FDA picks Nephrodite’s implantable dialysis system for TAP pilot

Nephrodite is joining the FDA Total Product Life Cycle Advisory Program (TAP) pilot with its Holly implantable continuous dialysis system, which won FDA Breakthrough Device Designation last year.

The medical device startup’s latest regulatory win puts it in a relatively small club. The FDA designed the TAP pilot to expedite patient access to innovative medical devices by giving breakthrough device developers improved communication with FDA and other stakeholders. The FDA said it has selected just 122 medical devices into the TAP pilot as of April 23, 2026.

Nephrodite says it plans to coordinate its request for FDA authorization and Medicare coverage through the new Regulatory Alignment for Predictable and Immediate Device (RAPID) pathway.

“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,” Nephrodite co-founder and CEO Nikhil Shah said in a statement shared with Medical Design & Outsourcing ahead of the announcement.

“This recognition from the FDA demonstrates our shared goals and the structured framework will support Nephrodite through clinical development,” he continued. “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.”

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Shah discussed his device developer’s proprietary technology in a December 2025 MDO interview.  Nephrodite designed the system for patients with end-stage kidney disease and envision it as a bridge for patients awaiting new kidneys and a treatment for dialysis patients who aren’t transplant candidates. The co-founders also see potential for the technology to be used as a liver filtering device, pancreas filtering device or even filtering for blood-borne pathogens and have had discussions with the Department of Defense and NASA.

“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,” Nephrodite co-founder and SVP of Science and Technology Dr. Hiep “Bob” Nguyen said in a statement shared with MDO ahead of the latest milestone.

“In patients with end-stage kidney disease, I see a clear and urgent need for our Holly device every day,” he continued. “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.”

In response to questions from MDO by email on Monday, Shah offered an update on his startup’s regulatory and fundraising efforts.

“With our recent TAP enrollment, we have been able to engage our resources at the FDA with several onboarding meetings,” he said. “This has been helpful and will hopefully provide clarity on our plans for our planned regulatory strategy.

“On financing, we continue to pursue our well established plan that meets our planned timeline and milestones,” he continued. “As we are now transitioning towards regulatory needs as opposed to just R&D, we are hopeful that our recent milestones with BDD and TAP as well as developing our human-ready device will resonate with investors and others.”

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