AngioDynamics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application to initiate the RELIEF study. This feasibility study evaluates the NanoKnife System's irreversible electroporation (IRE) technology as a minimally invasive treatment for lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH). The approval marks a significant step in expanding the application of the company's non-thermal ablation technology beyond oncology, addressing a critical gap in patient care by balancing treatment effectiveness with the preservation of sexual and urinary function.

Benign prostatic hyperplasia is a prevalent urologic condition in the United States, affecting an estimated 15 million men. More than 300,000 surgical procedures are performed annually to address this condition. BPH can cause debilitating symptoms such as urinary frequency, urgency, weak stream, and incomplete bladder emptying, which significantly impair daily function and quality of life. Current treatment options range from pharmacologic therapy to surgical interventions like transurethral resection of the prostate (TURP) and newer minimally invasive procedures.

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 will be evaluated for primary endpoints at six months post-treatment and 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, while the primary safety endpoint is the incidence and severity of device-related adverse events during that period.

"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 study is led by co-Principal Investigator Felix Cheung, MD, Urologic Surgeon at Memorial Sloan Kettering Cancer Center. In the procedure, 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.

Key Details of the RELIEF Study