CellaVision’s new analyzer receives FDA clearance for the US market

CellaVision AB (publ), which develops and sells digital morphology products for the routine analysis of blood and other body fluids, has received clearance by the Food and Drug Administration (FDA) to market and sell its new analyzer CellaVision® DM1200 in the US. The new product is expected to stimulate growth in the US market.

“The FDA’s clearance is an important step in our focus on the North American market,” says Yvonne Mårtensson, CEO for CellaVision. “The FDA clearance came earlier than expected, which means that we can start marketing and selling the product to customers in the US already during the first quarter of 2010. The CellaVision DM1200 is a fully automated analyzer aimed at medium-sized hospitals contributing to a more efficient workflow. We expect this value to increase sales in the US market.”

Since the third quarter this year, CellaVision® DM1200 is commercially available in Europe and Canada. The product is intended to replace manual microscopy of blood samples and is aimed at medium-sized hospital laboratories as well as independent commercial laboratories. The distribution between different types of blood cells and their appearances are important criteria in the diagnosis of a number of conditions such as infections and blood diseases. Automated technology permits to increase productivity, reduce response times, and improve diagnostic quality.

North America is one of CellaVision’s major growth markets. CellaVision’s products are sold in the US by the company’s own sales organization in parallel with the distributor Sysmex America. In Canada the products are sold through CellaVision’s own sales organization. During 2008 the North American market accounted for 43 percent of CellaVision’s total turnover.

About CellaVision
CellaVision AB develops, markets, and sells market leading image analysis based systems for routine analysis of blood and other body fluids. The company has a core competence in development of software and hardware for automatic image analysis of cells and cell changes for applications in health and medical care. The company develops and markets systems for automatic differentials of white blood cells and red morphology, and software for education and quality assurance of differentials. The company’s associates have expertise in advanced imaging analysis, artificial intelligence, and automated microscopy.

The company headquarters are in Lund, Sweden. The company also has subsidiaries in Florida, USA, Toronto, Canada and Yokohama, Japan. For more information, visit www.cellavision.com.

CellaVision’s share is listed on First North Premier at the OMX Stockholm Stock Exchange. The company’s Certified Advisor is Remium AB.