Nephrodite’s Continuous Dialysis Implant Chosen for FDA’s TAP Program

Nephrodite, a company developing an implantable, continuous renal replacement system, announced its Holly system was chosen to participate in TAP by the U.S. Food and Drug Administration (FDA).

Holly is an implantable, continuous dialysis system engineered to offer sustained toxin clearance and fluid balance without the burden of intemittent, clinic-based dialysis. The system is being developed as an alternative renal replacement solution for patients with end-stage kidney disease.

“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. This recognition from the FDA demonstrates our shared goals and the structured framework will support Nephrodite through clinical development,” said Nikhil Shah, DO, MPH, co-founder and CEO of Nephrodite. “We’re actively preparing for Good Laboratory Practice studies and compiling the necessary regulatory submissions to clear the path for early feasibility trials of our investigational device.”

TAP was designed to speed development and patient access for medical devices addressing critical unmet healthcare needs by enabling early, frequent engagement with FDA advisors to inform clinical, regulatory, and commercialization planning.

The company’s participation in TAP builds on its breakthrough device designation obtained in late 2025 and is meant to support regulatory alignment around the company’s Good Laboratory Practice (GLP) studies, a crucial step toward first-in-human evaluation. Early alignment with the FDA is anticipated to reduce regulatory uncertainty, improve development efficiency, and establish a more predictable track to FDA authorization and Medicare coverage through the recently announced RAPID program.

“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, MD, co-founder and senior VP 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. It’s a solution that I believe will deliver continuous, mechanical renal replacement therapy that supports independence in their daily lives. We are hearing from patients all over the United States, and universally they are eager for change that gives them more independence.”