AngioDynamics Receives FDA IDE Approval for RELIEF Feasibility Study Evaluating NanoKnife IRE Platform as Minimally Invasive Treatment for Benign Prostatic Hyperplasia (BPH)

AngioDynamics, Inc. (NASDAQ: ANGO), a 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, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational Device Exemption (IDE) application to initiate the RELIEF study. RELIEF is a feasibility study evaluating irreversible electroporation (IRE), the non-thermal ablation technology delivered by the Company’s NanoKnife System, for the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH).

BPH is among the most prevalent urologic conditions affecting men in the United States, with an estimated 15 million men exhibiting symptoms and more than 300,000 surgical procedures performed annually.^1,2 BPH can cause lower urinary tract symptoms, including urinary frequency, urgency, weak stream, and incomplete bladder emptying, that impair daily function and quality of life.

Current treatment options range from pharmacologic therapy to surgical interventions such as transurethral resection of the prostate (TURP) and newer minimally invasive procedures, underscoring the need for additional approaches that balance effectiveness with preservation of sexual and urinary function.

“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,” said Juan Carlos Serna, AngioDynamics Senior Vice President, Scientific and Clinical Affairs. “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 NanoKnife System is cleared for the surgical ablation of prostate tissue. In prior clinical experience with IRE in the prostate, physicians observed meaningful improvements in urinary symptoms associated with BPH in patients treated for intermediate-risk prostate disease, an observation that provided clinical rationale for the RELIEF study.³

The RELIEF study is a prospective, single-arm clinical study that will enroll 40 subjects at up to five clinical sites in the United States. Patients, at six months post-treatment, will be evaluated for the primary endpoints and will also be followed for a total of five years for secondary endpoints. The primary effectiveness endpoint is the mean change in International Prostate Symptom Score (IPSS) from baseline to six months post-procedure. The primary safety endpoint is the incidence and severity of device-related adverse events during that period.

The study is led by co-Principal Investigator Felix Cheung, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center. RELIEF will evaluate the preliminary safety and effectiveness of IRE delivered via the NanoKnife System for the relief of BPH-related symptoms. The results will establish the evidence foundation for future clinical development of IRE as a minimally invasive treatment option for BPH.

“The RELIEF study was designed with scientific rigor at its core. The study incorporates validated, well-established endpoints such as IPSS, uroflowmetry, and quality-of-life measures, alongside careful monitoring of sexual function and long-term durability through five years of follow-up,” said Felix Cheung, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer Center. “This thoughtful, methodical approach will generate the high-quality evidence needed to determine whether IRE can offer men with BPH/LUTS a non-resecting alternative with meaningful functional preservation.”

In the RELIEF study, electrodes are placed transperineally into predefined treatment zones of the prostate under transrectal ultrasound guidance and general anesthesia. Treatment planning targets the transition zone bilaterally while preserving critical structures, including the neurovascular bundles, external sphincter, and urethra. The NanoKnife System delivers short pulses of electrical energy to create permanent nanopores in cell membranes, resulting in precise, non-thermal ablation of prostate tissue.

For more information about the RELIEF study, visit: https://clinicaltrials.gov/study/NCT07640776.

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