CHATSWORTH, Calif., Aug. 7, 2003 (PRIMEZONE) -- INTERNATIONAL REMOTE IMAGING SYSTEMS, INC. (AMEX:IRI), a manufacturer and marketer of automated IVD urinalysis systems and medical devices used in hospitals and clinical reference laboratories worldwide, today announced the first shipments of the Company's new iQ(tm)200 product platform.
"This is a banner day for our Company as we officially roll out the iQ200 product platform to our customers and distributors," stated Dr. Kshitij Mohan, Chief Executive Officer of International Remote Imaging Systems. "It represents a key milestone in our growth and is the culmination of a three-and-a-half year, $17 million research and development program." Dr. Mohan said the first shipments went to hospitals in the United States and distributors in Europe.
The iQ200 Automated Urinalysis System (iQ200 System) is the world's first fully automated system that integrates both the chemistry and the microscopic analysis of urine. The iQ200 System is designed to streamline workflow, increase testing capacity and improve diagnostic quality in clinical laboratories. It provides the most comprehensive test panel on the market and highly reproducible, accurate results at lower costs to the clinical laboratory. The system consists of two modules, one for chemistry and another for microscopy, integrated by a state-of-the-art sample transport module and a single Laboratory Information System (LIS) interface. The iQ200 System features a completely re-designed neural network-based Auto-Particle Recognition (APR(tm)) software. The iQ200 product platform will be sold in two configurations, the iQ200 System that integrates the iQ200 Automated Urine Microscopy Analyzer (iQ200 Analyzer) with the chemistry system, the AUTION MAX(tm) AX-4280 (AX-4280) and the stand-alone iQ200 Analyzer.
The iQ200 System incorporates all these new features in a machine that is almost 50% smaller in size than any competitive device on the market. It offers functionality that medical technologists and physicians have always desired, but until now has not been available from traditional instrumentation. The iQ200 System is expected to increase the use and utility of urine microscopic analysis and enable better diagnosis through a complete urinalysis.
"These initial orders were shipped against an existing backlog of more than 30 units for the iQ200 product platform and we expect to see an acceleration in orders and shipments in coming months" Dr. Mohan said.
He added that the over-all potential market for the iQ200 is 7,500 independent and hospital laboratories in the U.S and 18,000 worldwide. "The immediate target market for the iQ200 product platform consists of labs performing more than 40 urinalysis tests per day that are likely to be interested in automation of urine microscopy," he stated. "These are estimated at more than 2,500 in the U.S. and 6,000 worldwide. We expect that, over time, this market will increase significantly due to the greater clinical utility of our system at a lower cost than manual microscopy. "
Cesar M. Garcia, President and Chief Operating Officer of the Company, said: "We can compete now in terms of product features, pricing and distribution channels. The lower selling price of the iQ200 product platform makes our technology affordable in the international markets, which are predominantly on a fee-per-test basis. This is the culmination of 18 months of hard work developing a significant international distribution network. So far, we have signed distribution agreements with nine major medical instrument distributors covering 17 countries and opened an European office in Italy, which will provide sales and technical support to our expanded European distribution network. Domestically, we have increased our direct U.S. sales force and invested in the expansion and modernization of our Iris Diagnostics Division's manufacturing facilities. We are prepared for growth."
He added that the Company expects to continue expanding its international distribution network in the coming months.
Iris Diagnostics has an exclusive distribution agreement in the U.S. for the AX-4280 with Japan's ARKRAY, Inc. ARKRAY has an existing installed base of some 800 AX-4280 units in Europe and Japan. Although the iQ200 analyzer will be sold separately to the international distributors, it can be connected to the AX-4280 using a Connectivity Kit developed by Iris.
"Since the iQ200 analyzer is compatible with the AX-4280, this provides a ready-made opportunity for our new product as we make our first major push into overseas markets," Dr. Mohan said. "Based on the interest shown by our distributors, we are anticipating that our marketing efforts in Europe and Asia will prove fruitful."
THE COMPANY
International Remote Imaging Systems, Inc. (www.proiris.com), based in Chatsworth, Calif., 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-Particle Recognition software (APR), 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. StatSpin 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 (ADIR) 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.
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 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 that 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.