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

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.

For the latest updates and in-depth insights into the world of Life Science, including breakthrough treatments, industry trends, and regulatory news, contact Adam Tiberius today!