U.S. distribution contract for LC Beads™
to expire on December 31, 2011
FDA approves IDE for NanoKnife®
System study in prostate cancer
Company expects to submit IDE for NanoKnife System study in
pancreatic cancer by mid-June
Oncology/Surgery division to enhance focus on NanoKnife, and
core ablation and surgical resection products
ALBANY, N.Y.--(BUSINESS WIRE)--
AngioDynamics (NASDAQ:ANGO), a leading provider of innovative, minimally
invasive medical devices for vascular access, surgery, peripheral
vascular disease and oncology, today reported several developments in
its Oncology/Surgery division.
After several months of discussions, AngioDynamics has concluded
negotiations with BTG (LSE:BGC) concerning a possible extension of its
distribution agreement for the LC Bead™ embolization product.
As a result, the Company will not distribute LC Beads in the U.S. beyond
the agreement's December 31, 2011 expiration date. The LC Bead product
line represented approximately 13% of AngioDynamics' net sales through
the first nine months of fiscal 2011. Following the conclusion of the
distribution agreement, AngioDynamics' Oncology/Surgery division will
increase its focus on the global growth opportunities of its high-margin
NanoKnife products and programs, and radio frequency ablation and
surgical resection devices. In addition, the Company continues to pursue
M&A transactions that would provide the Oncology/Surgery and Vascular
sales forces with additional products and services to offer customers.
"Our success with the LC Bead product over the past five years
demonstrates the strength and capabilities of our U.S. Oncology/Surgery
sales team," said Jan Keltjens, President and Chief Executive Officer.
"With the expiration of the distribution arrangement, we have an
opportunity to focus our Oncology/Surgery division on developing and
commercializing our fastest growing product line and single largest
growth opportunity, the NanoKnife System. In addition, we will increase
our attention on our ablation and surgical resection products. At the
same time, our strong balance sheet and strong operating cash flow
provide significant resources to acquire products or companies in the
Oncology/Surgery, as well as Vascular, space which would provide our
strong sales teams with additional growth opportunities. Despite the
loss of LC Bead revenue in the second half of fiscal 2012, our team is
focused on implementing strategies designed to drive overall top- and
bottom-line long-term growth in the next fiscal year."
NanoKnife Clinical Progress
The U.S. Food & Drug Administration (FDA) has granted Investigational
Device Exemption (IDE) approval for the NanoKnife System, allowing
AngioDynamics to conduct a clinical study of the NanoKnife System for
the ablation of low risk, localized prostate cancer. The FDA approval is
for an initial study of a total of six patients at up to three sites in
the U.S., which will provide the basis for additional clinical trials.
Additionally, the Company expects to submit an IDE application to the
FDA for a clinical study of the use of the NanoKnife System in
pancreatic cancer by mid-June 2011.
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, vascular access products, angiographic products and
accessories, angioplasty products, drainage products, thrombolytic
products, embolization products and venous products. More information is
available at www.angiodynamics.com.
Forward Looking Statements
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, 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, and its Quarterly
Reports on Form 10-Q for the periods ended August 31, 2011, November 30,
2011 and February 28, 2011. AngioDynamics does not assume any obligation
to publicly update or revise any forward-looking statements for any
Joseph Gersuk, CFO, 800-772-6446 ext. 1608
EVC Group, Inc.
Sherk / Gregory Gin, 415-896-6820
EVC Group, Inc.
Source: AngioDynamics, Inc.
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