FDA Grants Breakthrough Device Designation to Fresenius Medical Care North America’s Software for Fluid Management During Hemodialysis

Software in Development Aims to Create a Dialysis Machine with Embedded Intelligent Diagnostics to Personalize Treatments for People Living with Kidney Failure

WALTHAM, Mass. – March 14, 2019 – Fresenius Medical Care North America’s Renal Therapies Group, the leading provider of kidney care products, announced today that the U.S. Food and Drug Administration (FDA) has granted breakthrough device designation to its computer-assisted ultrafiltration (UF) control software currently in development to improve fluid management during hemodialysis and personalize treatments. The software will be designed to work with newer Fresenius Medical Care hemodialysis machines using the CLiC™ device.

Fluid management is a critical concern for dialysis patients, as both fluid overload and fluid depletion are associated with adverse cardiovascular events, morbidity and mortality. Working with the CLiC device which enables relative blood volume monitoring (RBV-M), the new software aims to create a dialysis machine with embedded intelligent diagnostics that will provide computer-assisted recommendations for achieving target levels of RBV.

“This new software represents our commitment to driving innovation and aims to become an essential tool in reducing cardiovascular events for people living with kidney failure,” said Mark Costanzo, president of Renal Therapies Group, the technologies and pharmaceuticals division of Fresenius Medical Care North America. “Effective fluid management is critical to creating the best hemodialysis treatment possible for each individual. We are proud of this effort to further advance our proven Crit-Line technology.”

Several abstracts presented at the 2018 ASN Kidney Week in San Diego, Calif. demonstrated that managing fluid with RBV-M is associated with reduced hospitalizations for patients new to hemodialysis (incident) and further established the link between RBV, central-venous oxygen saturation and mortality1,2. An additional analysis by the Renal Research Institute (RRI), published in Nephrology Dialysis Transplantation in September 2018, demonstrated that attainment of certain hourly RBV ranges is associated with improved survival in patients with end stage renal disease (ESRD) receiving hemodialysis.

The FDA Breakthrough Device Program seeks to provide patients with faster access to technologies that provide more effective treatment or diagnosis of life-threatening or debilitating diseases by speeding up the development and review process. The FDA announced final guidance for the Breakthrough Devices Program on December 19, 2018. The new program was established by the 21st Century Cures Act.

Any timeline for the final development and approval of the computer-assisted ultrafiltration control software remains uncertain given the nature of developing this complex and innovative technology.

For more information about Crit-Line® technology, visit https://fmcna.com/products/fluid-management/

1 Balter P, Rao PS, Li Y, Mullon C, Kossmann RJ, Ficociello LH. Lower Rates of Hospital Admissions During a Fluid Management Quality Improvement (QI) Project Utilizing Relative Blood Volume Monitoring (RBV-M) – A Retrospective Database Analysis [Abstract]. J Am Soc Nephrol 29, 2018: Page 626.

2 Zhang H, Preciado P, Chan L, Thijssen S, Kotanko P. All-Cause Mortality in Relation to Intradialytic Relative Blood Volume and Central-Venous Oxygen Saturation Among Hemodialysis Patients [Abstract]. J Am Soc Nephrol 29, 2018: Page 633.

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, outpatient cardiac and vascular labs and urgent care centers, 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.

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.