FDA grants Breakthrough Device status to Nephrodite's implantable continuous dialysis system

Nephrodite Inc., a medical device company developing an implantable, continuous renal replacement system, said the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Holly implantable, continuous dialysis system.

The designation recognizes Holly as a “novel, transformative therapy” for end-stage kidney disease, a condition affecting more than 850,000 people in the United States and costing more than $50 billion annually, the company said. Current treatments such as hemodialysis and peritoneal dialysis “limit mobility and patients’ quality of life,” and there have been “no adequately effective alternatives available to patients since the advent of hemodialysis more than 70 years ago.”

“I’m proud of our stellar team for earning this extraordinary recognition,” said Nikhil L. Shah, DO, MPH, co-founder and CEO of Nephrodite. “The designation reinforces the scientific and clinical significance of what we’re building.”

Shah said Holly “was designed from the ground up to free patients from the cycle of center-based dialysis,” adding that Breakthrough status “enables close collaboration with regulators and accelerates our path toward first-in-human studies.”

The FDA’s decision was supported by data from a successful multi-day large animal study that demonstrated “sustained kidney function replacement with strong safety and performance outcomes,” according to the company. The Breakthrough Device Designation is reserved for technologies that offer more effective treatment for life-threatening conditions and is intended to expedite patient access to promising innovations through enhanced FDA guidance and expedited review.

“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” said Hiep T. Nguyen, MD, co-founder and senior vice president of science and technology at Nephrodite. “Holly represents a complete rethinking of kidney replacement, with a continuously functioning implant capable of matching the body’s natural rhythm. It’s both a scientific milestone and a human one.”

The Holly system is designed as a continuously functioning internal implant that replaces natural kidney function. It combines advanced hemofiltration technology with biocompatible materials intended for long-term implantation and physiologic performance. The device is engineered to continuously filter waste, balance fluids and manage electrolytes without the frequent clinic visits required by traditional dialysis.

The system also integrates intelligent sensors, machine learning algorithms and secure remote monitoring to support physician oversight and individualized therapy. The internal implant is being designed to connect through an external interface to a small, portable home unit used nightly for dialysis support.

Building on the designation and its preclinical findings, the company said it is preparing for Good Laboratory Practice studies and regulatory submissions to enable first-in-human clinical trials.

Advances reshape the future of kidney replacement therapy

Kidney care is undergoing a period of rapid innovation as researchers and clinicians seek alternatives to traditional dialysis, which has changed little in decades and remains burdensome for patients. End-stage kidney disease is associated with high mortality, frequent hospitalizations and profound disruptions to daily life, driving interest in technologies that better replicate natural kidney function.

One major area of progress involves continuous renal replacement approaches that aim to more closely mimic how healthy kidneys work around the clock. Unlike intermittent dialysis sessions that can stress the cardiovascular system and cause rapid fluid and electrolyte shifts, continuous systems are designed to provide steadier physiologic balance, potentially reducing complications such as hypotension, fatigue and cardiac strain.

Advances in biomaterials have also played a central role. New generations of membranes and coatings are being engineered to improve biocompatibility, reduce clotting and inflammation, and support long-term implantation. These materials are critical for devices intended to function inside the body for extended periods without frequent replacement or intensive maintenance.

Digital health technologies are increasingly integrated into kidney replacement systems as well. Embedded sensors can track fluid status, solute clearance and device performance in real time, while software tools and adaptive algorithms allow therapies to be adjusted to individual patient needs. Secure remote monitoring has expanded the role of clinicians beyond the dialysis center, enabling oversight and intervention without requiring constant in-person visits.

Another trend is the push toward portability and home-based care. Smaller, more efficient components and simplified interfaces are making it possible for patients to receive treatment outside of traditional facilities, supporting independence and quality of life. This shift aligns with broader healthcare goals of reducing costs, easing strain on clinics and hospitals, and empowering patients to manage chronic conditions in their own homes.

Together, these advances signal a move away from one-size-fits-all dialysis toward personalized, physiologic kidney replacement. While many technologies remain in development or early clinical stages, momentum is building around the idea that kidney failure care can be safer, more humane and better aligned with how the body is meant to function.