SBIR Phase II: Endoluminal Fixation of a Distraction Enterogenesis Device

SBIR 第二阶段：牵引肠发生装置的腔内固定

• 批准号: 2232550
• 负责人: Andre Bessette
• 金额: $ 97.05万
• 依托单位: ECLIPSE ENTEROGENESIS, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2232550&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Endoluminal; Fixation

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the advancement of an innovative therapy for Short Bowel Syndrome. Compared to current non-curative treatments that are chronic and associated with dangerous complications, rehospitalization, and high mortality, the proposed solution has the potential to substantially improve outcomes and quality-of-life for patients and their families. The potential commercial impact of this project is likewise substantial. Treating short bowel syndrome currently costs hundreds of thousands of dollars per patient per year. adds more than $5 billion to US healthcare expenditures annually. Thus, the proposed curative solution can lead to enormous savings in dollars and in specialists’ time.This Small Business Innovation Research (SBIR) Phase II project will create a curative therapy for patients with Short Bowel Syndrome, which is currently managed with intravenous nutrition and lacks effective treatments. The proposed solution will lengthen the intestine, increasing the absorptive surface area and restoring the natural function of the gut, enabling patients to get sufficient nutrition from the food they eat. The proposed system comprises nondestructive tissue anchors and a spring that pushes against them to stretch the intestine and force it to grow. Having previously developed the tissue anchors, this project develops a delivery method that will allow the system to be implanted in the intestine through a minimally invasive procedure. Feedback will be gathered from pediatric gastroenterologists and surgeons about the delivery method, and device performance will be measured in pre-clinical large-animal studies. Successful completion of the proposed project will demonstrate intestinal lengthening in vivo, achieved via a minimally invasive procedure, and establish a foundation for planning subsequent preclinical testing that will be required for regulatory approval to commercialize the product.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.

这个小企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力是短肠综合征的创新疗法的进步。与目前的非治愈性治疗相比，这些治疗是慢性的，与危险的并发症，再住院和高死亡率相关，所提出的解决方案有可能大大改善患者及其家属的结局和生活质量。该项目的潜在商业影响同样巨大。治疗短肠综合征目前每年花费数十万美元。每年为美国医疗保健支出增加50多亿美元。因此，所提出的治疗方案可以节省大量的资金和专家的时间。这个小型企业创新研究（SBIR）二期项目将为短肠综合征患者创造一种治疗方法，目前这种疾病通过静脉营养进行管理，缺乏有效的治疗方法。拟议的解决方案将延长肠道，增加吸收表面积，恢复肠道的自然功能，使患者能够从他们吃的食物中获得足够的营养。所提出的系统包括非破坏性组织锚和弹簧，弹簧推压它们以拉伸肠道并迫使其生长。在先前开发了组织锚钉之后，该项目开发了一种输送方法，该方法将允许通过微创手术将系统植入肠道。将从儿科胃肠病学家和外科医生那里收集关于输送方法的反馈，并将在临床前大动物研究中测量器械性能。该项目的成功完成将展示通过微创手术实现的体内肠延长，并为计划随后的临床前测试奠定基础，这些测试将需要监管机构批准才能将产品商业化。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。