\nAngioDynamics, Inc. (NASDAQ: ANGO), a 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 that Palmetto GBA has issued a final Local Coverage Determination (LCD L40205) establishing Medicare coverage guidance for irreversible electroporation (IRE), the non-thermal ablation technology delivered by the Company’s NanoKnife System, in two clinical indications: favorable intermediate-risk prostate cancer and metastatic colorectal cancer to the liver. The final LCD becomes effective July 5, 2026.<\/p>\n
\nThe final LCD advances a reimbursement infrastructure already underway. Effective January 1, 2026, the American Medical Association CPT\u00ae<\/sup> Editorial Panel activated Category I CPT codes for IRE procedures in the prostate and liver, representing the AMA’s formal recognition that a procedure is clinically effective, reflects widespread physician adoption, and carries established clinical value. Category I codes include physician Relative Value Units (RVUs) and support standardized billing across hospital outpatient departments and ambulatory surgical center settings. The Palmetto GBA LCD provides the corresponding coverage framework, enabling eligible patients and treating physicians to access reimbursement for IRE procedures under Medicare and marking an important step toward broader national payer adoption.<\/p>\n \n\u201cThe Palmetto GBA final LCD advances patient access to IRE as a recognized treatment option for appropriately selected patients,\u201d said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. \u201cFor men with favorable intermediate-risk prostate cancer, focal therapy that targets the cancer while preserving the structures that affect urinary and sexual function addresses a real quality-of-life need. With Category I CPT codes now in place for prostate and liver procedures, and explicit coverage guidance from Palmetto GBA, we are in a strong position to support treating physicians and to continue building patient access across additional payer jurisdictions.\u201d<\/p>\n \nUnder LCD L40205, effective July 5, 2026, Palmetto GBA covers IRE in the following settings:<\/p>\n \nThe final LCD aligns with published clinical practice guidelines from major specialty societies. For prostate cancer, the determination is consistent with guidance from the American Urological Association (AUA) and the American Society for Radiation Oncology (ASTRO), which recognize ablative therapies as an area of active clinical investigation. For liver indications, the LCD aligns with National Comprehensive Cancer Network (NCCN) Colon Cancer Guidelines, which reference image-guided non-thermal ablation for select patients who are not candidates for surgical resection or margin-negative thermal ablation.<\/p>\n \nThe LCD follows a public comment process during which AngioDynamics, clinical investigators, and treating physicians submitted evidence supporting the clinical rationale for IRE. The finalized determination incorporated revised patient selection criteria, expanded references to published clinical evidence, and alignment with evolving clinical guidelines.<\/p>\n \nIRE utilizes high-voltage electrical pulses to destroy targeted cells while preserving surrounding critical structures, including nerves, bile ducts, blood vessels, and the urethra. This non-thermal mechanism makes the technology particularly well-suited for anatomically complex lesions where thermal ablation may not be appropriate.<\/p>\n \nThe NanoKnife System is the Company\u2019s commercial platform for delivering IRE to targeted soft tissue through minimally invasive probes placed percutaneously into or around a lesion. Rather than relying on heat, IRE uses high-voltage electrical pulses to create permanent openings in cell membranes, triggering cell death while preserving the architecture of surrounding nerves, bile ducts, blood vessels, and the urethra. The NanoKnife System is FDA-cleared for the surgical ablation of soft tissue, including prostate tissue. It is not FDA-cleared for the treatment of any specific cancer.<\/p>\n Palmetto GBA Jurisdiction Note:<\/b><\/p>\n \nPalmetto GBA administers Medicare Part A and Part B benefits in Jurisdiction J (Alabama, Georgia, Tennessee) and Jurisdiction M (North Carolina, South Carolina, Virginia, West Virginia).<\/p>\n \nFor complete coverage criteria and clinical requirements information refer to LCD L40205<\/a>.<\/p>\n About AngioDynamics, Inc.<\/b><\/p>\n \nAngioDynamics is a leading and transformative medical technology company focused on restoring healthy blood flow in the body\u2019s vascular system, expanding cancer treatment options and improving patient quality of life.<\/p>\n \nThe Company\u2019s 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<\/a>.<\/p>\n About the NanoKnife System<\/b><\/p>\n \nThe 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.1<\/sup> Visit nanoknife.com<\/a> for full product information.<\/p>\n \nUnited States: The NanoKnife System with six outputs is indicated for surgical ablation of soft tissue, including prostate tissue.<\/p>\n \nCanada: 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.<\/p>\n \nEuropean 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.<\/p>\n Safe Harbor<\/b><\/p>\n \nThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements regarding AngioDynamics\u2019 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 \u201cexpects,\u201d \u201creaffirms,\u201d \u201cintends,\u201d \u201canticipates,\u201d \u201cplans,\u201d \u201cbelieves,\u201d \u201cseeks,\u201d \u201cestimates,\u201d \u201cprojects,\u201d \u201coptimistic,\u201d 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\u2019 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\u2019 technology or assertions that AngioDynamics\u2019 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\u2019 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.<\/p>\n AngioDynamics, the AngioDynamics logo and NanoKnife are trademarks and\/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are property of their respective owners.<\/i><\/p>\n 1<\/sup> Lee EW, Thai S, Kee ST. Irreversible electroporation: a novel image-guided cancer therapy. Gut Liver. 2010;4 Suppl 1(Suppl 1):S99-S104. doi:10.5009\/gnl.2010.4.S1.S99<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260528366815\/en\/<\/a><\/span><\/p>\n Investor:\n
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Stephen Trowbridge
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Executive Vice President & CFO
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518-795-1408
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strowbridge@angiodynamics.com
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