An intracorporeal hemodialysis system (IHEMO) enabling home hemodialysis

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Silicon Kidney LLC $354,500 on September 1, 2026, under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847) to develop an Intracorporeal Hemodialysis System (IHEMO) enabling home hemodialysis for end-stage kidney disease patients.

Silicon Kidney LLC will develop and advance toward commercialization an implanted hemodialyzer (hemocartridge) that creates permanent vascular connections between a patient's vasculature and the device, eliminating the need for daily self-cannulation and associated risks of needle dislodgement and exsanguination. The system simplifies home hemodialysis by allowing patients to attach transcutaneous dialysate ports to the implanted hemocartridge, reducing operator error and barriers to frequent and prolonged intensive hemodialysis. This innovation addresses adoption barriers that have kept intensive hemodialysis—which offers survival rates comparable to kidney transplant—to fewer than 2 percent of the end-stage kidney disease population.

The award period runs from September 1, 2026, through August 31, 2027, with work performed in San Ramon, California. Silicon Kidney LLC is a self-certified small disadvantaged business specializing in silicon nanopore membrane technology for biomedical applications.

Abstract

Our ultimate objective is to develop and commercialize the first implanted hemodialyzer (HEMOCARTRIDGE) enabling safe and patient-centered intracorporeal hemodialysis system (ihemo dialysis system) lowering the barriers to frequent and prolonged home hemodialysis for end-stage kidney disease (ESKD) patients. In contrast to the poor 5-year survival rates (~35%) of in-center thrice-weekly hemodialysis, frequent and prolonged ("intensive") hemodialysis has demonstrated better quality of life, and in several studies, 5-year survival rates similar to kidney transplant (~80%). Unfortunately, intensive hemodialysis is performed by less than 2% of the ESKD 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 vascular cannulation with the risk of exsanguination and infection. The low adoption rate of home hemodialysis highlights the need for a simple-to-use and safe system for patients to perform self-care hemodialysis. Ihemo will simplify the tasks and reduce the risks of hemodialysis by creating permanent vascular connections between the patient's vasculature and the HEMOCARTRIDGE, thus eliminating daily self-cannulation and risks of exsanguination. Implanting the hemodialyzer (HEMOCARTRIDGE) permanently internalizes the blood loop and eliminates recurrent vascular cannulation by the patient or caregiver. This single innovation overcomes the three most cited barriers to self-care home hemodialysis: (1) vascular access by cannulation, (2) accidental needle dislodgement causing exsanguination, and (3) operator error of the extracorporeal blood pump. In practice, hemodialysis with ihemo will be performed by simply attaching the transcutaneous dialysate ports of the implanted HEMOCARTRIDGE to the external dialysate pump by dialysate tubing (analogous to peritoneal dialysis). Ihemo's key technology is a proprietary high-efficiency membrane with biomimetic pores: the silicon nanopore membrane (SNM). This sbir phase I project will demonstrate ihemo's long-term performance feasibility by achieving long-term (3-MONTH) in vivo HEMOCARTRIDGE performance (blood compatibility and filtration) in the anephric porcine model (aim 1) and by establishing long-term in vitro HEMOCARTRIDGE durability in a 3-MONTH benchtop accelerated aging study (aim 2). After the successful completion of this sbir phase I project, both a phase II project and private funds will complete the remaining pre-clinical testing and the first-in-human (FIH) study.