AngioDynamics Expands Indications for the NanoKnife System Across Europe, Strengthening Multi-Organ Tumor Ablation Platform

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 tumours 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 tumours that may be difficult to resect or located near critical structures.

The NanoKnife System utilises irreversible electroporation (IRE), a non-thermal ablation technology designed to destroy tumour cells while preserving critical surrounding anatomy such as blood vessels, bile ducts, and nerves. This differentiated mechanism of action makes it particularly suited for tumours 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 tumour 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 tumour 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 tumours. 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 tumour 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 tumours 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 tumours located near critical structures,” said Professor Siriwardena. “The LIVER-IRE Registry will help further characterise outcomes in real-world practice.”

About the NanoKnife System

The NanoKnife System utilises 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 tumours 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.

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