Rockwell has licensed the patent rights to a proprietary and potentially revolutionary Iron-Delivery product (SFP). Currently in development, Rockwell's SFP will deliver iron to the dialysis patient via the Company's dialysate product line. Once approved by the FDA, the Company believes its SFP will compete aggressively in the $450 million U.S. IV-Iron market. Rockwell's SFP has completed an FDA-approved Phase-I and Phase-II Clinical trial. A Phase-III Clinical trial will be completed prior to market launch which is estimated to be late 2008.

Iron deficiency is pervasive in the dialysis patient population. Blood has two major components; red blood cells which contain electrolytes, proteins, nutrients, hormones and other substances and white blood cells which fight infection. Red blood cells carry oxygen throughout the body to nourish tissue and sustain life. The most important constituent of red blood cells is hemoglobin, a complex molecule composed of protein and iron, which is responsible for carrying oxygen to the tissues. Red blood cells are produced in the bone marrow and the body carefully regulates that production so that enough cells are produced to carry oxygen. The kidneys of patients with ESRD are deficient in the production of red blood cells.

Anemia is characterized by an abnormally low number of red blood cells in the circulatory system. Severe anemia associated with ESRD is mainly due to a deficiency in erythropoietin, a hormone produced by healthy kidneys that stimulates red blood cell production. Most dialysis patients receive replacement therapy of recombinant human erythropoietin (Epoetin alfa). Treatment with this drug therapy requires adequate amounts of iron for new hemoglobin synthesis and new red blood cell formation. Dialysis patients being treated with Epoetin alfa therapy require rapid mobilization of iron reserves in order to meet the demands of new red blood cell growth. The demands of this therapy can outstrip the body's ability to mobilize iron stores and iron deficiency can result. Dialysis patients also suffer from iron deficiency due to blood loss from dialysis treatments and reduced dietary intake of iron. Iron supplementation is required not only to maintain proper iron balance but to ensure good therapeutic response.

Current intravenous parenteral iron compounds (IV-iron) deposit their iron load in the liver where it is slowly metabolized into a useable form through the reticuloendothelial system. While these intravenous forms of iron enter the blood stream, they do not pass iron directly to blood plasma to be carried to the bone marrow. Instead these IV compounds deposit iron into the liver. As a result, there is thought to be toxicity to the liver as well as volatility in iron stores, thus reducing the effectiveness of Epoetin alfa treatments.

Compared to the current IV-iron products used today, Rockwell's proprietary SFP has proven to be safer and more effective and provides a substantial improvement in the quality outcomes for dialysis patients with iron deficiency. SFP, delivered via dialysate, has a distinct patient-safety advantage in that it transfers the iron load directly from dialysate into the blood plasma (not into the liver thereby avoiding liver damage) and it is carried directly to the bone marrow for the formation of new red blood cells - the kinetic properties of the compound enable the rapid uptake of iron in blood plasma.

Furthermore, the greater frequency and smaller dosage of Rockwell's SFP maintains iron stores in a more effective and steady state which should produce a superior therapeutic response from Epoetin alfa treatment, as compared to IV-iron.

In addition, Rockwell's SFP, delivered via Dialysate, will produce substantial cost savings (est. $35M annually) by eliminating nursing time and supplies needed for current IV-iron drug administration. Cost and liability due to potential needle-stick risk will also be eliminated.

Aside from Rockwell's current FDA Clinical Trial protocol, the National Institutes of Health (NIH) has funded $500,000 for a clinical trial for the Company's proprietary SFP. That trial is scheduled to begin third quarter 2006.

Upon gaining FDA approval, Rockwell expects SFP to compete aggressively in the $450 million U.S. IV-Iron market. Global market potential is estimated to be greater than $750 million. Rockwell's SFP has completed an FDA-approved Phase-I and Phase-II Clinical trial. A Phase-III Clinical trial will be completed prior to market launch which is estimated to be late 2008.

News about Dialysate Iron
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WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products focused on the end-stage-renal-disease (ESRD) market, announced today that the National Institutes of Health (NIH) sponsored clinical study for Soluble Ferric Pyrophosphate (SFP), Rockwell's physiological iron-maintenance-therapy drug, has entered active treatment phase with the initiation of dosing.

The clinical design is a 9-month, 30-patient, prospective, randomized, open-label, multi-center, controlled clinical trial of the safety and efficacy of physiological iron maintenance in ESRD subjects by delivery of SFP via hemodialysate. ESRD subjects receiving maintenance hemodialysis will be enrolled and randomized to receive hemodialysis using dialysate solutions with SFP or conventional solutions lacking iron at every dialysis session with the goal of maintaining iron balance within a tight hemoglobin range.

Primary End-points:
• Efficacy: The amount of therapeutic IV iron needed by subjects in the group receiving SFP in their dialysate versus those who do not.
• Safety: Safety and tolerability determined by clinically significant changes on vital signs, clinical laboratory measures, and incidence and severity of adverse events.

Secondary End-points:
• Hemoglobin maintenance and variability within optimal target range.
• Efficiency of iron delivery to the erythron.
• Incidence and time to development of iron deficiency and iron overload.
• Markers of inflammation and oxidative stress.

Robert L. Chioini, Chairman and CEO of Rockwell stated, “Beginning the successful dosing of dialysis patients in this NIH sponsored study is another significant milestone in our clinical path for gaining FDA market approval for SFP. We expect to share news of our clinical progress as it becomes available.”

About National Institutes of Health

The National Institutes of Health (NIH), http://www.nih.gov, a part of the US 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 sponsored scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.

