First XPS™ installed in China
XVIVO Perfusion has installed the first XPS™ in China. The purpose is to start an EVLP (Ex Vivo Lung Perfusion)-study at Shanghai Pulmonary Hospital. The study is designed to complement existing EVLP data, with Chinese data. The company is planning to initiate an approval process of the XPS™ with CFDA (China Food and Drug Administration). STEEN Solution™ and Perfadex are already approved by CDFA.
China is currently the fastest growing lung transplant market in the world, with a 37% increase in lung transplants in 2016 (201 lung transplants performed). Due to the increased need for lung transplantation the number of clinics authorized to perform lung transplants has increased from 20 clinics in 2016 to 27 clinics in 2017. In parallel with the transplant centers growth, the organ donation system in China is also growing to meet this lifesaving demand. The current donor system is an OPO system, with the expectation to take advantage of increased utilization of marginal lungs for transplant. The end point of this collaboration is to reduce mortality on the waiting list.
The Lung Transplantation program lead by Professor Jiang Gening will head the first EVLP- study in China that will investigate the effects of EVLP on Lung transplantation. The study design is an investigator initiated single center trial with the intention to add Chinese data to the existing EVLP data from North America and Europe. The company plans to initiate a registration process of the XPS™ with the CFDA. In partnership with XVIVO Perfusion´s Distributor in China (Genext Ltd), we plan to scientifically support the Lung transplant clinic at Shanghai Pulmonary Hospital, the leading hospital in treatment of lung diseases in China. The hospital has over 1,000 beds and performed more than 10,000 thoracic surgery operations last year. With the addition of the XVIVO XPS™ system the Shanghai Pulmonary Hospital fully expects to become the EVLP Center of Excellence in Asia.
“We are delighted that we delivered the first XPS to China with the intention of a clinical study. China has put a lot of effort in increasing the number of transplants performed, and it has from a low level resulted in rapid growth in the past three years. Considering the size of the population and the fast increase in the standard of living and healthcare, China is expected to become an important market for XVIVO in a not too distant future”, says Magnus Nilsson, CEO of XVIVO Perfusion.
December 1, 2017
Magnus Nilsson, CEO
XVIVO Perfusion AB (publ)
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This is a translation of the Swedish version of the press release. When in doubt, the Swedish wording prevails.
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 Lund, Sweden and one office in Denver, the USA. The XVIVO share is listed on Nasdaq Stockholm and has the ticker symbol XVIVO. More information can be found on the website www.xvivoperfusion.com.
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: email@example.com. Website: www.xvivoperfusion.com