Rockwell Medical Technologies Receives European Patent Issuance For Proprietary Iron-Delivery Technology
WIXOM, Mich., April 19 /PRNewswire-FirstCall/ -- Rockwell Medical Technologies, Inc. , a leading, innovative hemodialysis products manufacturer in the healthcare industry, reported that the European Patent and Trademark Office has issued a patent for Rockwell's proprietary iron-delivery product SFP, which covers the "Method and Pharmaceutical Composition for Iron Delivery in Hemodialysis and Peritoneal Dialysis Patients." Rockwell reported on August 10, 2005 that the EPTO had allowed its claims for the proprietary drug/device.
Rockwell's proprietary product SFP is designed to provide physiological iron replacement in ESRD patients by delivering iron via dialysate during hemodialysis and peritoneal dialysis treatment. Rockwell has licensed the exclusive rights to the SFP patent and is in the process of seeking FDA approval to market the product.
The countries the patent grant will affect are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom.
Compared to intravenous (IV) iron administration, results based on an FDA approved Phase II Study have shown that delivering iron via dialysate is a safer and more effective method for maintaining iron balance in dialysis patients, while at the same time eliminating associated nursing and pharmaceutical IV iron administration costs. Rockwell estimates that the U.S. dialysis market for IV iron delivery represents $450 million annually while the global market potential is approximately $750 million annually. Upon FDA market approval, Rockwell expects SFP to compete aggressively for those markets. Visit Rockwell's website at http://www.rockwellmed.com/ironnews.htm for more information on SFP.
Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "This European patent issuance was expected based on the allowance we had previously received. It is a significant step for Rockwell as it enables us to protect our proprietary technology in a major market. Currently, we are making solid progress in our FDA development process and we expect to achieve several more significant milestones as we work towards market approval."
Rockwell Medical Technologies, Inc. is an innovative leader in manufacturing, marketing, and delivering high-quality dialysis solutions, powders, and ancillary products that improve 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 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%-8% on average each year over the last decade. Rockwell's products are used to cleanse the ESRD patient's blood and replace nutrients in the bloodstream. 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 with respect to Rockwell's business and operations, including statements regarding an anticipated response from the FDA on the Company's Phase III Clinical Trial proposal, non- clinical study timelines, FDA approval, the potential of Rockwell's proprietary Soluble FePPi, etc., and the Company's ability to raise additional capital 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: Thomas Klema of Rockwell Medical, +1-248-960-9009