About Soluble Ferric Pyrophosphate (SFP)

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. SFP is a highly stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell that facilities transfer of iron from transferrin to ferritin, by-passing the liver. Compared to intravenous (IV) iron administration, previous human clinical study results indicate that SFP can deliver iron (via dialysate) safely and effectively and can maintain iron balance in dialysis patients within the target range, while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA market approval. Patents for SFP have been secured in the United States, Japan and the European Union covering the largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $480 million annually while the global market potential is approximately $800 million annually.

About Rockwell Medical Technologies, Inc.

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 and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, cleaning blood and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary formulations for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. These novel technologies are designed to deliver safe and effective renal therapy to ESRD patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward- looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended September 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

(return to News Index) Wednesday, January 23, 2008

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products focused on the end-stage-renal-disease (ESRD) market, announced today that patient enrollment has started for a National Institutes of Health (NIH) sponsored clinical study for Soluble Ferric Pyrophosphate (SFP), the Company's physiological iron-maintenance-therapy drug.

Dr. Mordechai S. Nosrati, MD, Associate Professor of Clinical Medicine at Keck-USC School of Medicine and co-principal investigator stated, “SFP in dialysate allows for the slow infusion of iron over a 4-hour dialysis session and physiologically mimics how the human body normally handles and processes dietary iron, thereby potentially mitigating the side effects associated with intravenous iron such as release of free iron and excess storage of iron in the liver. I'm very excited to participate in the study of this revolutionary advancement in iron delivery.”

The NIH sponsored study is a 9-month, 30-patient, two-site, randomized, controlled, clinical study that will examine maintenance of hemoglobin, iron parameters, need for intravenous iron and oxidative stress markers in patients receiving SFP via dialysate versus patients receiving conventional iron-free dialysate. New data from this important study is expected to be published in late 2008.

About National Institutes of Health

The National Institutes of Health (NIH), http://www.nih.gov, a part of the US 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 sponsored scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.

About Soluble Ferric Pyrophosphate (SFP)

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. SFP is a highly stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell that facilities transfer of iron from transferrin to ferritin, by-passing the liver. Compared to intravenous (IV) iron administration, previous human clinical study results indicate that SFP can deliver iron (via dialysate) safely and effectively and can maintain iron balance in dialysis patients within the target range, while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA market approval. Patents for SFP have been secured in the United States, Japan and the European Union covering the largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $480 million annually while the global market potential is approximately $800 million annually.

About Rockwell Medical Technologies, Inc.

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 and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, cleaning blood and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary formulations for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. These novel technologies are designed to deliver safe and effective renal therapy to ESRD patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward- looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended September 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward-looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.
(return to News Index) Tuesday, December 4, 2007

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products, reported today that the FDA has approved initiation of a National Institutes of Health (NIH) sponsored clinical study for Rockwell's proprietary drug-delivery product SFP for chronic hemodialysis patients.

The NIH sponsored study is a 9-month, 30 patient, two site, randomized, controlled, clinical study that will examine maintenance of hemoglobin, iron parameters, need for intravenous iron and oxidative stress markers in patients receiving SFP via dialysate versus patients receiving conventional iron-free dialysate. Patients in both groups are eligible to receive intermittent intravenous (IV) iron sucrose per protocol if iron deficiency develops. The NIH sponsored study is being conducted by independent investigators and is scheduled to begin shortly with results expected to be published late in 2008.

Dr. Ajay Gupta, lead principal investigator and inventor of SFP stated, “This study will examine the hypothesis that SFP maintains iron balance and hemoglobin while significantly reducing the need for supplemental IV iron and without causing oxidant stress and inflammation.”

The National Institutes of Health (NIH), a part of the US 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 health and save lives, NIH sponsored scientists investigate ways to prevent disease as well as the causes, treatments, and even cures for common and rare diseases.

About SFP (Soluble Ferric Pyrophosphate) - Rockwell's Lead Renal Drug Product

SFP is a water soluble form of iron designed to provide physiological-iron-maintenance-therapy for anemic ESRD patients. SFP is uniquely delivered via dialysate directly to the bloodstream, during each kidney dialysis treatment. The physiological mode of action and ease of delivery of SFP is a highly stable, non-polymeric, simple iron salt that is administered directly into the bloodstream, avoiding liver build-up and toxicity thus overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell which facilitates transfer of iron from transferrin to ferritin, bypassing the liver entirely. Based on results of an initial Phase II clinical study and compared to IV iron administration, SFP delivered via dialysate, has shown to be a safe and effective method for maintaining optimal iron balance in dialysis patients while at the same time reducing nursing and physician time and pharmaceutical IV iron costs currently associated with IV iron administration. Furthermore, recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to SFP and is collaborating with the FDA in its development. Rockwell has secured patents for SFP in multiple countries, including the United States, Japan, and the European Union, covering the largest commercial markets in the world for dialysis and iron supplementation. The Company has patents issued and pending in a number of other countries as well.

Rockwell estimates the current U.S. IV-iron market is $480 million and the global IV-iron market is approximately $750 million. The Company believes the U.S IV-iron market has the potential to grow to $1 billion within the next 10 years while the world-wide market could reach $1.5 billion. Rockwell's dialysate products are used as the delivery method for SFP. Rockwell's current share of the U.S. dialysate market is estimated to be 26%.

