AngioDynamics Announces Two-Year Results for NanoKnife System
AngioDynamics announced two-year results from the PRESERVE pivotal trial demonstrating durable oncologic control and a sustained safety profile for the NanoKnife System in the focal ablation of intermediate-risk prostate cancer. The data will be discussed by Izak Faiena, M.D., of Columbia University at the 2026 American Urological Association Annual Meeting on Sunday, May 17 in Washington, D.C. The PRESERVE trial is a prospective, single-arm pivotal IDE study evaluating focal irreversible electroporation using the NanoKnife System in 121 patients 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. Primary 12-month results, published in European Urology in July 2025, demonstrated an 80% freedom-from-treatment-failure rate among protocol-biopsied patients. At 24 months, the updated findings confirm durability of outcomes: 94.4% of analysis-eligible patients (68 of 72) completed the 24-month assessment, reflecting strong cohort retention; No new treatment failures were identified among patients with available follow-up at 24 months; One patient (1.5%) underwent a clinically indicated biopsy, which was negative for any cancer; 97% of patients (66 of 68) had a PSA at 24 months below their baseline value; No new device- or procedure-related adverse events were reported between the 12- and 24-month assessments. The 24-month PRESERVE data complement an international long-term evidence base for focal IRE, including median five-year outcomes from a 2023 international multi-institutional cohort demonstrating sustained oncologic control and preservation of functional outcomes.
