LATHAM, N.Y.--(BUSINESS WIRE)--May 13, 2019--
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
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
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.
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
1American 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:
3American 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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Source: AngioDynamics, Inc.
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