These Startups Just Scored Rare FDA Breakthrough Device Status—Is Your Health at Risk?

In a significant achievement for Georgia's health technology sector, two startups from the Advanced Technology Development Center (ATDC) at Georgia Tech have earned the coveted Food and Drug Administration (FDA) Breakthrough Devices designation. This designation is awarded to only a fraction of applicants—approximately 40%—and is a strong indicator that the technology has the potential to significantly improve patient outcomes and warrants prioritized attention from the FDA.

The companies, Nephrodite and OrthoPreserve, are part of ATDC’s HealthTech portfolio, which is the incubator's largest focus area. This dual recognition highlights both the caliber of innovators in Georgia's health innovation ecosystem and the promising avenues that ATDC’s support fosters. “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 FDA’s Breakthrough Device Program is designed to facilitate faster communication and approval processes without waiving evidence requirements. According to Jungles, the program allows for shorter response times, more frequent meetings, and prioritized reviews. This means that teams can avoid potential dead ends and align earlier on study designs and endpoints, making it easier for founders to bring their innovations to market.

For Nephrodite, the designation marks a pivotal step toward advancing its continuously functioning artificial kidney technology aimed at improving the lives of dialysis patients with end-stage kidney disease. Co-founders Dr. Nikhil Shah and Dr. Hiep Nguyen recognized the substantial burdens that patients face while undergoing dialysis, which often entails spending three to four hours in a clinic multiple times a week. This process not only restricts their mobility but also severely limits their quality of life.

Dialysis is essential for patients whose kidneys no longer function, costing Medicare approximately $124.5 billion annually, according to the Centers for Disease Control and Prevention. This figure is expected to climb as rates of chronic kidney disease rise. “Dialysis, while lifesaving when it was pioneered in 1952, is incredibly burdensome,” Shah noted. He compared the process to running a marathon, emphasizing the physical toll it takes on patients.

Nephrodite’s solution involves a surgical device implanted in the pelvis, designed to function continuously without the complications associated with arm grafts. This technology allows for remote patient monitoring, freeing individuals from frequent clinic visits. “It’s like having an actual kidney but without all the issues of an unhealthy one,” Shah explained.

Meanwhile, OrthoPreserve is focused on addressing chronic knee pain by developing an innovative, minimally invasive artificial meniscus implant. Founded by Jonathan Schwartz, the company aims to provide relief for the quarter of patients who experience recurring pain following standard meniscus surgeries. “There are a million meniscus surgeries every year, and 25% of those patients still live with recurring pain,” Schwartz stated. The implant aims not only to alleviate discomfort but also to delay or prevent the need for knee replacement surgeries, representing a remarkable shift in patient care.

Schwartz originally conceived the implant as his master’s thesis at Georgia Tech, and he has returned to further develop the technology, tapping into the institution’s translational expertise. The company is currently raising $2 million in seed funding to validate its technology and initiate human trials expected to begin in 18 months. Schwartz sees the FDA breakthrough designation as an essential validation of his work, noting that the U.S. market opportunity for this technology is approximately $1.5 billion.

The Role of ATDC in Health Innovation

For both Nephrodite and OrthoPreserve, ATDC's coaching and resources have been crucial in navigating the complexities of fundraising and regulatory milestones. The organization has facilitated access to Georgia Tech’s labs, prototyping support, and clinical advisors, proving invaluable for the startups as they work toward commercialization. “We meet with ATDC coaches every two to four weeks to troubleshoot and plan,” Schwartz said. “Having that level of seasoned guidance, all without consultant-level costs, has been huge.”

Jungles emphasized that securing two Breakthrough Device designations in a single year not only reflects the strength of the companies within ATDC but also the collaborative spirit of the health innovation ecosystem in Georgia. As the health tech landscape continues to evolve, breakthroughs such as those achieved by Nephrodite and OrthoPreserve could redefine patient care standards across the nation.