ATDC Startups Achieve Exclusive FDA ‘Breakthrough Device’ Designation

Key Takeaways

Georgia Tech’s Advanced Technology Development Center celebrates two HealthTech startups, Nephrodite and OrthoPreserve, receiving the FDA Breakthrough Devices designation.
Nephrodite aims to improve dialysis for patients by developing a continuously functioning artificial kidney, while OrthoPreserve is innovating a minimally invasive meniscus implant.
Both companies benefit from expedited FDA processes, enhancing their chances for market readiness and addressing significant healthcare challenges.

Advancements in Health Technology

Georgia Tech’s Advanced Technology Development Center (ATDC) recently announced that two of its HealthTech startups, Nephrodite and OrthoPreserve, have received the FDA Breakthrough Devices designation. This designation is awarded to technologies showing great potential for improving patient outcomes, allowing companies to expedite interactions with the FDA.

Nephrodite, co-founded by Dr. Nikhil Shah and Dr. Hiep Nguyen, focuses on improving care for dialysis patients suffering from end-stage kidney disease. The company has created a continuously functioning mechanical artificial kidney that avoids the burdensome, lengthy dialysis sessions. With the FDA’s breakthrough designation, Nephrodite is a step closer to pursuing human trials related to its implant technology, which aims to provide greater mobility and reduced pain for patients.

The innovation stems from inspiration gleaned from a pediatric artificial heart demonstration observed in Germany, leading Nephrodite’s founders to explore similar advancements for kidney treatments. Their approach includes surgically implanting a filter that connects to blood vessels and allows for continuous function, thus significantly alleviating the burdens associated with traditional dialysis methods.

OrthoPreserve is addressing knee pain with a minimally invasive artificial meniscus implant. Founded by Jonathan Schwartz, the company aims to provide a solution for the substantial number of patients still suffering from pain after meniscal surgeries. Current statistics show that nearly 25% lack effective recovery, which reveals a significant medical gap.

With over a million meniscus surgeries performed annually, the potential for OrthoPreserve’s technology to delay or prevent invasive knee replacements offers a promising avenue for patients and the healthcare system alike. Schwartz began developing the product during his master’s thesis at Georgia Tech and is now preparing to raise funds to validate the technology further and initiate human trials within 18 months.

Both companies have praised the ATDC for its invaluable support and structured guidance through the regulatory and funding hurdles. The emphasis on navigating the FDA approval process has been crucial for these startups. According to Greg Jungles, an ATDC health tech catalyst, having two breakthrough designations in one year underscores the quality of the startups and their capacity to tackle significant healthcare problems.

These developments contribute positively to Georgia’s reputation as a health innovation hub, showcasing the strength and collaboration of its ecosystem.

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