SBIR-STTR Award

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop a dialysis-like platform for selective bacterial separation and removal from blood. This technology could potentially serve as a novel blood cleansing therapy for the treatment of disease, including sepsis. Sepsis, a life threatening organ dysfunction caused by infection, is a condition where the risk of death is extremely high (25%-72%), yet no effective treatments exist. In the US, over 1M people suffer from sepsis annually. Sepsis is the most expensive condition treated in U.S. hospitals, costing more than $20 billion per year. There are currently no approved therapies in the US to treat sepsis. This developing technology will serve as an effective, next-generation sepsis treatment through the direct removal of pathogens and associated toxins from blood. The technology in this project holds many advantages over competitors, including increased effectiveness, hemocompatibility, elimination of pore size limitations, and elimination of clogging issues. Commercialization of this innovation may reduce sepsis-associated length of stay, decrease mortality rates, and potentially reduce the current $23.7B annual US expenditure for sepsis. Fundamental understanding generated by this work has alternative applications, including the development of diagnostic devices for rapid infection detection.The proposed project seeks to leverage the unique properties of a novel, fluidic platform to provide a more effective and rapid method of bacterial and endotoxin removal from circulation for the treatment of sepsis. Sepsis is one of the leading causes of death worldwide and no effective therapy exists for the syndrome. The anticipated research involves 1) scale up of the device for operation at flow rates suitable for humans, 2) developing features for bacteria and endotoxin capture, and 3) evaluation of the rate of bacterial and endotoxin capture from fluid circulating through the scaled-up fluidic platform. It is anticipated that this work will result in a fluidic platform capable of removing pathogens and associated toxins from blood at a clinically translatable flow rate. The goal of this work is to provide an easy to use, cost-effective fluidic platform for separation and capture of bacteria and associated toxins from circulating fluid and to facilitate the use offluidic platforms as research tools. Successful completion of these studies will establish the commercial viability of the fluidic platform and enable the subsequent development of a prototype device for field testing.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will be the development of a fluidic platform for selective bacterial and endotoxin removal from blood. This technology can potentially serve as a novel blood cleansing therapeutic for diseases such as sepsis. Sepsis is a life-threatening complication caused by infection. In the U.S., sepsis afflicts over 1.6 million annually and has an associated mortality rate ranging from 25-50%. Realization of this fluidic platform technology will address the broader societal needs of inhibiting sepsis progression and developing more specific and effective therapeutics for the treatment of human disease. Commercialization and implementation of the proposed innovation may reduce the hospital length of stay associated with sepsis, decrease sepsis morbidity and mortality rates, and potentially reduce the annual U.S. expenditure for sepsis. Scientific and technological understanding generated by this work has additional applications for other blood-borne diseases, such as HIV, leukemia, and Lyme disease. Ultimately, this technology will revolutionize life science research through inertial-based fluidic platform use, enabling new discoveries in cell/particle focusing phenomena and interactions that have profound implications for elucidating inertial focusing mechanisms and for the development of novel platform technologies.This Small Business Innovation Research (SBIR) Phase II project proposes a novel approach to address the problem of sepsis through the direct removal of pathogens and associated toxins from circulation. Sepsis is the leading cause of death of the critically ill in the United States, costing over $24 Billion in treatment annually. The primary treatment for sepsis is system antibiotic administration, which is failing due to the rise of drug resistance and new, emerging pathogens. The research objectives of this project will result in an easy to use, efficient, and cost-effective fluidic platform for separation and removal of bacteria and associated toxins from circulation. This will facilitate the broad use of inertial-based fluidic platforms as research tools and for clinical applications, such as sepsis. The proposed research will 1) optimize fluidic platform design for clinical application, economical use, and workflow efficiency, 2) demonstrate efficient fluidic platform-mediated bacteria and endotoxin capture, and 3) confirm the biological benefits of the fluidic platform technology using a validated animal model of sepsis. Successful completion of these studies will demonstrate the positive biological consequences of direct pathogen and toxin removal from circulation and establish the commercial viability of the fluidic platform technology.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.