SBIR Phase II: A Novel Device Alternative to Temporary Ostomies

SBIR 第二阶段：替代临时造口的新型设备

• 批准号: 2127137
• 负责人: Kenton Fong
• 金额: $ 99.97万
• 依托单位: Savage Medical Inc.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2127137&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Novel; Device

The broader impact of this Small Business Innovation Research (SBIR) Phase II project is to improve the care and quality of life of colon cancer patients while reducing healthcare costs. The development of a reliable, reversible, and cost-effective means to protect segments of bowel has potential applications to treating a number of common disease conditions such as colon cancer, Crohn’s disease, ulcerative colitis, diverticulitis, ischemic bowel disease, and abdominal trauma. There are more than 120,000 temporary ostomies (surgical openings) performed each year in the US, and a majority of these can be eliminated with the development of the funded technology, addressing a $6.4 Billion total market opportunity. This funded device will initially target the over 40,000 individuals who have low bowel resections, the majority for rectal cancer. This represents an initial market size of $200 million in US. The overall impact with full market penetration in just the US rectal resection market is $2.4 billion in savings.This Small Business Innovation Research (SBIR) Phase II project advances the development of a novel technology to protect segments of bowel. Colorectal cancer is the third most common cancer with about 30-40% of cases involving the rectum. Rectal cancer is typically treated with surgical resection. However, anastomotic leaks can occur in up 10-18% of patients after resection, with an associated high mortality due to severe abdominal sepsis. Currently, diverting ostomies are typically placed above the anastomosis to mitigate the severe consequences of an anastomotic leak, but temporary ostomies themselves are highly morbid, have significant risk of mortality, are expensive to the healthcare system, and drastically impact patient’s quality of life. The funded technology is a medical device that provides temporary, minimally invasive protection of bowel during the healing process, avoiding the need for a diverting ostomy. This project will perform design verification testing, end user testing, and large animal validation testing required for human study approval. The goal of this project is to have a fully validated (both benchtop and animal testing completed), clinically ready medical device ready for further development.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

这项小型企业创新研究（SBIR）II期项目的更广泛影响是改善结肠癌患者的护理和生活质量，同时降低医疗保健成本。一种可靠，可逆和成本效益的方法来保护肠道段的一种潜在应用，可以治疗许多常见疾病，例如结肠癌，克罗恩病，溃疡性结肠炎，憩室炎，缺血性肠病和腹部创伤。在美国，每年都有超过120,000个临时术（外科开放）进行，其中大多数可以随着资助技术的开发而消除，这是64亿美元的总市场机会。该资助的装置最初将针对40,000多名肠切除率低的人，即直肠癌的大多数。这代表美国的初始市场规模2亿美元。仅美国直肠切除市场的全面市场渗透率的总体影响为24亿美元的储蓄。这项小型企业创新研究（SBIR）第二阶段项目推进了一种新型技术，以保护肠道的细分市场。结直肠癌是第三大常见的癌症，约有30-40％的直肠病例。直肠癌通常通过手术切除治疗。然而，在切除后10-18％的患者中可能发生吻合术泄漏，由于严重的腹部败血症而导致高死亡率相关。目前，转移术通常位于吻合术上方，以减轻吻合式泄漏的严重后果，但是临时的骨质本身高度病态，死亡率很大，对医疗保健系统的昂贵，并且对患者的生活质量产生了巨大影响。资助的技术是一种医疗装置，可在愈合过程中为肠提供暂时的，微创的肠道保护，从而避免进行转移造口术。该项目将执行设计验证测试，最终用户测试以及人类研究批准所需的大型动物验证测试。该项目的目的是对临床准备的医疗设备进行全面验证（台式和动物测试完成），准备进一步开发。该奖项反映了NSF的法定任务，并通过使用基金会的知识分子优点和更广泛的影响评估标准来评估值得支持。