Fresenius Medical Care North America Announces FDA Clearance of New Heat Purification System for Hemodialysis Water with Industry-Leading Efficiency

AquaAtm Water System Uses Advanced Heat Disinfection Technology to Automate and Improve Performance for Hemodialysis Water, Reducing Power and Water Consumption

WALTHAM, Mass., Nov. 3, 2022 /PRNewswire/ -- Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that the U.S. Food and Drug Administration (FDA) has cleared the AquaAtm water system, one of the industry's most efficient water purification systems available for hemodialysis. The new system, from the nation's leading dialysis products company, uses advanced technology to optimize water and power usage with full heat disinfection, while being customizable to the unique needs of each dialysis center.

"This new water treatment system seeks to make heat disinfection an industry standard by providing an innovative and flexible system," said Pat McCarthy, Senior Vice President of FMCNA's Renal Therapies Group. "Water is an essential component of dialysis and we are excited to introduce these remarkable innovations that reduce cost and create efficiencies for our customers."

The AquaA system uses reverse osmosis (RO) to remove organic and inorganic substances and microbial contaminants from the water required for hemodialysis treatment. The new AquaA RO system uses intelligent technology and a resource-efficient design that has low maintenance requirements so it can work in multiple clinical settings.

The innovative features of the AquaA water system include:

• Full heat disinfection: The system fully automates heat disinfection, making chemicals obsolete for routine system disinfections while adding the capability to supply a hot rinse for up to 35 hemodialysis devices in one process.
• Water and energy saving: AquaA minimizes water intake and leads the industry in efficiency with an up-to-85-percent water recovery rate. Smart monitoring automatically detects suboptimal water and energy consumption and adjusts accordingly to save energy.
• Intelligent technology: The intuitive design, user-friendly touch screen display and remote monitoring enable access to the right information at the right time.
• Expanded functionality: The modular system fits in a flexible footprint to meet each center's unique needs. One AquaA system has the capacity to supply up to 75 dialysis stations with product water at 800 mL per minute consumption flow.
• Enhanced safety: With full heat disinfection, patients are assured ANSI/AAMI-quality water for their treatments. Added redundancy of the double-stage RO water system ensures uninterrupted treatments during an emergency and minimal downtime.

"We are excited to help lead the way in heat disinfection, reducing the use of chemicals and ensuring for our patients that this new system creates the highest industry standard for safety," said Dr. Mike Anger, Chief Medical Officer of FMCNA's Renal Therapies Group.

This new system is the latest in a series of water system innovations from FMCNA that include the AquaBplustm and AquaC UNO Htm, which were both introduced in late 2019. The company expects to have availability of the AquaA this year with more widespread inventory in the first half of 2023.

INDICATIONS FOR USE
The AquaA Water Purification Systems are reverse osmosis units intended for use with hemodialysis systems to remove organic and inorganic substances and microbial contaminants from the water used for treating hemodialysis patients or other related therapies. These devices are intended to be a component in a complete water purification system and are not complete water treatment systems. Each reverse osmosis unit must be preceded by pre-treatment devices and may need to be followed by post-treatment devices as well, to meet current AAMI/ANSI/ISO and Federal (US) standards.

About Fresenius Medical Care North America
Fresenius Medical Care North America (FMCNA) is the premier healthcare company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities and outpatient cardiac and vascular labs, Fresenius Medical Care North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world's largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com/.

Media Contact:
Fresenius Medical Care North America
Scott Sayres, Corporate Communications
[email protected]
(940) 297-5678

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 certain factors, including changes in business, economic and competitive conditions, regulatory reforms, 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.

SOURCE Fresenius Medical Care Holdings, Inc.