All patients included in the clinical study on STEEN Solution™ in the USA

In the clinical study that was begun during 2011 on STEEN Solution™ with the aim
of forming a basis for sales approval in the USA, a total of 13 patients have
now received transplants. The required number of patients, which was 12, has
thereby been included in the study. “Even if some work remains and it is
difficult to assess how the FDA will reply it is now reasonable to assume that
this is a big step closer to sales approval in the most important market in the
world,” says Dr Magnus Nilsson, who is responsible for Vitrolife’s
transplantation area.
Since autumn 2011 Vitrolife has run a clinical study on STEEN Solution™ in the
USA with the aim of forming a basis for an application for sales approval in the
USA. At least 12 patients were to receive transplants using organs that
initially were assessed to be unusable. These organs have then been perfused
with STEEN Solution™ at body temperature, which means that fluid is pumped
through the blood vessels of the organ in the same way as blood in the body.
After a few hours treatment the organ has been evaluated regarding clinical
usability and then been approved.

The patients will be compared with the same
number of control patients who at the same hospitals during the same period of
time have undergone transplantation using conventionally acquired and assessed
organs. It still remains to include a couple of control patients, after which
the collected data in the study will be analysed and compiled. Vitrolife
estimates that an application for market approval can be submitted to the U.S.
Food and Drug Administration (FDA) for scrutiny during the second quarter. If
the FDA approves the application it is estimated that sales in the USA will be
able to begin during the second half of 2012.

Vitrolife plans to apply for
Humanitarian Device Exemption (HDE), which means a quicker application procedure
and which can be granted to products of crucial importance when the indication
for use is relatively limited. HDE approval means that the company may sell the
product under controlled forms. The clinical study is continuing with the aim of
including a larger number of patients in order to strengthen documentation of
the advantages of using STEEN Solution™, which is important in the marketing of
the new treatment method. Vitrolife also intends on a later occasion, the timing
of which depends on the assessment of the FDA, to use these more extensive data
to apply for full approval, so-called Premarket Approval (PMA).

Vitrolife’s
product STEEN Solution™ is part of a method where, after an organ has been taken
out from the donor, a fluid (STEEN Solution™) is pumped at body temperature
through its blood vessels, whereby the organ has the opportunity to recover and
can also be tested for function. Using the STEEN Solution™ method the number of
organs available for transplantation can be significantly increased. So far
approximately 150 lung transplants have been performed using the method, which
today is approved in Europe and Australia.

April 18, 2012
Gothenburg,
Sweden
VITROLIFE AB (publ)
Thomas Axelsson
CEO
For further information, please contact:
Thomas Axelsson, CEO, +46 31 721 80
01
Mikael Engblom, CFO, +46 31 721 80 14

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.

_________________________________________________________________________
________________________________________

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/