AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of
innovative, minimally invasive medical devices for vascular access,
peripheral vascular disease, and oncology, today announced
enrollment of the first patient in its NanoKnife® Irreversible
Electroporation (IRE) “Data
IRE Cancer Treatment” clinical study (DIRECT).
The DIRECT Study supports a proposed expanded indication for the
NanoKnife System in the treatment of Stage III pancreatic cancer.
The first patient enrollment closely follows the United States Food
and Drug Administration’s (FDA) April 1, 2019 approval of
AngioDynamics’ investigational device exemption (IDE)
application.
“The enrollment of our first patient soon after receiving FDA
approval is a strong signal that clinicians are eager to evaluate
treatment alternatives that improve the dismal prognosis for Stage
III pancreatic cancer patients,” said Brent Boucher, AngioDynamics
Senior Vice President and General Manager of Oncology. “We look
forward to confirming that our proprietary NanoKnife technology
offers a compelling alternative to the current standard of care and
believe that this study will provide a pivotal dataset for claims
and reimbursement purposes.”
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,
which allows participating sites to obtain coverage for procedures
performed in addition to any related routine costs.
“We are pleased to be the first enrolling site. The DIRECT Study
represents an important milestone in the standardization of care
for patients with Stage III pancreatic cancer. Our goal is to
generate important data that should standardize and optimize the
use of IRE in the treatment of locally advanced pancreatic cancer,
significantly improving outcomes for patients with this late-stage
diagnosis,” said Dr. Robert C.G. Martin, Co-Principal Investigator
of the DIRECT Study and Surgical Oncologist at the University of
Louisville.
The DIRECT Study comprises a Randomized Controlled Trial at up
to 15 sites, as well as a Real-World Evidence, 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 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.
There are approximately 57,000 new cases and 46,000 estimated
deaths from pancreatic cancer in the United States annually1. Total
deaths due to pancreatic cancer are projected to increase
dramatically to become the second leading cause of cancer-related
deaths before 20302. The mortality rate is high due to the
aggressive nature of the disease and lack of early warning signs,
and less than 20 percent of patients are candidates for surgical
resection at time of diagnosis3. Approximately 35 to 40 percent of
patients will present with Stage III and 45 to 55 percent with
metastatic disease3. Regardless of the stage of pancreatic cancer,
it is one of the least survivable cancers, and survival rates have
not improved substantially for more than forty years3. For all
stages combined, the five-year relative survival rate is 8 percent
and, for those with advanced disease at the time of diagnosis, the
five-year survival rate remains at 3 percent3.
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.
1 American Cancer Society. (2019). Cancer Facts &
Figures. Retrieved March 14th, 2019,
from https://www.cancer.org/cancer/pancreatic-cancer/about/key-statistics.html
2 Projecting Cancer Incidence and Deaths to 2030: The Unexpected
Burden of Thyroid, Liver, and Pancreas Cancers in the United
States. Lola Rahib, Benjamin D. Smith, Rhonda
Aizenberg, Allison B. Rosenzweig, Julie M. Fleshman and Lynn
M. Matrisian DOI:
10.1158/0008-5472.CAN-14-0155 https://www.ncbi.nlm.nih.gov/pubmed/24840647
3 American Society of Clinical Oncology. (2019). Pancreatic
Cancer: Statistics. Retrieved March 14th, 2019,
from https://www.cancer.net/cancer-types/pancreatic-cancer/statistics
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version on businesswire.com: https://www.businesswire.com/news/home/20190513005244/en/
Investor Relations Contact:AngioDynamics, Inc.Michael
Greiner518-795-1821mgreiner@angiodynamics.com
Media Contact:AngioDynamics, Inc.Saleem
Cheeks518-795-1174scheeks@angiodynamics.com
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