Pivotal Study of NanoKnife System for Ablation
of Prostate Tissue in an Intermediate-Risk Patient Population
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 quality of life for patients, today announced the
completion of enrollment and final treatment in its Pivotal Study
of the NanoKnife System for Ablation of Prostate Tissue in an
Intermediate-Risk Patient Population (PRESERVE).
The PRESERVE study was initiated by AngioDynamics, Inc. in
partnership with the Society of Urologic Oncology Clinical Trials
Consortium (SUO-CTC).
"The PRESERVE study demonstrates AngioDynamics’ commitment to
innovating care delivery,” said Juan Carlos Serna, AngioDynamics
Senior Vice President of Clinical and Scientific Affairs. “As we
mark the completion of enrollment and final treatment in the study,
we take another important step towards demonstrating the NanoKnife
System’s ability to expand treatment options for patients with
intermediate-risk prostate cancer and advance our mission to
improve patient quality of life. We appreciate the support provided
by our PRESERVE study sites and the partnership with the SUO-CTC
team in this important effort.”
Final patient enrollment in the study was initially announced
during AngioDynamics’ Fiscal 2023 Fourth Quarter and Full-Year
Financial Results conference call on July 12, 2023.
Co-Principal Investigators leading the study are Jonathan
Coleman, MD, Urologic Surgeon, Memorial Sloan Kettering Cancer
Center, and Arvin George, MD, Urologic Surgeon, University of
Michigan. The PRESERVE study will have its primary endpoint
analysis at 12 months following treatment.
“As diagnostic tools develop to allow earlier identification and
localization of clinically significant forms of prostate cancer,
there is a matching need to establish effective forms of treatment
that target the disease and preserve patients' quality of life.
Evidence is growing to support the use of partial gland ablation
for prostate cancer as a reasonable alternative treatment strategy
in carefully selected patients. The PRESERVE study, studying the
efficacy of irreversible electroporation (IRE) with the NanoKnife
System from AngioDynamics in men with intermediate-risk tumors
(Gleason Grade 3+4 and 4+3), will help to address further the
validity of this therapeutic approach using a treatment, which is
well tolerated and easy to apply in prostate tissue,” said
Co-Principal Investigator Jonathan Coleman, MD, Urologic Surgeon,
Memorial Sloan Kettering Cancer Center.
In 2023, the American Cancer Society estimates that there will
be about 288,300 new cases of prostate cancer and about 34,700
deaths from the disease in the U.S. It is estimated that 1 out of
every 8 men will be diagnosed with prostate cancer during their
lifetime, and prostate cancer is more likely to develop in older
and non-Hispanic Black men. It is American men's second leading
cause of death.1
The NanoKnife System utilizes Irreversible Electroporation (IRE)
technology to effectively destroy targeted tissue, delivering
precise treatment margins while preserving vital structures by
retaining the structural integrity of the targeted tissue. The
delivery of non-thermal energy allows for the preservation of the
extra-cellular matrix, facilitating post-ablation histological and
functional tissue regeneration. To learn more and view risk
information, visit NanoKnife.com.
The PRESERVE study’s primary objectives are determining the
NanoKnife System’s ablation effectiveness by measuring the negative
in-field biopsy rate at 12 months and determining the NanoKnife
System’s procedural and post-procedural safety profile by
evaluating adverse event incidence, type and severity through 12
months. The study enrolled and treated 121 patients in 17
facilities across the United States. Learn more about PRESERVE at
angiodynamics.com/studies/preserve.
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.
Visit bit.ly/NanoKnifeRiskInfo for risk information. The
NanoKnife System has been cleared by the FDA for the surgical
ablation of soft tissue. It has not received clearance for the
therapy or treatment of any specific disease or condition.
The NanoKnife System, when used for the treatment of prostate
cancer, is an investigational device. It is limited by United
States law to investigational use.
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
quality of life for patients.
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 Society of Urologic Oncology Clinical Trials
Consortium (SUO-CTC)
Created, owned and operated by its members, the Society of
Urologic Oncology Clinical Trials Consortium (SUO-CTC) is a
clinical research investigator network of more than 400 members
from more than 200 clinical sites in the U.S. and Canada. This
national alliance of leading academic and community based
uro-oncologists is committed to furthering urology research. The
SUO-CTC is a registered 501c3 not-for-profit corporation and has a
cooperative relationship with the Society of Urologic Oncology
(SUO). For more information, visit suoctc.org.
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 health care 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, 2022. 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. ©2023 AngioDynamics, Inc
________________________ 1 Key Statistics for Prostate Cancer |
Cancer.org.
https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
Published 2023. Accessed July 27, 2023.
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version on businesswire.com: https://www.businesswire.com/news/home/20230803091690/en/
Investor Relations: Stephen Trowbridge 518-795-1408
strowbridge@angiodynamics.com
Media: Saleem Cheeks 518-795-1174
scheeks@angiodynamics.com
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