AngioDynamics Announces Publication of PRESERVE Study of NanoKnife® System for Prostate Tissue Ablation in European Urology

Peer-reviewed findings demonstrate high disease control and quality-of-life preservation, supporting shift toward focal therapy in prostate treatment

AngioDynamics, Inc. (NASDAQ: ANGO), 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, today announced the publication of results from the PRESERVE study, which assessed the safety and effectiveness of irreversible electroporation (IRE) with the NanoKnife System to ablate prostate tissue in patients with intermediate-risk prostate cancer (PCa), in European Urology, a leading journal in urologic research that delivers high-impact research informing clinical practice and policy worldwide, including in the United States, titled “Irreversible Electroporation for Prostate Tissue Ablation in Patients with Intermediate-risk Prostate Cancer: Results from the PRESERVE Trial.”

Prostate cancer is the second most common cancer among men in the United States. ¹ For many, especially those diagnosed at an early stage with less aggressive tumors, active surveillance remains the preferred initial management strategy. ² The NanoKnife System is a leading non-thermal, radiation-free, ablation technology designed to treat prostate tissue by using IRE technology, offering patients a minimally invasive option for prostate treatment.

“The publication of the PRESERVE study in European Urology provides strong supporting evidence for the use of Irreversible Electroporation as a focal therapy in prostate treatment,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “This is an important milestone for patients and providers seeking new options beyond traditional whole-gland therapies. These results reinforce the NanoKnife System’s role in helping patients receive effective treatment while preserving quality of life, particularly urinary and sexual function, which are often impacted by conventional treatments.”

The NanoKnife System received FDA clearance for prostate tissue ablation in late 2024, following the successful completion of the PRESERVE study. Conducted across 17 clinical sites in collaboration with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), the trial enrolled 121 patients who met the key inclusion criteria: age >50 yr with organ-confined, grade group 2 or 3 PCa, clinical stage ?T2c, prostate-specific antigen (PSA) ?15 ng/mL, or PSA density <0.15 ng/mL ² .

The PRESERVE clinical study met its primary effectiveness endpoint, demonstrating the performance of the NanoKnife System for the ablation of prostate tissue in patients with intermediate-risk PCa. At 12 months post-procedure, 84.0% of men were free from in-field, clinically significant disease (defined by the Delphi consensus criterion). The study also demonstrated strong quality-of-life outcomes: urinary continence was largely preserved (97% at baseline vs. 96% at 12 months), and at 12 months, 84% of patients with good baseline sexual function maintained erections sufficient for penetration. ³

These results confirm the NanoKnife System’s robust safety and efficacy profile, building on a foundation of more than 32 clinical studies involving over 2,600 patients worldwide. ³

The PRESERVE study was led by Co-Principal Investigators Jonathan Coleman, MD, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and Arvin George, MD, a urologic oncologist at Johns Hopkins Medicine. Dr. George previously practiced at the Veterans Affairs Ann Arbor Healthcare System and Michigan Medicine.

“The PRESERVE data supports the long-term data that we are seeing in practice, patients are benefiting from effective, targeted treatment without compromising their quality of life,” said Dr. Coleman. “The ability to preserve urinary and sexual function while treating prostate tissue with precision is a meaningful advancement for both clinicians and patients.”

The NanoKnife System uses a non-thermal technique called irreversible electroporation (IRE) to ablate targeted prostate tissue while sparing critical structures. Unlike thermal ablation, IRE avoids damaging critical structures, helping preserve urinary and sexual function.

The PRESERVE results arrive at a pivotal time, as global urologic societies increasingly recognize focal therapy, and patients seek alternatives to whole-gland treatments that may carry a greater risk of side effects.

For more information on the NanoKnife System and focal therapy in prostate tissue, visit: www.angiodynamics.com/nanoknife . For important risk information, visit https://www.angiodynamics.com/about-us/risk-information/#inano

About European Urology

European Urology is ranked the top urology journal in the world by the Scimago Journal Rank (SJR). The journal is recognized globally for its high-impact research across oncology, surgical innovation, and more. This ranking reaffirms its role as the premier publication advancing urologic science and care. ⁴

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. ⁵ 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.

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 .

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, tariffs, 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, 2025. 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 the property of their respective owners. ^© 2025 AngioDynamics, Inc.

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Investor:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com

Media:
Saleem Cheeks
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com