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

这项小企业创新研究（SBIR）第一阶段项目旨在对一种新技术进行技术可行性研究和临床前测试，该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。这个第一期项目提出了三个主要目标。首先，设备的设计和工程？S的关键抗感染机制将通过定量计算机建模和台式测试最终确定，然后在人体尸体上与外科医生进行定性验证。第二，将在适当的设计控制下建立第一批灭菌的原型。第三，这些原型将在大型动物手术模型中进行安全性和技术有效性测试。如果这些目标得到满足，II期活动将包括生产工艺的最终确定，人体临床试验的启动，以及FDA监管许可的申请。该项目的广泛影响/商业潜力与医疗保健的重大转变相一致，以提高患者护理的质量。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在伤口感染率方面面临更严格的审查，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，目前的解决方案已被证明是不够的，并且在手术器械领域的大型现有战略公司在市场上没有引人注目的产品。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。这项技术最初的市场是在结肠直肠手术中；在300美元的高度竞争性价格点上，这意味着最初的目标市场为5亿美元。向其他腹部手术的大量扩张机会将潜在市场总额提高到10亿美元。

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.