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