Dialysate regeneration system based on photo-electrochemical urea oxidation and reactive adsorption to enable portable hemodialysis

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PROJECT SUMMARY/ ABSTRACT Currently in the US there are over 400,000 kidney patients on dialysis. The primary therapy mode is hemodialysis and is performed in a hospital or private clinic. Current dialysis therapy requires a large device that must be continuously connected to a reverse osmosis (RO) system. A single treatment will require over 150L of AAMI dialysate making portable device unattainable. Kuleana Technology, Inc., in partnership with the Center for Dialysis Innovation (CDI) and the University of Washington (UW), is developing a new technology that will allow a hemodialysis therapy without the need for plumbing modifications to their home. The equipment design target is to fit within the dimensions of standard rolling suitcases, enabling portability to move between rooms, bring to the workplace or travel, which will expand the home hemodialysis (HDD) market significantly. This technology, the Photo Oxidation Urea Removal, or POUR, system will remove uremic toxins from the dialysis machine’s waste dialysate and recycle the clean dialysate back to the dialysis machine. Allowing any dialysis machine to perform without a continuous water connection and only priming with a few liters of sterile bagged water. Kuleana Technology, incorporated in the State of Washington in 2020, is rethinking today’s hemodialysis. The particular focus for Kuleana is portable, ambulatory dialysis (The AKTIV, ambulatory kidney to increase vitality) and dialysis without a water hook-up or expensive and bulky urea sorbents. The CDI at UW focuses on science advancements essential to portable hemodialysis. The CDI is funded by the Northwest Kidney Centers (NKC), a not-for-profit dialysis provider seeking better care and outcomes for their patients. In a memorandum of agreement between NKC and the University of Washington, a mechanism for IP flow between CDI, the UW and Kuleana is specified (the UW, on behalf of CDI, has filed numerous patent applications). In addition, NKC, has donated ample space and other resources to incubate Kuleana for the start-up effort. The space is within one of NKC’s Seattle dialysis centers. The close proximity of medical personnel and patients will enhance HD developments and save Kuleana considerable expense. The CDI and the UW will be performing the necessary scientific research and development of the POUR technology. The Hinds lab will build, test, and modify the initial POUR technology. Then, Kuleana Technology will migrate these prototypes to the follow the necessary medical development processes and complete the development of the POUR system into a Dialysis Regeneration Module which will be submitted to the FDA for 510k approval. All under the necessary QMS and DC as regulated by the FDA’s Code of Federal Regulation.