AngioDynamics receives FDA approval for study

• AngioDynamics (NASDAQ:ANGO) received FDA approval for an Investigational Device Exemption to launch the RELIEF clinical study.
• The study evaluates the NanoKnife System for treating lower urinary tract symptoms in men with benign prostatic hyperplasia.
• AngioDynamics aims to generate safety and effectiveness data to advance its non-thermal ablation technology as a new treatment option.

AngioDynamics (NASDAQ:ANGO) announced that the U.S. Food and Drug Administration approved its Investigational Device Exemption application to begin the RELIEF feasibility study.

This study marks an expansion for the NanoKnife System, which is currently cleared for the surgical ablation of prostate tissue.

The prospective, single-arm trial will enroll 40 subjects across five clinical sites in the United States to assess outcomes over a five-year period.

AngioDynamics stated the results from this study are intended to establish a foundation for the future clinical development of its technology in treating benign prostatic hyperplasia.

The company focuses on vascular restoration and cancer treatment technologies, with the NanoKnife System representing its primary platform for non-thermal ablation.

Recent clinical efforts have centered on expanding the utility of this system beyond oncology into prevalent urologic conditions like benign prostatic hyperplasia.