WIXOM, Michigan, Oct. 18 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. , a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end- stage-renal-disease market (ESRD), reported today that it submitted its Soluble Ferric Pyrophosphate (SFP) Dose Ranging Study protocol to the FDA.
The SFP Dose Ranging Study design is a double-blinded, randomized, multi- center, parallel groups, placebo controlled study. Subjects will undergo hemodialysis treatment three times per week for 36 weeks followed by a one week treatment-free follow-up. Rockwell is currently on schedule to begin enrollment for the study in the fourth quarter of this year.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We are encouraged by the solid progress we continue to make towards obtaining FDA approval for our proprietary SFP product. This study will enable us to define the optimal dose for iron maintenance therapy for a majority of ESRD patients, as well as determine the minimum and maximum dose limits for those special ESRD patients who may need more or less iron."
Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron called Ferric Pyrophosphate. SFP is designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatment. Rockwell has licensed the exclusive world-wide rights to the SFP patent and is in the process of seeking FDA approval to market the product.
Compared to intravenous (IV) iron administration, early clinical study results suggest that delivering iron via dialysate is a safe and effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs.
Rockwell has licensed the exclusive rights to the patents for the SFP technology which grant the Company the right to manufacture and market the combination drug/device. Rockwell estimates that the U.S. dialysis market for IV-iron delivery represents approximately $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively in those markets. For more information on SFP visit Rockwell's website at http://www.rockwellmed.com/ironnews.htm.
Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients whose kidneys have failed to work properly and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 350,000 dialysis patients in the United States and the incidence of ESRD has increased approximately 6% on average each year over the last decade. Rockwell manufactures, markets and delivers high-quality dialysis solutions, powders and ancillary products that are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. Rockwell's proprietary formulations for iron-delivery and vitamin/carnitine-delivery, utilizing its dialysate as the delivery mechanism, are designed to provide replacement therapy with unprecedented patient safety and efficacy while eliminating nursing time and supply cost. Rockwell offers the proprietary Dri-Sate(R) Dry Acid Concentrate Mixing System, RenalPure(R) Liquid Acid Concentrate, SteriLyte(R) Liquid Bicarbonate Concentrate, RenalPure(R) Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items. Visit Rockwell's website at http://www.rockwellmed.com for more information.
Certain statements in this press release including statements regarding FDA approval to market SFP, the market potential for iron supplementation and the ability of SFP to compete for market share once approved by the FDA constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect management's expectations and are based upon currently available information. Management of Rockwell believes the expectations reflected in the forward-looking statements made in this press release are based upon reasonable assumptions. However, certain factors could occur that might cause actual results to vary. These include, but are not limited to, general economic conditions, economic conditions in the hemodialysis industry, modified regulatory requirements, competitive factors, and other factors discussed in Rockwell's reports filed with the Securities and Exchange Commission. The forward-looking statements should be considered in light of these risks and uncertainties.
Rockwell Medical Technologies, Inc.CONTACT: Ron Aubrey - Investor Relations, 1-866-565-6139, or Thomas Klema,+1-248-960-9009, for Rockwell Medical Technologies, Inc.
Web site: http://www.rockwellmed.com/
