GOTEBORG, Sweden, Sept. 11, 2002 (PRIMEZONE) -- The American Food and Drug Administration (FDA) has approved Vitrolife's application for market clearance, 510(k), of a new complete product line of sequential cell culture media for in-vitro fertilization developed by Vitrolife in collaboration with the Colorado Center for Reproductive Medicine in Denver, Colorado, USA.
Extensive research lies behind the new product line of cell culture media which initially will be manufactured in Vitrolife's production facility in Kungsbacka, Sweden. The manufacturing will subsequently be carried out in Denver upon completion of Vitrolife's U.S. manufacturing facility.
The GIII series is in line with Vitrolife's strategy to develop advanced cell culture media products exceeding the increasing regulatory demand avoiding human or animal components. Further advantages with the new sequential media are to offer a complete system that more physiologically resembles the environment in the female body, aiming at minimizing intracellular stress of the embryo, which is necessary for a positive treatment outcome. Clinical data shows statistical significant improvement of parameters such as embryo development and implantation rate.
Albumin is a protein present in the blood, which is used in most culture media in order to create an optimal growth environment for cells outside the body. Until now, the only available source of albumin has been blood donors, which results in variable medium quality and, consequently, variability in the treatment outcome. In addition, albumin derived from blood carries an inherent risk of transferring infectious agents. By using recombinant albumin, produced by biotechnological methods, the use of components from humans can be avoided. Vitrolife has the exclusive right to use recombinant albumin on the world market for in vitro fertilization. The world market for culture media for infertility treatment is estimated to approximately 1 billion SEK.
For further information, please contact: President and CEO, Dr. Peter Svalander, Phone: +46 708 228001 or +1 303 898 1949 CFO, Stefan Jacobsson Phone: +46-708-228010 www.vitrolife.com
Vitrolife
Vitrolife's business mission is to develop, produce and sell advanced products and systems for the preparation, cultivation, preservation and support of cells, tissues and organs. Vitrolife intends to further expand the Company's production capacity to meet an expected increase in demand for its products, as well as strengthen its global market position as a leading company in the development of innovative cell and tissue technologies.
Vitrolife believes that the number of procedures performed annually involving tissue and cell technologies will increase as new treatments are introduced and existing treatments are improved. In addition, Vitrolife expects that the regulation surrounding approval processes and quality control for its products will increase. Vitrolife aims to create competitive advantages from this regulation by meeting and exceeding expected future demands of regulatory authorities, ahead of the Company's competitors.
Since it commenced its operations in 1993, Vitrolife has expanded rapidly. The Company currently has over 100 employees and sells its products in over 80 countries. During the latest five-year period, sales have steadily increased by and totalled more than SEK 100 million for the fiscal year 2001. The Vitrolife share is listed on the Stockholm Exchange (StockholmsbOrsen) O-list under the ticker VITR.
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