XVIVO Perfusion has received approval of its STEEN Solution by the China Food and Drug Administration (CFDA).
This decision enables the company to market and sell STEEN Solution for clinical use in China.
CFDA has approved STEEN Solution for lung transplantation, which allows sales of STEEN Solution for clinical use in lung transplants in China. China currently accounts for less than five percent of all lung transplants in the world, despite the large share of the world’s population, but the market has shown rapid growth in recent years and there is a great need for more donated lungs for lung transplantation.
“The approval of STEEN Solution ™ in China is important for future growth because there is a great need for lung transplants and an interest in utilizing EVLP with STEEN Solution ™ to increase the availability of usable donor lungs. To be present early in the growth phase and establish the products increases the chances of becoming a leader when the market matures,” says Magnus Nilsson, CEO of XVIVO Perfusion.