Nephrodite has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation to the company’s Holly implantable, continuous dialysis system.
The designation recognises Holly as a novel, transformative therapy addressing end-stage kidney disease (ESKD), the company says in a press release, adding that current treatment options including haemodialysis and peritoneal dialysis limit mobility and patients’ quality of life.
“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, co-founder and chief executive officer of Nephrodite. “Holly was designed from the ground up to free patients from the cycle of centre-based dialysis. Breakthrough status enables close collaboration with regulators and accelerates our path toward first-in-human studies.”
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, the company states in its press release. Breakthrough device designation is reserved for technologies that offer more effective treatment for life-threatening conditions and designed to expedite patient access to promising innovations. The designation allows Nephrodite to benefit from expedited review and enhanced FDA guidance.
“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” said Hiep T Nguyen, 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.”
The Holly system is an implantable platform engineered to function continuously inside the body, replacing natural kidney function. The proprietary platform combines advanced haemofiltration technology with biocompatible materials optimised 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, centre-based dialysis.
The Holly system integrates intelligent sensors, machine learning algorithms, and secure remote monitoring for physician oversight and individualised 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.
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.
