ECLIPSE REGENESIS, INC. — Department of Health and Human Services SBIR Phase I: 300

Description

PROJECT SUMMARY Short Bowel Syndrome (SBS) is a rare, chronic, and devastating malabsorption condition where patients are unable to absorb enough nutrients naturally to sustain life. This condition is due to the loss of the majority of their small intestine from a massive surgical resection necessitated by certain diseases that destroy the small intestine. In the pediatric patient population, the most common diseases that lead to SBS are necrotizing enterocolitis, midgut volvulus, and intestinal atresia. In the adult population, diseases include Crohn’s, cancer, intestinal ischemia, and trauma. These conditions all result in the need for a massive resection of the small intestine leaving the patient without enough functional small intestine to absorb nutrients naturally. Current chronic therapies for SBS include, parenteral nutrition, expensive daily medication and intestinal surgery, which come at a staggering average 5-year cost of $1.6M per patient. It is estimated that the first year of treatment for a pediatric SBS patient is in excess of $500,000. Complications from daily parenteral nutrition include liver failure and central line infections (sepsis). Mortality rates as high as 30% by age 5 have been reported and none of the currently available treatments for SBS restore natural absorption of nutrients. Over the last decade, intestinal lengthening via distraction enterogenesis has emerged as a potential restorative treatment option for patients with short bowel syndrome. Preclinical research has shown that mechanical distraction devices can stimulate the growth of healthy small intestine tissue in multiple animal models. Literature has shown that for every additional 1% of expected small bowel a child possesses, the odds of weaning from parenteral support increases by 3% (Belza et al, 2019). The goal of this project is to move this emerging technology from the lab to the bedside by completing an FDA requested pre-clinical study, receiving IDE approval, and conducting a First-In-Human clinical trial. The Phase I portion of the project will produce the pre-clinical safety data on the final design of the Eclipse XL1 distraction enterogenesis device required for FDA IDE submission. Based on feedback from the FDA, Phase II will produce the First In Human clinical trial data in a stepwise fashion to ensure safety and probable benefit. If successful, this novel treatment will revolutionize the care of SBS patients and potentially return them to enteral autonomy.NARRATIVE Short Bowel Syndrome (SBS) is a rare, chronic, and devastating malabsorption condition caused by a lack of enough functioning small intestine. Current treatment options for SBS are extremely expensive, have significant side effects, and do not restore intestinal function. Via distraction enterogenesis, the Eclipse XL1 System is able to harness the body’s own tissue regenerative capabilities to produce new, fully functional intestine in vivo to help solve the SBS dilemma.