XVIVO Perfusion receives marketing approval for STEEN Solution™ in Canada.
The current main focus for XVIVO Perfusion is to gain marketing approval in North America for the company’s unique product, STEEN Solution™, which has the potential to increase the number of available organs for transplantation. XVIVO Perfusion has now gained marketing clearance from the Canadian regulatory authorities (Health Canada) for Steen Solution™. Canada is an important market and Toronto General Hospital is one of the most important and active lung transplant centers in the world. It was there that the world’s first successful clinical lung transplant was performed.
The company has an ongoing multicenter trial in the USA for STEEN Solution™ and has submitted an application to the FDA to market it there. XVIVO Perfusion has previously obtained marketing approval for STEEN Solution™ in the major markets outside North America.
November 8, 2012
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson
CEO
FOR FURTHER INFORMATION, PLEASE CONTACT
Magnus Nilsson, CEO, tel: 46 31 788 21 50, e-mail: magnus.nilsson@xvivoperfusion.com
Christoffer Rosenblad, CFO, tel: 46 73 519 21 59, e-mail: christoffer.rosenblad@xvivoperfusion.com
For further information on Xvivo Perfusion’s business, please refer to the company’s website, www.xvivoperfusion.com
Xvivo Perfusion 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 November 8, 2012 at 13:30 a.m.
This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
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XVIVO Perfusion AB is a medical technology company which develops solutions and systems for assessing and preserving organs outside the body and for selecting usable organs and maintaining them in optimal condition pending transplantation.
The company is headquartered in Gothenburg, Sweden, and has one office in the USA. The Xvivo share is listed on NASDAQ OMX First North and has the ticker symbol XVIVO. More information can be found on the website www.xvivoperfusion.com. The Certified Adviser is Redeye, www.redeye.se.
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XVIVO Perfusion AB (publ), Box 53015, SE-400 14 Göteborg. Corporate identity number 556561-0424.
Tel: +46 31 788 21 50. Fax: +46 31 788 21 69.
E-mail: info@xvivoperfusion.com. Website: www.xvivoperfusion.com