The Advanced Technology Development Center (ATDC) in Georgia Tech’s Office of Commercialization announced two of its health technology (HealthTech) portfolio companies, Nephrodite and OrthoPreserve, received the Food and Drug Administration’s (FDA) Breakthrough Devices designation.

Achieving this milestone, according to a univeersity press release, underscores the caliber of founders, science, and support in ATDC’s 30-company HealthTech portfolio, the incubator’s largest focus area. It’s also a win for Georgia because it reflects the strength of the state’s health innovation ecosystem.

“This designation is one of the strongest signals the FDA gives that a technology could change the standard of care,” said Greg Jungles, HealthTech catalyst at ATDC. “For ATDC to have two in the same year is remarkable.”

The Breakthrough Device Program doesn’t waive evidence requirements, but it accelerates learning with the FDA, ATDC’s Jungles said. “That means shorter response times, more frequent meetings, and prioritized review. Teams avoid dead ends and align earlier on study designs and endpoints.”

For the founders of both startups, their technologies come one step closer to moving their innovations to market. Nephrodite’s technology improves the lives of dialysis patients. OrthoPreserve’s device addresses challenges faced by those who suffer from chronic knee pain.

Nephrodite: Advancing Continuous Artificial Kidney Technology

Dr. Nikhil Shah and Dr. Hiep Nguyen, cofounders of Nephrodite, aim to improve care for dialysis patients with end-stage kidney disease who need transplants. These patients often spend three to four hours in a dialysis clinic up to three times a week. Being tethered to stationary machines with needles drawing blood via arm grafts complicates everyday activities — from work tasks to the ability to travel.

OrthoPreserve: Innovating a Minimally Invasive Meniscus Implant

OrthoPreserve’s technology aims to address issues from people have with their meniscus, the C‑shaped piece of cartilage in a knee joint that acts as a shock absorber between the thigh bone and shin bone.

Though patients undergo a now-routine surgery to address it, incomplete recoveries are also common. An estimated quarter of patients later experience recurring knee pain. No FDA-approved implant currently exists for this population. Now, OrthoPreserveis developing a minimally invasive, artificial meniscus implant to restore cushioning, relieve pain, and delay — or even prevent — knee replacement for some patients.