CHATSWORTH, Calif., Feb. 24, 2003 (PRIMEZONE) -- International Remote Imaging Systems, Inc. (AMEX:IRI), a highly regarded manufacturer and marketer of automated IVD urinalysis systems and medical devices used in hospitals and reference clinical laboratories worldwide, announced today that its Iris Diagnostics Division has received EN ISO 9001, EN ISO 13485, and EN 46001 certification.
"Certification to these international standards is a step toward providing expanded entry of our new product platform, the iQ(tm)200 System, into the European market through the Company's network of new and existing distributors," stated Cesar Garcia, Executive Vice President of International Remote Imaging Systems. "Once we obtain the CE Mark of approval for the European Union, which we anticipate receiving before Iris Diagnostics begins shipment of the iQ200, the certification process will be complete. We are extremely pleased to have received these certifications, which represent a significant achievement and important milestone for Iris Diagnostics, as it was for our StatSpin(r) subsidiary last year."
Dr. Kshitij Mohan, President and Chief Executive Officer of International Remote Imaging Systems, noted that the Iris Diagnostics Division and the Company's StatSpin subsidiary, which received ISO 9001 and EN 46001 certification in May 2002, have always excelled in high quality products and service. "These certifications recognize our excellent quality system and the high standards set by our Company and our employees."
The International Organization for Standardization (ISO) 9001 is a comprehensive standard covering the quality of design, development, production, installation, and servicing of products and systems. ISO 13485 is the international quality standard for the design and manufacture of medical devices. EN 46001 is the European quality standard for the manufacture of medical devices. The certifications were granted by TUV Rheinland, a European Union Registrar and Notified Body. Compliance with ISO 9001 is required for regulation of in vitro diagnostic products sold into the European Union.
International Remote Imaging Systems, Inc. has an established reputation as a leader in automated urinalysis technology and image flow cytometry. The Company's Iris Diagnostics Division is a leader in automated urinalysis technology with workstations in major medical institutions throughout the world. Using a patented Automated Intelligent Microscopy (AIM) technology and Auto Analyte Recognition software (AAR), a significant reduction in the cost and time consuming steps for manual microscopic analysis can be achieved.
The StatSpin(r) subsidiary, based in Norwood, Mass., is a worldwide leader in accelerated sample preparation for blood, body fluids and urine analysis. The subsidiary makes innovative centrifuges and blood analysis products, including the world's fastest blood separator (30 seconds). StatSpin's worldwide markets include medical institutions, commercial laboratories, clinics, doctors' offices, veterinary labs and research facilities. Its bench top centrifuges are dedicated to applications for manual specimen preparation for coagulation, cytology, hematology, and urinalysis.
Advanced Digital Imaging Research, LLC, is a research and development subsidiary based in the Houston, Texas area. ADIR assists in the advancement of proprietary imaging technology while conducting government-sponsored research and development in medical imaging and software, and contract research for corporate clients.
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 commercial revenues, market growth, capital requirements, new product introductions, 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, competition and capital requirements. Other factors and uncertainties that could affect the Company's forward-looking statements include, among other things, the following: unexpected technical and marketing difficulties inherent in major product development efforts such as the current project to improve the Company's urinalysis workstation product line; the potential need for changes in long-term strategy in response to future developments; future advances in diagnostic testing methods and procedures, as well as 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 increasing competition from imaging and non-imaging based in-vitro diagnostic products. The Company refers interested persons to its most recent Annual Report on Form 10-K and its other SEC filings for a description of additional uncertainties and factors that may affect forward-looking statements. The Company assumes no duty to update its forward-looking statements.