Nephrodite, a medical device company developing a renal replacement system, today announced that the FDA has granted Breakthrough Device Designation to the company’s Holly implantable, continuous dialysis system.
The designation recognizes Holly as a novel therapy addressing end-stage kidney disease (ESKD). Current treatment options including hemodialysis and peritoneal dialysis limit mobility and patients’ quality of life.
The Holly system is an implantable platform 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. The device is designed to continuously filter waste, balance fluids, and manage electrolytes without the need for frequent clinic visits required by traditional, center-based dialysis.
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.
Data from Nephrodite’s successful multi-day large animal study demonstrating sustained kidney function replacement with strong safety and performance outcomes helped enable the FDA’s Breakthrough Device Designation.
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.
Nephrodite
