RMTI Rockwell Medical Inc.

0.71
-0.02  -3%
Previous Close 0.74
Open 0.72
52 Week Low 0.7091
52 Week High 1.98
Market Cap $66,850,914
Shares 93,628,731
Float 80,273,804
Enterprise Value $48,189,973
Volume 363,654
Av. Daily Volume 1,145,690
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Drug Pipeline

Drug Stage Notes
FPC
Iron deficiency anemia (IDA) - home infusion setting
Phase 2
Phase 2
Phase 2 trial to be initiated 2H 2021.
IV Triferic
Anemia
Approved
Approved
FDA approval announced date March 27, 2020.
Soluble Ferric Pyrophosphate
Anemia
Approved
Approved
Approved January 26, 2015.

Latest News

  1. WIXOM, Mich., July 29, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it will host a conference call on Monday, August 16, 2021, at 4:30 p.m. ET to discuss its financial results for the three months ended June 30, 2021, and recent operational highlights.

    To access the conference call, please dial (877) 377-7548 (local) or (760) 666-3756 (international) at least 10 minutes prior to the start time and refer to conference ID 1254179. A live webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's…

    WIXOM, Mich., July 29, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it will host a conference call on Monday, August 16, 2021, at 4:30 p.m. ET to discuss its financial results for the three months ended June 30, 2021, and recent operational highlights.

    To access the conference call, please dial (877) 377-7548 (local) or (760) 666-3756 (international) at least 10 minutes prior to the start time and refer to conference ID 1254179. A live webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, https://ir.rockwellmed.com/. An archived webcast will be available on the Company's website approximately two hours after the event and will be available for 30 days.

    To submit questions in advance, please email your questions to .

    About Rockwell Medical

    Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients' lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. The Company is developing FPC for the treatment of iron deficiency in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting, a large and rapidly growing segment of healthcare, and where these patients suffer from chronic diseases associated with high incidence of iron deficiency and anemia. In addition, Rockwell Medical is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States. For more information, visit www.RockwellMed.com.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



    Primary Logo

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  2. RMTI)" src="https://www.getnews.info/wp-content/uploads/2021/07/1626704860.png" alt="Advancing New Therapies for Anemia which Affects 1.6 Billion People Worldwide: Rockwell Medical (NASDAQ:RMTI)" width="225" height="57" />
    • Commercial Stage Developer of Advanced Treatments for Anemia. 

    • Major Supplier of Hemodialysis Concentrate Products to Kidney Dialysis Clinics in the United States.

    • Pre-IND Meeting Request with FDA for Proposed Clinical Trial of Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion. 

    • Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates – Minimum Value $11.4 Million. 

    • Exclusive License Agreement with Drogsan Pharmaceuticals in Turkey. 

    Rockwell

    RMTI)" src="https://www.getnews.info/wp-content/uploads/2021/07/1626704860.png" alt="Advancing New Therapies for Anemia which Affects 1.6 Billion People Worldwide: Rockwell Medical (NASDAQ:RMTI)" width="225" height="57" />
    • Commercial Stage Developer of Advanced Treatments for Anemia. 

    • Major Supplier of Hemodialysis Concentrate Products to Kidney Dialysis Clinics in the United States.

    • Pre-IND Meeting Request with FDA for Proposed Clinical Trial of Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion. 

    • Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates – Minimum Value $11.4 Million. 

    • Exclusive License Agreement with Drogsan Pharmaceuticals in Turkey. 

    Rockwell Medical (NASDAQ: RMTI) is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives. 

    RMTI has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. RMTI is developing FPC for the treatment of iron deficiency in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting, a large and rapidly growing segment of healthcare, and where these patients suffer from chronic diseases associated with high incidence of iron deficiency and anemia. In addition, RMTI is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States.

    THE ROLE OF IRON IN MAINTAINING HEALTH

    Iron is very important in maintaining many body functions, including the production of hemoglobin, the molecule in the blood that carries oxygen. If the body doesn’t have sufficient hemoglobin, tissues and muscles don’t get enough oxygen to function effectively. This leads to a condition called anemia.

    Iron deficiency is very common, and approximately 10 million people are iron deficient in the United States. Inadequate iron intake due to poor diet or restrictive diets can lead to iron deficiency, as well as numerous other underlying diseases and risk factors.

