Application for market approval of STEEN Solution™ in the USA has been submitted to the FDA

Vitrolife has submitted an application to the American Food and Drug
Administration (FDA) regarding market approval of STEEN Solution™, a product
used for cleansing and evaluation of lungs outside the body (ex vivo) before
transplantation.
The application was based on successful results from the clinical trial that
Vitrolife is conducting in the USA with STEEN Solution™. This new innovative
method has been shown to enable that those lungs that previously had been deemed
not usable, were usable after performing perfusion with STEEN Solution™ when the
organ was taken out of the donor’s body. The use of STEEN Solution™ has
therefore the potential to significantly increase the number of lungs available
for transplantation, something that could be lifesaving for many patients since
there today is a lack of available organs to transplant.

“The submission of the application to the FDA for market approval is a milestone
in the clinical and commercial development of Vitrolife’s unique and innovative
STEEN Solution™” says Magnus Nilsson, head of Vitrolife’s subsidiary Xvivo
Perfusion AB that focus on developing and commercializing products for organ
transplantation.

If the application is approved by the FDA, it is estimated that sales in the USA
can commence in the end of 2012 whereafter Xvivo Perfusion AB can start
marketing STEEN Solution™ and other products related to the clinical use of
STEEN Solution™ that the company has developed.

July 10, 2012

Gothenburg, Sweden

VITROLIFE AB (publ)

Thomas Axelsson

CEO
Queries should be addressed to:

Thomas Axelsson, CEO, phone 46 31 721 80 01

Mikael Engblom, CFO, phone 46 31 721 80 14

Vitrolife is required to publish the information in this press release in
accordance with the Swedish Securities Market Act and/or the Financial
Instruments Trading Act. The information was submitted for publication on July
10, 2012 at 5:00 p.m.

This is a translation of the Swedish version of the press release. When in
doubt, the Swedish wording prevails.
Vitrolife (http://www.vitrolife.com/en/Corporate/) is a global
biotechnology/medical device Group that works in the areas of Fertility and
Transplantation. The Fertility (http://www.vitrolife.com/en/Fertility/) product
area works with nutrient solutions (media), cryopreservation products and
advanced consumable instruments such as needles and pipettes, for the treatment
of human infertility. Work is also carried out to enable the use and handling of
stem cells for therapeutic purposes. The
Transplantation (http://www.xvivoperfusion.com/transplantation/) product area
works with solutions and systems for assessing and preserving organs outside the
body, so as to be able to select usable organs and keep them in optimal
condition pending transplantation.

Vitrolife (http://www.vitrolife.com/en/Corporate/) today has approximately 220
employees and its products are sold in almost 90 markets. The company is
headquartered in Gothenburg, Sweden, and there are also offices in USA,
Australia, France, Italy, United Kingdom, China and Japan. The Vitrolife
share (http://www.vitrolife.com/en/Corporate/Financial/The-share1/) is listed on
NASDAQ OMX
Stockholm (http://www.nasdaqomxnordic.com/aktier/shareinformation?Instrument=SSE
1 
3469), Small Cap.

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Vitrolife AB (publ), Box 9080, SE-400 92 Göteborg, Sweden. Corporate identity
number 556354-3452. Tel: 46 31 721 80 00. Fax: 46 31 721 80 99. E-mail:
info@vitrolife.com. Website: www.vitrolife.com/