As XVIVO Perfusion has previously reported, the company has developed a new ready to use version of its product for cold preservation of lungs. Patent applications for the new formulation, which is called Perfadex® Plus, have been submitted in all important markets and the European patent authority has now approved the patent in Europe. Perfadex® Plus was launched in the principal markets, the US and Europe, in 2018 and the work on regulatory approval for Perfadex® Plus is ongoing, with the aim that the product is approved in all markets in 2019.
Perfadex® has been the market standard for lung preservation for more than 15 years and has been marketed by XVIVO Perfusion since 1999. Perfadex® Plus is now taking over this market-leading role in those markets where the product is approved. It is used for cold preservation of lungs, that is rinsing away donor blood and keeping the donated lungs in good condition at a cold temperature during transportation and preservation before transplantation. Perfadex® or Perfadex® Plus are used in the vast majority of all lung transplantations performed in the world and together are estimated to have a worldwide market share of approximately 90 percent. The advantage of Perfadex® Plus is that it is a complete fluid that is used without the clinic adding buffer and calcium ions before use. This facilitates administration and reduces the risk of improper use.
“It is positive that the patent has been approved in Europe and that the company can now offer clinics a new patented product for cold preservation of lungs. The new version of XVIVO’s gold standard product, Perfadex® Plus, will save time, reduce the risk of mistakes during preparation and thus facilitate the work of the transplantation teams that procure donated lungs,” says Magnus Nilsson, CEO of XVIVO Perfusion.
August 21, 2019
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO