Nephrodite, a medical device company developing an implantable, continuous dialysis system, has announced successful results from a multi-day large animal study of its Holly implantable renal replacement device with proprietary haemofiltration technology.
Holly is designed to work continuously inside the body to support patient mobility and day-to-day living. The proprietary platform blends advanced filtration technology with biocompatible materials engineered for long-term implantation, Nephrodite says in a press release.
The large animal study demonstrates sustained, continuous kidney function replacement by the fully mechanical implantable device in a living sheep, without the complications typically associated with current dialysis technologies.
During the 72-hour study performed at the Conrad Jobst Vascular Research Laboratories at the University of Michigan (Ann Arbor, USA), the Holly device achieved continuous waste removal with effective filtration of key toxins including urea, creatinine and potassium from blood to dialysate. Measurable waste products appeared in dialysate within hours of implantation, alongside clinically relevant fluid management with an average ultrafiltration rate consistent with physiologic norms and aligned with the fluid removal requirements of standard dialysis protocols.
There was no evidence of blood clotting, haemolysis or device leakage throughout the study period. The animal subject maintained natural behavioural patterns with normal eating, drinking and activity, underscoring the device’s compatibility with active daily life.
The device demonstrated self-regulatory function, including intelligent fluid management that automatically supplied fluid when needed and removed excess fluid as required.
“This study and the encouraging results represent a watershed moment in the treatment of end-stage kidney disease,” said Hiep T Nguyen, co-founder and SVP, Science and Technology of Nephrodite. “For the first time, a fully implantable device has safely and effectively replaced kidney function continuously over multiple days in a large animal model, bringing us closer to freeing patients from the constraints of traditional dialysis.”
“The successful animal study further validates Nephrodite’s strategy to solve underlying fundamental challenges in kidney replacement therapy. The implications of this success extend far beyond the technical achievement,” said Nikhil L Shah, co-founder and CEO of Nephrodite, and transplant surgeon. “Hundreds of thousands of Americans and millions worldwide live with end-stage kidney disease, and the current standard of care limits their ability to work, travel and participate fully in life. Holly is being developed as both a bridge-to-transplant and a potential destination therapy, with the aim of improving health outcomes and enabling patients to regain independence, dignity and hope.”
Building on these preclinical findings, Nephrodite is preparing for Good Laboratory Practice (GLP) studies and subsequent regulatory submissions to enable first-in-human clinical trials.
