The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) awarded a $350,000 Project Grant under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to Katharos, Inc., a for-profit woman-owned business based in Denver, Colorado. The goal of this 1-year project is to develop and evaluate a novel extracorporeal device called the "PhosFilter" that can enhance phosphate removal from the blood of patients undergoing hemodialysis for...
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) awarded a $299,999 Project Grant (CFDA 93.847) to Hibar Microsciences, LLC to develop a prototype for CLEAR, a novel hemodialysis cartridge designed to improve the clearance of protein-bound uremic toxins (PBUTs) from the blood of patients with end-stage renal disease. The key objectives are to: 1) Develop a method for immobilizing lipocalin proteins onto dialysis membrane matrices to enhance PBUT removal; 2) Create and...
The National Heart, Lung, and Blood Institute (NHLBI), under the federal Cardiovascular Diseases Research program (CFDA 93.837), awarded a $306,643 project grant to Mira Medical, LLC to develop a new extracorporeal membrane oxygenation (ECMO) pump designed to efficiently accommodate the low flow rates needed for pediatric and neonatal patients. The project aims to design, develop, and test a low-flow ECMO pump capable of operating at flow rates from 0.05 to 0.5 L/min, which is an order of...
This Project Grant award from the National Heart, Lung, and Blood Institute (NHLBI), under the Cardiovascular Diseases Research program (CFDA 93.837), supports the development of a novel bearingless (magnetically levitated) flux reversal motor for neonatal and pediatric extracorporeal life support applications. The $870,467 award to Ension Inc. aims to extend the operating range of this innovative blood pump technology to meet the high pressure and low flow requirements for cardiac and...
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 $704,672 to Flowpoint Medical Inc. to develop an implantable self-sealing needle guide system to improve vascular access and safety for hemodialysis patients. The award will fund the refinement of the device's manufacturability and operational parameters, as well as a large animal...
This $518,661 Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (CFDA 93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research) aims to advance the design of hemodialysis cartridges beyond the focus on urea removal. The project will test a novel parallel-plate dialyzer design that controls shear forces to potentially reduce platelet activation and clotting risks for the 548,000 Americans who rely on dialysis. The award to Vanderbilt...
This Project Grant award from the National Institute of Diabetes and Digestive and Kidney Diseases (CFDA 93.847) provides $171,639 to The Children's Hospital of Philadelphia (CHOP) to conduct a multi-omics investigation of uremic toxin sources and accumulation in children with kidney failure. The key goals are to: Characterize novel and known contributions of gut microbes to the biosynthetic pathways of selected uremic toxins using a multi-meta-omics approach. Identify differences in toxin...
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) awarded a $499,890 Project Grant (CFDA 93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research) to Pavaj Vascular Corporation to develop a novel therapy to prevent arteriovenous fistula (AVF) venous stenosis, a common complication in end-stage kidney disease patients requiring hemodialysis. The funding will support two main goals: 1) evaluating the stability and biocompatibility of a nanoparticle-based...
This Project Grant award of $3,740,270, 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), supports the development and evaluation of a subnormothermic (room temperature) oxygenated perfusion platform for extended preservation of high-risk kidney grafts. The awardee, Biomedinnovations, Inc. (BMI), is collaborating with investigators at the Duke Ex Vivo Organ Lab...
This Project Grant award from the National Heart Lung and Blood Institute (NHLBI) under the Cardiovascular Diseases Research program (CFDA 93.837) aims to develop a modern Electrical Impedance Tomography (EIT) device for monitoring children in the Intensive Care Unit (ICU). The $299,900 award to Goodlife Inventors LLC will fund efforts to (1) generate initial designs for an advanced lightweight EIT belt and (2) assess the technical feasibility of a miniaturized, easier to use EIT core device. If...
