AngioDynamics, Inc. (NASDAQ: ANGO) announced that the U.S. Food and Drug Administration has approved its Investigational Device Exemption application to begin the RELIEF feasibility study, which will evaluate the company's NanoKnife System as a treatment for lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH).

The NanoKnife System uses irreversible electroporation (IRE), a non-thermal ablation technology that delivers high-voltage electrical pulses to destroy targeted tissue. The device is currently cleared in the United States for the surgical ablation of soft tissue, including prostate tissue, but its use for BPH remains investigational.

The RELIEF study is a prospective, single-arm trial that will enroll 40 subjects across up to five U.S. clinical sites. The primary effectiveness endpoint is the mean change in International Prostate Symptom Score from baseline to six months post-procedure. The primary safety endpoint is the incidence and severity of device-related adverse events over the same period. Patients will be followed for a total of five years for secondary endpoints.

The study is co-led by Felix Cheung, MD, urologic surgeon at 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," Cheung said.

According to the press release, BPH affects an estimated 15 million men in the United States, with more than 300,000 surgical procedures performed annually. The clinical rationale for the RELIEF study stems from prior observations in which physicians reported urinary symptom improvements in patients treated with the NanoKnife System for intermediate-risk prostate cancer.

The procedure involves placing electrodes transperineally into predefined prostate treatment zones under ultrasound guidance, targeting the transition zone while aiming to preserve surrounding structures including the neurovascular bundles, external sphincter, and urethra.