VITROLIFE PRODUCTS RECEIVE EUROPEAN APPROVAL
2004-06-28
VITROLIFE PRODUCTS RECEIVE EUROPEAN APPROVAL
Vitrolife has received European approval (CE mark) for a complete series
of products within ART (Assisted Reproductive Technology). "This gives
us competitive strength in established markets and enables us to more
easily introduce the products on new markets" says Tony Winslöf,
Director of Marketing at Vitrolife.
Vitrolife has received CE approval for the products G-RINSE(TM), G-
MOPS(TM), G-SPERM(TM), G-FERT(TM), G-1(TM) (version 3), G-2(TM) (version 3),
G-MM(TM), EmbryoGlue®, G- PGD(TM), G-FreezeKit Blast(TM) and
G-ThawKit Blast(TM). This means that all of Vitrolife's GIII culture
media products (the latest developed IVF media system focusing on
mimicking the natural environment for gametes and embryos) are now CE
marked which gives the company additional competitive strength in the
European countries where the products have already been introduced.
Based on available official statistics, the European market is the
largest IVF (In Vitro Fertilization) market in the world, representing
more than 50% of the 500,000 treatments performed worldwide each year.
"An increasing number of clinics today demand CE marked culture media
products. Their quality systems and supplier selection systems rule out
products that do not meet the requirements for a CE marking" says Tony
Winslöf, Director of Marketing at Vitrolife. "The approval signals to
the market that ART culture media products now definitely are being
classified as medical devices and have to meet the requirements of the
European Medical Device Directive. This also means that we will now be
able to present our products to the new members in the European Union,
which we know hold a great potential. These markets have previously been
more or less closed to us since conflicting local regulations have made
it virtually impossible to compile the necessary documentation for
application."
"To my knowledge this is the first complete ART culture media system
that receives the CE mark" says Hans Lehmann, Vitrolife's Manager of
Development. "It is positive for Vitrolife in many aspects, the most
apparent one being the fact that regulatory authorities acknowledge our
products as being safe and efficacious in their intended use."
The Quality Control Director of Vitrolife, Göran Mellbin, emphasizes
that the CE mark is yet another recognition of the high quality standard
which is essential for all Vitrolife products.
Gothenburg, June 28, 2004.
Vitrolife AB (publ)
For further information, please contact; CEO: Acting Marketing Director: Dr. Magnus Nilsson Tony Winslöf Tel: +46 31 721 80 00 Tel: +46 31 721 80 00 Mobile +46 708 22 80 61 Mobile +46 708 22 80 15 [email protected] [email protected]
________________
Vitrolife is a global biomedical corporation that works with products
for cell and tissue technology. The Vitrolife group consists of the
parent company, Vitrolife AB (Publ) and two wholly owned subsidiaries:
Vitrolife Sweden AB (Gothenburg, Sweden), Vitrolife Inc. (Denver,
Colorado). The group's operations is focused on three geographic areas.
· Europe/Middle East
· The Americas
· Rest of the World
Vitrolife's business concept is to develop, produce and sell advanced
products and systems for the preparation, cultivation, preservation and
support of cells, tissues and organs.