Vitrolife receives product approval in USA

Vitrolife has received sales approval from the Food and Drug Administration (FDA) to start marketing of its product ICSI™. The product is the first of its kind that contains synthetically manufactured albumin instead of albumin purified from blood, which increases safety and simplifies handling. ICSI stands for intracytoplasmatic sperm injection and is a technology for the treatment of male infertility. This is one of the most rapidly growing segments within assisted fertilization. “Our new ICSI product is a good example of our ability to develop the safest and most effective products within the treatment of infertility” says Magnus Nilsson, Vitrolife’s CEO.

The American Food and Drug Administration (FDA), has given Vitrolife sales approval in the USA, so-called 510(k), for ICSI™, a product which is used in the treatment of male infertility. As ICSI™ contains recombinant albumin (synthetically manufactured) instead of albumin purified from blood, ICSI™ is the first product for this technology that allows the risk of infection to be completely ruled out (albumin that has been purified from blood may contain a source of infection that could cause diseases, even though the risk is small). The use of recombinant albumin also gives more stable results and simplifies handling. The use of intracytoplasmatic sperm injections (ICSI) is increasing in most countries. The sperms are washed and the healthy ones are selected. Using a very fine needle, a healthy sperm is then injected into the egg. The technology is now also used for patients with milder degrees of reduced sperm quality, which makes it one of the most important growth segments within the IVF market (IVF = In Vitro Fertilization). “With the approval from the FDA, Vitrolife can begin to sell ICSI™ in the USA shortly, which it is estimated will be at the same time as the introduction in Europe. This will be an important addition to our product portfolio, which will enable the clinics that wish to do so to completely rule out the risk of infection from blood components,” says Tony Winslöf, Vitrolife’s Marketing Director. According to the most recent available statistics for the American market, approximately 52% of the 115 000 in vitro fertilizations carried out included intracytoplasmatic sperm injections. January 27, 2005 Kungsbacka, Sweden Magnus Nilsson CEO Questions should be addressed to: Magnus Nilsson, CEO, phone +46 31 721 80 00 or +46 708 22 80 61. Tony Winslöf, Marketing Director, phone +46 31 721 80 15 or +46 708 22 80 15.