OPKO Receives FDA 510(k) Clearance for Spectral OCT SLO Combination Imaging System
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