Regenesis

HEALTH CENTER CLUSTER

HEALTH CENTER CLUSTER

AMERICAN RESCUE PLAN ACT FUNDING FOR HEALTH CENTERS

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.

SBIR PHASE II: ENDOLUMINAL FIXATION OF A DISTRACTION ENTEROGENESIS DEVICE -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.

FY 2021 ENDING THE HIV EPIDEMIC - PRIMARY CARE HIV PREVENTION

HEALTH CENTER CORONAVIRUS AID, RELIEF, AND ECONOMIC SECURITY (CARES) ACT FUNDING

HEALTH CENTER INFRASTRUCTURE SUPPORT

FISCAL YEAR 2023 CAPITAL ASSISTANCE FOR HURRICANE RESPONSE AND RECOVERY EFFORTS (CARE)

ARRA - CAPITAL IMPROVEMENT PROGRAM

AFFORDABLE CARE ACT (ACA) GRANTS FOR SCHOOL-BASED HEALTH CENTERS CAPITAL PROGRAM

THE COMMUNITY BASED DOULA PROGRAM

FY 2020 EXPANDING CAPACITY FOR CORONAVIRUS TESTING (ECT)

SBIR PHASE I: ENDOLUMINAL FIXATION OF A DISTRACTION ENTEROGENESIS DEVICE

FY 2023 EXPANDING COVID-19 VACCINATION

ARRA - INCREASE SERVICES TO HEALTH CENTERS

FY 2020 CORONAVIRUS SUPPLEMENTAL FUNDING FOR HEALTH CENTERS

FY 2023 BRIDGE ACCESS PROGRAM

HOUSING COUNSELING ASSISTANCE PROGRAM

HOUSING COUNSELING ASSISTANCE PROGRAM

HOUSING COUNSELING

HOUSING COUNSELING

HOUSING COUNSELING ASSISTANCE PROGRAM