CHATSWORTH, Calif.--(BUSINESS WIRE)--June 15, 2006--IRIS INTERNATIONAL, INC. (NASDAQ: IRIS - News), a manufacturer and marketer of automated IVD urinalysis systems and medical devices used in hospitals and clinical reference laboratories worldwide, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration for its new iChem(TM)100 Urine Chemistry Analyzer. The iChem 100 is a benchtop instrument designed for small public and private hospital labs, outpatient clinics, reference laboratories and large physician office labs testing up to 50 urine samples a day. The Company will also initiate shipments of its new vChem(TM) line of visual-read test strips designed for lower volume physician office laboratories.
“The release of the iChem100 and vChem are significant milestones for IRIS as they enable the Company to better penetrate the urine chemistry market with a proprietary brand of urine chemistry analyzers and test strips,” stated President and Chief Executive Officer Cesar Garcia. “The iChem100 is the most productive semi-automated urine chemistry analyzer available on the market today. It fills a gap for us in the international market and enhances our portfolio of urinalysis instruments.”
“The iChem100 addresses a significant portion of the urine chemistry market, which we estimate to be about 8,000 sites globally, while the vChem line can be used in most physicians’ offices.” Mr. Garcia noted. “We are also continuing to develop a fully automated urine chemistry analyzer, which is scheduled for release during the second half of 2007, that will give us an even more comprehensive product line for the international automated urine chemistry market and enable IRIS to become a full-line player in addressing a $350 million total market opportunity.”
IRIS plans to launch the iChem100 analyzer and related iChem test strips, as well as the vChem Urine Chemistry Strips in July to the international market through its overseas distribution network, except in Japan. As part of an existing distribution agreement with Arkray, Inc., IRIS will continue to market the Japan-based company’s chemistry analyzer in the U.S and Arkray will also continue to market IRIS’ microscopy analyzers in Japan.
The Iris Diagnostics Division’s flagship product line, the iQ®200 Automated Urine Microscopy Analyzers and Systems, were launched in August 2003. The original iQ200 performs up to 60 analyses per hour and meets the needs of the mid-sized laboratory market doing more than 45 urinalysis tests per day. The iQ®200 Sprint(TM), a high-speed analyzer launched in March 2005, processes 101 tests an hour and is the fastest device of its type on the market. The Sprint addresses the high specimen throughput requirements of clinical reference and high volume hospital laboratories.
THE COMPANY
IRIS International, Inc. (www.proiris.com), based in Chatsworth, Calif., is a leader in automated urinalysis technology with systems in major medical institutions throughout the world. The Company’s Sample Processing business unit (formerly the StatSpin® subsidiary), based in Westwood, Mass., manufactures innovative centrifuges and blood analysis products. Advanced Digital Imaging Research, LLC (ADIR), based near Houston, Texas, is the Company’s imaging research and development subsidiary. The IRIS Molecular Diagnostics (IMD) Subsidiary develops innovative ultra-sensitive diagnostics and sample processing products with applications in the urinalysis, oncology and infectious disease markets.
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.
Contact: IRIS International, Inc. Cesar Garcia, 818-709-1244 x 7123 or The Wall Street Group, Inc. Ron Stabiner, 212-888-4848
Source: IRIS International, Inc.
