AngioDynamics Announces Two-Year PRESERVE Trial Data Demonstrating Durable NanoKnife IRE System Outcomes in Intermediate-Risk Prostate Cancer

AngioDynamics, Inc., a 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 two-year results from the PRESERVE pivotal trial (NCT04972097) 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 (AUA) 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 (IRE) 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 (SUO-CTC). Primary 12-month results, published in European Urology in July 2025, demonstrated an 80% freedom-from-treatment-failure rate among protocol-biopsied patients.¹

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.²

PRESERVE Trial — 24-Month Results Summary

Focal IRE Ablation Using the NanoKnife System for Intermediate-Risk Prostate Cancer

Study Design

Key 24-Month Results

12-Month Primary Endpoint (Reference)

“Two years of prospective pivotal data in the United States, combined with more than five years of international follow-up evidence, paints a coherent and compelling picture of sustained efficacy,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “These results reinforce that the NanoKnife System is a clinically meaningful focal therapy option that physicians across care settings are actively incorporating into practice.”

With a growing body of prospective U.S. pivotal data and long-term international evidence supporting the safety and efficacy of focal IRE, the NanoKnife System continues to gain traction as a meaningful treatment option for men with intermediate-risk prostate cancer who seek durable oncologic control while preserving quality of life. AngioDynamics is advancing the NanoKnife IRE System evidence base and the reimbursement infrastructure needed to bring this option to more patients and physicians across care settings.

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