KIDNEY SUPPORT IN PEDIATRIC PATIENTS USING AN ULTRAFILTRATION DEVICE - ABSTRACT KORONIS BIOMEDICAL TECHNOLOGIES (KBT) PROPOSES TO DEVELOP AND FULLY EVALUATE A RENAL REPLACEMENT THERAPY (RRT) MACHINE SPECIFICALLY TARGETED FOR CRITICALLY-ILL SMALL CHILDREN AND NEONATES WITH ACUTE KIDNEY INJURY (AKI), FLUID OVERLOAD, AND KIDNEY FAILURE. IN RECENT YEARS, CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) HAS EMERGED AS THE PREFERRED METHOD FOR PROVIDING KIDNEY SUPPORT TO THESE PATIENTS, ESPECIALLY THOSE WHO ARE HEMODYNAMICALLY UNSTABLE. CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) IS A FORM OF CRRT BUILT ON HEMOFILTRATION: WASTE PRODUCTS AND FLUID IN PLASMA ARE REMOVED FROM THE BLOOD BY A PRESSURE GRADIENT OVER A FILTER, WHILE A REPLACEMENT FLUID IS INFUSED TO MAINTAIN FLUID BALANCE. UNFORTUNATELY, NEONATES INFREQUENTLY RECEIVE RENAL REPLACEMENT THERAPY DUE TO THE TECHNICAL CHALLENGES OF TRADITIONAL CRRT MACHINES THAT MAKE THERAPY INITIATION VERY DIFFICULT, EVEN AT EXPERIENCED TERTIARY CHILDREN'S HOSPITALS. MACHINES DESIGNED FOR ADULT- SIZED PATIENTS, BUT COMMONLY USED IN PEDIATRIC CARE, REQUIRE LARGE CATHETERS, TUBING, AND FILTERS. THIS RESULTS IN A HIGH EXTRACORPOREAL VOLUME (ECV, THE TOTAL VOLUME OF BLOOD IN THE EXTERNAL CIRCUIT-THE TUBING AND HEMOFILTER) RELATIVE TO A SMALL PATIENT'S SIZE, AS WELL AS HIGHER BLOOD FLOWS, HIGHER CLEARANCE RATES, AND HIGHER RISKS. NUMEROUS MEDICAL CENTERS DO NOT EVEN OFFER CRRT TO INFANTS, LET ALONE FOR CRITICALLY-ILL NEONATES OR PREMATURE INFANTS, DUE TO THE INHERENT RISKS. AT THERAPY INITIATION, A VOLUME OF FLUID ROUGHLY EQUIVALENT TO THE ECV MUST BE INJECTED INTO THE BLOOD CIRCUIT TO "PRIME" THE PUMP. FOR CRRT IN LARGER CHILDREN AND ADULTS, THE PRIMING FLUID IS SIMPLY SALINE. IF, HOWEVER, THE AMOUNT OF FLUID REQUIRED TO PRIME THE CIRCUIT IS GREATER THAN 10% OF THE PATIENT'S TOTAL BLOOD VOLUME, THE SALINE FLUID COULD SIGNIFICANTLY DILUTE THE PATIENT'S BLOOD, LEADING TO HEMODYNAMIC INSTABILITY. TO AVOID THIS OUTCOME, A DONOR "BLOOD PRIME" IS USED, THOUGH IT IS NOT WITHOUT RISKS, SUCH AS HYPOCALCEMIA, ACIDOSIS, HYPERKALEMIA, AND A LOSS OF PLATELETS AND COAGULATION FUNCTIONS. KBT'S PHASE II SBIR PROJECT PROPOSES TO BRING A NEW CRRT DEVICE WITH A LOWER ECV TO MARKET THAT IS SPECIFICALLY TARGETED FOR SMALL CHILDREN AND NEONATES, ELIMINATING THE NEED FOR BLOOD PRIMES. THE PERFORMANCE AND SAFETY OF THE PROPOSED HIGHLY INTEGRATED CRRT SYSTEM WILL BE EVALUATED IN A CLINICAL TRIAL.