Attached files
file | filename |
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8-K - ERBA Diagnostics, Inc. | v209079_8k.htm |
Exhibit
99.1
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Company
Contact:
Kevin
D. Clark, CEO, COO & President
305-324-2300
|
FOR
IMMEDIATE RELEASE
IVAX
DIAGNOSTICS RECEIVES F.D.A. CLEARANCE FOR MAGO®
4S
MIAMI —
(BUSINESS WIRE) — January 26, 2011 — IVAX Diagnostics, Inc. (NYSE Amex: IVD)
today announced that it has received clearance from the United States Food and
Drug Administration (FDA) on the 510(k) premarket submission that IVAX
Diagnostics had filed for the Mago®
4S. The Mago® 4S is
IVAX Diagnostics’ next-generation fully-automated Enzyme-linked Immunosorbent
Assay (ELISA) and Immunofluorescence Assay (IFA) instrumentation system for
autoimmune and infectious disease testing that IVAX Diagnostics intends to
market in the United States.
About
IVAX Diagnostics, Inc.
IVAX
Diagnostics, Inc. (www.ivaxdiagnostics.com), headquartered in Miami, Florida, is
a fully integrated in vitro diagnostics company that develops, manufactures and
distributes in the United States and internationally, proprietary diagnostic
reagents, test kits and instrumentation, primarily for autoimmune and infectious
diseases, through its three subsidiaries: Diamedix Corporation
(U.S.), Delta Biologicals S.r.l. (Europe), and ImmunoVision, Inc.
(U.S.).
Safe
Harbor Statement
Except
for the historical matters contained herein, statements in this press release
are forward-looking and are made pursuant to the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Investors are cautioned that
forward-looking statements involve risks and uncertainties that may affect the
business and prospects of IVAX Diagnostics, Inc., including, without limitation,
the risks and uncertainties associated with: the pending commercial
release of the Mago® 4S; the
ability of the Mago® 4S to be
available when expected, or at all; the ability of the Mago® 4S to
perform as expected; the impact of the anticipated timing of the commercial
release of the Mago® 4S on
the judgments and estimates IVAX Diagnostics has made with respect to its
financial condition, operating results and cash flows; the impact on IVAX
Diagnostics’ financial condition and operating results of making or changing
judgments and estimates as a result of future design changes to, or the
development of improved instrument versions of, the Mago® 4S or as
a result of future demand for the Mago® 4S; the
ability of the Mago® 4S to be
a source of revenue growth for IVAX Diagnostics; IVAX Diagnostics’ ability to
receive financial benefits or achieve improved operating results and cash
flow after the commercial release of the Mago® 4S; the
ability of the Mago® 4S to be
a factor in the growth of IVAX Diagnostics; the ability of the Mago® 4S to
expand the menu of test kits IVAX Diagnostics offers; IVAX Diagnostics’ ability
to successfully market the Mago® 4S; IVAX
Diagnostics’ customers’ integration of the Mago® 4S into
their operations; IVAX Diagnostics’ ability to generate positive cash flow or
otherwise improve its liquidity, whether from existing operations, strategic
initiatives or possible future sources of liquidity; constantly changing, and
IVAX Diagnostics’ compliance with, governmental regulation; IVAX Diagnostics’
ability to achieve cost advantages from its own manufacture of instrument
systems, reagents and test kits; and other risks and uncertainties that may
cause results to differ materially from those set forth in the forward-looking
statements. In addition to the risks and uncertainties set forth
above, investors should consider the economic, competitive, governmental,
technological and other risks and uncertainties discussed in IVAX Diagnostics’
filings with the Securities and Exchange Commission, including, without
limitation, the risks and uncertainties discussed under the heading “Risk
Factors” in such filings.
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