AngioDynamics announced that its NanoKnife irreversible electroporation system has received European approval for soft‑tissue ablation of tumors in the liver, pancreas, kidney, and prostate, including intermediate‑risk prostate cancer. The expansion adds four new organ sites to the platform’s existing prostate indication, broadening the system’s therapeutic reach across major solid‑tumor types.
The approval follows a growing body of prospective multicenter studies that demonstrate procedural feasibility and encouraging outcomes in metastatic colorectal cancer, hepatocellular carcinoma, pancreatic cancer, and renal tumors. By extending NanoKnife’s use to these organs, AngioDynamics aims to capture a larger share of the European minimally invasive oncology market, which is estimated to exceed 45,000 IRE procedures annually.
To strengthen evidence for the expanded indications and support future regulatory and reimbursement discussions, the company will launch a LIVER‑IRE Global Registry in partnership with the University of Manchester. The registry will collect real‑world outcomes for liver‑tumor patients treated with IRE and will provide data to validate the clinical benefits of the new indications.
The announcement comes amid a period of strong financial performance. In the first quarter of fiscal 2026, AngioDynamics reported net sales of $75.7 million, up 12.2 percent year‑over‑year, driven by a 26.1 percent increase in its Med Tech segment. Adjusted EBITDA rose to $2.2 million from a negative figure in the prior year, and the company raised its full‑year guidance to $312 million–$314 million, reflecting confidence in continued growth.
Senior Vice President and General Manager Laura Piccinini said, "NanoKnife prostate continues to gain clinical traction, and we remain committed to advancing that indication globally. 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." Chief Executive Officer Jim Clemmer noted, "We had an outstanding first quarter as we continued to build off of the strong momentum created in fiscal 2025. Our strategy to bring unique platform technologies to large, fast‑growing global markets has paid off."
Investors have responded positively to the company’s earnings and guidance, reflecting confidence in the expanded product portfolio and the company’s debt‑free balance sheet, which supports continued investment in clinical evidence and market penetration.
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