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

Pivotal U.S. Data Show Sustained Oncologic Control and Safety Profile at 24 months

Results Presented at AUA 2026

LATHAM, N.Y.--(BUSINESS WIRE)--AngioDynamics, Inc. (NASDAQ: ANGO), 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

Parameter	Detail
Trial Name	PRESERVE (NCT04972097)
Study Type	Prospective, single-arm, pivotal IDE study
Technology	NanoKnife System — Focal Irreversible Electroporation (IRE)
Population	Gleason Grade Group 2–3 (Gleason 3+4 or 4+3), clinical stage ≤T2c intermediate-risk prostate cancer
Sites	17 U.S. clinical centers
Partner	Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC)
Sponsor	AngioDynamics, Inc.

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, July 2025 (George et al.)

“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.

About AngioDynamics, Inc.

AngioDynamics is 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.

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.

United States: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.

Canada: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.

European Union: The NanoKnife System is indicated for the ablation of prostate tissue in patients with intermediate risk prostate cancer.

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 AngioDynamics include, without limitation, the scale and scope of the COVID-19 global pandemic, the ability of AngioDynamics to develop its existing and new products, technological advances and patents attained by competitors, infringement of AngioDynamics’ technology or assertions that AngioDynamics’ technology infringes the technology of third parties, the ability of AngioDynamics to effectively compete against competitors that have substantially greater resources, future actions by the FDA or other regulatory agencies, domestic and foreign healthcare reforms and government regulations, results of pending or future clinical trials, overall economic conditions (including inflation, labor shortages and supply chain challenges including the cost and availability of raw materials), the results of on-going litigation, challenges with respect to third-party distributors or joint venture partners or collaborators, the results of sales efforts, the effects of product recalls and product liability claims, changes in key personnel, the ability of AngioDynamics to execute on strategic initiatives, the effects of economic, credit and capital market conditions, general market conditions, market acceptance, foreign currency exchange rate fluctuations, the effects on pricing from group purchasing organizations and competition, the ability of AngioDynamics to obtain regulatory clearances or approval of its products, or to integrate acquired businesses, as well as the risk factors listed from time to time in AngioDynamics’ SEC filings, including but not limited to its Annual Report on Form 10-K for the year ended May 31, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

AngioDynamics, the AngioDynamics logo and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.

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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

^2 Scheltema MJ, Geboers B, Blazevski A, et al. Medium 5-Year Outcomes of Primary Focal Irreversible Electroporation for Localized Prostate Cancer. BJU International 2023;131(4):6-15. doi:10.1111/bju.15946

^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