“CE Mark certification represents a major milestone for IRIS as we proceed with the launch of our iChem VELOCITY automated chemistry system in more than 50 countries in the international marketplace, where we previously were unable to offer a chemistry unit,” stated César García, Chairman, President and Chief Executive Officer of IRIS International, Inc. “The iChem VELOCITY significantly enhances and rounds out our core urinalysis business. With CE certification and with more than 1,000 of our iQ®200™ automated urine microscopy analyzer units shipped outside the US, we can now compete as a complete urinalysis player in the international market. We plan to release the iChem VELOCITY in the US in January 2009 to gain full access to the balance of the $400 million global urine chemistry market. The iChem VELOCITY, when combined with the iQ200, forms the new iRICELL® complete urinalysis workstation, integrating both urine microscopy and chemistry under our proprietary technology platform, offering our distributors and customers a complete and unique bench top urinalysis solution,” Mr. García said.
“We have already initiated shipments of several iChem VELOCITY units to selected international distributors during the first quarter and are building a strong order backlog for shipment in the second quarter and beyond,” he added.
The iChem VELOCITY is currently pending FDA 510k clearance in the United States.
A CE Mark is a mandatory requirement for products intended for sale or placed into service in Europe, and covers an estimated 75% of all products sold today in the European Union (EU). CE Marking requirements, which involve rigorous testing to European and International standards for product safety, compatibility, durability and performance, apply to all manufacturers, whether located within or outside of the EU.
ABOUT THE iCHEM VELOCITY SYSTEM
The iChem VELOCITY with Kinetic Imaging leverages IRIS’ core image analysis technology to provide a complete and unique benchtop urine chemistry solution designed for medium to high volume laboratories that typically process more than 100 urine samples per day. The iChem VELOCITY combined with the iQ®200 family of urine microscopy analyzers as the iRICELL® urinalysis workstation embodies a major technological advance in complete urinalysis, a sector of the laboratory which has not seen significant innovation in many years.
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 press 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, regulatory developments, 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; obtaining regulatory approvals for new and enhanced products; 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. César García, 818-709-1244 Chairman and Chief Executive Officer or The Wall Street Group, Inc. Ron Stabiner, 212-888-4848
Source: IRIS International, Inc.
