Rockwell Medical Completes SFP Phase IIb Clinical Study

WIXOM, Mich., Oct. 29, 2009 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI),
a fully-integrated biopharmaceutical company offering innovative products and
services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD),
and iron deficiency anemia, announced today that the last patient has completed
the Phase IIb clinical study to investigate Soluble Ferric Pyrophosphate (SFP),
the Company's proprietary investigational iron maintenance therapy.

The Phase IIb, double-blinded, randomized, placebo-controlled, 6-month duration,
dose ranging study enrolled patients at 29 sites in the U.S. and Canada. 131
ESRD patients receiving chronic hemodialysis were dosed at 0, 5, 10, 12, or 15
ug of SFP-derived iron per deciliter of dialysate. The objective of the study
was to evaluate the safety of SFP at varying dose levels and to determine the
optimal concentration of SFP for maintenance of hemoglobin in the target range
by maintaining iron balance. Two Data Safety Monitoring Board reviews of interim
study data did not identify any safety concerns nor necessitate any change in
the study design or conduct, and the study advanced until the targeted patient
enrollment was achieved.

Mr. Robert L. Chioini, Chairman and CEO of Rockwell Medical, commented, "We are
pleased to have completed our phase IIb study. We have seen an encouraging
safety profile for SFP to date and we anticipate having un-blinded data from the
study in the first quarter of 2010."

About SFP:

SFP is a novel, investigational, continuous iron therapy designed to treat iron
deficiency anemia in ESRD patients. SFP is a proprietary, water-soluble form of
iron that travels directly to the bloodstream and transfers iron at a cellular
level, similar to normal, physiologic dietary iron intake. SFP is designed as a
continuous replacement treatment delivering small doses of iron during every
dialysis session in order to offset iron losses during the dialysis procedure,
thereby maintaining hemoglobin in the target range as per Kidney Disease Quality
Outcomes Initiative (KDQOI) recommendations. Clinical trials to date suggest
that SFP, delivered during each dialysis treatment via dialysate, maintains
optimal iron balance and avoids liver toxicity while decreasing associated drug
administration costs. Recent academic studies have shown that more frequent
maintenance doses of iron improve the therapeutic response to erythropoiesis
stimulating agents (ESA), thereby decreasing the ESA doses needed to maintain
hemoglobin in the target range. Rockwell has licensed exclusive world-wide
rights to manufacture and sell SFP and has secured patents for SFP in multiple
countries, including the three largest dialysis markets in the world: the United
States, Japan, and the European Union. Based on current market data, the U.S.
dialysis market for IV iron is approximately $560 million annually while global
market potential is approximately $850 million.

About Rockwell:

Rockwell is a fully-integrated biopharmaceutical company offering innovative
products and services initially targeting end-stage renal disease (ESRD),
chronic kidney disease (CKD), and iron-deficiency anemia. An established
manufacturer and leader in delivering high-quality hemodialysis
concentrates/dialysates to dialysis providers and distributors in the U.S. and
abroad, Rockwell provides products that are used to maintain human life by
removing toxins and replacing critical nutrients in the dialysis patient's
bloodstream. Dialysis is a process that duplicates healthy kidney function for
patients who suffer from ESRD. There are approximately 400,000 ESRD patients in
the United States growing at an annual rate of 4 percent, and approximately 2
million ESRD patients world-wide.

The Company is currently developing unique, proprietary renal drug therapies for
iron treatment. These exclusive renal drug therapies support disease management
initiatives to improve the quality of life and care of dialysis patients and are
designed to deliver safe and effective therapy, while decreasing drug
administration costs and improving patient convenience. Rockwell is developing a
pipeline of drug therapies, including extensions of the SFP technology for
indications outside of hemodialysis. Please visit www.rockwellmed.com for more
information.

The Rockwell Medical Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=6773

Certain statements in this press release constitute "forward-looking statements"
within the meaning of the federal securities laws. Words such as "may," "might,"
"will," "should," "believe," "expect," "anticipate," "estimate," "continue,"
"predict," "forecast," "projected," "intend" or similar expressions, or
statements regarding intent, belief, or current expectations, are
forward-looking statements. While the Company believes these forward-looking
statements are reasonable, undue reliance should not be placed on any such
forward-looking statements, which are based on information available to us on
the date of this release. These forward looking statements are based upon
current estimates and assumptions and are subject to various risks and
uncertainties, including without limitation those set forth in the Rockwell's
SEC filings. Thus, actual results could be materially different. Rockwell
expressly disclaims any obligation to update or alter statements whether as a
result of new information, future events or otherwise, except as required by
law.

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