About Rockwell Medical

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of renal drug therapies and critical products 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 and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary renal drug therapies for both iron-delivery and carnitine/vitamin-delivery, utilizing its dialysate as the delivery mechanism. These exclusive renal drug therapies support disease management initiatives to improve the quality of care for dialysis patients and are designed to deliver safe and effective therapy to patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended September 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

(return to News Index) Tuesday, October 23, 2007

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of renal drug therapies and essential dialysate products, focused on the end-stage-renal-disease (ESRD) market, reported that a Mexican patent was granted for its proprietary drug, Soluble Ferric Pyrophosphate (SFP). The Mexican SFP patent grant covers the method and pharmaceutical composition for iron delivery administered in hemodialysis and peritoneal dialysis patients.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are pleased to add Mexico, estimated to be the 8th largest ESRD market in the world, to further strengthen and protect our proprietary intellectual property for SFP worldwide. In conjunction with the successful completion of our SFP clinical development program, we look to expand into the worldwide markets through the development of our own distribution channels and/or with an established international marketing partner.”

About Soluble Ferric Pyrophosphate (SFP) - Rockwell's Lead Renal Drug Therapy

SFP is a water soluble form of iron designed to provide physiological-iron-maintenance-therapy for anemic ESRD patients. SFP (iron) is uniquely delivered via dialysate directly to the bloodstream, during each kidney dialysis treatment. SFP is a highly stable, non-polymeric iron salt that is administered directly into the bloodstream, avoiding liver toxicity build-up thus overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell which facilitates transfer of iron from transferrin to ferritin, bypassing the liver entirely.

Based on previous FDA Phase II clinical study results and compared to intravenous (IV) iron administration, SFP delivered via dialysate, has shown to be a safe and effective method for maintaining optimal iron balance in dialysis patients while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Furthermore, recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic response and benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to SFP and is collaborating with the FDA in its development. Rockwell has secured patents for SFP in multiple countries, including the United States, Japan, and the European Union, covering the largest commercial markets for iron supplementation in the world. Rockwell has issued and pending patents in a number of other markets as well. Rockwell estimates that the U.S. dialysis market for IV-iron delivery is approximately $450 million annually while global market potential is approximately $750 million.

About Rockwell Medical

Rockwell Medical Technologies, Inc. is a leading, innovative manufacturer and developer of renal drug therapies and critical products focused on improving the quality of care for dialysis patients. Dialysis is a process that duplicates kidney function for those patients who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 1.6 million ESRD patients world-wide. Rockwell's products are used to maintain life, removing toxins and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary renal drug therapies for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. 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 to these patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward-looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), announced today that it has begun dosing patients in its Phase IIb Dose-Ranging Clinical Study for Soluble Ferric Pyrophosphate (SFP), the Company's physiological iron-maintenance-therapy drug.

The Phase IIb Clinical Design is a double-blind, multi-center, randomized, placebo-controlled, nine-month study consisting of up to 130 patients at multiple dialysis centers in the United States. The primary end points of the study are to evaluate SFP at varying dosage levels in hemodialysis patients and to determine the optimal concentration of SFP in dialysate that will maintain iron balance within their target hemoglobin range. Secondary end points include evaluating efficacy for changes in hemoglobin levels over time, reticulocyte hemoglobin content, incidence of systemic infection episodes and to quantify the amount of SFP iron transferred from the dialysate directly to the blood during the dialysis session.

Robert L. Chioini, Chairman and CEO of Rockwell stated, “Beginning the successful dosing of dialysis patients is another significant milestone in our clinical path for gaining FDA market approval for SFP. Going forward, we anticipate sharing news of our clinical progress as it becomes available.”

About Soluble Ferric Pyrophosphate (SFP)

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron designed to provide physiological iron- maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. SFP is a highly stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell, that facilities transfer of iron from transferrin to ferritin, by-passing the liver. Compared to intravenous (IV) iron administration, previous human clinical study results indicate that SFP can deliver iron (via dialysate) safely and effectively and can maintain iron balance in dialysis patients within the target range, while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to SFP and is seeking FDA market approval. Patents for SFP have been secured in the United States, Japan and the European Union covering the three largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $450 million annually while the global market potential is approximately $750 million annually.

About Rockwell Medical

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 and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, cleaning blood and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary formulations for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. These novel technologies are designed to deliver safe and effective renal therapy to ESRD patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative manufacturer and developer of concentrates and specialty pharmaceuticals focused on the end-stage-renal-disease market (ESRD), announced today that it has commenced enrollment in its Phase IIb dose-ranging study for Soluble Ferric Pyrophosphate (SFP), a physiological iron-maintenance therapy drug.

The Phase IIb dose-ranging study is a nine-month, controlled multi-center, double-blind study consisting of up to 130 patients at multiple dialysis centers in the United States. Patients will receive SFP during their normal three times/week dialysis regimen. The primary objectives of this study are to evaluate both safety and efficacy of SFP at varying dosage levels and to determine the optimal concentration of SFP that will maintain iron balance within the target hemoglobin range, in patients undergoing hemodialysis. Secondary endpoints include evaluating efficacy for changes in hemoglobin levels over time, reticulocyte hemoglobin content, incidence of systemic infection episodes and to quantify the amount of SFP iron transferred from the dialysate directly to the blood during the dialysis session. Results of this Phase IIb study are expected by the end of 2008.

Robert L. Chioini, Chairman and CEO of Rockwell stated, “We are excited to initiate this important step in our clinical development plan for SFP, a key product in Rockwell's renal drug development pipeline. The completion of this study will enable us to initiate our planned Phase III pivotal study program for FDA market approval of SFP.” Mr. Chioini also stated, “We have assembled a team of top-tier investigators who will be conducting this important work. Dosing is expected to begin in less than two weeks. As information is obtained from our Data Safety Monitoring Board it will be presented to the scientific and investment communities.”

