ATDC Startups Achieve Rare FDA Breakthrough Device Designation

Key Takeaways

Two health tech startups from Georgia Tech’s ATDC, Nephrodite and OrthoPreserve, received the FDA’s Breakthrough Devices designation.
Nephrodite aims to improve dialysis care with a continuous artificial kidney, while OrthoPreserve develops a minimally invasive meniscus implant.
The designations will expedite the FDA approval process, fostering innovation and enhancing patient care in Georgia’s health tech ecosystem.

FDA Breakthrough Device Designation Boosts Georgia Startups

Receiving the FDA’s Breakthrough Devices designation is a rare achievement for startups, as only about 40% of applicants qualify. This distinction indicates significant potential to enhance patient care, allowing for priority review by the FDA. Recently, two companies from Georgia Tech’s Advanced Technology Development Center (ATDC)—Nephrodite and OrthoPreserve—achieved this important milestone, highlighting the strength of Georgia’s health innovation landscape.

According to Greg Jungles, HealthTech catalyst at ATDC, having two startups gain this designation in a single year is remarkable. The Breakthrough Device Program does not eliminate evidence requirements but facilitates accelerated learning and expedites FDA interactions, including shorter response times and more frequent meetings. This environment supports startups in effectively navigating the regulatory landscape, keeping their projects aligned with FDA expectations.

Nephrodite, founded by Dr. Nikhil Shah and Dr. Hiep Nguyen, concentrates on advancing care for dialysis patients facing burdensome and time-consuming treatments. With their continuous artificial kidney, they aim to address the physical limitations and quality-of-life concerns of end-stage kidney disease patients. This innovative device, once approved, could significantly lower healthcare costs tied to chronic kidney disease, which imposes a hefty financial burden on Medicare.

On the other hand, OrthoPreserve focuses on developing a minimally invasive implant designed to restore cushioning in the knee joint damaged by meniscus issues. Founder Jonathan Schwartz noted that many patients suffer ongoing knee pain despite routine surgeries. OrthoPreserve’s technology aims to provide a lasting solution and prevent the need for invasive knee replacements, which would offer substantial benefits to both patients and the healthcare system.

The FDA Breakthrough designation positions both companies on a quicker trajectory towards market readiness. Investors view this fast-tracking as a de-risking milestone, validating the technological potential and the specific problems these startups aim to solve. ATDC’s HealthTech vertical, launched in 2018 and backed by Catalyst by Wellstar, supports various medical device, biotech, and digital health ventures and plays a crucial role in fostering innovation.

The coaching and resources provided by ATDC have been instrumental for both companies. Regular meetings with experienced coaches enhance strategic planning and fundraising efforts while accessing Georgia Tech’s labs and facilities bolsters product development. Jungles emphasized that the dual designations reflect the quality of the startups and the collaborative environment in Georgia’s health innovation ecosystem.

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