AngioDynamics Receives FDA Approval to Launch RELIEF Study Evaluating NanoKnife Technology for Benign Prostatic Hyperplasia
AngioDynamics, Inc., a medical technology company focused on advancing innovative therapies that improve vascular health, expand cancer treatment options, and enhance patient quality of life, has announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for the RELIEF clinical study. The approval enables the company to begin a feasibility trial evaluating the use of irreversible electroporation (IRE), delivered through its NanoKnife System, as a potential treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
The FDA’s authorization marks an important milestone for AngioDynamics as it seeks to expand the clinical applications of its NanoKnife technology beyond its established role in prostate tissue ablation. Through the RELIEF study, the company aims to investigate whether IRE can offer a minimally invasive, tissue-sparing treatment option for millions of men affected by BPH while preserving urinary and sexual function.
The study is expected to generate foundational safety and effectiveness data that could support future development of IRE as a novel therapeutic approach for one of the most common urologic conditions affecting aging men.
Understanding the Burden of Benign Prostatic Hyperplasia
Benign prostatic hyperplasia is one of the most prevalent health conditions affecting men, particularly as they grow older. The condition involves the noncancerous enlargement of the prostate gland, which surrounds the urethra and plays a role in reproductive function.
As the prostate enlarges, it can place increasing pressure on the urethra, interfering with normal urine flow and leading to a variety of urinary symptoms. These symptoms are collectively referred to as lower urinary tract symptoms and can significantly affect daily life.
Common symptoms associated with BPH include frequent urination, especially during the night, sudden urges to urinate, difficulty initiating urination, a weak urinary stream, prolonged urination, and the sensation that the bladder has not fully emptied after urination.
Although benign prostatic hyperplasia is not cancerous, its impact on quality of life can be substantial. Persistent urinary symptoms may disrupt sleep, limit daily activities, affect work productivity, and contribute to emotional distress.
According to estimates cited by AngioDynamics, approximately 15 million men in the United States experience symptoms associated with BPH. The condition also contributes to a significant healthcare burden, with more than 300,000 surgical procedures performed annually to address prostate enlargement and related urinary symptoms.
Given the large number of affected individuals and the chronic nature of the condition, there is continued interest in developing treatment options that are both effective and minimally disruptive to patients’ lives.
Current Treatment Landscape and Remaining Challenges
Treatment options for benign prostatic hyperplasia vary depending on symptom severity, prostate size, patient preferences, and overall health status.
Many patients initially receive medication-based therapies designed to relax prostate muscles or reduce prostate size. While these treatments can provide symptom relief, they may not be effective for all patients and can sometimes cause side effects that affect treatment adherence.
For individuals whose symptoms progress or fail to respond adequately to medications, surgical intervention may become necessary.
One of the most widely used procedures is transurethral resection of the prostate (TURP), which involves removing portions of prostate tissue that obstruct urine flow. TURP has long been considered a standard treatment for moderate to severe BPH but is associated with potential risks and side effects, including bleeding, urinary complications, and sexual dysfunction.
In recent years, several minimally invasive alternatives have emerged, offering less invasive approaches to prostate tissue reduction. These technologies seek to reduce recovery times and minimize treatment-related complications while maintaining effectiveness.
Despite these advances, many clinicians and patients continue to seek treatment options capable of delivering durable symptom relief while preserving important urinary and sexual functions.
The RELIEF study has been designed to explore whether irreversible electroporation may offer such a balance.
Expanding the Potential of NanoKnife Technology
The NanoKnife System represents AngioDynamics’ proprietary platform for delivering irreversible electroporation, a unique form of tissue ablation that differs significantly from conventional thermal ablation technologies.
Traditional ablation techniques typically destroy tissue using heat or cold. While effective, thermal approaches can sometimes affect surrounding structures and increase the risk of damage to critical anatomical features.
Irreversible electroporation operates through a different mechanism. Instead of using temperature extremes, the technology delivers carefully controlled electrical pulses that create permanent nanopores in cellular membranes.
These nanopores disrupt normal cellular function and ultimately lead to targeted cell death while preserving much of the surrounding structural framework, including connective tissues, blood vessels, and nerves.
This non-thermal mechanism has attracted attention because of its potential to selectively remove unwanted tissue while reducing collateral damage to nearby structures.
The NanoKnife System is currently cleared for the surgical ablation of prostate tissue and has established a role in treating men with intermediate-risk prostate disease.
Importantly, clinicians using the technology for prostate-related procedures have reported notable improvements in urinary symptoms among treated patients. These observations provided the scientific and clinical rationale for exploring the technology’s potential application in patients with benign prostatic hyperplasia.
Clinical Observations Inspire New Research Direction
According to AngioDynamics, physicians treating intermediate-risk prostate disease with the NanoKnife System consistently observed improvements in urinary function following treatment.
These findings suggested that IRE may influence prostate tissue in a manner that reduces urinary obstruction and improves lower urinary tract symptoms.
While these observations were not originally collected as part of a dedicated BPH study, they generated sufficient interest to warrant formal clinical investigation.
Juan Carlos Serna, Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, emphasized the significance of these clinical observations.