Enrollment in the Phase IIb dose ranging study commenced following successful completion of an extensive pre-clinical safety, pharmacology and toxicology study program.

About Soluble Ferric Pyrophosphate (SFP)

Rockwell's proprietary iron-delivery product, SFP, is a soluble form of iron designed to provide physiological iron- maintenance therapy in ESRD patients by delivering iron via dialysate during dialysis treatments. SFP is a highly stable and non-polymeric iron salt and is designed to be administered directly into the bloodstream, overcoming the need for iron release from reticuloendothelial stores in the liver and other organs. The ferric iron core is tightly chelated to a pyrophosphate shell, that facilities transfer of iron from transferrin to ferritin, by-passing the liver. Based on previous human clinical study results, and compared to intravenous (IV) iron administration, Rockwell has shown that SFP can deliver iron via dialysate as a safe and effective method for maintaining iron balance in dialysis patients within the target iron range, while at the same time decreasing associated nursing and pharmaceutical IV iron administration costs. Recent academic studies have shown that more frequent maintenance doses of iron improve the therapeutic benefits of recombinant erythropoietin treatments.

Rockwell has licensed the exclusive world-wide rights to the SFP and is collaborating with the FDA in its development. Patents for SFP have been secured in the United States, Japan and the European Union covering the three largest commercial markets for iron supplementation. Rockwell estimates that the U.S. dialysis market for IV iron delivery is approximately $450 million annually while the global market potential is approximately $750 million annually.

About Rockwell Medical

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 and who suffer from chronic kidney failure, a condition also known as end-stage-renal-disease (ESRD). There are an estimated 360,000 ESRD patients in the United States growing approximately 4-5% on average each year. There are approximately 2 million ESRD patients world-wide. Rockwell's products are used to maintain life, cleaning blood and replacing nutrients in the dialysis patient's bloodstream. Rockwell has licensed and is currently developing proprietary formulations for both iron-delivery and carnitine/vitamin-delivery utilizing its dialysate as the delivery mechanism. These novel technologies are designed to deliver safe and effective renal therapy to ESRD patients while decreasing nursing time and supply cost. The Company offers the proprietary Dri-Sate® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When we use words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "projected," "intend" or similar expressions, or make statements regarding our intent, belief, or current expectations, we are making forward-looking statements. While we believe these forward-looking statements are reasonable, you should not place undue reliance on any such forward-looking statements which are based on information available to us on the date of this release. Because these forward looking statements are based upon estimates and assumptions that are subject to significant business, economic and competitive uncertainties, many of which are beyond our control or are subject to change, actual results could be materially different. Factors which could cause such a difference include, without limitation, the risk factors set forth in the Company's SEC filings, including its Form 10-Q for the quarter ended June 30, 2007 and its Form 10-KSB for the year ended December 31, 2006. The forward- looking statements should be considered in light of these risks and uncertainties. We do not undertake, and expressly disclaim any obligation, to update or alter our statements whether as a result of new information, future events or otherwise, except as required by law.

WIXOM, Mich. -- 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 Japanese patent was granted for its proprietary anemia drug, Soluble Ferric Pyrophosphate (SFP). The patent covers the “Method and Pharmaceutical Composition for Iron Delivery administered in Hemodialysis and Peritoneal Dialysis Patients”.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “This is another important patent approval for Rockwell. According to recent data, Japan is the 2nd largest national ESRD market after the United States with approximately 250,000 patients on hemodialysis, growing 6% annually. Coupled with our U.S. and European patents, we have IP protection for SFP in the three largest ESRD markets in the world. We expect to fully capitalize on these markets.”

By delivering iron via dialysate during dialysis treatment, Rockwell's proprietary iron-delivery product SFP is designed to provide Physiological Iron Maintenance Therapy in ESRD patients. As opposed to current intravenous (IV) iron delivery, SFP is delivered to the patient in small doses via dialysate solution during the typical three-times-weekly dialysis session, closely matching normal red blood cell maintenance-function. Rockwell has licensed the global rights to SFP and its patents and is in the process of seeking FDA approval to market this innovative maintenance therapy.

Compared to IV iron administration, clinical study results 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 estimates that the U.S. market for IV iron delivery is as much as $450 million annually while the global market potential is approximately $750 million annually. Rockwell expects SFP to compete aggressively for those markets upon FDA market approval.

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® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

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.

WIXOM, Mich. -- 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 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 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 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® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

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.

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WIXOM, Mich. -- 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 Polish patent was granted for its proprietary drug, Soluble Ferric Pyrophosphate (SFP). The patent covers the "Method and Pharmaceutical Composition for Iron Delivery administered via Dialysate in Hemodialysis and Peritoneal Dialysis Patients".

Rockwell's proprietary iron-delivery product SFP is a soluble form of iron designed to provide physiological iron maintenance therapy in ESRD patients by delivering iron via dialysate during a dialysis treatment. Rockwell has licensed the exclusive rights to SFP and its patents and is in the process of seeking FDA approval to market the product.

Compared to intravenous (IV) iron administration, early clinical study results 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 estimates that the U.S. market for IV iron delivery is as much as $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 www.rockwellmed.com/ironnews.htm for more information on SFP.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “This patent approval is another important step for protecting our proprietary drug-delivery delivery technology internationally.”

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® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

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.

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WIXOM, Mich. -- 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.

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® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

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.

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WIXOM, Mich. -- 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 Hong Kong Patent and Trademark Office has issued a patent for Rockwell's proprietary SFP product. The patent covers the "Method and Pharmaceutical Composition for Iron Delivery administered via Dialysate in Hemodialysis and Peritoneal Dialysis Patients".

