Eclipse Regenesis, Inc. received a $970,484 Project Grant from the National Science Foundation (NSF) under the Technology, Innovation, and Partnerships program to develop a minimally invasive delivery method for their distraction enterogenesis device to treat short bowel syndrome. The device uses nondestructive tissue anchors and a spring to stretch the intestine and promote intestinal lengthening, restoring natural nutrient absorption in patients who currently rely on intravenous nutrition....
The U.S. Food and Drug Administration (FDA) awarded a $741,663 Project Grant under the FDA Research program (CFDA 93.103) to the University of Pittsburgh to define the natural history of pediatric intestinal failure (IF). The grant will utilize the existing International Intestinal Failure Registry to collect high-quality longitudinal data on demographics, clinical characteristics, nutrition, genotype, and outcomes for children with both short bowel syndrome-related IF and functional IF. In...
This Project Grant award of $295,000.00 from the National Science Foundation (NSF) under the NSF Technology, Innovation, and Partnerships (CFDA 47.084) program supports the development of a novel implantable system leveraging distraction osteogenesis as a treatment for diabetic foot ulcers (DFUs). The project aims to design and develop a low-profile implantable transverse tibial transport device with an active mechanical mechanism to transversely distract or retract a cut tibia bone segment in a...
This Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $722,908 to The Children's Hospital of Philadelphia to conduct research aimed at finding new ways to prevent and treat Hirschsprung disease-associated enterocolitis (HAEC), a life-threatening bowel inflammation. The key goals are to analyze stool metabolites, stool microbes, and gut...
This Project Grant award of $2,175,283.00 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) supports research to reprogram intestinal immunity and prevent/cure necrotizing enterocolitis (NEC) in preterm neonates. The research, led by the University of North Carolina at Chapel Hill, will utilize a large NEC biorepository with samples from thousands of premature infants to...
The federal Project Grant award R43DK137616 for $275,766.00 was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847). The award funds Biosurfaces Inc., a for-profit medical device company, to develop and evaluate an implantable, electrospun cell chamber device loaded with human pancreatic islets. The device aims to provide an immune-protected environment to support...
This Project Grant award from the National Center for Advancing Translational Sciences (NCATS) under CFDA 93.350 will provide $463,150 to The Regents of the University of California, San Francisco (UCSF) to establish proof-of-concept for enzyme replacement therapy (ERT) as a lifesaving treatment for sphingosine phosphate lyase insufficiency syndrome (SPLIS), an ultra-rare and often lethal metabolic disorder. The project aims to demonstrate the efficacy of ERT in preserving kidney function and...
This federal Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $324,984 to Syntis Bio Inc. to develop an oral therapeutic platform for treating homocystinuria, a rare metabolic disorder. Specifically, the project aims to optimize a formulation combining a methionine-gamma-lyase enzyme with a gastrointestinal synthetic epithelial lining to...
This federal Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847), provides $708,138 to support the development of a biomechanocompatible small molecule-releasing scaffold for bladder augmentation. The goal is to create an alternative to conventional surgical approaches that use detubularized bowel tissue, which can have significant complications. The...
This federal Project Grant award of $1,255,725.00 from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) aims to advance defined live biotherapeutic products (LBPs) for the treatment of recurrent Clostridioides difficile infection (rCDI) and ulcerative colitis. The key objectives are to: 1) Develop a solid-state fermentation platform to increase the scale and throughput of...
INTESTINAL LENGTHENING VIA DISTRACTION ENTEROGENESIS FOR THE TREATMENT OF SHORT BOWEL SYNDROME - 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.