SBIR Phase II: Endoluminal Fixation of a Distraction Enterogenesis Device

小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力是短肠综合征创新疗法的进步。与目前的非根治性治疗相比，这些治疗都是慢性的，并与危险的并发症、再住院和高死亡率有关，建议的解决方案有可能显著改善患者及其家人的结局和生活质量。这一项目的潜在商业影响同样是巨大的。目前，短肠综合征的治疗费用为每位患者每年数十万美元。美国每年的医疗支出增加超过50亿美元。因此，拟议的根治解决方案可以在美元和专家的时间上节省大量资金。这个小企业创新研究(SBIR)第二阶段项目将为短肠综合征患者创造一种根治疗法，这种综合症目前通过静脉营养进行管理，缺乏有效的治疗。建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，使患者从所吃的食物中获得足够的营养。拟议的系统由非破坏性组织锚和一个弹簧组成，弹簧推动组织锚拉伸肠道并迫使其生长。在之前开发了组织锚之后，这个项目开发了一种输送方法，可以通过微创程序将该系统植入肠道。儿科胃肠病专家和外科医生将收集有关给药方法的反馈，并将在临床前的大型动物研究中测量设备性能。拟议项目的成功完成将展示通过微创程序实现的活体肠道延长，并为规划后续的临床前试验奠定基础，该试验将需要监管部门的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智力优势和更广泛的影响审查标准进行评估，被认为值得支持。

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.