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CellaVision AB, Lund, Sweden Receives FDA Clearance For The CellaVision(TM) DM96 Digital Cell Morphology System


10/19/2005 5:10:02 PM

LUND, Sweden, Feb. 18 /PRNewswire/ -- CellaVision AB announced today that the CellaVision DM96 automated digital cell morphology system has been cleared by the Food and Drug Administration for sale in the United States. The FDA clearance was received one month earlier than originally expected. The CellaVisionDM96 is the Next Generation of the company's first product DiffMaster(TM) Octavia. The CellaVisionDM96 locates and pre-classifies blood cells by means of automatic microscopy and advanced image processing, resulting in greater efficiency and standardization of the blood differential process.

"We are very happy to receive the FDA clearance so fast. It is very important to CellaVision to introduce the product in the U.S. Early market feedback has been extremely enthusiastic, and we expect to have a significant number of laboratory sites using the DM96 in day-to-day routine before the end of the year," says Yvonne Martensson, CEO, CellaVision AB.

The CellaVision(TM)DM96 was successfully introduced in Europe in late 2003. The product will be formally launched in the U.S., at the CLMA/ASCP 2004 Annual Conference and Exhibition in Atlanta, Georgia. March 28-30, and can be seen in the Sysmex America exhibit booth.

In December, Sysmex America Inc. and CellaVision AB signed an exclusive distribution agreement giving Sysmex the right to sell, market and support the CellaVision(TM)DM96 to hematology laboratories in the United States. CellaVision Inc., Jupiter, FL, a subsidiary to the Swedish company CellaVision AB, will provide support to Sysmex America while continuing to supply and support existing CellaVision MICRO21 and DiffMaster customers.

For more information, please contact; Yvonne Martensson, VD, CellaVision AB, +46 46-286 44 01, +46 708-33 77 82

CellaVision AB is a young high-tech company whose core competence is the development of software for automatic image analysis of cells with applications in the health care sector. The company represents cutting-edge competence in image processing, image analysis and automated microscopy. CellaVision currently markets three products: CellaVisionaDM96, DiffMaster(TM) and CellAtlas(TM). All are based on cell databases and are tools to facilitate cell analysis and diagnosis. Most of the company's 40 employees today work with software development. Further information is available at http://www.cellavision.com/.

DiffMaster(TM) locates, identifies and pre-classifies blood cells by means of automatic microscopy and advanced image processing. The microscope is connected to a computer equipped with software trained on a large cell database. The software controls the microscope and a camera that finds and photographs images of blood cells and suggests classifications of the cell types. In most cases, the operator merely confirms the classifications, and can focus on borderline classifications.

CellaVision(TM) DM96 locates, identifies and pre-classifies blood cells by means of automatic microscopy and advanced image processing. The system is a merge of experiences. The highly appreciated automation of slide handling in Micro21 is combined with the user-friendly interface and sophisticated pre- classification software of DiffMaster(TM). CellaVision DM96 The result takes morphological image analysis one-step further. CellaVision DM96 minimizes the manual workload and produces results faster than ever before. The operator can focus on performing high quality results under the high production demands facing today's modern laboratories. Not yet available in the U.S. MICRO21(R) is an instrument functionally similar to the DiffMaster. It has a more advanced slide handling system, making it well suited for larger laboratories. More than 50 laboratories, most of them hospital laboratories in the U.S, use MICRO21 which is only available in the U.S.

CellAtlas(TM), http://www.cellatlas.com/, is an Internet-based reference library with high quality cell images, meant for education and quality assurance.

Sysmex America, Inc. Based in Mundelein, Illinois, Sysmex America, Inc. is the U.S. headquarters of Sysmex Corporation (Kobe, Japan), a leading international manufacturer of medical diagnostic systems focused on hematology, hemostasis, immuno-chemistry, particle counting, urinalysis and laboratory information systems. To meet the needs of different global areas, Sysmex has its own corporate network of marketing, production, research and development in 14 countries, including Sysmex America, Inc. Its products are sold and supported in more than 150 countries. Sysmex offers customized in vitro diagnostics and IT solutions that enhance clinical information and increase productivity by integrating technological innovation, automation platforms and information solutions for all of its customers around the world. Sysmex America, Inc.'s website is located at http://www.sysmex.com/usa.

CellaVision AB

CONTACT: Yvonne Martensson, VD of CellaVision AB, +46-46-286-44-01, or+46-708-33-77-82


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