Nephrodite’s Continuous Dialysis Implant Earns FDA Breakthrough Status

Nephrodite has been awarded U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Holly implantable, continuous dialysis system.

This designation recognizes Holly as a novel, transformative therapy to address end-stage kidney disease (ESKD). Current treatment options like hemodialysis and peritoneal dialysis limit mobility and quality of life, with no adequately effective alternatives available since hemodialysis’ advent over 70 years ago.

The implantable platform is engineered to function continuously outside of the body to replace natural kidney function. The platform merges advanced hemofiltration tech with biocompatible materials optimized for long-term implantation and physiologic performance. Holly was designed to continuously filter waste, balance fluids, and manage electrolytes without needing frequent clinic visits.

The system marries intelligent sensors, machine learning algorithms, and secure remote monitoring for oversight and individualized therapy. The internal implant is being engineered to link through an external interface to a small, portable home unit used nightly to support dialysis.

“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 L. Shah, DO, MPH, co-founder and CEO of Nephrodite. “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.”

Data from the company’s successful large animal study showed sustained kidney function replacement with strong safety and performance outcomes, which supported the FDA’s breakthrough status award. The designation lets Nephrodite to benefit from expedited review and enhanced FDA guidance.

The company is now preparing for Good Laboratory Practice (GLP) studies and subsequent regulatory submissions to enable first-in-human clinical trials.

“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” said Hiep T. Nguyen, MD, co-founder and SVP of Science and Technology at Nephrodite. “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.”