Xenios AG receives approval in China for ECMO devices
In early May, Xenios AG, a Fresenius Medical Care company, received approval for two patient kits in China.
In early May, Xenios AG, a Fresenius Medical Care company, received approval for two patient kits in China. It follows NMPA’s approval of the Xenios console back in December 2020. As a result, a complete Xenios system is now permitted for ECMO therapy in China.
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Xenios launch event in China (Photo: Business Wire)
Xenios received the approval through a process called “Fast Registration”. This expedited process is only offered for products that, for example, are urgently needed for clinical use and can treat serious, life-threatening diseases. This Xenios ECMO complete system is certified in China for nine days application period. It is also the first ever “Fast Registration” for new imported medical devices in China.
“We are particularly proud to have received this approval!” says Jörg Buschbell, CEO of Xenios AG, and adds, “In just over a year, we have gained access not only to the US market, but also to the Chinese market for our ECMO therapy products. This marks another milestone for Xenios AG and Fresenius Medical Care.”
“The expedited approval was a joint effort by Xenios and Fresenius Medical Care China Team. Since the beginning of the pandemic, they strived to make the advanced critical care products available in China for treating the critically ill patients.” says Harry De Wit, President and CEO of Fresenius Medical Care Asia Pacific. “The approval means that we will be able to support the Chinese critical care community further with our advanced developments, ultimately benefitting the patients.”
About Xenios AG:
Xenios AG - a company of the Fresenius Medical Care Group - is a pioneer in extracorporeal heart and lung support. The Novalung and Medos products offer a wide range of heart and lung support products via a single platform, the Xenios console.
Xenios’ mission is to improve patient well-being and care. The Novalung therapy aims at a paradigm shift in lung support: enabling the treatment of patients who are more awake, more self-determined and more mobile.
Xenios AG has been part of Fresenius Medical Care, the world's leading provider of products and services for people with kidney disease since the end of 2016. Xenios complements the group's portfolio in the area of holistic multi-organ support of Fresenius Medical Care.
About Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of products and services for individuals with renal diseases of which around 3.7 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,110 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 344,476 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with its core business, the Renal Care Continuum, the company focuses on expanding in complementary areas and in the field of critical care. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).
For more information, please visit the company’s website at www.freseniusmedicalcare.asia.
Disclaimer
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
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