Yahoo Finance

Nephrodite Announces Industry’s First Successful Multi-Day Large Animal Study for a Fully Implantable Renal Replacement Device

ATLANTA, December 09, 2025--(BUSINESS WIRE)--Nephrodite Inc., a medical device company developing an implantable, continuous dialysis system, today announced successful results from a multi-day large ...
Yahoo Finance

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

The FDA’s Total Product Life Cycle Advisory Program (TAP) provides Nephrodite with deeper solution-focused engagement from FDA experts and other stakeholders "We are dedicated to moving our technology ...
Business Wire

Nephrodite Earns FDA’s First Breakthrough Device Designation for an Implantable Kidney Replacement System

Holly™ by Nephrodite becomes the first device to achieve the designation, marking a major regulatory milestone toward first-in-human clinical studies ATLANTA--(BUSINESS WIRE)--Nephrodite, Inc., a ...
BioWorld

Nephrodite's Holly renal replacement named breakthrough device

Nephrodite Inc.'s Holly, an implantable, continuous renal replacement system, received U.S. FDA breakthrough device designation as a novel and potentially life-changing treatment for end-stage kidney ...
Healio

‘A bridge to transplant’: Implantable dialysis device receives FDA breakthrough status

Please provide your email address to receive an email when new articles are posted on . Nephrodite received breakthrough status to pursue steps for eventual testing in humans. The device, implanted in ...
Morningstar

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 ...