GÖTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News: SpermFreeze Solution™, which is used for freeze storage of sperm, has obtained a CE mark and is thereby approved for sales within the European Economic Area (EEA).
The freezing of sperm is used in connection with IVF treatment for patients who find it difficult to produce sperm samples or who are diagnosed as having cancer. In order to be able to become parents, these patients are completely dependent on the sperm surviving and functioning after freezing and thawing.
Vitrolife’s SpermFreeze Solution™ has been developed to retain sperm DNA integrity and function after freeze storage, which has also been demonstrated in a clinical evaluation.
The CE mark means that SpermFreeze Solution™ complies with the demands made of this type of product in the EU’s Medical Device Directive.
“An increased number of clinics today require a CE mark for products. Vitrolife has worked for and will continue to drive the question of the importance of CE marked products becoming a requirement in fertility treatment, with a view to increasing patient safety”, says Magnus Nilsson, CEO.
SpermFreeze Solution™ will be launched as from February 2011.
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 in order to select usable organs and keep 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 220 employees and its 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 located in Sweden and the USA. The Vitrolife share is listed on NASDAQ OMX Stockholm, 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 90. E-mail: info@vitrolife.com. Website: www.vitrolife.com
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Contact:
Vitrolife AB Magnus Nilsson, CEO Phone +46 31 721 80 61 or Anne-Lie Sveder, CFO Phone +46 31 721 80 13
