SBIR-STTR Award

This Small Business Innovation Research phase I research addresses hospital infections which currently afflict 1.7 million patients and kill 99,000 in the US annually, the majority of which are associated with medical devices. Medical devices provide a surface for bacterial growth and, when penetrating the skin, a route for external bacteria to enter the bloodstream. If these infections reach the bloodstream, they lengthen average hospital stays from 5.4 to 20 days and cost up to $50,000 to treat. Existing antimicrobial coatings, which utilize the slow release of metals or other antibiotics, have a limited lifespan and increase concerns of bacterial drug resistance due to the distribution of active agent in the bloodstream. In contrast, SteriCoat is developing a coating in which the antimicrobial agent remains permanently attached to the medical device while providing antimicrobial protection. The broader impact of this development of a highly active, permanent antimicrobial coating, SteriCoat technology will be to help reduce these human and economic costs by preventing infection with fewer side effects and greater efficacy than existing, slow release coatings. The novelty and commercial potential of this technology has been recognized throughout the entrepreneurial community through awards such as first place in both the MIT 100K and the Oxford University business plan competitions. SteriCoat will first produce coated central venous catheters, which have a US market of approximately $350 million, but this highly versatile coating can be applied to devices of any size, shape, or material, leading to a host of follow on products to increase the commercial viability of the product and the impact of the product on the nation's health

This SBIR Phase II project continues SteriCoat's development of a permanent antimicrobial coating for use on central venous catheters. Current leaching antimicrobial technology does not possess the duration of efficacy required to protect these devices over the lifetime of implantation, especially for peripherally inserted central lines (PICCs). Research during this Phase II project will focus on the integration of proprietary polymer technology with tethered antimicrobial peptide (AmP) technology developed in Phase I to maximize the efficacy and bioavailability of the immobilized AmPs in vivo. Work will also be performed to ensure the manufacturability of SteriCoat's coating technology, including prototype production. After transitioning this formulation to the intra- and extraluminal surfaces of a polyurethane tube, efficacy and biocompatibility will be demonstrated both in vitro and in vivo. By the end of this Phase II project, SteriCoat will have an antimicrobial CVC model with efficacy proven in vivo using the models designed by industry thought leaders and will be ready for scale-up and manufacturing. This SBIR Phase II project addresses the hospital infections afflicting 1.7 million patients and killing 99,000 in the US annually, the majority of which are associated with medical devices. Existing slow-release antimicrobial coatings are insufficient in addressing device infection. They have a limited lifespan and concerns over drug resistance and toxicity because the drug gets distributed in the bloodstream. SteriCoat is developing a permanent coating using antimicrobial peptides (AmPs) to prevent bacterial colonization of central venous catheters (CVCs), a $350M market. The goal of this project is to deliver a polyurethane-based antimicrobial CVC model which incorporates a surface functionalization with AmPs and to test the ability of this approach in resisting bacterial colonization. By the end of this phase II project, SteriCoat will have verified in vivo efficacy of prototype catheters and be positioned to begin GLP studies for FDA product approval. In addition, achievement of the technical objectives of this Phase II will open up avenues for additional investigation in the field of bioactive ligand presentation as the developed technology could lend to the efficacy of many biomaterial applications in addition to antimicrobials.