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ROCKWELL - MEDICAL Rockwell Medical , Inc. Provides Third Quarter 2021 Financial and Operational Update November 15 , 2021 - Third quarter net sales of $ 16.0 Million , up 6 % sequential quarter - over - quarter and 5 % year - over - year Company recently submitted Investigational New Drug application with FDA for its proposed clinical trial of FPC as a treatment for iron deficiency anemia in patients receiving home infusion - - Company recently presented Triferic® real world evidence update at ASN Kidney Week 2021 ; results from pilot observational analysis demonstrate maintenance of hemoglobin and reduction of total IV iron requirement in adult patients on Triferic receiving chronic hemodialysis - - Q3 2021 conference call and webcast scheduled for today at 4:00 p.m . ET WIXOM , Mich . , Nov. 15 , 2021 ( GLOBE NEWSWIRE ) Rockwell Medical , Inc. ( Nasdaq : RMTI ) ( " Rockwell Medical " or the " Company " ) , a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world , today reported financial results and a business update for the three months ended September 30 , 2021 . -- " Driven by accelerating growth in dialysis concentrates products , Rockwell Medical delivered a strong third quarter , which saw an increase in net sales versus both the second quarter of 2021 and third quarter of last year , " said Russell Ellison , M.D. , M.Sc. , President and Chief Executive Officer of Rockwell Medical . " We continue to make steady progress to develop and deliver innovative treatment to patients with iron deficiency anemia ( IDA ) . We recently submitted an Investigational New Drug application ( IND ) for our proposed clinical trial of Ferric Pyrophosphate Citrate ( FPC ) as a treatment for IDA in patients receiving home infusion , which is the first potential study of its kind in this patient population . At ASN Kidney Week 2021 in early November , we presented a real - world evidence update reflecting results from a pilot observational analysis , which demonstrated maintenance of hemoglobin and reduction of total IV iron requirement in adult patients on Triferic receiving chronic hemodialysis , " concluded Dr. Ellison . Third Quarter 2021 Operational Highlights Dialysis Business • Third quarter revenue from hemodialysis concentrates was approximately $ 15.7 million . The Company is in the process of analyzing its supply chain to identify efficiencies , while actively exploring U.S. and international expansion of this business with its customers . • Revenue from Triferic was approximately $ 280,000 in the third quarter . Rockwell Medical continues to generate data in clinics showing the benefits of Triferic when integrated into anemia management protocols . As part of this initiative and due to the current economic environment , the Company has adjusted its sales and marketing efforts for Triferic and Triferic AVNU and is seeking a commercial partner within the United States . This decision was based on the dynamics of the hemodialysis market , including provider consolidation , the effects of the CMS bundled payment system and competitive product bundling tactics . Home Infusion Program • The Company submitted an IND application with the U.S. Food and Drug Administration ( FDA ) in support of its proposed Phase 2 clinical trial of FPC , designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting . Following IND submittal , a sponsor must wait 30 calendar days before initiating any clinical trials . During this time , the FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk . • Home infusion represents a large and rapidly growing segment of healthcare . According to the National Home Infusion Association , the number of patients served by home infusion therapy has grown from approximately 800,000 in 2010 to over 3,000,000 in 2019. The home infusion setting is expected to continue to expand , which has been further accelerated by the COVID - 19 pandemic and the desire to reduce or eliminate hospital and or clinic exposure . Many patient groups requiring home infusion therapies suffer from diseases that are associated with an incidence of iron deficiency and anemia . For example , it is estimated that 40 % to 55 % of all home parenteral nutrition patients are iron deficient . Management believes , based on the Company's data with hemodialysis patients , that FPC as a home infusion therapy for iron deficiency anemia may have distinct advantages over currently available iron replacement therapy options . Pipeline Development • Rockwell Medical continues to explore the use of its FPC platform for the treatment of hospitalized patients with acute