WIXOM, Mich., July 20 /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 that the Western Institutional Review Board (WIRB) has approved the Company’s National Institutes of Health (NIH) sponsored study protocol for examining the prospective advantages of soluble ferric pyrophosphate (SFP) delivery via dialysate in hemodialysis patients. The nine-month study is expected to begin in the third quarter of 2006.
The WIRB provides review services for more than 100 institutions (academic centers, hospitals, networks and in-house biotech research), as well as for individual investigators in all 50 states and internationally. The WIRB has worked with all major pharmaceutical and device manufacturers, CRO’s and the biotech industry.
The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the primary Federal agency for conducting and supporting medical research. Helping to lead the way toward important medical discoveries that improve people’s health and save lives, NIH scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.
Rockwell’s proprietary iron-delivery product, SFP, is a soluble form of iron called Ferric Pyrophosphate. SFP is designed to provide physiological iron maintenance for hemodialysis patients by delivery of SFP via dialysate. Compared to intravenous (IV) iron administration, early clinical study results for SFP have shown 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 is seeking FDA approval to market the product and estimates that the U.S. dialysis market for IV-iron delivery represents $400 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 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 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 www.rockwellmed.com for more information.
Certain statements in this press release with respect to Rockwell’s anticipated sales revenue and earnings 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, any breach of a contract by a major customer, 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, 866-565-6139, or Thomas Klema,+1-248-960-9009, both for Rockwell Medical Technologies, Inc.
Web site: http://www.rockwellmed.com//
