SBIR Phase II: Endoluminal Fixation of a Distraction Enterogenesis Device

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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.