FDA Grants Breakthrough Device Designation to Holly Implantable Dialysis System

The US Food and Drug Administration has granted Breakthrough Device Designation to Nephrodite’s Holly™ implantable, continuous dialysis system.1

Announced on December 15, 2025, the designation recognizes Holly as a novel, transformative therapy addressing end-stage kidney disease (ESKD), for which current treatment options include hemodialysis and peritoneal dialysis. Both approaches notably limit mobility and patients’ quality of life, with no adequately effective alternatives available to patients since the advent of hemodialysis > 70 years ago.1

“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” Hiep Nguyen, MD, co-founder and SVP of Science and Technology at Nephrodite, said in a statement.1 “Holly represents a complete rethinking of kidney replacement, with a continuously functioning implant capable of matching the body’s natural rhythm. It’s both a scientific milestone and a human one.”

As described by Nephrodite, the first-of-its-kind implantable platform is engineered to function continuously inside the body, replacing natural kidney function. The proprietary platform combines advanced hemofiltration technology with biocompatible materials optimized for long-term implantation and physiologic performance. It is designed to continuously filter waste, balance fluids, and manage electrolytes without the need for frequent clinic visits required by traditional, center-based dialysis.1

The Holly system integrates intelligent sensors, machine learning algorithms, and secure remote monitoring for physician oversight and individualized therapy. The internal implant is being designed to link through a simple external interface to a small, portable home unit used nightly for dialysis support.1

Holly’s Breakthrough Device Designation was supported by data from Nephrodite’s multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes. On December 9, 2025, the Company announced successful results from this study showing 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.​​ The 72-hour study was performed at the Conrad Jobst Vascular Research Laboratories at the University of Michigan.1,2

The designation allows the Company to benefit from expedited review and enhanced FDA guidance.1

“I’m proud of our stellar team for earning this extraordinary recognition. The designation reinforces the scientific and clinical significance of what we’re building,” said Nikhil Shah, DO, MPH, co-founder and CEO of Nephrodite.1 “Holly was designed from the ground up to free patients from the cycle of center-based dialysis. Breakthrough status enables close collaboration with regulators and accelerates our path toward first-in-human studies.”

As described in the December 15, 2025, release, building on the Breakthrough Device designation and the preclinical animal study findings, Nephrodite is preparing for Good Laboratory Practice (GLP) studies and subsequent regulatory submissions to enable first-in-human clinical trials.1

References

1. Nephrodite. Nephrodite Earns FDA’s First Breakthrough Device Designation for an Implantable Kidney Replacement System. December 15, 2025. Accessed December 15, 2025. https://www.businesswire.com/news/home/20251215001657/en/Nephrodite-Earns-FDAs-First-Breakthrough-Device-Designation-for-an-Implantable-Kidney-Replacement-System

2. Nephrodite. Nephrodite Announces Industry’s First Successful Multi-Day Large Animal Study for a Fully Implantable Renal Replacement Device. December 9, 2025. Accessed December 15, 2025. https://nephrodite.com/newsroom/nephrodite-announces-industrys-first-successful-multi-day-large-animal/