About Rockwell Medical
Rockwell Medical (NASDAQ: RMTI) is a fully-integrated biopharmaceutical company offering innovative products and services initially targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia.
As an established manufacturer and leader in delivering high-quality hemodialysis concentrates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products used to maintain human life, removing toxins and replacing critical nutrients in the dialysis patient's bloodstream.
The Company is currently developing unique, proprietary renal drug therapies. These exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience and outcome.
Soluble Ferric Pyrophosphate (SFP), the Company’s lead investigational drug, is a novel iron salt capable of delivering iron in a physiological manner, providing continuous-iron-maintenance therapy for the treatment or prevention of iron deficiency anemia in dialysis patients.
Unlike current IV iron treatment used in dialysis, SFP travels directly to the bloodstream and transfers its iron load at a cellular level, similar to normal dietary iron uptake. SFP is currently progressing through U.S. clinical development and has received patent protection in several countries including in the three largest ESRD markets in the world: the U.S., Japan and Europe.
Rockwell is further developing new drug opportunities in the areas of women’s health, oncology, gastroenterology and parenteral nutrition based on the SFP platform, as well as new drugs for other targeted renal therapies and indications.
Innovator in the Renal Market
Rockwell has a history of successfully addressing unmet needs in the renal market.
The Company was the first to develop, patent and successfully market a dry acid mixing system, replacing bulky, liquid 55-gallon drums. The Dri-Sate® Dry Acid Concentrate Mixing System delivers hemodialysis concentrate in a cost-effective manner while creating valuable storage space and increasing its value proposition to its customers. It is the top selling dry acid product in the market.
The Company’s innovative delivery model is unique and designed to better serve customers and reduce costs. Utilizing its own transportation specialists and fleet of trucks, Rockwell delivers product to dialysis centers directly from its manufacturing facilities while meeting the individual delivery needs of its customers, providing exceptional and unmatched delivery service.
Recently, in late 2010, the Company introduced a new acid concentrate product called CitraPure®, currently the only acid concentrate completely free of acetate, while containing citrate in its place. Acetate promotes inflammation and an acetate-free dialysiate, containing citrate in its place, has been shown in recent clinical studies to reduce inflammation in hemodialysis patients during dialysis, leading to better clinical outcomes with regard to albumin, hemoglobin and ESA sparing. Furthermore, citrate acts as an anti-coagulant and clinical studies have shown that a citrate-based dialysate reduces heparin use considerably during the dialysis treatment. CitraPure® is fast becoming Rockwell’s # 1 selling product.
The Company’s lead drug candidate, SFP, is a novel investigational drug in Phase III clinical development and is designed to continuously deliver and maintain optimal iron balance in dialysis patients by replacing iron as it’s lost during the dialysis treatment. SFP is the first drug designed to deliver iron through dialysate, continuously during the dialysis treatment, replacing lost iron real-time. It's unique mode of action delivers iron in a physiologic manner, similar to how a healthy person receives normal dietary iron.