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

Key Terms

local coverage determination regulatory

A local coverage determination is a region-specific decision by a public health insurer about whether a particular medical test, treatment, or device will be paid for in that area. Think of it like a local rulebook that says which procedures qualify for reimbursement; it matters to investors because such rules directly affect how much revenue health providers, device makers, or diagnostic companies can earn in that market and how widely a product will be adopted.

medicare coverage regulatory

Medicare coverage is the set of health insurance benefits provided by the U.S. federal Medicare program that pays for hospital care, doctor services, prescription drugs and certain medical supplies for eligible beneficiaries. Investors pay attention because changes in what Medicare will cover, how much it reimburses, or who qualifies can materially affect revenue and pricing for hospitals, drugmakers, medical device manufacturers and insurers—like rewriting the rulebook for a very large, steady customer.

cpt codes regulatory

CPT codes are standardized five-digit codes used to describe medical procedures, tests and services for billing, insurance reimbursement and data tracking. Think of them like barcodes for healthcare services: they tell payers what was done and influence how much providers get paid. Investors watch CPT codes because changes in coding, coverage or reimbursement rates can materially affect a healthcare provider’s revenue, equipment manufacturers’ sales and overall adoption of new treatments.

relative value units financial

Relative value units are a standardized measure used in healthcare to score the amount of work, resources and overhead associated with a medical service; they are converted into payment amounts by insurers and government programs. For investors, RVUs act like a storefront’s price tag calculator—higher RVUs or higher payment per RVU generally mean more revenue for providers, while changes to RVU values or conversion rates can materially affect earnings and profitability.

irreversible electroporation medical

Irreversible electroporation is a medical tissue‑ablation technique that uses short, high‑voltage electrical pulses to create permanent microscopic holes in cell membranes, causing targeted cells to die while leaving nearby structural tissue and blood vessels largely intact. Investors should care because it is a non‑thermal alternative to surgery or heat‑based ablation, so its clinical adoption, regulatory approvals, device sales, reimbursement policies and competitive position can materially affect the revenue and valuation of companies that develop or sell these medical technologies.

non-thermal ablation medical

Non-thermal ablation is a medical technique that destroys unwanted tissue using methods other than heat, such as electrical pulses or injected chemicals, so the target is disabled without cooking it. For investors, it matters because these approaches can reduce collateral damage to nearby structures, extend treatment to cases where heat is unsafe, and create distinct device and regulatory opportunities that affect adoption, reimbursement and market size. Think of it as disabling a faulty circuit rather than burning out the wiring.

metastatic colorectal cancer medical

Metastatic colorectal cancer is cancer that started in the colon or rectum and has spread to other parts of the body, most often the liver or lungs, making it harder to treat. For investors, it matters because advanced disease drives demand for more intensive treatments, ongoing clinical trials, and long-term care costs; think of it like a fire that has jumped from one room to multiple rooms, requiring bigger, more expensive responses and creating larger market opportunities and regulatory scrutiny.

jurisdiction regulatory

A jurisdiction is the geographic or legal area whose laws, courts and regulators have authority over a company, transaction or asset—like a playground where one set of rules and referees applies. It matters to investors because those rules determine taxes, reporting standards, investor protections, liability and how disputes are resolved, all of which affect risk, valuation and the ease of doing business.

Palmetto GBA Medicare Coverage Effective July 5, 2026 Advances NanoKnife IRE Reimbursement Access in Prostate and Liver Cancer, Building on Category I CPT Codes Toward Broader National Payer Coverage

LATHAM, N.Y.--(BUSINESS WIRE)-- AngioDynamics, 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.

The final LCD advances a reimbursement infrastructure already underway. Effective January 1, 2026, the American Medical Association CPT^® 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.

“The Palmetto GBA final LCD advances patient access to IRE as a recognized treatment option for appropriately selected patients,” said Juan Carlos Serna, AngioDynamics Senior Vice President of Scientific and Clinical Affairs. “For 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.”

Under LCD L40205, effective July 5, 2026, Palmetto GBA covers IRE in the following settings:

• Favorable intermediate-risk prostate cancer grade group 2 (Gleason Score 3+4): For appropriately selected patients following documented discussion of available treatment alternatives.

• Metastatic colorectal cancer to the liver: For patients who cannot be safely resected or treated with margin-negative thermal ablation due to proximity to central bile ducts or other critical structures, when IRE is determined to be medically necessary over available alternatives.

The 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.

The 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.

IRE 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.

The NanoKnife System is the Company’s 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.

Palmetto GBA Jurisdiction Note:

Palmetto 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).

For complete coverage criteria and clinical requirements information refer to LCD L40205.

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.

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.¹ Visit nanoknife.com for full product information.

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.

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 property of their respective owners.

¹ 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

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Investor:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com

Media:
Saleem Cheeks
Vice President, Communications
518-795-1174
scheeks@angiodynamics.com

Source: AngioDynamics, Inc.