Rockwell Medical
Technologies, Inc. (Nasdaq: RMTI), 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 rockwellmed/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
rockwellmed 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
rockwellmed