Nephrodite Achieves Major Breakthrough as Holly Device Delivers Continuous Kidney Function in Multi-Day Large Animal Study
Nephrodite a medical device innovator advancing an implantable, fully mechanical renal replacement system, has announced highly encouraging results from a landmark multi-day large animal study of its Holly™ implantable renal replacement device. This achievement marks one of the most significant milestones in the pursuit of next-generation therapies for end-stage kidney disease (ESKD), demonstrating sustained, continuous kidney function replacement in a living large animal for the first time using a fully implantable, mechanical device.
Holly™ is designed to bring a dramatic shift to kidney care by functioning continuously inside the body, supporting mobility, improving quality of life, and offering the potential to reduce or eliminate the burdens associated with current dialysis treatments. At the core of the platform is Nephrodite’s proprietary hemofiltration technology, which integrates advanced filtration mechanisms with biocompatible materials engineered for safe and durable long-term implantation. This approach is intended to replicate essential kidney functions while minimizing complications that are common with existing dialysis technologies, such as clotting, membrane fouling, or device failure.
A First-of-Its-Kind Demonstration of Continuous Kidney Function Replacement
In the recently completed 72-hour study conducted at the Conrad Jobst Vascular Research Laboratories at the University of Michigan, the Holly™ device was evaluated in a living sheep. Over the course of the multi-day trial, the device consistently delivered essential kidney replacement functions, setting new benchmarks in performance, safety, and physiologic integration.
One of the most compelling aspects of the study is that it represents what Nephrodite believes to be the first demonstration of sustained, continuous kidney function replacement by a fully implantable mechanical device in a large animal. This achievement underscores the potential of the Holly™ platform to offer a transformative therapeutic option that could one day free patients from the constraints of traditional dialysis.
Key Performance Results from the 72-Hour Study
Throughout the study, Holly™ achieved several critical outcomes that collectively validate the feasibility of continuous, autonomous kidney support in a moving, active large animal:
• Effective continuous waste removal:
The device successfully filtered key metabolic toxins, including urea, creatinine, and potassium, mirroring essential kidney function. Measurable levels of these toxins began appearing in the dialysate within hours of implantation, confirming the device’s rapid engagement and sustained operational performance.
• Robust and physiologically aligned fluid management:
Holly™ maintained a clinically relevant ultrafiltration rate consistent with normal physiologic expectations. Its fluid management capabilities aligned with traditional dialysis targets while offering a self-regulating mechanism that automatically adjusted fluid delivery and removal based on the animal’s needs.
• Demonstrated biocompatibility and operational stability:
Over the full 72-hour period, the study observed no evidence of blood clot formation, hemolysis, device leakage, or other complications that often hinder long-term dialysis technologies. This clean safety profile highlights the promise of Nephrodite’s engineering approach and materials selection.
• Maintenance of natural behaviors in the test animal:
The sheep retained typical behaviors—including normal eating, drinking, and movement—throughout the study. This observation reinforces the device’s compatibility with active daily life, a critical requirement for future clinical adoption and patient independence.
• Adaptive, intelligent fluid regulation:
The Holly™ system showcased its intelligent self-regulatory function, supplying fluid when needed and removing excess fluid when appropriate. This type of autonomy underscores the platform’s potential to dramatically reduce the need for patient intervention or ongoing external oversight.
Expert Perspectives on the Breakthrough
Dr. Hiep T. Nguyen, MD, Co-Founder and Senior Vice President of Science and Technology at Nephrodite, emphasized the magnitude of the achievement, noting:
This study and the encouraging results represent a watershed moment in the treatment of end-stage kidney disease. For the first time, a fully implantable device has safely and effectively replaced kidney function continuously over multiple days in a large animal model, bringing us closer to freeing patients from the constraints of traditional dialysis.”
The success of Holly™ may pave the way toward a future where individuals with kidney failure can regain independence—living active lives without being tethered to complex dialysis regimens.
Dr. Nikhil L. Shah, DO, MPH, Co-Founder and CEO of Nephrodite and a practicing transplant surgeon, further underscored the potential impact:
The successful animal study further validates Nephrodite’s strategy to solve underlying fundamental challenges in kidney replacement therapy. The implications of this success extend far beyond the technical achievement. Hundreds of thousands of Americans and millions worldwide live with end-stage kidney disease, and the current standard of care limits their ability to work, travel, and participate fully in life. Holly is being developed as both a bridge-to-transplant and a potential destination therapy, with the aim of improving health outcomes and enabling patients to regain independence, dignity and hope.”
A Global Health Crisis in Need of Innovation
End-stage kidney disease remains one of the most pressing—and costly—public health challenges worldwide. More than 850,000 people in the United States live with ESKD, and annual treatment costs exceed $50 billion, largely due to the recurring and labor-intensive nature of dialysis care. Current treatment approaches, including hemodialysis and peritoneal dialysis, require frequent sessions lasting several hours each week. These treatments can restrict mobility, disrupt work and family life, and result in inadequate long-term outcomes.
On a global scale, the kidney replacement therapy market is expected to surpass $200 billion by 2030, driven by an aging population, rising rates of diabetes and hypertension, and persistent organ shortages that limit the availability of kidney transplants. As the demand for more flexible, effective, and patient-centered therapies grows, technologies like Holly™ could play an essential role in reshaping the future landscape of kidney care.
Next Steps: Advancing Toward Human Studies
Following the success of this multi-day study, Nephrodite is preparing to embark on Good Laboratory Practice (GLP) studies, a required step before regulatory filings. These efforts will support future submissions to federal agencies and pave the way for first-in-human clinical trials. The company’s long-term vision is to establish Holly™ as a scalable and reliable therapy that can serve as both a bridge-to-transplant solution for eligible patients and a destination therapy for those who are not candidates for transplantation.
As Nephrodite continues to push forward, the company remains committed to advancing technology that not only extends life but enhances the daily lived experience of patients with kidney disease.
ABOUT NEPHRODITE
Nephrodite is a medical device company dedicated to creating a better alternative to dialysis by developing Holly, a fully 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, with operations in Mumbai, India, Nephrodite is backed by leading investors and supported by a robust intellectual property portfolio.
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