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ROCKWELL MEDICAL Rockwell Medical , Inc. Provides Second Quarter 2021 Financial and Operational Update August 16 , 2021 -Entered into exclusive license agreement with Drogsan Pharmaceuticals for the rights to commercialize Triferic® in Turkey -Extended multi - year distribution agreement with Nipro Medical for dialysis concentrates in LATAM and the Caribbean -Q2 2021 conference call and webcast scheduled for today at 4:30 p.m. ET WIXOM , Mich . , Aug. 16 , 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 June 30 , 2021 . " We made significant progress in the second quarter on a number of fronts to develop and deliver innovative treatment to patients with iron deficiency anemia ( IDA ) , " said Russell Ellison , M.D. , M.Sc. , President and Chief Executive Officer of Rockwell Medical . " Ferric pyrophosphate citrate ( FPC ) for the treatment of IDA in home infusion patients remains our top development priority . We have received a written response to our pre - IND submission and intend to engage with the FDA to clarify and refine study design elements for our planned Phase II study , the first potential study of its kind in this patient population . In the meantime , we continue to work on the logistics and preparatory aspects of the trial . Assuming positive FDA feedback , we expect a potential commencement date in 2H 2021. " " In the second quarter , we also extended our multi - year distribution with Nipro Medical for the distribution of dialysis concentrates in Latin America and the Caribbean , and we entered into an exclusive license agreement for the right to commercialize Triferic in Turkey , with new partner Drogsan Pharmaceuticals , " concluded Dr. Ellison . Second Quarter 2021 Operational Highlights Dialysis Business • Revenue from hemodialysis concentrates was approximately $ 14.9 million . The Company is in the process of analysis of its supply chain to identify efficiencies while actively exploring U.S. expansion of this business with our two largest customers . • Revenue from Triferic was approximately $ 273,000 . Rockwell Medical continues to generate data in clinics showing the benefits of Triferic in real world protocols . The Company announced in April that Triferic AVNU ( ferric pyrophosphate citrate injection ) received a Notice of Compliance ( marketing approval ) from Health Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis - dependent chronic kidney disease . Rockwell Medical expects Triferic AVNU to become commercially available in Canada during 2022 . • The Company announced in June an exclusive license agreement with Drogsan Pharmaceuticals , a leading pharmaceutical company in Turkey with an established presence in the nephrology space , for the rights to commercialize Triferic AVNU ( ferric pyrophosphate citrate injection ) in Turkey . With approximately 65,000 patients receiving hemodialysis annually , Turkey represents a potentially significant and expanding market opportunity . The Company also announced in June that it extended its distribution agreement with its long - term distribution partner , Nipro Medical Corporation ( NMC ) , for a period of three years through May 2024. The agreement was originally initiated in 2008. With the extension of the agreement , NMC will continue to distribute dialysis concentrates manufactured by Rockwell Medical to numerous countries in Latin America and the Caribbean . NMC is a leading renal , medical , surgical , and interventional radiology products manufacturer and a major distributor of renal products in these regions . Home Infusion Program • The Company received a written response to its pre - IND submission and intends to work with FDA to clarify and refine study design elements for our planned Phase II study of FPC in patients with IDA receiving long - term home infusion therapy . Pipeline Development • Rockwell Medical continues to explore the use of its FPC platform for the treatment of hospitalized patients with acute