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Profile: Rockwell Medical Inc (RMTI.OQ)

RMTI.OQ on NASDAQ Stock Exchange Global Market

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Rockwell Medical, Inc. (Rockwell), incorporated on October 25, 1996, is a biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. The Company operates through the hemodialysis market segment, which involves the manufacture, sale and distribution of hemodialysis products to hemodialysis clinics, including pharmaceutical, dialysis concentrates, dialysis kits and other ancillary products used in the dialysis process.

Drug Products

The Company's drug products include Triferic (ferric pyrophosphate citrate) and Calcitriol (Active Vitamin D) Injection. Triferic contains ferric pyrophosphate citrate as an active ingredient. Triferic is a product for the treatment of iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic is an iron compound that is delivered to hemodialysis patients through dialysate, replacing the iron loss that occurs during their dialysis treatment. Triferic is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. The Company has completed Phase III clinical trial program SFP-3 and SFP-4 (CRUISE-1and CRUISE-2) that included a long-term safety program where Triferic demonstrated a safety profile similar to placebo patients. In addition, the Company completed clinical study, the PRIME study, which demonstrated that Triferic could reduce the need for erythropoiesis stimulating agents (ESA).

The Company's product Calcitriol (active vitamin D) injection is indicated for the treatment of secondary hyperparathyroidism in dialysis patients. It is also indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis.

Dialysis Concentrate Products

The Company manufactures, sells, delivers and distributes hemodialysis concentrates, along with a range of ancillary products abroad. The Company's concentrate products are diluted with clean water on-site at the clinic in the dialysis machine, creating dialysate, which works to clean the patient's blood. The Company's dialysis concentrate products include CitraPure citric acid concentrate, Dri-Sate Dry Acid Concentrate, Renal Pure Liquid Acid Concentrate, dry acid concentrate mixer, RenalPure Powder Bicarbonate Concentrate and SteriLyte Liquid Bicarbonate Concentrate. CitraPure contains citric acid, sodium chloride, dextrose, magnesium, potassium and calcium. CitraPure is packaged as dry acid concentrate in 20-gallon cases and liquid acid concentrate in 50-gallon drums and four one-gallon jugs to a case. Dri-Sate contains acetic acid, sodium chloride, dextrose, magnesium, potassium and calcium.

Dri-Sate is packaged as dry acid concentrate in 20-gallon cases. RenalPure Liquid Concentrate is acetate-based and contains acetic acid, sodium chloride, dextrose, magnesium, potassium and calcium and packaged in 50-gallon drums and four one-gallon jugs to a case. Dry Acid Concentrate Mixer is designed for the Company's CitraPure and Dri-Sate Dry Acid product and allows a clinic to mix its acid concentrate on-site. RenalPure bicarbonate is a dry powder mixed on-site at the clinic and is packaged for bulk and individual treatment. SteriLyte bicarbonate is liquid packaged in four one-gallon jugs to a case and is used in acute care settings. The Company also offers a range of ancillary products, including blood tubing, fistula needles, specialized custom kits, dressings, cleaning agents, filtration salts and other supplies used by hemodialysis providers.

The Company competes with Fresenius Medical Care NA, Galenica, Sanofi-Aventis, Watson, AMAG Pharmaceuticals, Inc. and Abbott Laboratories.

Company Address

Rockwell Medical Inc

30142 S Wixom Rd
WIXOM   MI   48393-3440
P: +1248.9609009
F: +1248.9609119

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