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 a 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.

Compared to intravenous (IV) iron administration, early clinical study results 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 estimates that the U.S. market for IV iron delivery is as much as $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 www.rockwellmed.com/ironnews.htm for more information on SFP.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, "We believe the markets along the pacific rim hold tremendous potential for SFP. This patent approval in Hong Kong is a significant step toward commercial realization of SFP in an important market. Overall, we are pleased with our progress toward FDA approval."

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® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

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.

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WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative dialysis products manufacturer serving the healthcare industry, reported today that it has submitted a pre-IND package to the FDA for their review. This pre-IND package contains Rockwell's Phase III clinical trial protocol for its proprietary iron-delivery product Soluble Ferric Pyrophosphate (SFP). Rockwell's SFP is designed to provide physiological iron maintenance in ESRD patients by delivering iron via dialysate during hemodialysis. Pending FDA approval of its IND development plan, the Company anticipates initiating the Phase III clinical trial during the fourth quarter of 2006.

Rockwell has non-clinical safety studies ongoing in support of the SFP product development. Out of a total of 19 non-clinical safety studies, eleven studies have been completed to date, five studies are on-going and the final three studies are scheduled to begin in May of this year. The final three studies are projected to conclude in the first quarter of 2007.

Based on the results of an FDA approved Phase II study, delivering SFP via dialysate has shown to be a safer and more effective method for maintaining iron balance in dialysis patients, as compared to intravenous iron (IV-iron) administration. Also demonstrated during the study, SFP delivered via dialysate appeared to have a distinct safety advantage for patients in that it transferred the iron load directly from dialysate into the blood plasma, thereby avoiding liver toxicity that may occur during IV-iron administration. The study results also appeared to demonstrate a reduction in the amount of Epoetin-alfa (EPO) needed during the dialysis treatment.

In addition, as compared to IV-iron administration, SFP delivered via dialysate is expected to produce substantial cost savings for dialysis providers by eliminating the nursing time and the medical supplies needed for current IV-iron administration. Cost and liability due to a potential needle-stick is expected to be eliminated as well.

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 $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. For more information on SFP visit Rockwell's website at www.rockwellmed.com/ironnews.htm

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are pleased to have submitted our pre-IND package to the FDA. This submission, including the Phase III protocol, should enable us to save valuable time on our development plan for SFP. Our overall goal is to attain FDA market approval of SFP as quickly as possible so that we can provide a safe and effective delivery method for patients undergoing hemodialysis who require physiological iron maintenance.”

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® Dry Acid Concentrate Mixing System, RenalPure® Liquid Acid Concentrate, SteriLyte® Liquid Bicarbonate Concentrate, RenalPure® Powder Bicarbonate Concentrate, Blood Tubing Sets, Fistula Needles and a wide range of ancillary dialysis items.

Certain statements in this press release with respect to Rockwell's business and operations, including statements regarding an anticipated commencement on the Company's Phase III clinical trial, non-clinical study timelines, FDA approval, the potential of Rockwell's proprietary SFP, etc., 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.

(return to News Index)

WIXOM, Mich. -- 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 maintenance 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 effect 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.

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.”

(return to Top of Page) Wednesday, January 11, 2006

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative dialysis products manufacturer serving the healthcare industry, reported today that it has completed its Phase III Clinical Trial protocol for its proprietary Iron-Delivery Product (Soluble FePPi) for Physiological Iron Maintenance in Patients on Hemodialysis. Several non-clinical safety studies are also underway in support of the product's development.

Rockwell's Phase III Clinical Trial protocol has been finalized and is scheduled to be submitted to the FDA during the second quarter 2006. This prospective, randomized, double-blinded, multi-center, controlled clinical trial will evaluate Soluble FePPi, delivered via dialysate solution, as a physiological iron replacement in patients undergoing chronic hemodialysis. Pending FDA approval of its development plan, the Company anticipates initiating the Phase III Clinical Trial during the third or fourth quarter of 2006.

Currently, a battery of non-clinical studies to support the initiation of the Company's Phase III Clinical Trial is underway. To date, six of fourteen studies have started. The remaining eight are planned to begin during the first quarter of 2006. Three genetic toxicity studies are scheduled to be completed in Q1 2006. A preliminary reproductive toxicology study and a safety pharmacology study for central nervous system effects are to be completed in Q2 2006. A safety pharmacology study of cardiovascular effects is scheduled to be completed in Q3 2006. Five studies, including reproductive toxicity studies and three-month repeat-dose toxicity studies are to be completed in Q4 2006. The entire battery of non-clinical studies is projected to be complete in Q1 2007 when the results of a six and nine month repeat-dose study and an embryonic and fetal development study are expected to become available.

Also, a NIH-funded study is scheduled to begin March 2006. This academic study, separate from the Phase III Clinical Trial, will evaluate Soluble FePPi, delivered via dialysate solution, for physiological iron maintenance in chronic hemodialysis patients. The study will evaluate the safety and effectiveness of Soluble FePPi with regards to the incidence and time to development of iron deficiency, the severity of iron deficiency and the amount of intravenous (IV) iron required. This study will evaluate the markers of inflammation and oxidative stress, considered to be integral processes in progression of end-stage renal disease (ESRD. Fifteen patients will be given Soluble FePPi via the dialysate and fifteen will receive conventional dialysate that does not contain iron.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We are pleased to have completed our Phase III Clinical Trial protocol as well as to have made substantial progress on our non-clinical supporting studies. We will continue to accelerate our development progress and strive to attain FDA approval as quickly as possible. We are truly excited about this innovative product which has the potential to be one of the most significant advances to affect the dialysis market in the last 20 years.”

