SBIR Phase I: Preventing surgical wound infections in high-risk abdominal surgery

This Small Business Innovation Research (SBIR) Phase I project seeks to conduct technical feasibility research and pre-clinical testing of a novel technology designed to prevent one of the most frequent, morbid, and costly hospital-acquired infections: surgical wound infection. The technology is an innovative surgical tool that provides a comprehensive anti-contamination strategy for the wound that is also user-friendly for the surgeon. This device has the potential to be a transformative innovation in the quality of surgical care, particularly in the 3.5 million patients undergoing high-risk abdominal-gastrointestinal (GI) surgery in whom wound infections are the most common. This Phase I project proposes three main objectives. First, the design and engineering of the device?s critical anti-infective mechanism will be finalized using quantitative computer modeling and benchtop testing, and then validated qualitatively with surgeon-users in a human cadaver. Second, an initial batch of sterilized prototypes will be built under appropriate design controls. Third, these prototypes will be tested for safety and technical efficacy in a large animal surgical model. If these objectives are met, Phase II activities will include finalization of manufacturing processes, initiation of clinical trials in human subjects, and application for FDA regulatory clearance. The broader impact/commercial potential of this project aligns with a major shift in healthcare to improve the quality of patient care. At a cost of over $1.5B and 600,000 extra hospital days in the US alone, surgical wound infection in high-risk abdominal surgery patients is a major healthcare burden. In addition, providers and hospitals face greater scrutiny on their wound infection rates today, and the sweeping changes in healthcare reform have incentivized these critical stakeholders to invest in preventative solutions. However, current solutions have been shown to be insufficient, and the large existing strategic companies in the surgical device space have no compelling products on the market. The proposed technology enjoys a competitive advantage in that it operates in a relatively open competitive landscape, and its unique mechanism of action provides a comprehensive wound protection strategy. Thus, this technology has the potential to make a significant worldwide impact on wound infection, both from a healthcare quality and commercialization standpoint. The initial market for this technology is in colorectal surgery; at a highly-competitive $300 price point, this translates to an initial target market of $500 million. Ample expansion opportunities to other abdominal operations raise the total potential market to $1 billion.