AngioDynamics Expands Indications for the NanoKnife System Across Europe, Strengthening Multi-Organ Tumor Ablation Platform
Growing Clinical Evidence and Physician Adoption Broaden NanoKnife IRE Technology as Treatment Option for Major Solid Tumor Types
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 expanded European indications for its NanoKnife System to include soft tissue ablation for tumors of the liver, pancreas, kidney, and prostate, including in patients with intermediate-risk prostate cancer.
The expanded indications increase physician access to the NanoKnife System's irreversible electroporation (IRE) technology across key oncologic applications, supporting the treatment of patients with tumors that may be difficult to resect or located near critical structures.
The NanoKnife System utilizes irreversible electroporation (IRE), a non-thermal ablation technology designed to destroy tumor cells while preserving critical surrounding anatomy such as blood vessels, bile ducts, and nerves. This differentiated mechanism of action makes it particularly suited for tumors located in complex anatomical regions, such as the pancreas and liver.
"NanoKnife prostate continues to gain clinical traction, and we remain committed to advancing that indication globally," said Laura Piccinini, Senior Vice President and General Manager, Cardiovascular & International. "The expansion of additional organ indications in Europe underscores the broader potential of IRE technology and strengthens NanoKnife as a scalable platform for complex tumor ablation. Our goal is to ensure physicians have access to differentiated tools that expand treatment options for patients across multiple disease states."
A growing body of clinical evidence supports the use of the NanoKnife System's IRE technology across multiple solid tumor indications. Prospective and multicenter studies have demonstrated procedural feasibility and encouraging clinical outcomes in metastatic colorectal cancer,1 liver and pancreatic cancer,2,3 hepatocellular carcinoma,4 and renal tumors. Comparative and real-world analyses continue to reinforce the safety profile and expanding clinical utility of IRE in anatomically challenging disease states.5,6,7
Collectively, this expanding evidence base has contributed to increasing physician adoption of IRE across Europe and other global markets.
Europe accounts for approximately 28% of global IRE procedures. Annual IRE procedures are estimated to have surpassed 45,000 globally and continue to grow, supported by rising cancer incidence, expanding physician adoption, technological advancements in image guidance, and strong demand for minimally invasive treatment options.8
The expanded indications position the NanoKnife System to participate more broadly across this growing European market and reinforce its role as a multi-organ tumor ablation platform.
To further support clinical adoption and long-term evidence development, AngioDynamics will initiate the LIVER-IRE Global Registry in collaboration with Professor Ajith Siriwardena, MD FRCS, at the University of Manchester in the United Kingdom. The registry is designed to prospectively evaluate outcomes in patients undergoing IRE treatment for liver tumors and contribute to the growing body of real-world clinical data supporting multi-organ applications of the NanoKnife System technology.
"Irreversible electroporation offers an important treatment consideration for patients with liver tumors located near critical structures," said Professor Siriwardena. "The LIVER-IRE Registry will help further characterize outcomes in real-world practice."
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.6
For more information, visit https://nanoknife.com/.
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 soft tissue and tumors of the pancreas, kidney, liver, or prostate, including 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. ©2026 AngioDynamics, Inc
1 Meijerink MR, Ruarus AH, Vroomen LGPH, et al. Irreversible electroporation to treat unresectable colorectal liver metastases (COLDFIRE-2): A Phase II, two-center, single-arm clinical trial. Radiology. 2021;299(2):470-480. doi:10.1148/radiol.2021203089
2 https://www.angiodynamics.com/studies/direct-study/
3 Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous irreversible electroporation in locally advanced and recurrent pancreatic cancer (PANFIRE-2): a multicenter, prospective, single-arm, phase II study. Radiology. 2020;294(1):212-220. doi:10.1148/radiol.2019191109.
4 Cribbs KA, Baisley WT, Lahue BJ, Peddu P. Clinical and safety outcomes in unresectable, very early and early-stage hepatocellular carcinoma following irreversible electroporation (IRE) and transarterial chemoembolization (TACE): a systematic literature review and meta-analysis. PLoS One. 2025;20(4):e0322113. doi:10.1371/journal.pone.0322113.
5 Frühling P, Stillström D, Holmquist F, Nilsson A, Freedman J. Irreversible electroporation of hepatocellular carcinoma and colorectal cancer liver metastases: a nationwide multicenter study with short- and long-term follow-up. Eur J Surg Oncol. 2023;49(11):107046. doi:10.1016/j.ejso.2023.107046.
6 Gupta P, Maralakunte M, Sagar S, Kumar-M P, Bhujade H, Chaluvashetty SB, Kalra N. Efficacy and safety of irreversible electroporation for malignant liver tumors: a systematic review and meta-analysis. Eur Radiol. 2021;31(12):6511-6521. doi:10.1007/s00330-021-07742-y.
7 Wah TM, Lenton J, Smith J, Bassett P, Jagdev S, Ralph C, Vasudev N, Bhattarai S, Kimuli M, Cartledge J. Irreversible electroporation (IRE) in renal cell carcinoma (RCC): a mid-term clinical experience. Eur Radiol. 2021;31(10):7491-7499. doi:10.1007/s00330-021-07846-5.
8 https://www.globalgrowthinsights.com/blog/irreversible-electroporation-ablators-companies-837
View source version on businesswire.com: https://www.businesswire.com/news/home/20260219441352/en/
Investor Contact:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com
Media Contact:
Saleem Cheeks
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com