms of management for IgG-driven pathologies. However, these forms of treatments are not patient-friendly, and in many cases do more harm than good. The proposed endovascular blood IgG detoxification device could potentially provide safe and rapid elimination of circulating IgGs, eliminating the need for unfavorable or in cases harmful treatments such as therapeutic apheresis or potent systemic immunosuppressives. The device will be comprehensively investigated in an ex vivo venous simulation system, testing its hemocompatibility, IgG-elimination capacity, and the influence of different parameters including rod material, rod diameter, rod length, flow rate, and therapeutic protein concentration. Furthermore, the safety, durability, immune response, and therapeutic efficacy of the device will be investigated in a lethal IgG-induced immune thrombocytopenic purpura (ITP) model in minipigs.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.
