Although a relatively rare disorder that affects 24.5 infants in 100,000 live births, short bowel syndrome (SBS) carries significant morbidity and mortality. This condition refers to the inability of the digestive system to meet the nutritional demands of the body, secondary to a significant loss of intestinal length and thus absorptive surface area. The causes may be either congenital or acquired, and include necrotizing enterocolitis, intestinal atresia, gastroschisis, and midgut volvulus. Mortality of SBS is high at 20-40% as a result of numerous complications such as electrolyte and metabolic derangements, catheter-associated infections, renal failure, and liver failure. This rare condition also poses an incredible financial burden, as the median cost is estimated to be $1.6 million per child over a 5-year period.

Treatment of SBS is multifaceted and includes dietary supplements, total parenteral nutrition (TPN), and medications to slow gut transit and improve intestinal adapta...
Although a relatively rare disorder that affects 24.5 infants in 100,000 live births, short bowel syndrome (SBS) carries significant morbidity and mortality. This condition refers to the inability of the digestive system to meet the nutritional demands of the body, secondary to a significant loss of intestinal length and thus absorptive surface area. The causes may be either congenital or acquired, and include necrotizing enterocolitis, intestinal atresia, gastroschisis, and midgut volvulus. Mortality of SBS is high at 20-40% as a result of numerous complications such as electrolyte and metabolic derangements, catheter-associated infections, renal failure, and liver failure. This rare condition also poses an incredible financial burden, as the median cost is estimated to be $1.6 million per child over a 5-year period.

Treatment of SBS is multifaceted and includes dietary supplements, total parenteral nutrition (TPN), and medications to slow gut transit and improve intestinal adaptation, the natural process by which the intestine deepens its mucosal folds to increase surface area and nutrient absorption. Some patients may an undergo invasive surgery called "intestinal tailoring", to maximize bowel length, but the risk of these procedures often outweighs the probable benefit of weaning patients from TPN. Ultimately, patients may need an intestinal transplant, but 5-year survival for pediatric patients after transplant is 74.6%. As such, new and improved therapies are being sought to help patients with SBS.

Distraction enterogenensis utilizes mechanical force to generate new intestine. Based on over a decade of research development work, we have shown that it is feasible to triple the length of the intestine in murine and porcine animal models. This is accomplished through the placement of a compressed, helical spring in the lumen of the intestine, secured on each end by a sutured plication. Within 3 weeks, the intestine grows in response to the applied mechanical force. We have shown that the newly generated intestinal tissue is functional, as evidenced by mucosal hypertrophy and neovascularization (intestinal adaptation). The goal of the company is to develop a commercial product that can be used in the clinical setting.

We are in the process of submitting an FDA application to qualify our product as a Humanitarian Use Device. This will allow us to initiate a first-in-human trial to demonstrate the feasibility and safety in 5-10 patients.
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