New Codes Expand Market Access to Treatment
with the NanoKnife® System
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 NanoKnife System 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
______________________________ 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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version on businesswire.com: https://www.businesswire.com/news/home/20241017440579/en/
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
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