|Exchange:||NASDAQ national market|
|Stock:||Rockwell Medical Inc|
|Industry:||Drug Manufacturers - Major|
|Rockwell Medical Inc was incorporated in the state of Michigan in 1996. The Company is a fully-integrated biopharmaceutical company targeting end-stage renal disease (‘ESRD’) and chronic kidney disease (‘CKD’) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis. The Company manufactures, sells, delivers and distributes hemodialysis concentrates, along with a full line of ancillary products, to customers in the U.S. and abroad. Dialysate concentrates account for over 92% of its revenue and consist of two products known in the industry as ‘acid’ and ‘bicarbonate’ and are packaged as liquid or powder. All of its products are manufactured according to AAMI and GMP guidelines. Its concentrate products are used in conjunction and are diluted with clean water on-site at the clinic in the dialysis machine, creating dialysate, which works to clean the patient's blood. Its CitraPure® concentrate is 100% acetate-free, in contrast to the acetate-based products used for many years. Acetate promotes inflammation so its removal is beneficial to the patient. Dry powder acid concentrate for use with its Dry Acid Mixing System, containing acetic acid, sodium chloride, dextrose and electrolyte additives such as magnesium, potassium, and calcium. It supplies dry acid in 25 gallon cases. Its Dry Acid Concentrate Mixing System is designed for its CitraPure® and Dri-Sate® Dry Acid product and allows a clinic to mix its acid concentrate on-site. The clinic technician, using a specially designed mixer, adds pre-measured packets of the necessary ingredients to purified water (AMII standard). RenalPure® bicarbonate sold in powder form is used mainly in chronic settings. Each clinic mixes bicarbonate on-site as required. teriLyte® bicarbonate is sold in liquid form and is used mainly in acute care settings. It offer 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. Its largest competitor is US based Fresenius Medical Care NA, which is mainly in the business of operating dialysis clinics, as well as manufacturing and marketing dialysis devices, drugs and supplies. The testing, manufacture and sale of its hemodialysis concentrates and the ancillary products it distribute are subject to regulation by numerous governmental authorities, principally the FDA and corresponding state and foreign agencies.|
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