New Codes Expand Market Access to Treatment with the NanoKnife^® System

LATHAM, N.Y.--(BUSINESS WIRE)--Oct. 21, 2024-- AngioDynamics, Inc. (NASDAQ: ANGO), 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, today announced that IRE has received CPT^® Category I codes for the treatment of lesions in the prostate and liver.

The decision by the American Medical Association’s (“AMA”) CPT^®Editorial Panel will facilitate reimbursement for healthcare providers performing IRE ablation procedures and enables broader access to the NanoKnifeSystem for patients. The new codes will be effective, with physician Relative Value Units (RVUs) attached, on January 1, 2026.

The NanoKnife System utilizes 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 minimally invasive treatment offers unique advantages over traditional surgery or thermal ablation techniques enabling physicians to treat all segments of an organ, with precise treatment margins, and a lower likelihood of side effects due to its preservation of nerve and blood vessel architecture.^1,2,3

“Achieving CPT^® Category I status is a significant milestone for the NanoKnife System and underscores our commitment to providing innovative and effective treatment options for patients,” said Jim Clemmer, President and Chief Executive Officer of AngioDynamics, Inc. “This achievement highlights the value of AngioDynamics' strategic investments in our innovative NanoKnife System and IRE technology. With CPT^® Category I codes now established for prostate and liver lesions, we will continue to work to expand patient access to these life-changing treatments.”

With these new CPT^® Category I codes, healthcare providers will be able to bill more precisely for the treatments provided and should achieve broader insurance coverage and defined reimbursement rates for NanoKnife procedures, increasing market access to this minimally invasive IRE technology.

The CPT^® Category I codes are reserved for services and procedures that have demonstrated clinical efficacy, widespread use, and proven value in the medical community. The recognition of Irreversible Electroporation under these codes follows rigorous clinical studies and peer-reviewed data using the NanoKnife System that met the requirements for Category I CPT® codes.

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.⁴ Visit nanoknife.com for full product information.

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.

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, 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, 2024. AngioDynamics does not assume any obligation to publicly update or revise any forward-looking statements for any reason.

In the United States, the NanoKnife System has received a 510(k) clearance by the Food and Drug Administration for use in the surgical ablation of soft tissue and is similarly approved for commercialization in Canada, the European Union and Australia. The NanoKnife System has not been cleared for the treatment or therapy of a specific disease or condition.

AngioDynamics, the AngioDynamics logo, and NanoKnife are trademarks and/or registered trademarks of AngioDynamics, Inc., an affiliate or subsidiary. All other trademarks are the property of their respective owners. ^©2024 AngioDynamics, Inc

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¹ Faiella E, Santucci D, D'Amone G, et al. Focal minimally invasive treatment in localized prostate cancer: comprehensive review of different possible strategies. Cancers (Basel). 2024;16(4):765. doi:10.3390/cancers16040765
² Scheltema MJ, Geboers B, Blazevski A, et al. Median 5-year outcomes of primary focal irreversible electroporation for localised prostate cancer. BJU Int. 2023;131 Suppl 4:6-13. doi:10.1111/bju.15946
³ 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
⁴ 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 Contact:
Stephen Trowbridge
Executive Vice President & CFO
518-795-1408
strowbridge@angiodynamics.com

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

Source: AngioDynamics, Inc.