January 23, 2009 9:13am EST
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MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE Alternext US:OPK) today announced that it has
received 510(k) clearance from the U.S. Food and Drug Administration
("FDA") to begin marketing in the United States its Spectral OCT SLO
Combination Imaging System. Currently marketed internationally by the
Company's subsidiary, OPKO Instrumentation, LLC, the Spectral OCT SLO is
the product of more than a decade of innovation in the field of
combination imaging. High-resolution images are produced with inner
retinal choroid and vitreous detail that allow for improved monitoring
of ophthalmic disease progression or regression.
"We are pleased to receive 510(k) clearance for the OPKO Spectral OCT
SLO Combination Imaging System," said Jane H. Hsiao, Ph.D., Vice
Chairman and Chief Technical Officer of OPKO Health, and President of
OPKO Instrumentation. "We believe that the high image quality produced
by our Spectral OCT SLO and its versatile user-friendly interface offer
the clinician a valuable tool for the detection and visualization of
ocular pathologies. In addition, we recently hosted a FDA audit at our
facility in Toronto, Canada where we manufacture our Spectral OCT SLO
and ultrasound products and are pleased to announce it was accepted
without any citation of deficiency after the inspection."
About the Spectral OCT SLO
The Spectral OCT SLO is a non-contact, high-resolution non-invasive
tomographic and confocal imaging device indicated for in vivo viewing,
axial cross-sectional, and three-dimensional imaging and measurement of
posterior ocular structures including: retina, macula, retina nerve
fiber layer and optic disk. It is used as a diagnostic device to aid in
the detection and management of ocular diseases affecting the posterior
segment of the eye. In addition, the system can image the cornea, sclera
and conjunctiva by changing the focal position.
About OPKO Health, Inc.
Miami-based OPKO is a specialty healthcare company engaged in the
development, marketing, and sales of novel agents and both diagnostic
and therapeutic devices for the management of ophthalmic diseases. For
more information visit the company's website at www.opko.com .
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding our product development efforts,
our ability to commence sales of the Spectral OCT SLO in the United
States, and our ability to develop a preclinical pipeline of novel
agents for ophthalmic diseases, as well as other non-historical
statements about our expectations, beliefs or intentions regarding our
business, technologies and products, financial condition, strategies or
prospects. Many factors could cause our actual activities or results to
differ materially from the activities and results anticipated in
forward-looking statements. These factors include those described in our
filings with the Securities and Exchange Commission, as well as risks
inherent in funding, developing and obtaining regulatory approvals of
new, commercially-viable and competitive products and treatments. In
addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
Source: OPKO Health, Inc.
Released January 23, 2009
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