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
Company received central Institutional Review Board (IRB) approval
to conduct its NanoKnife® Irreversible Electroporation
“Direct IRE Cancer Treatment” clinical study (DIRECT). The IRB
approval closely follows the United States Food and Drug
Administration’s (FDA) approval of AngioDynamics’ investigational
device exemption (IDE) application announced on April 1.
Today’s approval enables AngioDynamics to accelerate its
engagement with local IRBs and marks a significant milestone in the
process of making Irreversible Electroporation (IRE) available to
patients through the DIRECT clinical study. The Western IRB (WIRB)
will serve as AngioDynamics’ IRB of record for the DIRECT clinical
study.
“AngioDynamics is committed to providing physicians and patients
with additional options for the treatment of Stage III pancreatic
cancer. The DIRECT IRB approval demonstrates our commitment to
initiating this next-generation clinical study as quickly as
possible to advance our pursuit of innovative, lifesaving
treatments,” said Brent Boucher, AngioDynamics Senior Vice
President and General Manager of Oncology.
AngioDynamics’ DIRECT clinical study features a comprehensive
data collection strategy that will provide meaningful clinical
information to healthcare professionals, support a regulatory
indication for the treatment of Stage III pancreatic cancer, and
facilitate reimbursement for hospitals and treating physicians. The
next-generation study is classified as a Category B IDE by the FDA,
allowing participating sites to obtain coverage for procedures
performed as well as related routine costs.
The DIRECT clinical study comprises a Randomized Controlled
Trial (RCT) at up to 15 sites, as well as a Real-World Evidence
(RWE), next-generation registry at up to 30 sites, each with a
NanoKnife System treatment arm and a control arm. AngioDynamics
expects each NanoKnife arm to consist of approximately 250 patients
with an equal number of control patients. The primary endpoint of
the study is overall survival.
As part of the DIRECT clinical study, AngioDynamics launched
AngioDIRECT.com to facilitate the enrollment of participants. The
online platform provides patients and their families with
information about pancreatic cancer and details about the study. It
also features a physician locator to help prospective participants
and referring healthcare professionals identify clinical study
locations.
The DIRECT clinical study supports a proposed expanded
indication for the NanoKnife System in the treatment of Stage III
pancreatic cancer.
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 Ablation 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 in a matter
of weeks, mimicking natural cell death. Unlike other ablation
technologies, the NanoKnife Ablation System does not achieve tissue
ablation using thermal energy.
The NanoKnife Ablation System consists of two major components:
a Low Energy Direct Current, or LEDC Generator and needle-like
electrode probes. Up to six (6) 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190417005231/en/
Investor Relations Contact:AngioDynamics, Inc.Michael
Greiner518-795-1821mgreiner@angiodynamics.com
Media Contact:AngioDynamics, Inc.Saleem
Cheeks518-795-1174scheeks@angiodynamics.com
AngioDynamics (NASDAQ:ANGO)
Historical Stock Chart
From Aug 2024 to Sep 2024
AngioDynamics (NASDAQ:ANGO)
Historical Stock Chart
From Sep 2023 to Sep 2024