Rockwell has licensed the patent rights to Soluble FePPi; Physiological Iron Maintenance for Patients on Hemodialysis. Soluble FePPi is a proprietary, innovative and potentially ground-breaking iron-delivery product. Currently in development, Rockwell's Soluble FePPi will deliver iron to the dialysis patient via the Company's dialysate product line. Once approved by the FDA, the Company believes its Soluble FePPi will compete aggressively in the $300 million U.S. IV-Iron market.

Compared to the current IV-iron products used today, Rockwell's proprietary Soluble FePPi is believed to be safer and more effective and provides a substantial improvement in the quality outcomes for dialysis patients with iron deficiency. Soluble FePPi, delivered via dialysate, has a distinct patient-safety advantage in that it transfers the iron load directly from dialysate into the blood plasma (not into the liver thereby avoiding liver damage) and it is carried directly to the bone marrow for the formation of new red blood cells - the kinetic properties of the compound enable the rapid uptake of iron in blood plasma. Furthermore, the greater frequency and smaller dosage of Soluble FePPi maintains iron stores in a more effective and steady state which should produce a superior therapeutic response from Epoetin alfa treatment, as compared to IV-iron.

In addition, Soluble FePPi, delivered via Dialysate, will produce substantial cost savings by eliminating nursing time and supplies needed for current IV-iron drug administration. Cost and liability due to potential needle-stick risk will also be eliminated.

(return to Top of Page) Thursday, November 17, 2005

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative hemodialysis products manufacturer serving the healthcare industry, reported today that it has formed a Scientific Advisory Board (SAB) to advise the Company on its clinical development and market preparation for its proprietary iron-delivery product, Soluble Ferric Pyrophosphate. The SAB consists of experts in the fields of renal anemia, iron therapy, nephrology and FDA regulatory approval. The SAB's role is to provide direction and guidance as the product moves through the FDA approval process.

The SAB is comprised of

• Anatole Besarab, MD, Director of Clinical Research, Division of Nephrology and Senior Staff Physician, Henry Ford Hospital, Detroit
• Rajiv Agarwal, MD, Associate Professor of Medicine,Indiana University School of Medicine, Indianapolis
• Ajay Gupta, MD, Associate Professor of Medicine,Division of Nephrology, UCLA and Drew University Schools of Medicine, Los Angeles
• Bert Spilker, PhD, MD,President Bert Spilker & Associates, LLC
• Nancy Chew, M.S.,RAC President, Regulatory Affairs, North America LLC

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “We have assembled an extraordinary group of world-class nephrologists and clinicians who are leaders in the area of renal anemia and iron therapy to advise us as we advance through our Phase III development program for our proprietary iron-delivery product. The SAB will play an important role in the achievement of both short- and long-term objectives for our Soluble Ferric Pyrophosphate development. We are extremely pleased that such brilliant individuals have joined us in our efforts to develop and commercialize this revolutionary iron-delivery product.”

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative hemodialysis concentrate manufacturer in the healthcare industry, reported today that it received notice from the European Patent and Trademark Office that it has allowed claims and will be issuing a patent for Rockwell's proprietary iron delivery product. The European Patent and Trademark Office will issue the patent for “Method and Pharmaceutical Composition for Iron Delivery in Hemodialysis and Peritoneal Dialysis Patients”.

The countries the European patent is expected to cover are Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden, Switzerland and the United Kingdom.

Mr. Rob Chioini, Chairman, CEO and President of Rockwell stated, “This patent approval in the European Union is a significant step for protecting our proprietary iron delivery technology.”

WIXOM, Mich. -- Rockwell Medical Technologies, Inc.reported that the FDA is reviewing its Pre-Clinical Safety Pharmacology Study proposal for its iron delivery technology. Once the Company receives FDA approval for the Pre-Clinical Safety Pharmacology Study, the Company will finalize for submission its Clinical Study protocol. Ferric pyrophosphate (FePPi), a water-soluble form of iron, is the cornerstone of Rockwell's proprietary technology for its iron-therapy product line.

Rockwell has been developing a proprietary concentrate product containing FePPi to be used as a treatment for anemia in dialysis patients. The Company is seeking FDA approval of the product, which it intends to market. The Company believes that the current market for intravenous (IV) iron is $300 million in the United States and more than $500 million globally. As compared to IV iron administration, the Company believes that administering the drug through its dialysate is a safer and more effective method for maintaining iron balance in dialysis patients, while at the same time eliminating the associated nursing and pharmaceutical IV iron administration costs. Rockwell holds the exclusive rights to the patents which cover the pharmaceutical composition, methods of use and delivery of iron to be administered via dialysate to both hemodialysis and peritoneal dialysis patients.

WIXOM, Mich. -- Rockwell Medical Technologies, Inc. a leading, innovative hemodialysis concentrate manufacturer in the healthcare industry, reported that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has awarded a RO-1 grant for studying the prospective advantages of ferric pyrophosphate (FePPi) delivery via dialysate in end stage renal disease (ESRD) patients. FePPi, a water-soluble form of iron, is the cornerstone of Rockwell's proprietary technology for its iron-therapy product line.

Rockwell has been developing an innovative, proprietary concentrate product containing FePPi to be used as a treatment for iron deficiency in dialysis patients. The Company is seeking FDA approval of this product which it intends to market. As compared to intravenous (IV) iron administration, the Company believes that administering the drug through its dialysate is a safer and more effective method for maintaining iron balance in dialysis patients, while at the same time eliminating the associated nursing and pharmaceutical IV iron administration costs. Rockwell licensed the exclusive rights to the patent which covers the pharmaceutical composition, methods of use and delivery of iron to be administered via dialysate to both hemodialysis and peritoneal dialysis patients.

