Nephrodite’s Holly™ Implantable Continuous Dialysis System Awarded Selection into FDA’s TAP to Accelerate Development and Patient Access

• Nephrodite is among a select group of companies to hold both FDA Breakthrough Device Designation and TAP acceptance
• The FDA’s Total Product Life Cycle Advisory Program (TAP) provides Nephrodite with deeper solution-focused engagement from FDA experts and other stakeholders

ATLANTA--(BUSINESS WIRE)--Nephrodite, Inc., a medical device company developing an implantable, continuous renal replacement system, today announced that its Holly™ system has been selected to participate in TAP by the U.S. Food and Drug Administration (FDA).

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

Nephrodite’s participation in TAP builds on its Breakthrough Device Designation received in late 2025 and is intended to support regulatory alignment around the company’s upcoming Good Laboratory Practice (GLP) studies, a key step toward first-in-human evaluation. This early alignment with the FDA is expected to reduce regulatory uncertainty, improve development efficiency and establish a more predictable path 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 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. 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.”

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

Follow Nephrodite on LinkedIn and visit nephrodite.com for ongoing updates.

Holly™ is an investigational device and is not yet approved for commercial use.

About Nephrodite

Nephrodite is a medical device company dedicated to creating a better alternative to dialysis by developing Holly, an implantable, continuous renal replacement device designed to restore freedom, function and independence in people living with end-stage kidney disease. Founded by board-certified urologists Nikhil L. Shah, DO, MPH, and Hiep T. Nguyen, MD, the company combines deep clinical expertise with engineering innovation to deliver a true renal replacement platform. Headquartered in Atlanta, Georgia, Nephrodite is backed by leading investors and supported by a robust intellectual property portfolio.