AngioDynamics Announces Two-Year PRESERVE Trial Data Demonstrating Durable NanoKnife IRE System Outcomes in Intermediate-Risk Prostate Cancer
Pivotal
Results Presented at AUA 2026
The PRESERVE trial is a prospective, single-arm pivotal IDE study evaluating focal irreversible electroporation (IRE) using the NanoKnife System in 121 patients with
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
|
Parameter |
Detail |
|
Trial |
PRESERVE (NCT04972097) |
|
Study Type |
Prospective, single-arm, pivotal IDE study |
|
Technology |
NanoKnife System — Focal Irreversible Electroporation (IRE) |
|
Population |
|
|
Sites |
17 U.S. clinical centers |
|
Partner |
|
|
Sponsor |
|
Key 24-Month Results
|
Endpoint |
Result |
|
Total Enrolled |
121 patients |
|
24-Month Analysis-Eligible |
72 patients |
|
24-Month Completers |
68 of 72 (94.4%) |
|
New Treatment Failures (12–24 mo) |
0 |
|
Clinically Triggered Biopsies |
1 (negative for any cancer) |
|
PSA Below Baseline at 24 Months |
66 of 68 (97%) |
|
New Device/Procedure-Related AEs (12–24 mo) |
0 |
12-Month Primary Endpoint (Reference)
|
Endpoint |
Result |
|
Freedom from Treatment Failure |
80% among protocol-biopsied patients |
|
Publication |
European Urology, |
“Two years of prospective pivotal data in
With a growing body of prospective
About
The Company’s innovative technologies and devices are chosen by talented physicians in fast-growing healthcare markets to treat unmet patient needs. For more information, visit www.angiodynamics.com.
About the NanoKnife System
The NanoKnife System utilizes Irreversible Electroporation (IRE) technology to effectively destroy targeted cells without the use of thermal energy by delivering high-voltage pulses, creating permanent nanopores within the cell membrane. This stimulus induces an apoptotic-like cellular death in the targeted tissue, resulting in a complete ablation of the targeted tissue.3 Visit nanoknife.com for full product information.
Safe Harbor
This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics’ expected future financial position, results of operations, cash flows, business strategy, budgets, projected costs, capital expenditures, products, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include the words such as “expects,” “reaffirms,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “projects,” “optimistic,” or variations of such words and similar expressions, are forward-looking statements. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Investors are cautioned that actual events or results may differ materially from AngioDynamics’ expectations, expressed or implied. Factors that may affect the actual results achieved by
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1 George AK, Miocinovic R, Patel AR, et al. Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-Risk Prostate Cancer: Results from the PRESERVE Trial. European Urology 2025;89(1):57-68. doi:10.1016/j.eururo.2025.06.003 |
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2 Scheltema MJ, Geboers B, Blazevski A, et al. Medium 5-Year Outcomes of Primary Focal Irreversible Electroporation for Localized Prostate Cancer. |
| 3 Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. 2010;4 Suppl 1(Suppl 1):S99-S104. doi:10.5009/gnl.2010.4.S1.S99 |
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