AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of
innovative, minimally invasive medical devices for vascular access,
peripheral vascular disease, and oncology, today announced that the
United States Food and Drug Administration (FDA) approved the
Company’s investigational device exemption (IDE) application for
its NanoKnife® Irreversible Electroporation pilot study for the
ablation of prostate cancer tissue in low-risk patients.
The prospective, non-randomized pilot study includes six
subjects at up to three clinical sites. The pilot study is intended
to inform the design of a pivotal clinical study in the United
States to support the approval of a future Premarket Approval
Application (PMA).
“On the heels of our first patient enrollment in our Stage III
pancreatic cancer IDE, we are excited to receive approval to
conduct a separate pilot IDE for the treatment of prostate cancer,”
said Brent Boucher, AngioDynamics Senior Vice President and General
Manager of Oncology. “This pilot study represents the next step in
our comprehensive approach to establish NanoKnife® as a platform
technology to treat numerous cancers and conditions.”
Prostate cancer is the second leading cause of cancer death in
American men1. Approximately one man out of every nine will be
diagnosed with prostate cancer during his lifetime1. Traditional
treatment options have focused on standard whole-gland therapies,
such as active surveillance, radical prostatectomy, and external
beam radiation2. However, over the last decade, focal therapy has
been evaluated as an alternative for select patients diagnosed with
localized prostate cancer in order to minimize treatment-related
toxicity2.
The NanoKnife® System is a unique, minimally invasive technique
that has been used to successfully treat focal prostate lesions
through irreversible electroporation.
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative,
minimally invasive medical devices used by professional healthcare
providers for vascular access, peripheral vascular
disease, and oncology. AngioDynamics’ diverse product
lines include market-leading ablation systems, fluid management
systems, vascular access products, angiographic products and
accessories, drainage products, thrombolytic products and venous
products. For more information,
visit www.angiodynamics.com.
About the NanoKnife System
The NanoKnife System has received 510(k) clearance from
the Food and Drug Administration for the surgical
ablation of soft tissue. The NanoKnife System utilizes low energy
direct current electrical pulses to permanently open pores in
target cell membranes. These permanent pores, or nano-scale
defects, in the cell membranes result in cell death. The treated
tissue is then removed by the body's natural processes over a
matter of weeks, mimicking natural cell death. Unlike other
ablation technologies, the NanoKnife System does not achieve tissue
ablation using thermal energy.
The NanoKnife System consists of two major components: a Low
Energy Direct Current, or LEDC Generator and needle-like electrode
probes. Up to six electrode probes can be placed into or around the
targeted soft tissue. Once the probes are in place, the user enters
the appropriate parameters for voltage, number of pulses, interval
between pulses, and the pulse length into the generator user
interface. The generator then delivers a series of short electric
pulses between each electrode probe. The energy delivery is
hyperechoic and can be monitored under real-time ultrasound.
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,"
"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 from AngioDynamics' expectations.
Factors that may affect the actual results achieved
by AngioDynamics include, without limitation, 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 fourth 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,
the results of on-going litigation, challenges with respect to
fourth-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 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,
2018. 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.
1 Key Statistics for Prostate Cancer.
https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html.
Accessed May 21, 2019.2 Giannarini, G., Gandaglia, G., Montorsi,
F., & Briganti, A. (2014). Will Focal Therapy Remain Only an
Attractive Illusion for the Primary Treatment of Prostate Cancer?
Journal of Clinical Oncology, 1299-1301
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version on businesswire.com: https://www.businesswire.com/news/home/20190522005236/en/
Investor Relations:AngioDynamics, Inc.Michael
Greiner518-795-1821mgreiner@angiodynamics.comMedia:AngioDynamics,
Inc.Saleem Cheeks518-795-1174scheeks@angiodynamics.com
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