Vitrolife receives FDA approval for RapitVit Blast and RapidWarm Blast vitrification products

“The majority of clinics in the USA that vitrify embryos do so at the blastocyst stage. This approval means that Vitrolife gains both access to yet another non-processed market and opportunities for additional sales to current customers”

Vitrolife (STO:VITR) has received approval from the U.S. Food and Drug Administration, FDA, the equivalent of the Swedish Medical Products Agency, for the products RapitVit™ Blast and RapidWarm™ Blast. So-called 510(k) clearance has been obtained for these products, which are used for so-called vitrification, the rapid freezing and thawing of blastocysts (embryos days 5-7 after fertilization). Vitrolife has since before approved products for vitrification of embryos in an earlier stage of the fertilization (embryos day 2-3 after fertilization).

Products for vitrification involve considerable technological progress and open up new opportunities within in vitro fertlization (IVF) treatment. Vitrification involves very rapid freezing, to prevent the formation of ice crystals that otherwise can destroy the cells.

In IVF treatment, the woman has been stimulated with hormones and has more oocytes than normal. The oocytes that are fertilized but not put back in the woman can then be kept in cold storage. Clinical studies have shown that using the vitrification method considerably increases survival after cold storage compared with the previously used method. The chance of the woman getting pregnant again thereby also increases, without her having to undergo new hormone treatment and the removal of more oocytes.

RapitVit™ Blast and RapidWarm™ Blast have been previously approved in Europe and Canada.

The products will be launched on the American market as from the end of December 2010.

"The majority of clinics in the USA that vitrify embryos do so at the blastocyst stage. This approval means that Vitrolife gains both access to yet another non-processed market and opportunities for additional sales to current customers," says Nils Sellbom, Director of Marketing and Sales at Vitrolife.

December 21, 2010

Gothenburg

Magnus Nilsson

CEO