Nephrodite Announces Industry’s First Successful Multi-Day Large Animal Study for a Fully Implantable Renal Replacement Device

The Holly™ by Nephrodite device demonstrated continuous kidney function replacement in a large animal marking a critical milestone toward commercialization

ATLANTA--(BUSINESS WIRE)--Nephrodite Inc., a medical device company developing an implantable, continuous dialysis system, today announced successful results from a multi-day large animal study of its Holly™ implantable renal replacement device with proprietary hemofiltration technology.

Holly™ by Nephrodite 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. This large animal study represents what is believed to be the first demonstration of sustained, continuous kidney function replacement by a 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, the Holly device achieved multiple critical performance milestones:​

• Continuous waste removal with effective filtration of key toxins including urea, creatinine and potassium from blood to dialysate.
• Measurable waste products appearing in dialysate within hours of implantation.​
• Clinically relevant fluid management with an average ultrafiltration rate consistent with physiologic norms and aligned with the fluid removal requirements of standard dialysis protocols.​
• No evidence of blood clotting, hemolysis or device leakage throughout the study period.​
• The animal subject maintained natural behavioral 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, MD, 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.”​​

End-stage kidney disease affects more than 850,000 people in the U.S., costing more than $50 billion annually. Current treatment options (hemodialysis, peritoneal dialysis) limit mobility and provide suboptimal outcomes. The global kidney replacement therapy market may surpass $200 billion by 2030, driven by an aging population and increasing prevalence of chronic disease.

“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, DO, MPH, 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.

Follow Nephrodite on LinkedIn and visit nephrodite.com for the latest news and information.

Holly™ is an investigational device and is not yet approved for commercial use.​​

ABOUT NEPHRODITE

Nephrodite is a medical device company dedicated to creating a better alternative to dialysis by developing Holly, a fully implantable, continuous renal replacement device designed to restore freedom, function and independence in people living with end-stage kidney disease. Founded by board-certified urologists Nikhil L. Shah, DO, MPH, and Hiep T. Nguyen, MD, the company combines deep clinical expertise with engineering innovation to deliver a true renal replacement platform. Headquartered in Atlanta, Georgia, with operations in Mumbai, India, Nephrodite is backed by leading investors and supported by a robust intellectual property portfolio.