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An intracorporeal hemodialysis system (iHemo) enabling home hemodialysis

Award Number: R43DK146593
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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An intracorporeal hemodialysis system (iHemo) enabling home hemodialysis - Project Summary 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2027 ( Subtotal = $0 )
2027	2026	SILICON KIDNEY LLC	255 KANSAS ST STE 300	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/21/2026	NEW	$0
														Subtotal = $0

Issue Date FY: 2026 ( Subtotal = $354,500 )
2026	2026	SILICON KIDNEY LLC	255 KANSAS ST STE 300	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/25/2026	NEW	$354,500
														Subtotal = $354,500

Grand Total All Awards = $354,500

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An intracorporeal hemodialysis system (iHemo) enabling home hemodialysis

Award Number: R43DK146593

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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