The RO-1 grant has been awarded to Ajay Gupta, M.D., Associate Professor of Medicine at UCLA and inventor of FePPi delivery via dialysate, and Charles R. Drew University of Medicine and Science in Los Angeles, California. The acute and chronic effects of dialysate iron on serum levels of catalytically active iron and markers of inflammation and oxidative stress will be measured.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting the kidney. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields as well as many basic science disciplines.

(return to Top of Page) Wednesday February 11, 2004

WIXOM, Mich. -- Rockwell Medical Technologies, Inc. a leading, innovative hemodialysis concentrate manufacturer in the healthcare industry, reported that the U.S. Patent and Trademark Office (USPTO) served notice of issuance for the patent covering the use of ferric pyrophosphate (FePPi), a form of iron, for which the Company has licensed the exclusive rights.

Rockwell has been developing an innovative, proprietary concentrate product that contains iron. The Company is seeking FDA approval of the product which it intends to market. Ferric pyrophospate (FePPi), a water-soluble form of iron, is the cornerstone of Rockwell's proprietary technology for its iron-therapy product line. The Company plans to administer FePPi via dialysate for iron maintenance treatment in dialysis patients. As compared to intravenous (IV) iron administration, the Company believes that administering the drug through its dialysate is a safer and more effective method for maintaining iron balance in dialysis patients, while at the same time eliminating the associated nursing and pharmaceutical IV iron administration costs. Rockwell licensed the exclusive rights to the patent which covers the pharmaceutical composition, methods of use and delivery of iron to be administered via dialysate to both hemodialysis and peritoneal dialysis patients.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “This patent approval covering the U.S. market is a significant step for Rockwell. It protects the Company's potential future revenue stream generated from its proprietary iron-therapy product line. We believe Rockwell's iron-therapy initiative could have major impact on the dialysis market in terms of providing a safer and more economical alternative to the current IV iron drugs, as well as capturing significant market share. This is another step in potentially positioning Rockwell to become a global leader in providing improved patient outcomes worldwide.”

In July of 2003, Rockwell's iron-therapy product received "combination product" classification from the FDA. The iron-therapy product has been classified as a drug within a device. The Company anticipates submitting its Phase III clinical trial protocol to the FDA sometime during the first half of 2004. Rockwell estimates that the U.S. dialysis market for IV iron generates between $270 million to $300 million in annual revenue.

Based on results from FDA approved Phase II clinical studies, using dialysate as the delivery mechanism in hemodialysis patients, FePPi decreases the need for IV iron by 80% and consequently reduces the risks associated with the toxic effects of IV iron such as hypotension and anaphylactoid reactions, which can be life threatening. Unlike IV iron, FePPi does not require processing by the liver and thereby eliminates liver toxicity. Phase II clinical studies also showed that FePPi is well tolerated by patients without any short-term or long-term side effects. Moreover, it maintains a constant state of iron balance thereby facilitating the hematopoietic effects of erythropoietin without overloading the tissues with iron and thereby mitigating oxidative injury. Released pyrophosphate is also an anti-oxidant, which reduces the negative impact of oxidative stress that occurs to the patient during dialysis.

Iron deficiency is very common among hemodialysis patients due to 1) the administration of a drug called EPOGEN® (trademark of Amgen, Inc.; generic name Epoetin alfa) which helps the body make red blood cells but also increases the need for iron, and 2) the loss of blood the dialysis patient experiences during treatment. Currently, a dialysis patient can receive iron orally, which is not very effective due to stomach problems, nausea and poor patient compliance, or intravenously, whereas iron is absorbed into the liver and is slowly released into the bloodstream losing some of its potency, and which can also cause serious adverse reactions. IV iron is the most prevalent form of iron administration presently used in dialysis and is manufactured by American Regent Laboratories, Inc. under the trademark Venofer® and by Watson Pharmaceuticals, Inc. under the trademark Ferrlecit®.


(return to Top of Page) Monday July 14, 2003

WIXOM, Mich. -- Rockwell Medical Technologies, Inc., a leading, innovative hemodialysis concentrate manufacturer in the healthcare industry, reported today that it received notification from the U.S. Food and Drug Administration (FDA) that's its Dialysate Iron Concentrate has received product classification as a "combination product" for the approval process going forward. The allowed submission is a unique embedded classification (drug within a device).

The FDA's Center for Devices and Radiological Health (CDRH) will have lead responsibility for the combination product's premarket review and regulation. CDRH has advised that a premarket approval application (PMA) will be required. Complete information related to the drug component will be submitted to the Center for Drug Evaluation and Research (CDER) in a format similar to that required for a new drug application (NDA) as a separate section of the PMA. Clinical investigations of the combination product are already in progress under an investigational new drug (IND) application and will continue. CDER will retain lead responsibility for the clinical investigations and consult with CDRH as appropriate.

Mr. Robert L. Chioini, Chairman, CEO and President of Rockwell stated, “This determination of regulatory responsibility from the FDA is a significant milestone toward getting marketing approval in the U.S. for Dialysate Iron. This decision was consistent with our expectation and we are pleased that we can now proceed with the next steps in the FDA approval process. We believe Rockwell's Dialysate Iron has the potential to become the preferred dialysate in the provider market while at the same time to aggressively compete for the $270 million-plus U.S. iron maintenance therapy market.”

