| CONTACTS: |
César García,
Chairman, President and CEO |
|
818-709-1244 x 7123
|
|
-or-
|
|
Ron Stabiner, The Wall Street Group, Inc. |
|
212-888-4848 |
CHATSWORTH, Calif., Dec 19, 2007 - Iris Diagnostics, a division of IRIS International, Inc. (NASDAQ GM: IRIS)
today announced that it has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance to market its iChem® VELOCITY™ Automated Urine Chemistry Analyzer
utilizing the Company's proprietary Kinetic Imaging technology.
"We are very pleased to file an FDA application for marketing clearance of our iChemVELOCITY, marking a major milestone for the Company and the culmination of a major R&D
effort. The iChemVELOCITY embodies a major technological advance in urine chemistry, a sector of the laboratory which has not seen significant innovation in many years," said César García, IRIS Chairman,
President and Chief Executive Officer. "This device will leverage our core image analysis technology to provide a complete and unique benchtop urinalysis solution which, when combined with the iQ®200
Automated Urine Microscopy Analyzer, forms the iRICELL™ Complete Urinalysis™ Workcell."
Mr. García went on to note that the iChemVELOCITY opens up an incremental $350 million market opportunity in urine chemistry and uniquely positions IRIS as the only company to offer
a complete range of fully and semi-automated urinalysis solutions combining both urine chemistry and urine microscopy.
"While pursuing FDA clearance, we are proceeding with the international launch of the iChemVELOCITY scheduled for March of 2008," Mr. García said. "This will allow us
to market an integrated system with our iQ200 Automated Urine Microscopy Analyzer in the international marketplace for the first time," he added.
The iChemVELOCITY system is designed for ease of use and high throughput workload requirements. It is the first urinalysis system to employ IRIS' proprietary Kinetic Imaging
technology, a state-of-the-art imaging system that will optimize the sensitivity and dynamic range of the Company's urine chemistry strips. The iChemVELOCITY is designed for medium to high volume laboratories
that typically process more than 100 urine samples per day.
THE COMPANY
IRIS International, Inc. (www.proiris.com), based in Chatsworth, Calif., is a leading developer, manufacturer, and marketer of medical
devices, diagnostic systems and consumables. The Iris Diagnostics Division (www.irisdiagnostics.com) is a leader in automated urinalysis technology with
systems in major medical institutions throughout the world. Iris Molecular Diagnostics develops innovative ultra-sensitive diagnostics and sample processing products with applications in the urinalysis, oncology and
infectious disease markets. The Company's Sample Processing business unit (formerly the StatSpin® subsidiary) (www.statspin.com), based in
Westwood, Mass., manufactures innovative centrifuges and blood analysis products.
SAFE HARBOR PROVISION
This news release contains forward-looking statements made in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements
include, but are not limited to, the Company's views on future financial performance, market growth, capital requirements, new product introductions and acquisitions, and are generally identified by phrases
such as "thinks," "anticipates," "believes," "estimates," "expects," "intends," "plans," and similar words. Forward-looking statements are not
guarantees of future performance and are inherently subject to uncertainties and other factors which could cause actual results to differ materially from the forward-looking statement. These statements are based
upon, among other things, assumptions made by, and information currently available to, management, including management's own knowledge and assessment of the Company's industry, R&D initiatives,
competition and capital requirements. Other factors and uncertainties that could affect the Company's forward-looking statements include, among other things, the following: identification of feasible new product
initiatives, management of R&D efforts and the resulting successful development of new products and product platforms; acceptance by customers of the Company's products; integration of acquired businesses;
substantial expansion of international sales; reliance on key suppliers; the potential need for changes in long-term strategy in response to future developments; future advances in diagnostic testing methods and
procedures; potential changes in government regulations and healthcare policies, both of which could adversely affect the economics of the diagnostic testing procedures automated by the Company's products; rapid
technological change in the microelectronics and software industries; and competitive factors, including pricing pressures and the introduction by others of new products with similar or better functionality than our
products. These and other risks are more fully described in the Company's filings with the Securities and Exchange Commission, including the Company's most recently filed Annual Report on Form 10-K and
Quarterly Report on Form 10-Q, which should be read in conjunction herewith for a further discussion of important factors that could cause actual results to differ materially from those in the forward-looking
statements. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