He noted that the NanoKnife System has already demonstrated value in prostate treatment settings and that physicians have repeatedly reported meaningful improvements in urinary symptoms after IRE procedures. According to Serna, these outcomes provided a compelling signal that deserved systematic evaluation through a dedicated clinical study.
He stated that the RELIEF trial is intended to generate the initial evidence necessary to determine whether irreversible electroporation can serve as a tissue-sparing treatment option for the millions of men living with BPH and associated urinary symptoms.
Design of the RELIEF Clinical Study
The RELIEF study has been structured as a prospective, single-arm feasibility trial designed to evaluate the safety and preliminary effectiveness of IRE delivered via the NanoKnife System.
Researchers plan to enroll 40 participants across as many as five clinical sites throughout the United States.
The study will focus on men experiencing lower urinary tract symptoms caused by benign prostatic hyperplasia. Participants will undergo treatment using the NanoKnife System and then be monitored over an extended period to evaluate both short-term and long-term outcomes.
The primary effectiveness endpoint of the trial is the mean change in the International Prostate Symptom Score (IPSS) measured from baseline to six months after treatment.
The IPSS is one of the most widely accepted and validated tools used to assess urinary symptoms associated with prostate enlargement. The questionnaire evaluates factors such as urinary frequency, urgency, incomplete bladder emptying, weak stream, and overall symptom burden.
Improvement in IPSS scores would indicate a reduction in symptom severity and improved patient quality of life.
The study’s primary safety endpoint focuses on the incidence and severity of device-related adverse events occurring during the first six months after treatment.
Beyond these primary measures, investigators will continue monitoring participants for a total of five years to assess long-term durability, functional outcomes, and overall treatment effectiveness.
Scientific Rigor and Long-Term Evaluation
The RELIEF study is being led by co-Principal Investigator Felix Cheung, M.D., a urologic surgeon at Memorial Sloan Kettering Cancer Center.
Cheung emphasized that the study has been carefully designed to generate high-quality clinical evidence using established scientific methodologies.
In addition to IPSS assessments, researchers will evaluate objective measures of urinary function, including uroflowmetry, which measures the rate and efficiency of urine flow.
Quality-of-life assessments will also be incorporated to better understand the patient experience and determine whether symptom improvements translate into meaningful daily benefits.
A particularly important aspect of the study is its focus on preserving sexual function, an area of concern for many men considering treatment for BPH.
Investigators will carefully monitor sexual health outcomes throughout the study, helping determine whether IRE can deliver symptom relief without compromising erectile function or other aspects of sexual well-being.
Cheung noted that the study’s comprehensive design, combined with five years of follow-up, will provide critical information regarding both treatment durability and long-term safety.
How the Procedure Works
In the RELIEF study, treatment is performed using a transperineal approach under general anesthesia.
During the procedure, physicians place specialized electrodes through the perineum into carefully defined treatment zones within the prostate. Placement is guided by transrectal ultrasound imaging to ensure precision and accuracy.
The treatment plan focuses on targeting the prostate’s transition zone, the area most commonly associated with enlargement and urinary obstruction in BPH.
A key advantage of the NanoKnife approach is its ability to spare critical surrounding structures. Treatment planning is specifically designed to preserve important anatomical features, including the neurovascular bundles responsible for sexual function, the external urinary sphincter, and the urethra.
Once electrodes are positioned, the NanoKnife System delivers short pulses of electrical energy that create permanent nanopores within targeted cells. This process leads to selective tissue ablation without relying on heat or cold.
The non-thermal nature of the procedure may help reduce injury to surrounding structures and support faster recovery while maintaining functional outcomes.
The FDA’s approval of the RELIEF study represents an important step in evaluating a potentially innovative treatment option for benign prostatic hyperplasia. With millions of men experiencing lower urinary tract symptoms and many seeking alternatives to traditional surgical interventions, there is significant interest in therapies that can provide durable symptom relief while preserving quality of life.
By investigating irreversible electroporation as a tissue-sparing, minimally invasive approach, AngioDynamics hopes to expand the therapeutic potential of the NanoKnife System and address an important unmet need in urology.
If the RELIEF study demonstrates favorable safety and effectiveness results, it could establish the foundation for larger clinical trials and future regulatory development efforts. Ultimately, the research may pave the way for a new treatment paradigm that offers men with BPH meaningful symptom improvement while minimizing the functional trade-offs often associated with existing therapies.
As enrollment begins and data emerge, the study will provide valuable insights into whether irreversible electroporation can become a viable new option in the evolving landscape of BPH treatment.
About AngioDynamics, Inc.
AngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life.
The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit angiodynamics.com.
About the NanoKnife System
The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue.4 Visit nanoknife.com for full product information.
United States: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.
Canada: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.
European Union: The NanoKnife System is indicated for the ablation of soft tissue and tumors of the pancreas, kidney, liver, or prostate, including intermediate risk prostate cancer.
The NanoKnife System has not received clearance for the therapy or treatment of any specific disease or condition.
The NanoKnife System when used for the treatment of benign prostate hyperplasia is an investigational device. Limited by United States law to investigational use.
