AngioDynamics, Inc. (NASDAQ: ANGO), a leading and transformative medical technology company focused on restoring healthy blood flow in the body’s vascular system, expanding cancer treatment options and improving patient quality of life, today announced the publication of results from the PRESERVE study, which assessed the safety and effectiveness of irreversible electroporation (IRE) with the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa), in European Urology, a leading journal in urologic research that delivers high-impact research informing clinical practice and policy worldwide, including in the United States, titled “Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial.”
Prostate cancer is the second most common cancer among men in the United States.1 For many, especially those diagnosed at an early stage with less aggressive tumors, active surveillance remains the preferred initial management strategy.2 The NanoKnife System is a leading non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment.
“The publication of the PRESERVE study in European Urology provides strong supporting evidence for the use of Irreversible Electroporation as a focal therapy in prostate treatment,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “This is an important milestone for patients and providers seeking new options beyond traditional whole-gland therapies. These results reinforce the NanoKnife System’s role in helping patients receive effective treatment while preserving quality of life, particularly urinary and sexual function, which are often impacted by conventional treatments.”
The NanoKnife System received FDA clearance for prostate tissue ablation in late 2024, following the successful completion of the PRESERVE study. Conducted across 17 clinical sites in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), the trial enrolled 121 patients who met the key inclusion criteria: age >50 yr with organ-confined, grade group 2 or 3 PCa, clinical stage ≤T2c, prostate-specific antigen (PSA) ≤15 ng/mL, or PSA density <0.15 ng/mL2.
The PRESERVE clinical study met its primary effectiveness endpoint, demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. At 12 months post-procedure, 84.0% of men were free from in-field, clinically significant disease (defined by the Delphi consensus criterion). The study also demonstrated strong quality-of-life outcomes: urinary continence was largely preserved (97% at baseline vs. 96% at 12 months), and at 12 months, 84% of patients with good baseline sexual function maintained erections sufficient for penetration.3
These results confirm the NanoKnife System’s robust safety and efficacy profile, building on a foundation of more than 32 clinical studies involving over 2,600 patients worldwide.3
The PRESERVE study was led by Co-Principal Investigators Jonathan Coleman, MD, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and Arvin George, MD, a urologic oncologist at Johns Hopkins Medicine. Dr. George previously practiced at the Veterans Affairs Ann Arbor Healthcare System and Michigan Medicine.
“The PRESERVE data supports the long-term data that we are seeing in practice, patients are benefiting from effective, targeted treatment without compromising their quality of life,” said Dr. Coleman. “The ability to preserve urinary and sexual function while treating prostate tissue with precision is a meaningful advancement for both clinicians and patients.”
The NanoKnife System uses a non-thermal technique called irreversible electroporation (IRE) to ablate targeted prostate tissue while sparing critical structures. Unlike thermal ablation, IRE avoids damaging critical structures, helping preserve urinary and sexual function.
The PRESERVE results arrive at a pivotal time, as global urologic societies increasingly recognize focal therapy, and patients seek alternatives to whole-gland treatments that may carry a greater risk of side effects.
For more information on the NanoKnife System and focal therapy in prostate tissue, visit here.
