Product approval in USA
Through its newly acquired subsidiary, Swemed, Vitrolife has obtained approval from the U.S. Food and Drug Administration (FDA) to begin marketing and sales of a product for the introduction of an embryo into the uterus after in vitro fertilization, called ClearVision™ Embryo Transfer Catheter (ETC). “With the approval, the product range of medical instruments and solutions for in vitro fertilization is complete, which means greater customer benefit and market potential“, says Magnus Nilsson, CEO of Vitrolife.
ClearVision™ ETC is a medical instrument that is used to introduce the embryo into the uterus. The transfer of the embryo constitutes the last stage of in vitro fertilization (IVF) and is a critical step in the process. In recent years it has been shown that the properties of the embryo transfer catheters together with simultaneous use of ultrasound can improve pregnancy frequency. ClearVision™ ETC is designed together with leading Swedish IVF clinics and is designed to meet the market’s high quality requirements. The product can be used with or without ultrasound. It is estimated that approximately 600 000 in vitro fertilizations are carried out per year in the world and that the total market value for ClearVision™ ETC amounts to approximately SEK 140 million. The total value of Vitrolife’s and Swemed’s products per in vitro treatment is around SEK 2 000, of which ClearVision™ ETC constitutes just over 10 percent. February 14, 2006 Kungsbacka, Sweden Magnus Nilsson CEO Contact persons: Magnus Nilsson, CEO, phone +46 31 721 80 00 or +46 708 22 80 61. Anna Ahlberg, CFO, phone +46 31 721 80 13 or +46 708 22 80 13.