The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system.
In an exclusive interview ahead of the official announcement, Nephrodite co-founder and CEO Nikhil Shah described the first-of-its-kind system as a “healthy alternative” to dialysis centers and at-home options.
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The Atlanta-based device developer hopes to start its first-in-human study as soon as late 2027 and follow with a first regulatory approval as soon as early 2028, he said.
Shah — a former urologic oncology surgeon — founded the company in 2020 with Dr. Hiep “Bob” Nguyen, a pediatric urologist who serves as Nephrodite’s SVP of Science and Technology.
“Dialysis sustains life, but at tremendous cost to a patient’s freedom and physiology,” Nguyen said in a statement shared with MassDevice. “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 novel Holly system is designed for patients with end-stage kidney disease (ESKD), of which there are more than 850,000 in the U.S. at a cost of more than $50 billion per year, Nephrodite says.
“We think at a minimum, we’re a bridge to transplant,” Shah said. “We can keep patients on the transplant list, keep them healthy. Because we’re a continuous device, we’re acting differently than intermittent dialysis every other day. But there are patients that aren’t transplant candidates, and because we’re an implantable device, we think this could be a standalone device as well for a lot of patients.”
Nephrodite designed the Holly system to continuously filter waste, balance fluids and manage electrolytes without dialysis center visits. The company says its proprietary platform includes advanced hemofiltration technology, intelligent sensors, machine learning algorithms and secure remote monitoring for physician oversight and individualized therapy.
Just days ago, the company announced successful animal study results at the University of Michigan’s Conrad Jobst Vascular Research Laboratories, showing the system worked in a sheep without blood clotting, hemolysis or device leakage.
“Our animal studies have completely mimicked everything that we’ve seen on the bench,” Shah said.
Nephrodite is now preparing for a Good Laboratory Practice (GLP) study next year ahead of regulatory submissions for first-in-human clinical trials.
Through the FDA’s Breakthrough Devices Program, the company will get enhanced guidance from agency staff, expedited regulatory review and eligibility for the FDA’s Total Product Life Cycle (TPLC) Advisory Program (TAP) pilot to accelerate patient access.
The company is also seeking investors through a Series A priced equity funding round after previously raising an amount that Shah described as in “the low seven figures.”
“We have a healthy runway right now,” he said. “… We were staying under the radar. We wanted to come out and announce what we were doing when we had something really meaningful.”
