SBIR-STTR Award

End-Stage Renal Disease (ESRD) affects just over 600,000 people in the United States and costs Medicare ~$33 billion annually. In-center thrice-weekly hemodialysis is the most commonly performed treatment for ESRD, but it suffers from poor 5-year survival rates, reduced patient quality of life, and is costly. In contrast, daily-extended hemodialysis has demonstrated 5-year survival rates similar to kidney transplant and has improved intermediate outcomes. Even though daily-extended hemodialysis yields superior outcomes than in- center thrice-weekly hemodialysis, it is performed by less than 1% of the ESRD population because it is too costly to perform in-center and too complex to perform at home. Current home hemodialysis systems require patients and caregivers to perform complicated tasks associated with life threatening risks, such as self-care needle sticks. The superior outcomes but low adoption rate of daily-extended home hemodialysis creates an opportunity for a simple-to-use and safe home hemodialysis system. The long-term objective of our project is to create a new home hemodialysis system (nHHD) that will increase the practice of daily-extended home hemodialysis and improve End-Stage Renal Disease (ESRD) outcomes. This NIH SBIR Phase I proposal aims to demonstrate the feasibility of the nHHD that will empower ESRD patients to perform daily-extended home hemodialysis and consequently receive the associate health benefits.

Thesaurus Terms:
Adoption;Affect;Anemia;Biocompatible;Biological Markers;Biomaterial Compatibility;Blood;Blood Coagulation;Blood Flow;Blood Platelets;Blood Vessels;C-Reactive Protein;Canis Familiaris;Cannulations;Cardiovascular System;Caregivers;Complex;Cost;Data;Deposition;Design;Devices;Dialysis Procedure;Disease Outcome;Empowered;End Stage Renal Failure;Expenditure;Fda Approved;Fluid Flow;Fracture;Goals;Haptoglobins;Health;Health Benefit;Hemodialysis;Hemolysis;Home Environment;Home Hemodialysis;Housing;Implant;Improved;In Vitro;Inflammation;Interleukin-6;Kidney;Kidney Transplantation;Lactate Dehydrogenase 3;Life;Mechanics;Medicare;Membrane;Metabolism;Minerals;Modeling;Nanopore;Needlestick Injuries;Outcome;Patients;Performance;Performance Tests;Phase;Phase 2 Study;Physiology;Population;Property;Proteins;Pump;Quality Of Life;Risk;Risk Reduction;Self Care;Side;Silicon;Sleep;Small Business Innovation Research Grant;Survival Rate;System;Technology;Testing;Thrombosis;Thrombus;United States;United States National Institutes Of Health;Urea;Venous;

End-Stage Renal Disease (ESRD) affects just over 600,000 people in the United States and costs Medicare ~$33 billion annually. In-center thrice-weekly hemodialysis is the most commonly performed treatment for ESRD, but it suffers from poor 5-year survival rates, reduced patient quality of life, and is costly. In contrast, frequent hemodialysis has demonstrated 5-year survival rates similar to kidney transplant and has improved intermediate outcomes. Even though frequent hemodialysis yields superior outcomes than in-center thrice- weekly hemodialysis, it is performed by less than 1% of the ESRD population because it is too costly to perform in-center and too complex to perform at home. Current home hemodialysis systems require patients and caregivers to perform complicated tasks associated with life threatening risks, such as self-care needle sticks. The superior outcomes but low adoption rate of frequent home hemodialysis creates an opportunity for a simple-to-use and safe home hemodialysis system. The long-term objective of our project is to create a new home hemodialysis system (the iHemo) that will increase the practice of frequent home hemodialysis and improve End-Stage Renal Disease (ESRD) outcomes.

Public Health Relevance Statement:
Project Narrative End-Stage Renal Disease (ESRD) affects over 600,000 people in the US and costs Medicare approximately 33 billion dollars annually. Silicon Kidney is developing a new dialysis treatment that will improve ESRD patient outcomes, increase patient quality of life, and significantly reduce Medicare's expenditures on ESRD.

Project Terms:
Adoption; Affect; Anemia; Animal Model; Animals; biomaterial compatibility; Biomimetics; Blood; Blood flow; Blood Vessels; Cannulations; Caregivers; Clinical; Clinical Research; Complex; cost; design; Dialysis procedure; Disease Outcome; End stage renal failure; Expenditure; Family suidae; first-in-human; fluid flow; Future; Goals; Hemodialysis; Home environment; Home Hemodialysis; Housing; human study; Implant; implantation; improved; in vivo; Infection; Kidney; Kidney Transplantation; Legal patent; Life; mechanical properties; Mechanics; Medicare; Membrane; Metabolism; Minerals; Modeling; nanopore; Needlestick Injuries; Outcome; Patient-Focused Outcomes; Patients; performance tests; Peritoneal Dialysis; Phase; Physiology; Population; pre-clinical; pressure; prototype; Pump; Quality of life; Risk; Risk Reduction; Safety; Self Care; Side; Silicon; Site; Sleep; Small Business Innovation Research Grant; Survival Rate; System; targeted biomarker; Technology; Testing; United States; Urea