The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to Nephrodite for its Holly™ implantable dialysis system.
The designation recognises Holly as a novel and transformative therapy for end-stage kidney disease (ESKD), a condition affecting over 850,000 people in the U.S. and costing more than $50 billion annually.
Current treatment options, such as haemodialysis and peritoneal dialysis, limit patients’ mobility and quality of life, and no substantially improved alternatives have been available since haemodialysis was introduced more than 70 years ago.
The Holly system is designed to operate continuously inside the body, replacing natural kidney function. It combines advanced haemofiltration technology with biocompatible materials optimised for long-term implantation.
The device continuously removes waste, balances fluids, and manages electrolytes, reducing the need for frequent clinic visits required by traditional dialysis.
The system also integrates intelligent sensors, machine learning algorithms, and secure remote monitoring, allowing physicians to oversee therapy and personalise treatment. An external interface links to a small, portable home unit used overnight for dialysis support.
The FDA designation follows successful multi-day large animal studies showing sustained kidney function with strong safety and performance results.
Breakthrough status allows expedited regulatory review, enhanced guidance, and supports preparation for Good Laboratory Practice (GLP) studies and first-in-human trials, representing a major step towards improving patient independence and quality of life.
