AngioDynamics Secures FDA Approval to Begin Benign Prostatic Hyperplasia Study

MT Newswires Live06-17

AngioDynamics (ANGO) said Wednesday its investigational device exemption application has received US Food and Drug Administration approval to begin the RELIEF study, which will evaluate its NanoKnife irreversible electroporation technology as a treatment for lower urinary tract symptoms in men with benign prostatic hyperplasia.

The study will enroll 40 subjects at up to five clinical sites in the United States, the company said.

The primary effectiveness endpoint of the study 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 during that period, AngioDynamics said.

Shares of the company were down 1.7% in Wednesday's premarket activity.

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