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FDA Approves New Container System for Peritoneal Dialysis Solutions

Ģ����ý North America Announces Next Generation Solution Bags to Support Continued Home Dialysis Expansion

WALTHAM, Mass. Ģ����ý� Oct. 19, 2020 Ģ����ý�����(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 companyĢ����ý�s commitment to grow home dialysis through new and improved products.

Ģ����ý�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,Ģ����ý� said Mark Costanzo, President of FMCNAĢ����ý�s Renal Therapies Group. Ģ����ý�We are excited to bring this innovative new product, which aims to make home treatment even easier, to market.Ģ����ý�

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 yearĢ����ý�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 Ģ����ý patients around the world. This product also demonstrates the companyĢ����ý�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.

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

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

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 companyĢ����ý�s line of home dialysis equipment and products is located at��.

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��.

To report SUSPECTED ADVERSE REACTIONS, contact Ģ����ý 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��. Visit MedWatch or call 1-800-FDA-1088.

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

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Ģ����ý Ģ����ý North America
Ģ����ý 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, Ģ����ý North America provides coordinated healthcare services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the worldĢ����ý�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��.