Regulatory News:
Vitrolife(STO:VITR):
A total of 22 patients have been recruited to the study, which has been designed in consultation with the FDA, (the US Food and Drug Administration). The results of the study will be reported within a few months.
22 patients have been included in the clinical study, which started during the autumn of 2008. Lungs from further patients have been evaluated using the STEEN Solution™ method, but have been assessed as not being sufficiently good to be transplanted.
The STEEN Solution™ method considerably increases the number of potential organs that can be transplanted. Today less than 20 percent of the lungs donated in the USA are transplanted, due to uncertainty about the functioning of the organ. In the long term the STEEN Solution™ method can lead to five to ten times more lung transplantations being performed, as the demand for donated organs using today's methods considerably exceeds the supply.
STEEN Solution™ is approved for sales in Europe, i.e. it is CE marked. The recently completed clinical study in Canada will be part of an application for sales approval in the USA and Canada.
Magnus Nilsson
CEO
Vitrolife is a global biotechnology/medical device Group that works with developing, manufacturing and selling advanced products and systems for the preparation, cultivation and storage of human cells, tissue and organs. The company has business activities within three product areas: Fertility, Transplantation and Stem Cell Cultivation.
The 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. The Transplantation product area works with solutions and systems to evaluate and maintain organs outside the body order to select usable organs and keeping them in optimal condition while waiting for transplantation. The Stem Cell Cultivation product area works with media and instruments to enable the use and handling of stem cells for therapeutic purposes.
Vitrolife today has approximately 160 employees and the company's products are sold in more than 85 markets. The company is headquartered in Gothenburg, Sweden, and there are subsidiaries in USA, Australia, France, Italy, United Kingdom and Japan. Production facilities are housed in Sweden and USA.
The Vitrolife share is listed on NASDAQ OMX Nordic Exchange, 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.
Homepage: www.vitrolife.com.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
This information was brought to you by Cision http://www.cisionwire.com
Contacts:
Vitrolife
Magnus Nilsson, CEO
phone +46 31 721 80 61
or
Eva
Nilsagård, CFO
phone +46 31 721 80 13
