Oct 19, 2020   SOURCE: PR NewsWire

FDA Approves New Container System for Peritoneal Dialysis Solutions

WALTHAM, Mass., Oct. 19, 2020 /PRNewswire/ -- Fresenius Medical Care North America's (FMCNA) Renal Therapies Group announced today that DELFLEX(®) peritoneal dialysis solutions in Biofine(®), an innovative bag material, has been approved by the U.S. Food and Drug Administration (FDA). The milestone marks another important step in the company's commitment to grow home dialysis through new and improved products.

"The new Biofine peritoneal dialysis solutions line is part of our ongoing commitment to expand supply of peritoneal dialysis solutions and make home dialysis available to more patients with kidney failure," said Mark Costanzo, President of FMCNA's Renal Therapies Group. "We are excited to bring this innovative new product, which aims to make home treatment even easier, to market."

The Biofine line of products offers three key advantages for peritoneal dialysis (PD) patients and the clinicians who manage their care:

    --  Additional capacity to support patient growth: For physicians and
        clinicians interested in encouraging more patients to do their dialysis
        therapy at home, the new manufacturing line offers additional capacity
        to support the growing patient population, in line with the objectives
        of last year's Executive Order on Advancing American Kidney Health.
    --  Built in convenience for patients: User-friendly design for easy storage
        and use.
    --  Environmentally friendly: Biofine material generates less waste and is
        PVC-free to address the growing concerns about preserving our
        environment.

The Biofine bag material is already used by thousands of Fresenius Medical Care patients around the world. This product also demonstrates the company's commitment to sustainability, offering a bag that is up to 60 percent thinner than alternative materials, saving raw materials and reducing waste. Additionally, Biofine degrades upon incineration with no release of hydrochloric acid and eliminates DEHP plasticizers.

"We are pleased to ramp up the production and distribution of Biofine in our plant and new distribution center in Knoxville, Tennessee," said Kent Wanzek, CEO of Global Manufacturing, Quality & Supply at Fresenius Medical Care. "This extends and further leverages our global production and distribution footprint, providing a reliable supply of solutions to home patients worldwide."

"After transplantation, home therapy has repeatedly been demonstrated as the preferred alternative for many end stage renal disease patients and the healthcare system," said Dr. Mike Anger, Chief Medical Officer for FMCNA's Renal Therapies Group. "This expansion of Fresenius Medical Care's capacity with an innovative new product marks another step toward improving the quality of life for dialysis patients."

The new Biofine peritoneal solutions bag is expected to be first available to a limited number of patients in the U.S. this fall. More information about the company's line of home dialysis equipment and products is located at https://fmcna.com/products/home-dialysis-equipment/.

INDICATIONS AND USAGE

DELFLEX® is indicated in the treatment of chronic kidney failure in patients being maintained on peritoneal dialysis.

IMPORTANT SAFETY INFORMATION

    --  Intended for intraperitoneal administration only;
    --  Not for intravenous or intra-arterial administration;
    --  Use aseptic technique throughout the procedure;
    --  Monitor routinely for electrolyte, fluid, and nutrition imbalances;
    --  Monitor for signs of peritonitis or overfill;
    --  Inspect the drained fluid for fibrin or cloudiness;
    --  Ensure that there is no leakage around the catheter;
    --  Solution-related adverse reactions may include peritonitis, catheter
        site infection, electrolyte and fluid imbalances, hypovolemia,
        hypervolemia, hypertension, disequilibrium syndrome, muscle cramping,
        abdominal pain, abdominal distension, and abdominal discomfort.

DELFLEX is available by prescription only. For additional Safety Information, please see full Prescribing Information.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care North America at 1-800-323-5188. You are encouraged to report negative side effects of prescription drugs to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Visit MedWatch or call 1-800-FDA-1088.

This information is intended for use by US healthcare professionals only.

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/.

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.

Media Contact:

Fresenius Medical Care North America
Brad Puffer
Corporate Communications
brad.puffer@fmc-na.com
(781) 699-3331

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SOURCE Fresenius Medical Care Holdings, Inc.