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Fresenius Medical's (FMS) Xenios Gets NMPA Nod for ECMO System
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Fresenius Medical Care (FMS - Free Report) group’s Xenios AG company recently received National Medical Products Administration (NMPA) authorization for the entire Xenios system for extracorporeal membrane oxygenation (ECMO) therapy in China. Xenios AG offers a broad range of products for extracorporeal heart and lung support.
The Xenios console received NMPA’s approval last December. This was closely followed by the regulatory authority’s go-ahead for Xenios’ two patient kits in China during May 2021.
The latest approval is stated to be another milestone for Xenios AG and Fresenius Medical Care. It is expected to expand market access for Xenios’ ECMO therapy products, including the U.S. and China markets in just over a year.
More on the Approval
The approval was received through the "Fast Registration" process, which is only offered for products that are required urgently for clinical use and are capable of treating life-threatening diseases. The expedited approval was a combined effort by Xenios and Fresenius Medical Care China Team in their attempt to make the advanced critical care products available in China since the beginning of the pandemic.
Image Source: Zacks Investment Research
The Xenios ECMO complete system is the first to receive "Fast Registration" for new imported medical devices in China. This system is certified in China for a nine-day application period.
Industry Prospects
Per a report published in Grand View Research, the global ECMO machine market is expected to witness a CAGR of 5.1% during 2021-2028. Market growth is primarily driven by rising incidence of cardiopulmonary disease and respiratory failure. Other factors such as increasing number of hospitals offering ECMO services, surge in geriatric population, several awareness programs and technological advancements are expected to fuel market growth further.
Given the substantial market prospects, the recent authorization for the entire Xenios ECMO system in China seems well-timed.
Notable Developments
In June 2021, Fresenius Medical announced the grand opening of Fresenius Medical Care Training Center in Korea that will offer comprehensive education programs and share its knowledge and expertise in renal care, critical care, and treatment strategies with healthcare professionals. The Fresenius Medical Care Training Center is stated to be the first healthcare education facility in Korea to be run by a dialysis product provider. This training center is intended to help doctors, nurses, and clinical technicians access the recent knowledge and skills within their professional practice.
In March 2021, the company opened a new technology center at its Schweinfurt, Germany production and development site. This new center is designed to develop better dialysis machines for patients at a lower cost.
In the same month, Fresenius Medical made its own dialysis clinics available to its high-risk dialysis patients for COVID-19 vaccination.
Share Price Performance
The stock has underperformed its industry over the past year. It has declined 1.6% compared to the industry’s 17.6% growth.
Zacks Rank and Key Picks
Currently, Fresenius Medical carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space include Apollo Medical Holdings, Inc. , Envista Holdings Corporation (NVST - Free Report) and Teleflex Incorporated (TFX - Free Report) .
Image: Shutterstock
Fresenius Medical's (FMS) Xenios Gets NMPA Nod for ECMO System
Fresenius Medical Care (FMS - Free Report) group’s Xenios AG company recently received National Medical Products Administration (NMPA) authorization for the entire Xenios system for extracorporeal membrane oxygenation (ECMO) therapy in China. Xenios AG offers a broad range of products for extracorporeal heart and lung support.
The Xenios console received NMPA’s approval last December. This was closely followed by the regulatory authority’s go-ahead for Xenios’ two patient kits in China during May 2021.
The latest approval is stated to be another milestone for Xenios AG and Fresenius Medical Care. It is expected to expand market access for Xenios’ ECMO therapy products, including the U.S. and China markets in just over a year.
More on the Approval
The approval was received through the "Fast Registration" process, which is only offered for products that are required urgently for clinical use and are capable of treating life-threatening diseases. The expedited approval was a combined effort by Xenios and Fresenius Medical Care China Team in their attempt to make the advanced critical care products available in China since the beginning of the pandemic.
Image Source: Zacks Investment Research
The Xenios ECMO complete system is the first to receive "Fast Registration" for new imported medical devices in China. This system is certified in China for a nine-day application period.
Industry Prospects
Per a report published in Grand View Research, the global ECMO machine market is expected to witness a CAGR of 5.1% during 2021-2028. Market growth is primarily driven by rising incidence of cardiopulmonary disease and respiratory failure. Other factors such as increasing number of hospitals offering ECMO services, surge in geriatric population, several awareness programs and technological advancements are expected to fuel market growth further.
Given the substantial market prospects, the recent authorization for the entire Xenios ECMO system in China seems well-timed.
Notable Developments
In June 2021, Fresenius Medical announced the grand opening of Fresenius Medical Care Training Center in Korea that will offer comprehensive education programs and share its knowledge and expertise in renal care, critical care, and treatment strategies with healthcare professionals. The Fresenius Medical Care Training Center is stated to be the first healthcare education facility in Korea to be run by a dialysis product provider. This training center is intended to help doctors, nurses, and clinical technicians access the recent knowledge and skills within their professional practice.
In March 2021, the company opened a new technology center at its Schweinfurt, Germany production and development site. This new center is designed to develop better dialysis machines for patients at a lower cost.
In the same month, Fresenius Medical made its own dialysis clinics available to its high-risk dialysis patients for COVID-19 vaccination.
Share Price Performance
The stock has underperformed its industry over the past year. It has declined 1.6% compared to the industry’s 17.6% growth.
Zacks Rank and Key Picks
Currently, Fresenius Medical carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space include Apollo Medical Holdings, Inc. , Envista Holdings Corporation (NVST - Free Report) and Teleflex Incorporated (TFX - Free Report) .
Apollo Medical, which carries a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 20%. You can see the complete list of today’s Zacks #1 Rank stocks here.
Envista Holdings, which carries a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.4%.
Teleflex, sporting a Zacks Rank #2, has a long-term earnings growth rate of 11%.