CellaVision AB, which develops and sells image analysis based products for routine analysis of blood, evaluates conditions to establish sales in Japan and is applying for a Foreign Manufacturer Authorization (FMA). Authorizing the company as a manufacturer is the first step in the process of registering products for sale on the Japanese market.
At present CellaVision's products are being evaluated in a clinical routine setting in Japan. When the evaluation is completed it will be decided how the CellaVision products will be marketed and sold on the Japanese market. In order to shorten the process of a potential product introduction, CellaVision simultaneously applies for the FMA.
"Japan is a very interesting market for both CellaVision and medical devices in general. However, one must have great respect for the Japanese market considering its large size and the high standards of service clients are used to. We consider our products to match the Japanese market's high demands on quality and efficiency, but wish to ensure that introducing our products to the market there will be profitable," says Yvonne Martensson, CEO of CellaVision.
Regardless choice of distribution channel, the manufacturer needs to be authorized to market a foreign medical device in Japan. Once authorized, it is possible to apply for a product registration. CellaVision expects an FMA approval during the first half-year 2008.
For more information, please contact:
Yvonne Mårtensson, CEO, CellaVision AB
CellaVision AB develops, markets, and sells the market leading image analysis based systems for routine analysis of blood. 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 Jupiter, Fl, USA, and Toronto, ON, Canada. For more information, visit www.cellavision.com
CellaVision's share is listed on First North at the OMX Stockholm Stock Exchange. The company's Certified Advisor is Remium AB.