ALBANY, N.Y.--(BUSINESS WIRE)--
AngioDynamics (NASDAQ:ANGO) today announced the receipt of a warning
letter from the U.S. Food and Drug Administration (FDA) regarding
certain aspects of the Company's marketing program for its NanoKnife®
System. The NanoKnife System continues to be commercially available in
the United States under its 510(k) clearance for the surgical ablation
of soft tissue and in certain international markets under CE Mark or
other relevant approvals. The FDA letter states that certain statements
made by AngioDynamics, including those on its Web site, promote the use
of the NanoKnife System beyond its currently cleared indications.
AngioDynamics is taking actions to address the matters raised by the FDA
and will work closely with the agency to resolve any outstanding issues.
"Our goal is to always comply with all regulations regarding our
products," said Jan Keltjens, AngioDynamics President and CEO. "We have
already begun to respond to the matters raised by the FDA and are
committed to addressing them promptly. We remain committed to our
strategy of working with the FDA toward expanded labeling for the
AngioDynamics, Inc. is a leading provider of innovative medical devices
used by interventional radiologists, surgeons and other physicians for
the minimally-invasive treatment of cancer and peripheral vascular
disease. AngioDynamics' diverse product lines include market-leading
ablation systems, vascular access products, angiographic products and
accessories, dialysis products, angioplasty products, drainage products,
thrombolytic products, embolization products and venous products. More
information is available at 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," 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,
future actions by the FDA or other regulatory agencies, results of
pending or future clinical trials, overall economic conditions, the
results of on-going litigation, 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, 2010. AngioDynamics does not assume any obligation to
publicly update or revise any forward-looking statements for any reason.
Until the matters raised in the aforementioned warning letter are
corrected, we may be subject to additional regulatory action by the FDA,
and any such actions could significantly disrupt our business and
operations and have a material adverse impact on our financial position
and results of operations. There can be no assurance that the FDA will
be satisfied with our response. The warning letter will be posted on the
FDA's Web site at www.fda.gov
and, once posted, will be available for viewing.
D. Joseph Gersuk,
CFO, 800-772-6446 ext. 1608
Doug Sherk, 415-896-6820 (Investor Relations)
Gin, 415-896-6820 (Investor Relations)
Gale, 646-201-5431 (Media)
Source: AngioDynamics, Inc.
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