iron deficiency treatment
iron deficiency treatment
iron deficiency treatment
iron deficiency treatment
iron deficiency treatment
iron deficiency anemia treatment
iron deficiency anemia treatment
iron deficiency anemia treatment
iron deficiency anemia treatment
iron deficiency anemia treatment
treating iron deficiency and anemia
treating iron deficiency and anemia
treating iron deficiency and anemia
treating iron deficiency and anemia
treating iron deficiency and anemia
treating iron deficiency
treating iron deficiency
treating iron deficiency
treating iron deficiency
treating iron deficiency

Transforming
Anemia Management

Rockwell Medical is a biopharmaceutical company dedicated to improving patients' lives through effective treatment of iron deficiency and anemia.

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Our Company Vision

Our vision is to establish a new standard of care for patients suffering with iron deficiency and iron deficiency anemia. Iron deficiency anemia afflicts a subset of the two billion people worldwide who are nutritionally iron deficientREF. Approximately 10 million people are iron deficient in the United States, including 5 million who have iron deficiency anemia.

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Our Platform Technology

Ferric pyrophosphate citrate (FPC)

Our innovative therapeutic was developed to replace iron loss in patients with anemia in an entirely different way. Our unique and differentiated molecule, Ferric Pyrophosphate Citrate (FPC), provides a novel mechanism of action with a physiologic approach. FPC donates iron directly to circulating transferrin making it immediately bioavailable for critical body processes, which allows the body to use the iron in a physiologic manner.

Ferric Pyrophosphate Citrate in blood

FPC is introduced to the blood

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FPC for iron deficiency

FPC donates iron directly and completely to transferrin – providing bioavailable iron for red blood cell production

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avoids iron sequestration

FPC avoids iron sequestration in liver and other healthy tissues

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hemoglobin formation

Transferrin-bound iron immediately delivered to bone marrow for hemoglobin formation

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FPC for maintaining hemoglobin

FPC delivers 100% bioavailable iron to maintain hemoglobin

Ferric Pyrophosphate Citrate in blood

FPC is introduced to the blood

arrow
FPC for iron deficiency

FPC donates iron directly and completely to transferrin – providing bioavailable iron for for red blood cell production

arrow
avoids iron sequestration

FPC avoids iron sequestration in liver and other healthy tissues

arrow
hemoglobin formation

Transferrin-bound iron immediately delivered to bone marrow for hemoglobin formation

arrow
FPC for maintaining hemoglobin

FPC delivers the desired amount of iron maintenance over time

This novel approach to the treatment of iron deficiency and anemia has the potential for application in many disease states.

Our initial area
of focus

Renal Disease

The first disease state we are focused on is End-stage Renal Disease, specifically patients on hemodialysis. There are over 2 million people on dialysis worldwide, including over half million in the United States alone. Blood loss and iron sequestration are leading causes of anemia in hemodialysis patients. Anemia in hemodialysis patients is caused by insufficient production of red blood cells as a result of progressive kidney failure, compounded by blood loss occurring during weekly dialysis treatments.

The first formulation of our proprietary technology is approved by the FDA under the brand name TRIFERIC. A new formulation for intravenous infusion, also for hemodialysis patients, was approved by the FDA in 2020 under the brand name TRIFERIC AVNU.

end-stage renal disease treatment
triferic | ferric pyrophosphate citrate

TRIFERIC is the first and only FDA-approved product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

TRIFERIC is a novel physiologic approach to iron maintenance - delivering bioavailable iron to replace what is lost at every dialysis treatment, resulting in hemoglobin stability.REF

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Important Safety Information for TRIFERIC

Indication

TRIFERIC is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Limitations of Use

TRIFERIC is not intended for use in patients receiving peritoneal dialysis. TRIFERIC has not been studied in patients receiving home hemodialysis.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.

Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Adverse Reactions

Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

To report an Adverse Events (AE) or Product Quality Control (PQC) please call the Medical Information Department at (855) 333-4315 or e-mail at rockwell.pharmacovigilance@​propharmagroup.com.

For more information, please see full Prescribing Information.

triferic avnu | ferric pyrophosphate citrate injection

Triferic AVNU is designed for direct intravenous infusion, which provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians.

Triferic AVNU can be administered regardless of a dialysis center’s mode of bicarbonate delivery. Many dialysis centers in international markets and an increasing number of dialysis centers in the U.S. have converted to the use of dry bicarbonate cartridges or bags and on-line dialysate generation, which is not compatible with Triferic Dialysate.

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Important Safety Information for TRIFERIC AVNU

Indication

TRIFERIC AVNU (ferric pyrophosphate citrate for injection) is an iron-replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.

Iron status should be determined on pre-dialysis blood samples. Post-dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Adverse Reactions

Most common adverse reactions (incidence ≥3%) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

For full Safety and Prescribing Information please visit www.Trifericavnu.com.

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Latest News

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September 24, 2020

Rockwell Medical Announces Growth Plan and New Therapeutic Opportunities for Its Ferric Pyrophosphate Citrate (FPC) Platform

-New indications for FPC platform provide significant growth opportunity- -Anticipates Type C m eeting with FDA for home infusion in Q1 202 1   and for acute heart failure in 2H 202 1 - -Well capitalized to fund dialysis business and advance clinical development for home infusion indication-

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September 23, 2020

Rockwell Medical Announces $35.0 Million Registered Direct Offering Priced At-The-Market under Nasdaq Rules

WIXOM, Mich. , Sept. 23, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today

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September 15, 2020

Rockwell Medical Announces Appointment of Russell L. Skibsted as Executive Vice President, Chief Financial Officer and Chief Business Officer

WIXOM, Mich. , Sept. 15, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today

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September 9, 2020

Rockwell Medical Enters into Exclusive License Agreement with Jeil Pharmaceutical Co., Ltd., for the Rights to Commercialize Triferic® in South Korea

Sizable and growing market opportunity with over 78,000 patients receiving hemodialysis annually WIXOM, Mich. , Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron

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September 9, 2020

Rockwell Medical to Host Conference Call and Webcast with Management and Key Opinion Leaders to Discuss Potential Novel Indications for Its FPC Platform

Call and Webcast Scheduled for September 24, 2020, at 4:30 p.m. Eastern WIXOM, Mich. , Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (Nasdaq: RMTI) ("Rockwell Medical" or the “Company”), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia

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