RELIEF, a feasibility study, aims to evaluate the company’s irreversible electroporation (IRE) technology. Delivered by the company’s NanoKnife system, IRE already has FDA clearance for ablating prostate tissue associated with prostate cancer. Now,t he company has the green light to assess the technology in the treatment of lower urinary tract symptoms (LUTS) in men with benign prostatic hyperplasia (BPH).
AngioDynamics says that current treatments for BPH range from pharmacologic therapy to surgical interventions and newer minimally invasive procedures.
BPH continues to draw innovation from various areas of medtech. ProVerum and Zenflow announced FDA approvals for their implant-based technologies that treat BPH in December 2025. Robotic technology developer Procept then launched its BPH-treating system internationally and Prodeon won FDA clearance for its nitinol device for BPH. Butterfly Medical then raised $21 million to support its own BPH device.
Additionally, Rivermark Medical recently announced $20 million in funding as it advances a BPH treatment. The company aims to redefine the treatment of the condition through its FloStent platform.
Histotripsy pioneer HistoSonics also recently began a study using its therapy in BPH treatment.
More about the Relief Study
RELIEF is a prospective, single-arm clinical study that will enroll 40 subjects at up to five clinical sites in the U.S.
Investigators intend to evaluate patients at six months post treatment. Evaluation includes primary endpoints, plus five years of follow-up for secondary endpoints. The study’s primary effectiveness endpoint is he mean change in International Prostate Symptom Score (IPSS) from baseline to six months post-procedure. The primary safety endpoint is the incidence and severity of device-related adverse events during that period.
RELIEF sees electrodes placed transperineally into predefined treatment zones of the prostate. Placement takes place under trasnrectal ultrasound guidance and general anesthesia. NanoKnife delivers short pulses of electrical energy to create permanent nanopores in cell membranes. This results in precise, non-thermal ablation of prostate tissue.
Dr. Felix Cheung, a urologic surgeon at Memorial Sloan Kettering Cancer Center, serves as co-principal investigator, leading the study.
Commentary from AngioDynamics officials and RELIEF investigators
Juan Carlos Serna, AngioDynamics SVP, Scientific and Clinical Affairs, said:
“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. 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.”
Dr. Cheung added:
“The RELIEF study was designed with scientific rigor at its core. The study incorporates validated, well-established endpoints such as IPSS, uroflowmetry, and quality-of-life measures, alongside careful monitoring of sexual function and long-term durability through five years of follow-up. 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.”
