SBIR Phase II: Preventing surgical wound infections following high-risk abdominal surgery

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project aligns with a major shift in healthcare to reduce hospital acquired infections. 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 of their wound infection rates today, and the sweeping changes of healthcare reform have incentivized these critical stakeholders to invest in preventative solutions. However, currently available solutions are insufficient, and existing surgical device companies have not developed a compelling pipeline of products to address this unmet need. 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, with ample expansion opportunities into other abdominal surgical markets totaling over $1 billion. The proposed project seeks to develop and commercialize 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. The technology also allows surgeons to experiment with a variety of approaches to identify ?best practices? for intraoperative wound care. This Phase II project proposes three main objectives. First, the company will refine the scientific understanding of the local and systemic therapeutic of the anti-contamination therapy through numerical modeling and pre-clinical testing in a porcine model in order to provide clinical use recommendations. Second, the company will design and develop a product sized for laparoscopic surgeries in order to support a broad-based commercialization effort. Third, the company with develop scaled manufacturing capability to support commercial release of the CleanCision product platform.