AngioDynamics, Inc.

AngioDynamics Announces Publication of DIRECT Study Results and New Category I CPT Code for Pancreatic IRE

AngioDynamics announced peer-reviewed publication of the DIRECT study in The Oncologist, showing patients with Stage III pancreatic cancer treated with an IRE-based strategy using the NanoKnife System had median overall survival of 28 months versus 15 months with standard of care alone. The 137-patient, 18-site FDA IDE study also showed longer progression-free survival (9 vs 6 months) and fewer Grade 3+ serious adverse events (56% vs 71%), though it was non-randomized and shows association rather than causation. Separately, the AMA approved a new Category I CPT code for open pancreatic IRE effective January 1, 2027, following 2026 codes for liver and prostate IRE — establishing a standardized billing pathway, though it does not guarantee coverage or payment. Management emphasized prostate cancer remains the NanoKnife commercial priority, with pancreatic milestones adding to the clinical evidence base.

•11d ago

AngioDynamics Announces Humana Medicare Advantage Coverage Policy Supporting Broader Access to NanoKnife® IRE for Prostate and Liver Cancer

Humana updated its Medicare Advantage coverage policy, effective October 1, 2026, to apply LCD L40205 medical necessity criteria for NanoKnife IRE in intermediate-risk prostate cancer and certain liver tumors. The policy builds on Category I CPT codes 55877 and 47384 (effective January 1, 2026) and Palmetto GBA's final LCD, and Humana applies the criteria across MAC jurisdictions, covering roughly 7 million Medicare Advantage members. For AngioDynamics this is a meaningful reimbursement milestone that should broaden the addressable patient population for NanoKnife, though coverage remains subject to prior authorization and plan terms.

•18d ago

AngioDynamics and The PERT Consortium® Name Jacobi Hospital as ALPHA-PE Research Fund Award Recipient to Advance Real-World Pulmonary Embolism Evidence

AngioDynamics and The PERT Consortium named Dr. Jonathan Alis, Dr. Seth I. Sokol and their Jacobi Hospital team as ALPHA-PE Research Fund award recipients. The investigator-led study will evaluate CT pulmonary angiography radiomics as predictors of thrombus biology, thrombectomy success, and long-term outcomes in pulmonary embolism patients. The program offers awards of $50,000 to $750,000 over one to three years and reinforces AngioDynamics' evidence-generation efforts in vascular care, though it carries no near-term financial impact.

•0mo ago

AngioDynamics Reports Record Fiscal Year 2026 Fourth Quarter and Full Year Financial Results; Continued Execution Drives Med Tech Growth and Full-Year Profitability

AngioDynamics reported record fiscal Q4 2026 revenue of $86.6 million, up 8.0% year-over-year on a pro forma basis, fueled by a 16.7% increase in Med Tech sales to $41.8 million. Full-year fiscal 2026 revenue grew 9.4% to $320.2 million, with Med Tech revenue rising 18.4% to $150.0 million, driving full-year adjusted EBITDA of $13.2 million and a debt-free balance sheet with $53.9 million in cash. The company provided fiscal 2027 guidance for net sales of $336.0 million to $341.0 million, highlighting continued regulatory and clinical progress including FDA IDE approvals for the RELIEF and APEX-Return studies and finalized Medicare coverage for NanoKnife IRE.

•3mo ago

AngioDynamics Receives FDA IDE Approval for RELIEF Feasibility Study Evaluating NanoKnife IRE Platform as Minimally Invasive Treatment for Benign Prostatic Hyperplasia (BPH)

AngioDynamics received FDA IDE approval to initiate the RELIEF feasibility study, evaluating its NanoKnife System for treating benign prostatic hyperplasia (BPH). The single-arm study will enroll 40 subjects across up to five U.S. sites, focusing on safety and effectiveness endpoints over a five-year follow-up period. BPH affects an estimated 15 million men in the U.S., representing a potential expansion opportunity for the company's non-thermal ablation technology.

•4mo ago

AngioDynamics Expands Patient Access to NanoKnife IRE for Prostate and Liver Cancer as Medicare Coverage Framework Takes Effect

Palmetto GBA issued a final Local Coverage Determination (LCD L40205) establishing Medicare coverage for AngioDynamics' NanoKnife IRE technology in favorable intermediate-risk prostate cancer and metastatic colorectal cancer to the liver. The coverage framework becomes effective July 5, 2026, building on Category I CPT codes activated by the AMA on January 1, 2026, which formalized the clinical value and billing standards for these procedures. This regulatory milestone enables eligible patients in Palmetto GBA’s jurisdictions (Alabama, Georgia, Tennessee, North Carolina, South Carolina, Virginia, and West Virginia) to access reimbursement, marking a critical step toward broader national payer adoption.

•5mo ago