This Small Business Innovation Research (SBIR) Phase I project aims to develop a topical formulation incorporating a polymeric platform that releases therapeutic levels of nitric oxide gas, and assess its efficacy in dispersing wound-relevant bacterial biofilms. The intellectual merit of the proposed project is built around the remarkable characteristics of the polymeric system, where under appropriate conditions this polymer can provide sustained release of nitric oxide over long periods of time and at low concentrations that are biocompatible. The benefit of this characteristic is substantial. Firstly, it avoids the toxicity problems associated with high levels of reactive species formed in response to concentrated nitric oxide release. Secondly, the low levels of nitric oxide release from the polymer will result in increased bioavailability of nitric oxide for promotion of wound healing. Taken together, the characteristics of the proposed nitric oxide releasing polymer prodrug may offer a significant improvement over current approaches to chronic wound treatment.
The broader impact/commercial potential of this project will be determined by market needs that the technology addresses. Colonization of surfaces by biofilms is a significant problem not only in the clinical field, but also across industry and environmental biotechnology sectors. As such, there is a growing requirement for technologies that can either prevent biofilm growth or disperse an existing biofilm, and that can be manufactured in a cost effective manner. The technology that is put forward for development in this Phase I proposal has characteristics that are in line with these requirements. By demonstrating successful development of a product for treatment of wound-related biofilms, a solid foundation will be put in place for exploring similar biofilm prevention or eradication needs across other market sectors.
Normal 0 false false false EN-US X-NONE X-NONE Overview Chronic wounds, including diabetic foot ulcers, pressure ulcers, and venous leg ulcers, are characterized by the presence of complex multi-species (polymicrobial) bacterial biofilms that are resistant to natural healing, systemic antibiotics, and generic topical biocides such as silver ion-releasing dressings. Recent research has demonstrated that wound-relevant bacterial biofilms are dispersed by physiological levels of nitric oxide (NO)—a ubiquitous gaseous signaling molecule that governs the normal function of multiple organ systems. As such, this NSF SBIR Phase I effort sought to initiate development and testing of a wound care technology that incorporates a NO-releasing polymer system. Results Nitric oxide released from the polymer effectively disrupts pathogenic biofilms formed in vitro. In comparison, a broad spectrum antibiotic had very little effect on biofilms, with the majority remaining intact after treatment. Furthermore, standardized in vitro biocompatibility assessment confirmed that the NO-releasing polymer system did not significantly impact mammalian cell viability when tested at levels relevant to biofilm disruption. Initial product development efforts demonstrated that the NO-releasing polymer system is compatible with common treatments currently available in the wound care market. Importantly, the inherent adaptability of this technology will enable its adoption across multiple biotechnology sectors where bacterial biofilms pose significant problems.
