LATHAM, N.Y., May 13, 2026
AngioDynamics announced new two-year data from the pivotal PRESERVE clinical trial, demonstrating that its NanoKnife Irreversible Electroporation (IRE) System delivered sustained oncologic control and maintained a strong safety profile in patients with intermediate-risk prostate cancer. The updated findings were presented at the 2026 Annual Meeting of the American Urological Association in Washington, D.C., further strengthening the growing clinical evidence supporting focal IRE as a minimally invasive prostate cancer treatment approach.
Two-Year PRESERVE Trial Data Reinforce NanoKnife Efficacy
The PRESERVE trial (NCT04972097) is a prospective, single-arm pivotal IDE study evaluating focal ablation using the NanoKnife System in men diagnosed with Gleason Grade Group 2–3 intermediate-risk prostate cancer. Conducted across 17 U.S. clinical centers in collaboration with the Society of Urologic Oncology Clinical Trials Consortium, the study enrolled 121 patients to assess the long-term effectiveness and safety of focal irreversible electroporation.
At the 24-month evaluation point, the study demonstrated highly durable results. Among the 72 analysis-eligible patients, 68 patients (94.4%) completed their two-year assessment, highlighting strong patient retention and follow-up consistency. Importantly, investigators reported zero new treatment failures between the 12- and 24-month periods in patients with available follow-up data. Only one patient underwent a clinically indicated biopsy during the period, and the biopsy tested negative for cancer.
The study also showed continued prostate-specific antigen (PSA) improvement, with 97% of evaluated patients maintaining PSA levels below baseline values at 24 months. Researchers additionally confirmed that no new device-related or procedure-related adverse events were reported during the second year of follow-up, reinforcing the procedure’s favorable safety profile.
NanoKnife Expands Momentum in Focal Prostate Cancer Therapy
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The updated data build on previously published 12-month results that appeared in European Urology in July 2025, where the NanoKnife System achieved an 80% freedom-from-treatment-failure rate among protocol-biopsied patients. Combined with international long-term evidence showing sustained outcomes beyond five years, the latest results further position focal IRE as an emerging alternative to more invasive prostate cancer therapies.
According to Juan Carlos Serna, Senior Vice President of Scientific and Clinical Affairs at AngioDynamics, the consistency of the data across U.S. and international studies presents a compelling case for broader clinical adoption. The company emphasized that physicians are increasingly integrating the NanoKnife platform into prostate cancer treatment pathways for patients seeking effective cancer control while preserving urinary and sexual function quality-of-life outcomes.
Unlike traditional thermal ablation technologies, irreversible electroporation (IRE) uses controlled electrical pulses to destroy cancer cells while minimizing damage to surrounding healthy tissue structures. This targeted approach has attracted growing interest among clinicians aiming to reduce treatment-related complications often associated with surgery or radiation.
AngioDynamics Strengthens MedTech Oncology Portfolio
AngioDynamics continues to expand the clinical and reimbursement infrastructure supporting the NanoKnife IRE System as part of its broader strategy to advance innovative medical technology solutions in oncology and vascular care. The company stated that the accumulating evidence base is helping accelerate physician adoption across multiple healthcare settings in the United States.
As demand rises for minimally invasive cancer therapies capable of balancing efficacy and quality-of-life preservation, the NanoKnife platform is emerging as a notable contender within the evolving focal therapy landscape. The latest PRESERVE trial outcomes provide additional validation that focal IRE may offer a durable treatment option for men with intermediate-risk prostate cancer seeking alternatives to conventional whole-gland treatments.
Source: AngioDynamics press release
