When deep seated, long-unmet clinical needs for a very large patient population meet one particular young patient’s journey, opportunity for innovation knocks. Loudly.

“All Holly wanted was to be ‘normal,’” said Nephrodite Co-Founder and Urologic oncologist Nikhil Shah, DO, MPH. “After years of living in fear, in constant sickness, full of stress, constantly in and out of dialysis centers, she did at last receive a kidney transplant. Ultimately the transplant failed and she succumbed to kidney failure.”

In the 1940s and 50s, pioneering dialysis technology extended the lives of patients with renal disease and kidney failure, previously a veritable death sentence. That technology has changed little in the past seven decades or more.

“Advancements in technologies for other high volume, high impact diseases like heart disease and heart failure, like LVAD [left ventricular assist devices], have improved the lives and outcomes by leaps and bounds in the past 10 years,” Dr. Shah said. “It is past time for new technologies to do the same for millions of patients who rely on dialysis for their very lives.”

Nephrodite co-founder and Pediatric Urologist Hiep Nguyen, MD, specializes in surgical advances in kidney disease and urinary reconstruction, including kidney transplantation. Almost 10 years ago, Drs. Shah and Nguyn set out to create a technology “to restore freedom, function and independence to individuals with end stage kidney disease.” 

Enter Holly(™), a continuously functioning dialysis device, one of only a few technolgies in the artificial kidney space to ever be developed. the nearest technology to an artificial kidney ever developed.

Given Holly’s potential impact across its patient population to improve outcomes and reduce cost for a disease with very high priorities for global health organizations, and very high investability potential, Nephrodite earned the winner’s position in the PitchRounds at AdvanSE 2022 device category in May of this year.

 

COMMITMENT

As a U.S. FDA Class III technology, Holly’s commercialization pathway is the most rigorous, time consuming and costly in the medtech innovation discipline. It is not unreasonable to assume total concept-to-commercialization costs for Class III devices to approach, or exceed $100 million.

“Our work started many years ago; trying to miniaturize a common, quite large dialysis machine to about the size of a small child’s fist, implantable in humans,” Dr. Shah said. “It has been no small task, but we have ensured our technology is sound and all these years later now have a functional prototype. 

“We have had many opportunities to walk away, which I suppose is not uncommon for an implantable technology that requires PMA (premarket authorization) as an FDA Class III device.

“But we have done a tremendous amount of de-risking, we have close ties to the unmet need, the patient population and the technology itself. Our team is dedicated, passionate and we intend to see this technology all the way through to commercialization.

“We are, without question, in it for the long haul.”

Current status

Nephrodite relocated its headquarters to Atlanta earlier this year where it entered into Georgia Tech’s Advanced Technology Development Center.

“We relocated to Atlanta in order to leverage the abundance of talent and resources not just in Atlanta, Georgia but in the Southeast,” Dr. Shah said. “But we were not aware at the time of just how robust the life science ecosystem is including the ATDC, Georgia Bio, SEMDA – now Southeast Life Sciences – and supporting entities like the Global Center for Medical Innovation on top of all the scientists, clinicians, regulatory experts and others. 

“We have been working to both make our presence known and avail ourselves of the local and regional assets and resources, which are plentiful.”

Nephrodite has recently accepted an invitation to be part of the Center for Medtech Excellence, which “will provide a reimagined, comprehensive approach for concept to commercialization and sustainable innovation, which is crucial for cultivating more agile healthcare organizations. Georgia Tech will develop the Center for MedTech Excellence – a three-year collaboration with the Advanced Technology Development Center (ATDC), the Georgia Manufacturing Extension Partnership (GaMEP), and the Global Center for Medical Innovation (GCMI).”

What’s next

In addition to its recent FDA application for a breakthrough technology designation, the company intends to raise Series A funding starting in Q2 2023 to complete development of a clinically appropriate, human-ready device in order to then initiate requisite preclinical testing in chronic models sometime in 2024. (Prospective, interested investors should contact Nikhil Shah, nshah@nephrodite.com).

“In the very near-term, we intend to raise awareness for our cause and its associated burden, in addition to forming a community advisory board for those on dialysis or those passionate about kidney disease to improve treatment options, outcomes and lives for patients worldwide,” Dr. Shah said. “We will be seeking volunteer based input on the device’s design and functional attributes with particular attention devoted to patient-centric needs for day-to-day living with our device.

“We welcome interested parties, be they patients, care givers, family members, clinicians or members of the scientific and research communities to contact Niraj Khurana, our Director of Operation (niraj@nephrodite.com) to learn more about participating in the community advisory board.

Lessons to Learn: Engage regulators early, often and never underestimate the importance of team acumen, timing

When asked what advice he would give to other medtech innovators, Dr. Shah shared the following:

“Try to include and understand what it’s going to take [to meet] regulatory requirements, milestones and inflection points as early as possible.

“Engage the formal regulatory body early and often. They will only help you. They are much more accessible, much more understanding and supportive of innovation and innovators with more available resources to help you verify actions or assumptions than people know. 

“Telling your story in a few minutes is an art that needs development and practice. It is important to understand your audience and your value proposition for them, but do not exclude your overarching value to the larger community, to everyone ‘in the room.’

“Assemble your team, internally or otherwise, carefully. Investors do indeed look closely at team members, their acumen, accomplishments and fit for function and timing.”

Southeast Life Sciences thanks Dr. Shah for sharing his insights with us.