UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
__________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): July 10, 2008
AngioDynamics,
Inc.
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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000-50761
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11-3146460
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(State
or Other Jurisdiction of Incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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603
Queensbury Avenue, Queensbury, New
York 12804
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(Address
of Principal Executive
Offices) (Zip
Code)
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(518)
798-1215
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(Registrant’s
telephone number, including area
code)
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Check the appropriate box
below if the Form 8-K filing is intended to simultaneously satisfy the filing
obligation of the registrant under any of the following provisions:
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR 240.14d-2 (b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR 240.13e-4 (c))
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Item
8.01 – Other Events.
On
July 10, 2008, AngioDynamics, Inc. (the “Company”) issued a press release, a
copy of which is attached as Exhibit 99.1, announcing that it has initiated a
voluntary recall of Centros™, its self-centering central venous catheter
for dialysis.
The
information set forth in Item 8.01 of this Form 8-K (including Exhibit 99.1)
shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the Exchange Act), or incorporated by
reference in any filing under the Securities Act of 1933, as amended, or the
Exchange Act, except as shall be expressly set forth by specific reference in
such a filing.
Forward-Looking
Statements
This
document and its attachments include "forward-looking statements" intended to
qualify for the safe harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Investors can identify these statements by the
fact that they do not relate strictly to historical or current facts. These
statements contain words such as "expect,"
"reaffirm," "anticipate," "plan," "believe," "estimate," "may," "will,"
"predict," "project," "might," "intend," "potential," "could," "would,"
"should," "estimate," "seek," "continue," "pursue," or "our future success
depends," or the negative or other variations thereof or comparable terminology,
are intended
to identify such forward-looking statements. In particular, they include
statements relating to, among other things, future actions, strategies, future
performance, future financial results of the Company. These
forward-looking statements are based on current expectations and projections
about future events.
Investors
are cautioned that forward-looking statements are not guarantees of future
performance or results and involve risks and uncertainties that cannot be
predicted or quantified and, consequently, the actual performance or results of
the Company may differ materially from those expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the factors described from time to time in the Company's
reports filed with the SEC, including the Company's Form 10-K for the fiscal
year ended June 2, 2007 and Form 10-Q for the period ended February 29, 2008,
financial community and rating agency perceptions of the Company; the effects of
economic, credit and capital market conditions on the economy in general, and on
medical device companies in particular; domestic and foreign health care reforms
and governmental laws and regulations; third-party relations and approvals,
technological advances and patents attained by competitors; and challenges
inherent in new product development, including obtaining regulatory
approvals. In addition to the
matters described above, the ability of the Company to integrate the Diomed
businesses previously disclosed, the ability of the Company to develop its
products, future actions by the FDA or other regulatory agencies, results of
pending or future clinical trials, the outcome of pending patent litigation,
overall economic conditions, general market conditions, market acceptance,
foreign currency exchange rate fluctuations, and the
effects on pricing
from group purchasing organizations and competition, may affect the actual
results achieved by the Company.
Any
forward-looking statements are made pursuant to the Private Securities
Litigation Reform Act of 1995 and, as such, speak only as of the date made. The
Company disclaims any obligation to update the forward-looking
statements. Investors are cautioned not to place undue reliance on
these forward-looking statements which speak only as of the date stated, or if
no date is stated, as of the date of this document.
Item
9.01 – Financial Statements and Exhibits.
(d) Exhibits.
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Exhibit No.
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Description
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99.1
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Press
Release dated July 10, 2008.
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SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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ANGIODYNAMICS,
INC.
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(Registrant)
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Date:
July 10, 2008
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By:
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/s/
D. Joseph Gersuk
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D.
Joseph Gersuk
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Chief
Financial Officer
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Exhibit No.
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Description
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99.1
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Press
Release dated July 10, 2008.
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Exhibit
99.1
FOR
IMMEDIATE RELEASE
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Company
Contact:
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Investor
Relations Contacts:
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Media
Contact:
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AngioDynamics,
Inc.
D.
Joseph Gersuk, CFO
(800)
772-6446 x1608
jgersuk@AngioDynamics.com
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EVC Group,
Inc.
Doug
Sherk / Donald Takaya
(415)
896-6820
dsherk@evcgroup.com
dtakaya@evcgroup.com
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EVC Group,
Inc.
Chris
Gale
(646)
201-5431
cgale@evcgroup.com
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AngioDynamics
Initiates Voluntary Recall of its Centros Catheter
QUEENSBURY, N.Y. July 10, 2008 — AngioDynamics, Inc.
(NASDAQ: ANGO), a leading provider of innovative medical devices used by
interventional radiologists, nephrologists and surgeons for the minimally
invasive treatment of cancer and peripheral vascular disease, announced today
that it has initiated a voluntary recall of all hospital inventory of Centros™,
its self-centering central venous catheter for dialysis.
The
Company became aware that the catheter cuff, a component intended to anchor the
catheter in subquetaneous tissue, was
inadequately attached to the catheter in a few instances, allowing movement of
the catheter within the insertion site, leakage around the site, or the
retention of the cuff in the tissue when the catheter is
removed. AngioDynamics has identified the cause of the cuff problem
and believes it is related to an outside manufacturer’s production process.
Pending the U.S. Food and Drug Administration review, shipments of Centros are
expected to resume during the Company’s fiscal third quarter, which begins
December 1, 2008.
AngioDynamics
has shipped approximately 1,500 Centros catheters as part of a limited launch
since January 2008. The number of instances reported to date amount to fewer
than 1% of the products shipped. AngioDynamics is informing all
affected customers of the recall action and noted that no adverse
patient outcomes have been reported as a result of this issue. The above
Customer Notification actions are being taken with the knowledge of the U.S.
Food and Drug Administration. Physicians, hospitals and patients with
product related questions may call AngioDynamics Customer Service at
1-800-772-6446.
The
Company expects the total costs associated with the recall to be
minimal.
About
AngioDynamics
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. The Company's diverse
product line includes market-leading radiofrequency 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.
Safe Harbor
The
statements made in this document include forward-looking statements intended to
qualify for the safe harbor from liability established by the Private Securities
Litigation Reform Act of 1995. Words such as "expects,” “reaffirms” "intends,"
"anticipates," "plans," "believes," "seeks," "estimates," or variations of such
words and similar expressions, are intended to identify such forward-looking
statements. Investors are cautioned that actual events or results may differ
from the Company's expectations. In addition to the matters described above, the
ability of the Company to integrate the Diomed businesses, the purchase of which
was previously disclosed, the ability of the Company to develop its products,
future actions by the FDA or other regulatory agencies, results of pending or
future clinical trials, overall economic conditions, general market conditions,
market acceptance, foreign currency exchange rate fluctuations, the effects on
pricing from group purchasing organizations and competition, as well as the risk
factors listed from time to time in the SEC filings of AngioDynamics, Inc.,
including but not limited to its Annual Report on Form 10-K for the year ended
June 2, 2007, may affect the actual results achieved by the
Company. The Company does not assume any obligation to publicly
update or revise any forward-looking statements for any reason.
###