AngioDynamics has received FDA approval for its investigational device exemption application to begin the RELIEF study, which will evaluate the company's NanoKnife System as a minimally invasive treatment for lower urinary tract symptoms caused by benign prostatic hyperplasia. The prospective, single-arm study will enroll 40 patients across up to five U.S. clinical sites, with primary endpoints including changes in International Prostate Symptom Score and device-related adverse events at six months, and follow-up continuing for five years. The NanoKnife System uses irreversible electroporation technology, already cleared for prostate tissue ablation, to deliver non-thermal electrical pulses that create permanent nanopores in targeted cells while preserving surrounding structures. AngioDynamics shares fell 3.4% on the day of the announcement, and the stock has declined 8.6% year-to-date, compared with a 19% drop for the industry and an 8.5% gain for the S&P 500. The company has a market capitalization of $502.2 million.
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West Pharmaceutical Services IncAngioDynamics IncFDA IDE approval for NanoKnife BPH study is a positive regulatory milestone for a new indication.
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