12/20/2025
Big news in kidney innovation. The FDA has granted Breakthrough Device Designation to the Holly™ system, an implantable, continuous dialysis device designed to work inside the body and function more like a natural kidney.
Developed by Nephrodite, Holly aims to free patients with end stage kidney disease from the limits of center based dialysis by continuously filtering waste, balancing fluids, and managing electrolytes. Early multi day animal studies showed strong safety and performance, helping fast track this technology toward first in human trials.
Important to note this is an investigational device and is not yet FDA approved for commercial use. Still, it represents an exciting and hopeful step toward improving quality of life for people living with kidney failure.
To follow ongoing progress, you can follow Nephrodite on LinkedIn and visit nephrodite.com for updates as this technology moves forward.