Nephrodite’s Holly Implantable Dialysis System Selected for FDA TAP Program, Advancing Path Toward Clinical Development
Nephrodite, a medical technology company focused on transforming treatment options for patients with end-stage kidney disease, has announced that its Holly™ implantable continuous dialysis system has been selected to participate in the U.S. Food and Drug Administration’s (FDA) Total Product Life Cycle Advisory Program (TAP). The selection represents a significant milestone for the company as it continues developing an innovative renal replacement therapy designed to reduce the burden associated with conventional dialysis treatments.
The FDA’s TAP program was created to support the development of medical devices that address critical unmet healthcare needs. Through the initiative, participating companies receive early and ongoing engagement with FDA experts and other stakeholders who can provide guidance on clinical, regulatory, and commercialization strategies. The goal is to help innovative technologies reach patients more efficiently while maintaining rigorous standards for safety and effectiveness.
Nephrodite’s inclusion in the program places the company among a limited number of medical device developers that have secured both FDA Breakthrough Device Designation and TAP acceptance. The achievement highlights growing regulatory recognition of the potential impact Holly could have on the treatment of patients living with end-stage kidney disease.
Supporting a New Approach to Kidney Failure Treatment
For millions of people worldwide, kidney failure requires ongoing dialysis treatments to perform essential functions normally handled by healthy kidneys. Conventional dialysis typically requires patients to visit specialized treatment centers multiple times each week, often for several hours per session. While life-sustaining, these treatments can impose significant physical, emotional, and logistical burdens on patients and their families.
Nephrodite is developing Holly as an implantable, continuous renal replacement system designed to provide a more consistent approach to dialysis. Unlike traditional intermittent dialysis therapies, the device is intended to continuously remove toxins and maintain fluid balance, potentially offering patients greater flexibility and independence in their daily lives.
The company believes this continuous treatment model could help address many of the limitations associated with current dialysis methods while improving overall quality of life for individuals with advanced kidney disease.
Regulatory Collaboration to Accelerate Development
According to Nephrodite leadership, participation in the TAP program will provide valuable opportunities for collaboration with FDA specialists throughout the product development process. This engagement is expected to help the company refine its development plans, align regulatory expectations, and prepare for future clinical studies.
Nikhil Shah, DO, MPH, Co-Founder and Chief Executive Officer of Nephrodite, emphasized the company’s commitment to bringing the technology to patients as efficiently and safely as possible.
He noted that the company’s objective is to reduce dependence on traditional clinic-based dialysis treatments and improve patient outcomes across multiple dimensions, including physical health, mental well-being, mobility, and overall quality of life. Shah described the FDA’s recognition as evidence of a shared commitment to advancing innovative solutions for patients facing severe kidney disease.
Nephrodite is currently preparing for Good Laboratory Practice (GLP) studies, an important stage in the development of medical devices intended for human use. The company is also assembling the regulatory submissions required to support future early feasibility studies involving human participants.
These activities represent critical steps toward demonstrating the safety and performance of the Holly system before broader clinical evaluation can begin.
Building on Breakthrough Device Designation
The TAP selection follows another important regulatory milestone achieved by Nephrodite in late 2025, when the FDA granted Breakthrough Device Designation to the Holly system.
The Breakthrough Devices Program is designed to expedite the development and review of technologies that may offer more effective treatment or diagnosis for serious or life-threatening conditions. Receiving the designation signaled the FDA’s recognition of the potential for Holly to address significant unmet needs among patients with end-stage kidney disease.
Participation in TAP is expected to further strengthen the development pathway established through the Breakthrough Device program. By facilitating earlier alignment between regulators and developers, the initiative may help reduce uncertainty surrounding study design, clinical evidence requirements, and regulatory expectations.
Company leaders believe this enhanced collaboration could improve development efficiency and create a more predictable route toward eventual FDA authorization.
In addition, early regulatory alignment may support future reimbursement and coverage considerations, including opportunities associated with recently introduced federal initiatives designed to accelerate access to innovative medical technologies.
Addressing a Significant Patient Need
End-stage kidney disease remains a major public health challenge, affecting hundreds of thousands of patients in the United States alone. For many individuals, dialysis becomes a lifelong necessity unless a kidney transplant becomes available.
Despite advances in dialysis technology over recent decades, many patients continue to experience significant disruptions to their daily routines due to frequent treatment schedules. Travel limitations, reduced flexibility, fatigue, and ongoing health complications can all impact quality of life.
Hiep Nguyen, MD, Co-Founder and Senior Vice President of Science and Technology at Nephrodite, highlighted the challenges faced by patients undergoing conventional dialysis and the motivation behind the company’s work.
According to Nguyen, dialysis remains a life-saving treatment but does not fully replicate normal kidney function. Patients often must adhere to strict treatment schedules that can affect their ability to work, travel, and participate in everyday activities.
Drawing on his clinical experience caring for patients with advanced kidney disease, Nguyen emphasized the need for innovative alternatives that can provide continuous renal support while allowing individuals greater independence.
He noted that patients across the United States have expressed strong interest in technologies that could reduce treatment burdens and offer more freedom in managing their lives. The company believes Holly has the potential to meet this demand by delivering continuous mechanical renal replacement therapy through an implantable platform.
As Nephrodite advances toward clinical testing, the company views participation in the FDA’s TAP program as an important step in bringing its technology closer to patients. The combination of TAP acceptance and Breakthrough Device Designation provides access to resources and regulatory engagement that could help streamline development efforts and support future commercialization plans.
The company’s immediate priorities include completing GLP studies, advancing regulatory preparations, and establishing the foundation for first-in-human evaluations of the Holly system. These milestones will be critical in determining the device’s potential to become a new treatment option for patients with end-stage kidney disease.
While Holly remains an investigational device and has not yet received approval for commercial use, its progress through key regulatory programs reflects increasing momentum behind the technology. If successful, the implantable continuous dialysis system could represent a significant advancement in kidney care, offering patients an alternative to traditional dialysis and potentially improving long-term quality of life.
With continued regulatory collaboration, clinical development, and patient-focused innovation, Nephrodite aims to redefine how renal replacement therapy is delivered and expand treatment possibilities for individuals living with kidney failure.
About Nephrodite
Nephrodite is a medical device company dedicated to creating a better alternative to dialysis by developing Holly, an implantable, continuous renal replacement device designed to restore freedom, function and independence in people living with end-stage kidney disease. Founded by board-certified urologists Nikhil L. Shah, DO, MPH, and Hiep T. Nguyen, MD, the company combines deep clinical expertise with engineering innovation to deliver a true renal replacement platform. Headquartered in Atlanta, Georgia, Nephrodite is backed by leading investors and supported by a robust intellectual property portfolio.
