In a significant move to expand its urological footprint, medical technology company AngioDynamics has received formal approval from the United States Food and Drug Administration (FDA) to initiate the RELIEF clinical trial. The study will evaluate the company’s flagship NanoKnife system as a minimally invasive, tissue-sparing treatment for men suffering from benign prostatic hyperplasia (BPH).
The RELIEF trial represents a strategic pivot for AngioDynamics, leveraging existing clinical evidence from the prostate cancer space to address one of the most common urological conditions affecting the aging male population.
Main Facts: The Scope of the RELIEF Study
The RELIEF clinical trial is a prospective, single-arm study designed to determine the safety and efficacy of irreversible electroporation (IRE) technology in managing the symptoms of BPH.
- Clinical Objective: To evaluate the change in International Prostate Symptom Score (IPSS) at six months post-procedure as the primary effectiveness endpoint.
- Safety Parameters: To monitor the incidence and severity of device-related adverse events over the six-month study period.
- Participant Capacity: The study will enroll up to 40 participants.
- Study Geography: Research will be conducted across a maximum of five clinical sites within the United States.
- Long-term Monitoring: Participants will be subject to a longitudinal follow-up period of up to five years to assess secondary outcomes, ensuring the durability of the IRE treatment.
The NanoKnife system, which utilizes non-thermal energy to create microscopic pores in cell membranes (irreversible electroporation), is already cleared in the US for the surgical ablation of soft tissue, including prostate tissue. The RELIEF trial specifically seeks to confirm whether this established technology can be safely applied to the non-malignant, yet highly disruptive, condition of BPH.
The Clinical Burden of BPH
Benign Prostatic Hyperplasia (BPH) is a condition characterized by the non-cancerous enlargement of the prostate gland. As the prostate grows, it can compress the urethra, leading to a constellation of debilitating lower urinary tract symptoms (LUTS). These symptoms, which significantly impair quality of life, include:
- Frequency: The need to urinate often throughout the day and night (nocturia).
- Urgency: A sudden, overwhelming need to urinate.
- Weak Stream: A reduction in the force of the urinary flow.
- Incomplete Emptying: The sensation that the bladder has not fully evacuated, which can lead to further complications such as bladder stones or urinary tract infections.
For millions of men, current standard-of-care treatments range from daily pharmacological interventions to invasive surgeries like Transurethral Resection of the Prostate (TURP). While effective, these options often come with side effects, including sexual dysfunction or long recovery periods. The RELIEF trial aims to fill the "middle ground" of the treatment spectrum, offering a minimally invasive, tissue-sparing alternative.
Chronology: From Prostate Cancer to BPH Innovation
The path to the RELIEF trial is rooted in several years of clinical development for the NanoKnife system.
Early Clinical Observations
The impetus for the RELIEF trial did not emerge in a vacuum. During clinical trials assessing the NanoKnife system for intermediate-risk prostate cancer, clinicians began reporting a secondary benefit: patients frequently noted significant improvements in their urinary symptoms following the IRE procedure. These anecdotal but consistent reports led AngioDynamics to hypothesize that the energy delivery mechanism of the NanoKnife might be uniquely suited to address the obstructive nature of BPH.
The PRESERVE Milestone
In May 2026, AngioDynamics reached a major milestone by reporting two-year results from the PRESERVE pivotal trial. The data demonstrated durable, positive outcomes for the NanoKnife system in treating intermediate-risk prostate cancer. The success of the PRESERVE trial provided the necessary clinical confidence and regulatory foundation to pursue the Investigational Device Exemption (IDE) for the new, non-oncological application of BPH.
FDA Approval and Future Roadmap
Following the submission of the IDE application, the FDA granted approval for the RELIEF study to proceed. With the trial now officially launching, AngioDynamics is preparing to coordinate with its five clinical sites to begin patient enrollment, marking the transition of NanoKnife from a cancer-focused device to a broader urological solution.
Supporting Data and Scientific Rationale
The scientific rationale for the RELIEF study rests on the unique properties of Irreversible Electroporation (IRE). Unlike thermal ablation techniques (such as laser or microwave therapy) that "cook" the tissue, IRE uses high-voltage, short-duration electrical pulses to induce cell death.
Why IRE Matters
Because IRE is non-thermal, it spares the connective tissue scaffolding and surrounding structures, such as the nerves and blood vessels that are critical for maintaining urinary and sexual function. This "tissue-sparing" capability is the cornerstone of the company’s value proposition.
Primary and Secondary Endpoints
The study’s reliance on the IPSS as the primary endpoint is industry-standard for BPH research. The IPSS is a validated questionnaire that quantifies the severity of symptoms, providing a clear numerical metric to evaluate the success of the intervention. By tracking these patients for up to five years, AngioDynamics intends to prove that the relief provided by NanoKnife is not merely a transient effect but a long-term solution that can withstand the test of time.
Official Responses: Insights from Leadership
The leadership team at AngioDynamics has expressed strong optimism regarding the potential for the RELIEF trial to redefine the BPH treatment landscape.
Juan Carlos Serna, Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, emphasized the strategic importance of the trial:
"The NanoKnife system has an established role in the treatment of men with intermediate-risk prostate disease. Physicians have consistently reported meaningful improvements in urinary symptoms following IRE with the NanoKnife system, a signal we believe warrants further clinical evaluation. The RELIEF study will generate the initial safety and effectiveness data needed to advance IRE as a tissue-sparing solution for the millions of men living with BPH."
The study will be under the clinical leadership of Dr. Felix Cheung of the Memorial Sloan Kettering Cancer Center, who serves as the co-principal investigator. His involvement underscores the high clinical standard the company is applying to this investigation, drawing on top-tier oncology and urology expertise to validate the technology’s performance.
Implications: A New Era for Urological Care?
The launch of the RELIEF trial has significant implications for both the medical device industry and the patient population.
1. Market Expansion
For AngioDynamics, success in the RELIEF trial could unlock a vastly larger patient demographic. While the market for prostate cancer treatment is substantial, the market for BPH is massive, with a significant percentage of the aging male population requiring intervention. Demonstrating efficacy here would position NanoKnife as a multi-indication platform.
2. Paradigm Shift in Treatment
If the study proves successful, the medical community may shift away from more invasive procedures toward "office-based" or minimally invasive procedures. This would reduce the burden on healthcare systems by lowering the need for prolonged hospital stays and reducing the rate of complications associated with traditional surgical resection.
3. Regulatory and Legal Caution
Despite the excitement, the company remains cautious in its communication. The NanoKnife system remains an investigational device for the treatment of BPH and is strictly limited by US law to investigational use. The company must successfully navigate the trial phases and subsequent regulatory filings before it can market the device for this new indication.
4. Patient Quality of Life
Ultimately, the goal of the RELIEF trial is to restore normalcy to the lives of men struggling with BPH. By avoiding the thermal damage associated with older technologies, NanoKnife offers the promise of symptom relief without the trade-offs that often force patients to delay treatment until their condition becomes acute.
As the RELIEF trial moves into its enrollment phase, the urological community will be watching closely. Should the results mirror the positive outcomes seen in the PRESERVE trial, the NanoKnife system could well become a standard of care for one of the most common, yet under-treated, conditions in modern men’s health.
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