Continuous dialysis implant wins FDA Breakthrough Device Designation

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.

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.

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