About Rockwell Medical

Rockwell Medical (NASDAQ: RMTI) 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 anemia, secondary hyperparathyroidism and hemodialysis in the U.S. and throughout the world.

As an established manufacturer and leader in delivering high-quality, innovative drug therapies and hemodialysis concentrates to dialysis providers and distributors in the U.S. and abroad, Rockwell provides products used to save and sustain human life, removing toxins and replacing critical nutrients in the dialysis patient's bloodstream.  Our life-sustaining products are not considered discretional in nature nor their use capable of being deferred.

The Company continues to develop unique, proprietary drug therapies for the treatment of iron-deficiency anemia for use in the renal and cancer industries. These exclusive drug therapies support disease management initiatives to improve the quality of life and care of the patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience and outcome.

Triferic, is the only iron product that is FDA approved for delivery via dialysate to replace iron and maintain hemoglobin to treat anemia in the hemodialysis patient population in the United States.  Triferic is a novel iron salt that delivers iron to the bone marrow via dialysate in a non-invasive physiological manner, providing continuous iron maintenance therapy for the treatment or prevention of iron deficiency anemia in dialysis patients.

Unlike current IV iron treatment administered by a nurse to treat anemia, Triferic is infused directly into the bloodstream during the dialysis treatment and transfers its iron load at a cellular level, similar to normal dietary iron uptake.  The Company received U.S. Food & Drug Administration (FDA) approval of Triferic on January 24, 2015 and commercially launched in September for commercial sale as an iron replacement product to treat anemia and maintain hemoglobin in adult patients with hemodialysis dependent chronic kidney disease.  The Company 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 brand extensions based on the Company's FDA-approved Triferic iron drug delivery therapy to treat other iron-deficiency anemia indications including:  Triferic TPN Solution, Triferic PD Solution, Triferic IV Solution, Triferic Orphan Indication, as well as new drugs for other targeted therapies and iron-deficiency anemia indications such as, cancer-induced anemia, outside the renal industry.

Innovator in the Renal Market

Rockwell has a reputation as an industry innovator and history of successful new product launches addressing unmet needs in the renal market since its founding in 1994.

For example:

  • In 1998, 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.
  • Also in 1998, the Company introduced SteriLyte® liquid bicarbonate targeting acute and chronic care patients.
  • In 2008, the Company introduced RenalPure® 100-Dex acid concentrate

In late 2010, the Company introduced a new citrate-based acid concentrate called CitraPure®, currently the only acid concentrate completely free of acetate which promotes inflammation.  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 considerably reduces heparin use and the need for pumping equipment. Today, CitraPure® is Rockwell’s # 1 selling product.

In October 2014, Rockwell Medical entered into a new 10-year, exclusive agreement with Baxter International for the marketing, sales and distribution of the Company's core dialysate products in the U.S. and selected international markets.  The Company maintains its strong brand recognition and presence in the renal space while benefitting from the additional resources and global scale that Baxter brings, as well as, allows the Company to strategically focus on developing the drug pharmaceuticals business in the U.S. and around the world.

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.

In September 2015, the Company commercially launched it’s FDA-approved and leading renal drug, Triferic, a novel therapy that continuously delivers and maintains optimal iron balance in dialysis patients.  Triferic is the first drug that delivers iron through dialysate via slow infusion during the dialysis treatment, replacing the 5-7 mg of iron that is permanently lost during every treatment.  It's unique mode of action delivers iron via dialysate in a non-invasive physiologic manner, similar to how a healthy person receives normal dietary iron.

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