Rockwell's Dialysate Iron has two modes of action. One action of the product is to remove excess waste products and toxins from the blood of patients with renal failure, just like the Company's commercially available dialysate concentrates. Another action is to provide supplementary iron during the dialysis treatment as an alternative to maintenance oral or intravenous (IV) iron therapy to prevent the development of iron deficiency. The FDA determined that the dialysate (device) component's role represents the primary mode of action of the combination product.

WIXOM, Mich. -- Rockwell Medical Technologies, Inc. a leading, innovative hemodialysis concentrate manufacturer in the healthcare industry, reported today that it has signed separate licensing agreements that give the Company exclusive, worldwide proprietary rights to manufacture, market and distribute a water-soluble iron supplement via the Company's dialysate.

Rockwell Medical Technologies, Inc. has entered into global licensing agreements, with both Ash Medical Systems, Inc. and Charak, LLC, that grant the Company the exclusive, worldwide rights to manufacture, market and distribute liquid and dry dialysate compositions containing water-soluble iron to be administered to both hemodialysis and peritoneal dialysis patients with renal failure.

Ash Medical Systems, Inc., based in Indiana, was co-founded by Nephrologist Dr. Stephen Ash who serves as the Chairman and Director of Research and Development. Charak, LLC, based in Ann Arbor, MI, was founded by Nephrologist Dr. Ajay Gupta who serves as the President and CEO.

Rockwell has licensed all patents, issued and pending, from both Ash Medical Systems, Inc. and Charak, LLC relating to the pharmaceutical composition, methods of use and delivery for all iron compounds, and specifically ferric pyrophosphate, to a dialysis patient. Based on results from FDA approved Phase II clinical studies, using dialysate as the delivery mechanism in hemodialysis patients, ferric pyrophosphate decreases the need for intravenous iron (IV iron) by 80% and consequently reduces the risks associated with the toxic effects of IV iron such as hypotension and anaphylactoid reactions, which can be life threatening. Unlike the IV iron, ferric pyrophosphate does not require processing by the liver and thereby eliminates the liver toxicity. It is effective in treating patients who are not able to release iron from storage sites due to a co-existent inflammatory state. Phase II clinical studies also showed that ferric pyrophosphate is well tolerated by patients without any short-term or long-term side effects. Most importantly, it maintains a constant state of iron balance thereby facilitating the hematopoietic effects of erythropoietin (EPOGEN), without overloading the tissues with iron and thereby mitigating oxidative injury. Released pyrophosphate is also an anti-oxidant, which reduces the negative impact of oxidative stress that occurs to the patient during dialysis.

Iron administration via dialysate is ideally suited for hemodialysis and peritoneal dialysis patients, and also those receiving hemodialysis at home who currently must travel to a hospital on a regular basis to receive IV iron. Furthermore, iron delivery via the dialysate eliminates nursing and pharmaceutical administration costs associated with IV iron administration.

Iron deficiency is very common among hemodialysis patients due to the administration of a drug manufactured by Amgen, Inc. (Nasdaq: AMGN), called EPOGEN (Epoetin alfa), that helps the body make red blood cells but also increases the body's need for iron, and due to the loss of blood that the dialysis patient experiences during treatment. Currently, a dialysis patient can receive iron orally, which is not very effective due to stomach problems, nausea and poor patient compliance, or intravenously, whereas iron is absorbed into the liver and is slowly released into the bloodstream losing much of its potency, and which can also cause serious adverse reactions. IV iron is the most prevalent form of iron administration currently used in dialysis and is manufactured by both American Regent Laboratories, Inc. and Watson Pharmaceuticals, Inc. (NYSE: WPI).

Rockwell estimates that the U.S. dialysis market for IV iron supplements represents greater than $350,000,000 annually. Worldwide it estimates that there are more than 1 million dialysis patients. The Company estimates that the global market potential for iron supplementation is more than double the U.S. potential representing approximately $750,000,000 annually.

Mr. Rob Chioini, Chairman, CEO and President of Rockwell said, “We are extremely pleased to have secured these exclusive, proprietary licensing rights. Dr. Gupta and Dr. Ash are experienced and well respected nephrologists within the renal community, and both have a passion for their work. This product will benefit both the dialysis patient and the dialysis provider. Dialysis patients need iron and based on clinical work, ferric pyrophosphate administered via dialysate is a safer, more effective and less costly method to deliver the needed iron to the dialysis patient.” Mr. Chioini further stated, “Adding ferric pyrophosphate to our acidified concentrate product line will give us a proprietary product and should put us in a strong position to increase market share in the dialysis concentrate market. This development, coupled with our Dri-Sate Dry Acid Concentrate and our recent exclusive blood tubing contract, gives us the ability to offer innovative, high-quality, proprietary pr oducts that not only lower the cost-per-treatment for the dialysis provider but that also improve the quality of patient care every dialysis provider can offer.”

Dr. Ajay Gupta, President of Charak, LLC stated, “Administration of ferric pyrophosphate via dialysate is a major advancement in the treatment of anemia in hemodialysis patients. It is the first demonstration that a simple iron salt can be delivered safely and effectively directly into the blood stream. It has potential to overcome functional iron deficiency, a hallmark of kidney failure, and thereby overcome resistance to EPOGEN action. Compared with the polymeric iron complexes delivered intravenously it has potential to reduce liver iron accumulation and liver injury, reduce oxidative stress and the associated vascular disease that predisposes heart attacks, strokes and gangrene and reduce vascular calcification.”

Dr. Stephen Ash, Chairman and Director of R&D of Ash Medical Systems, Inc. said, “The cost, effort and risk of IV iron is a problem to every dialysis unit in the country. The safe and effective administration of iron salts through dialysate should very quickly become the most desirable dialysate for the great majority of dialysis patients worldwide.”


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