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

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力与医疗保健领域的重大转变相一致，以减少医院获得性感染。仅在美国就有超过15亿美元的成本和60万天的额外住院天数，高危腹部手术患者的手术伤口感染是主要的医疗负担。此外，提供者和医院今天面临着对其伤口感染率的更严格审查，医疗改革的全面变化激励了这些关键利益攸关方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，现有的外科器械公司还没有开发出令人信服的产品流水线来满足这一未得到满足的需求。拟议的技术具有竞争优势，因为它在相对开放的竞争环境中运行，其独特的作用机制提供了全面的伤口保护战略。因此，无论从医疗质量还是从商业化的角度来看，这项技术都有可能对伤口感染产生重大的全球影响。这项技术的最初市场是结直肠手术，有大量机会扩展到其他腹部外科市场，总额超过10亿美元。拟议的项目旨在开发一种新技术并将其商业化，旨在预防最常见、最病态和最昂贵的医院获得性感染之一：手术伤口感染。这项技术是一种创新的手术工具，为伤口提供了全面的防污染策略，同时也方便了外科医生。该设备有可能成为外科护理质量的变革性创新，特别是在伤口感染最常见的350万接受高风险腹部胃肠道(GI)手术的患者中。这项技术还允许外科医生试验各种方法来确定最佳实践？用于术中伤口护理。这一第二阶段项目提出了三个主要目标。首先，该公司将通过数值建模和猪模型的临床前测试，完善对抗污染治疗的局部和系统治疗的科学理解，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大小，以支持广泛的商业化努力。第三，具有规模化制造能力的公司支持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.