ATDC Startups Secure Rare FDA ‘Breakthrough Device’ Status

It's uncommon for any startup to receive the Food and Drug Administration's (FDA) Breakthrough Devices designation. For the roughly 40% of applicants who receive the designation, it shows that the technology has real potential to improve patient outcomes and should get priority attention from the agency.

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, earned the designation.

Achieving this rare milestone 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.

Dialysis addresses chronic kidney disease, which means kidneys no longer work properly. The treatments filter out toxins, waste, and other fluids in the blood. Kidney disease costs Medicare $124.5 billion every year, according to the Centers for Disease Control and Prevention. And those costs are expected to rise because of increasing rates of kidney failure and chronic kidney disease.

"Dialysis, while lifesaving when it was pioneered in 1952, is incredibly burdensome," Shah said. Besides being a long process that keeps the patient in a fixed location, it's physically tiring. "Taking out your blood continually many, many times over, and over the course of four hours is the equivalent of running the Boston Marathon, hitting the finish line, and then someone saying, 'You're not done; go do it again,' " he said.

A surgeon by training, with expertise in transplantation and oncology, Shah is also an adjunct associate professor in Tech's School of Interactive Computing. He worked with Nguyen to develop a continuously functioning mechanical artificial kidney, leading to Nephrodite's formation.

The FDA's breakthrough designation on its artificial kidney allows the company to pursue approvals to begin tests in human trials.

The company traces its beginnings to a German aerospace facility outside Munich, where Nguyen and Shah watched engineers demonstrate a pediatric artificial heart - the Berlin Heart.

"That's how we got started," Shah said. "Seeing an artificial heart that led us to think about doing this for kidneys - because the kidney space has been largely ignored for 70 years."

Backed by a German federal grant, Nephrodite grew, moving from Germany to Boston, Massachusetts, then to Austin, Texas, before calling Atlanta home. The company joined ATDC and tapped into other Georgia Tech programs. This included the Center for MedTech Excellence and the Georgia Manufacturing Extension Partnership. Nephrodite also drew on student talent as the researchers quietly worked on their continuous mechanical artificial kidney.

Nephrodite began interviewing patients to find out what they wanted the artificial kidney needed to solve.

They learned patients want the ability to be mobile. Patients also desire an alternative therapy to large needles being inserted into arm grafts because the injection sites are prone to infection and the grafts can fail. In addition, the process can be painful and disfiguring. Finally, patients want a quality of life independent of machines.

"Those quality-of-life needs, especially being free and mobile, were absolutely universal," Shah said.

Nephrodite began developing the technology to build its device - a filter surgically implanted in the pelvis area.

"We developed an implant designed to run constantly, connected to larger blood vessels in the pelvis to avoid arm graft failures, and paired with an external interface that lets patients sleep at night while the system removes toxins and excess fluid," Shah explained.

The device also has built-in sensors, with data uploaded to the cloud, enabling medical care teams to remotely monitor their patients while freeing patients from frequent in-clinic visits.

Shah said Nephrodite's device could restore everyday independence, while potentially lowering infection risk.

"It's like having an actual kidney, but without all the issues of an unhealthy one," Shah said.

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.

"There are a million meniscus surgeries every year, and 25% of those patients still live with recurring pain," said Jonathan Schwartz, OrthoPreserve's founder and CEO.

Patients can face daily pain from ordinary activities, such as prolonged standing or walking a dog. Other activities like jogging and recreational sports can trigger flares that can lead to swelling and prolonged discomfort, Schwartz said. "Those patients have no reliable options today," he said. "We're building a minimally invasive implant to restore cushioning and help people get back to the activities they love."

OrhoPreserve's durable implant restores cushioning, and it could help people return to normal activities and delay invasive knee replacement. Along with this comes potential cost and recovery benefits for the healthcare system. 

Schwartz created the implant as his Georgia Tech master's thesis in the lab of David Ku in the Lawrence P. Huang Endowed Chair for Engineering Entrepreneurship and Regents' Professor in the George W. Woodruff School of Mechanical Engineering. After industry experience, Schwartz returned to further develop the technology, building on Georgia Tech's translational expertise

OrthoPreserve has completed mechanical testing and a successful study. The company is raising a $2 million seed to complete validations and begin human trials, which Schwartz expects to start in 18 months.

"The FDA breakthrough designation validates that nothing like this technology exists, and that it has the potential to disrupt the standard of care," Schwartz said, adding the U.S.' market opportunity is roughly $1.5 billion. "We finally have a minimally invasive option to bridge the gap between meniscus surgery and knee replacement."

What FDA Breakthrough Designation Means for ATDC's HealthTech Startups

Having a faster and clearer path is a derisking milestone for investors who are evaluating capital intensive medical device technologies, Jungles said.

"This breakthrough device designation is a really big deal for medical device companies," Jungles said, adding that startups often fear navigating the FDA approval process. "But this designation adds to the legitimacy of their technologies and the problemsthey are solving. The designation will help them get to market faster, assuming their data continues to meet expectations."

ATDC launched its HealthTech vertical in 2018, which is now sponsored by Catalyst by Wellstar ATDC's HealthTech portfoilo companies include medical devices, biotech, and digital health, among other segments.

ATDC's Role in Accelerating HealthTech Innovation

Nephrodite and OrthoPreserve's founders noted ATDC's coaching and programming as critical in navigating fundraising and regulatory milestones. Another factor, they said, was ATDC's connection to Georgia Tech's labs and facilities and prototyping support and clinical advisors from across metro Atlanta.

"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 added that two Breakthrough device designations in the same year reflects ATDC's selection rigor, noting he's evaluated hundreds of technologies since the HealthTech vertical launched.

"It reflects the caliber of the companies in ATDC, specifically in the medical device space," Jungles said. "It's the strength of their teams, the persistence of the founders, and the collaboration of the ecosystem in Georgia and Atlanta."

Jonathan Schwartz, OrthoPreserve's founder and CEO.