Nephrodite’s implantable dialysis system selected for FDA program to advance kidney replacement therapy development

Nephrodite Inc., a medical device company developing an implantable renal replacement system, said that its Holly system has been selected to participate in the U.S. Food and Drug Administration’s Total Product Life Cycle Advisory Program (TAP), a regulatory pathway aimed at accelerating development of devices addressing unmet medical needs.

The TAP program is designed to provide early and frequent engagement with FDA advisors to help guide clinical, regulatory and commercialization planning for promising technologies.

Nephrodite’s selection builds on its Breakthrough Device Designation, which it received in late 2025, and is intended to support regulatory alignment ahead of planned Good Laboratory Practice (GLP) studies. The company said those studies represent a key step toward initiating early feasibility trials of its investigational device.

“We are dedicated to moving our technology as quickly and safely as possible into healthcare systems for eligible patients with end-stage kidney disease to stop the burden of three-times-weekly, clinic-based dialysis and improve their physical and mental health, mobility and quality of life,” said Nikhil Shah, D.O., M.P.H., co-founder and CEO of Nephrodite, Inc.. “This recognition from the FDA demonstrates our shared goals and the structured framework will support Nephrodite through clinical development.”

Shah said the company is preparing for GLP studies and compiling regulatory submissions needed to support early feasibility trials of its investigational system.

Holly is designed as an implantable, continuous renal replacement system intended to provide sustained toxin clearance and fluid balance without the need for intermittent, clinic-based dialysis sessions. The system is being developed as an alternative treatment option for patients with end-stage kidney disease.

“Dialysis is a life-saving, but burdensome and incomplete analog for kidney function, requiring patients to adhere to rigid treatment schedules that significantly impact quality of life,” said Hiep Nguyen, M.D., co-founder and senior vice president of science and technology at Nephrodite. “In patients with end-stage kidney disease, I see a clear and urgent need for our Holly device every day.”

Nguyen said the goal is to deliver continuous mechanical renal replacement therapy that supports greater independence for patients. He added that the company has heard from patients nationwide who are seeking alternatives to traditional dialysis.

Nephrodite said participation in TAP is expected to reduce regulatory uncertainty, improve development efficiency and support a more predictable pathway toward potential U.S. Food and Drug Administration authorization and Medicare coverage under emerging reimbursement frameworks.

U.S. Food and Drug Administration launched TAP to improve coordination between device developers and agency advisors for high-impact technologies.