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

这个小企业创新研究（SBIR）第二阶段项目的更广泛影响/商业潜力与医疗保健的重大转变相一致，以减少医院获得性感染。仅在美国，高风险腹部手术患者的手术伤口感染就造成了超过15亿美元的成本和60万额外的住院天数，是一个主要的医疗负担。此外，医疗服务提供者和医院今天面临着更严格的伤口感染率审查，医疗改革的全面变化激励了这些关键利益相关者投资于预防性解决方案。然而，目前可用的解决方案是不够的，现有的手术器械公司还没有开发出令人信服的产品管道来解决这一未满足的需求。所提出的技术具有竞争优势，因为它在一个相对开放的竞争环境中运作，其独特的作用机制提供了一个全面的伤口保护策略。因此，无论从医疗质量还是商业化的角度来看，这项技术都有可能在全球范围内对伤口感染产生重大影响。这项技术的最初市场是结肠直肠手术，在其他腹部手术市场有充足的扩展机会，总计超过10亿美元。拟议的项目旨在开发和商业化一种新技术，旨在预防最常见、最病态、最昂贵的医院获得性感染之一：手术伤口感染。该技术是一种创新的手术工具，为伤口提供了全面的抗污染策略，对外科医生来说也是用户友好的。该设备有潜力成为外科护理质量的革命性创新，特别是在350万接受高危腹胃肠道（GI）手术的患者中，伤口感染是最常见的。该技术还允许外科医生试验各种方法来识别？最佳实践?用于术中伤口护理。这个第二期项目提出了三个主要目标。首先，公司将通过数值模拟和猪模型临床前试验，完善对抗污染治疗局部和全身治疗的科学认识，以提供临床使用建议。其次，该公司将设计和开发一种适合腹腔镜手术的产品，以支持广泛的商业化努力。第三，该公司具有开发规模制造能力，以支持CleanCision产品平台的商业发布。

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.