LATHAM, N.Y.--(BUSINESS WIRE)--
AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative,
minimally invasive medical devices for vascular access, peripheral
vascular disease, surgery and oncology, today announced that the United
States Food and Drug Administration (FDA) has granted the Expedited
Access Pathway (EAP) designation to the Company's NanoKnife® System and
proposed indication for use for the treatment of Stage III pancreatic
The EAP program is designed to help patients gain more timely access to
medical devices that may provide more effective treatment or diagnosis
of life-threatening or irreversibly debilitating diseases or conditions,
for which no approved or cleared alternatives exist. This is achieved by
expediting the device's assessment and review processes through more
interactive and timely communication with the FDA, pre- and post-market
balance of data collection requirements, efficient and flexible clinical
study design, FDA review team support and Agency senior management
engagement, and priority review.
Pursuant to the recently enacted 21st Century Cures Act, the
FDA has released draft guidance for a Breakthrough Devices Program,
which, when finalized, will supersede the EAP. The FDA has indicated
that all devices that receive EAP designation will gain Breakthrough
Device designation when the guidance document becomes final.
Jim Clemmer, President and Chief Executive Officer of AngioDynamics,
Inc., commented, "The Expedited Access Pathway and Breakthrough Devices
Program is an important and meaningful initiative to prioritize review
and approval for novel, innovative devices needed by patients for the
treatment of life-threatening diseases and conditions. We are thrilled
that the FDA has granted the EAP designation to NanoKnife for the
treatment of Stage III pancreatic cancer and are excited to continue
working with the FDA toward approval of NanoKnife as a treatment for the
underserved patient population suffering from this deadly disease."
About Pancreatic Cancer
According to the American Cancer Society, pancreatic cancer is the third
leading cause of cancer related deaths in the US and is projected to
increase to the second leading cause within the next five years. There
are over 55,000 new cases and 44,000 estimated deaths in the US annually1
The mortality rate is high due to the aggressive nature of the disease
and lack of early warning signs. In fact, only 20-30% of patients are
candidates for surgical resection at time of diagnosis2.
Approximately 40% percent of patients will present with Stage III and
40% with metastatic disease. Regardless of the stage of pancreatic
cancer, it has the lowest survival rate of any cancer, with an overall
one- and five-year survival rate of 27% and 8% respectively1.
There are limited treatment options for Stage III and IV disease, with
chemotherapy and/or radiotherapy considered the standard of care2.
There have been advancements in both techniques, but this has come at
the cost of greater toxicity3, limiting the patients that are
candidates for the treatment.
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, 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.
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative, minimally
invasive medical devices used by professional healthcare providers for
vascular access, surgery, 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.
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 purchased
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, 2017. 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
CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub
2018 Jan 4.
J Natl Compr Canc Netw. 2017 Aug;15(8):1028-1061. doi:
N Engl J Med. 2011 May 12;364(19):1817-25. doi:
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Michael Greiner, 518-795-1821
Vice President & CFO
Source: AngioDynamics, Inc.
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