Application for market approval of STEEN Solution™ in the USA has been submitted to the FDA
Vitrolife has submitted an application to the American Food and Drug Administration (FDA) regarding market approval of STEEN Solution™, a product used for cleansing and evaluation of lungs outside the body (ex vivo) before transplantation.
The application was based on successful results from the clinical trial that Vitrolife is conducting in the USA with STEEN Solution™. This new innovative method has been shown to enable that those lungs that previously had been deemed not usable, were usable after performing perfusion with STEEN Solution™ when the organ was taken out of the donor’s body. The use of STEEN Solution™ has therefore the potential to significantly increase the number of lungs available for transplantation, something that could be lifesaving for many patients since there today is a lack of available organs to transplant.
“The submission of the application to the FDA for market approval is a milestone in the clinical and commercial development of Vitrolife’s unique and innovative STEEN Solution™” says Magnus Nilsson, head of Vitrolife’s subsidiary Xvivo Perfusion AB that focus on developing and commercializing products for organ transplantation.
If the application is approved by the FDA, it is estimated that sales in the USA can commence in the end of 2012 whereafter Xvivo Perfusion AB can start marketing STEEN Solution™ and other products related to the clinical use of STEEN Solution™ that the company has developed.
July 10, 2012
Gothenburg, Sweden
VITROLIFE AB (publ)
Thomas Axelsson
CEO
Queries should be addressed to:
Thomas Axelsson, CEO, phone 46 31 721 80 01
Mikael Engblom, CFO, phone 46 31 721 80 14
Vitrolife is required to publish the information in this press release in accordance with the Swedish Securities Market Act and/or the Financial Instruments Trading Act. The information was submitted for publication on July 10, 2012 at 5:00 p.m.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
Vitrolife is a global biotechnology/medical device Group that works in the areas of Fertility and Transplantation. 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. Work is also carried out to enable the use and handling of stem cells for therapeutic purposes. The 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 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 is listed on NASDAQ OMX Stockholm, Small Cap.
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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/
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