Investigator initiated trial seeks to validate
safety, efficacy of the NanoKnife System in treating targeted
tumors while reducing or delaying need for radical intervention
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 the launch
of an international multi-center prospective registry study to
assess the long term effects of treating men with unifocal
intermediate-risk prostate cancer with the NanoKnife® System in
partnership with the University College London Hospital (UCLH).
Approximately 40% of all diagnosed prostate cancer cases are
classified as intermediate risk.1 In the first year after surgery,
36% of men report urinary leakage, and 95% are affected by erectile
dysfunction (70% described as moderate/severe).2
The NanoKnife® System delivers an innovative alternative to
conventional radical surgery or radiotherapy, each of which often
results in significant dysfunction in urinary continence and
erectile potency. With its non-thermal approach, the NanoKnife
system is engineered to preserve vital structures inside and
outside the prostate, offering patients effective treatment of
tumors, low complication rates, and minimal impact on quality of
life.3
In 2023, the National Institute for Health and Care Excellence
(NICE) in the U.K. upgraded the use of the NanoKnife® System from
“Research Only” to “Special Arrangements” allowing hospitals to
start new services while collecting more data4 and signaling its
growing acceptance in national urology guidelines.
AngioDynamics is conducting the international multi-center
prospective registry study in partnership with UCLH. UCLH is the
largest center for robotic prostate surgery in the U.K. and a
leading provider of focal therapy, radiotherapy, robotic surgery,
and active surveillance treatment options for men with prostate
cancer. Additionally, UCLH was the first facility in the National
Health Service to use the NanoKnife® System to treat prostate
cancer,5 and provide standardized patient selection, treatment, and
long-term follow-up.
“Focal therapy has developed over the past ten years to identify
patients with the most to gain from treatment effectively. We can
now test a large cohort of patients to show benefit without adding
long-term risk,” said Laura Piccinini, AngioDynamics Senior Vice
President and General Manager of Endovascular Therapies and
International. “We are proud of the partnership with UCLH in
conducting this important study. This extensive prospective study
will help support broader adoption, expanded treatment pathways,
and increased patient access to improved treatment modalities for
men in the U.K. with prostate cancer and help establish treatment
with this technology as a standard of care. This collaboration
demonstrates our steadfast commitment to supporting the physician
community and their patients with innovative and effective
products.”
“The international registry will allow us to track patients’
outcomes over time and allow us to quality control the
dissemination of this novel technology across the world,” said
Professor Mark Emberton, Interventional Oncology, Division of
Surgery and Interventional Science at the University College
Hospital London. “This will enable us to learn from every patient
treated and, as a result, continue to refine this treatment that
allows men to have their prostate cancer treated and maintain their
quality of life.”
The study will enroll a minimum of 500 patients worldwide to
confirm the multiple single-center published papers indicating that
the NanoKnife® System is safe and effective in the treatment of
targeted tumors,3 and the prevention or delayed need for radical
intervention in the preservation of patient quality of life.
Complementing the ongoing Randomized Controlled Trial studies
evaluating NanoKnife versus radical treatment,6,7 this
investigator-initiated trial will closely monitor patients
post-treatment, measuring critical quality of life metrics and
tracking any necessary follow-up interventions. In addition to
quality of life, the study will assess overall and
prostate-specific mortality rates.
For important risk information, visit
https://www.angiodynamics.com/about-us/risk-information/#inano
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. Visit nanoknife.com
for full product information.
The NanoKnife System when used for the treatment of prostate
cancer is an investigational device in the United States. The
NanoKnife System has not received FDA clearance for the therapy or
treatment of any specific disease or condition. In the European
Union, the NanoKnife System is indicated for the ablation of
prostate tissue in patients with intermediate risk prostate cancer.
The use of this device in other organs for other disease states has
not been fully evaluated.
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.
NanoKnife and the NanoKnife logo are trademarks and/or
registered trademarks of AngioDynamics, Inc., an affiliate or
subsidiary.
_________________________ 1
https://www.npca.org.uk/wp-content/uploads/2021/01/NPCA-Annual-Report-2020_Final_140121.pdf
(p.25) 2
https://bjui-journals.onlinelibrary.wiley.com/doi/10.1111/bju.15739
3 https://doi.org/10.1016/j.urology.2023.01.024 4
https://www.nice.org.uk/guidance/ipg768 5
https://www.uclh.nhs.uk/news/uclh-first-nhs-use-nanoknife-prostate-cancer
6 https://fundingawards.nihr.ac.uk/award/17/150/01 7
https://clinicaltrials.gov/study/NCT05513443
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241023861610/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
AngioDynamics (NASDAQ:ANGO)
Gráfica de Acción Histórica
De Dic 2024 a Ene 2025
AngioDynamics (NASDAQ:ANGO)
Gráfica de Acción Histórica
De Ene 2024 a Ene 2025
