Approval

XVIVO Gains Regulatory Approval In China For PERFADEX(R) Plus - The Global Gold Standard For Lung Preservation

February 03,2022 10:10 AM
- By Admin

XVIVO Perfusion AB has gained regulatory approval in China from NMPA (National Medical Products Administration) for the company's ‘ready-to-use' product PERFADEX Plus. China is the second largest transplant market in the world. It is also currently the fastest growing lung transplant market with an average annual growth rate of 28 percent during the six-year period 2015-20201*. In 2020, 513 lung transplants were performed. Due to the increased need, the number of clinics authorized to perform lung transplants has grown from 20 in 2016 to 50 in 2021.

PERFADEX Plus is a ready-to-use version of PERFADEX which has been the gold standard for over 20 years. PERFADEX and PERFADEX Plus have been used in more than 65,000 lung transplantations and is used by more than 90 percent of all lung transplant clinics in the world.

A lung transplant is the last resort for patients with end-stage lung disease. It is the only treatment option available for patients with a life expectancy estimated to be less than 2 years who have exhausted all other treatment alternatives. PERFADEX Plus is used for the flushing, cold static storage and transportation of donated lungs.

"By introducing the new, ready-to-use, version of the product - PERFADEX Plus - on the Chinese market we are strengthening our offer to all lung transplant clinics", says Raymond Wood XVIVO General Manager in China.

"We are already active in China, and with this product launch we can intensify our presence. China is strategically very important for XVIVO and within a timeframe of 5 years we will expand our product offer to include all major organs