    Anemia affects more than 1.6 billion people globally and over 3 million people in the U.S. Iron deficiency is the most common cause of anemia worldwide, afflicting several hundred million people. Severe iron-deficiency anemia may cause fatigue or tiredness, shortness of breath, or chest pain.

    • RMTI Works to Manage Iron in a New Way 

    The RMTI ferric pyrophosphate citrate (FPC) product is a novel complex iron salt, developed to replace iron losses in patients with anemia in an entirely new way. This unique and differentiated molecule consists of an iron atom complexed to one pyrophosphate and two citrate anions. This RMTI formulation has been shown to allow for rapid donation of iron to transferrin, protein in the blood that binds to iron and transports it through the body, including to the bone marrow. This mechanism uses the body’s own means to transport iron safely to tissues that need iron (i.e. red blood cells and muscle).

    The RMTI FPC product is a form of protected iron in which citrate and pyrophosphate are tightly complexed to the iron. The molecule is water soluble, making the iron completely bioavailable. FPC has the ability to deliver iron directly and completely to transferrin. This transferrin-bound iron is immediately delivered to the bone marrow to be incorporated into hemoglobin.

    The structure of FPC minimizes the potential for the iron to be taken up into the body’s storage cells, such as those present in the liver and other tissues. Iron release from body storage cells can be slowed or blocked when inflammation is present. Because of its Mechanism of Action, FPC increases bioavailable iron without excessively increasing body iron stores or causing inflammation, iron toxicity, or oxidative stress.

    In addition, FPC iron is delivered regardless of other underlying conditions which might otherwise block the release of iron. Some of the challenges of managing iron in sick patients, including inflammation, hepcidin block, and functional iron deficiency, can be overcome with FPC due to its ability to provide bioavailable iron.

    • RMTI Files Pre-IND Meeting Request with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion 

    On June 28th RMTI announced that it has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.

    Home infusion represents a large and rapidly growing segment of healthcare. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue and can result in serious health risks, such as, poor immune function and heart failure.

    • Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates – Minimum of Approximately $11.4M in Purchases Over 3-year Period

    On June 11th RMTI announced that it extended its distribution agreement with its long-term distribution partner, Nipro Medical Corporation (NMC), for a period of three years through May 2024. The agreement was originally initiated in 2008. With the extension of the agreement, NMC will continue to distribute dialysis concentrates manufactured by RMTI to numerous countries in Latin America and the Caribbean. NMC is a leading renal, medical, surgical and interventional radiology products manufacturer and a major distributor of renal products in these regions.

    • RTIMand Drogsan Pharmaceuticals Enter into Exclusive License Agreement for the Rights to Commercialize TRIFERIC® in Turkey

    – With approximately 65,000 patients receiving hemodialysis annually, Turkey represents a significant and expanding market opportunity –

    On June 8th RMTI and Drogsan Pharmaceuticals, a leading pharmaceutical company in Turkey with an established presence in the nephrology space having launched the first locally manufactured biosimilar in 2014 and building it to be the leader in the Epoetin Alfa market in Turkey, announced that the Companies entered into an exclusive license agreement for the rights to commercialize the RMTI Triferic AVNU (ferric pyrophosphate citrate injection) product in Turkey.

    Under the terms of the license agreement, Drogsan will be the exclusive development and commercialization partner for Triferic in Turkey and RMTI will supply the product to Drogsan. The agreement also allows for Drogsan to negotiate further geographic expansion into the surrounding region. In consideration for the license, RMTI will receive an upfront fee and will be eligible for milestone payments based on reimbursement price approval.

    For more information on Rockwell Medical (RMTI) visit: https://www.rockwellmed.com

    DISCLAIMER:

    CAP/FrontPageStocks/CorporateAds.com (CA) is a third-party publisher and news dissemination service provider. CAP/FPS/CA is NOT affiliated in any manner with any company mentioned herein. CAP/FPS/CA is a news dissemination solutions provider and is NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. CAP/FPS/CA’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release or opinion of the writer. CAP/FPS/ CA is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. CAP/FPS/CA has been compensated $500 by a third party for dissemination of this article.

    Disclaimer/Safe Harbor:

    These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur.

    Media Contact
    Company Name: Rockwell Medical, Inc.
    Contact Person: Dr. Russell H. Ellison M.Sc., M.D., MSc. Pres, CEO & Director
    Email: Send Email
    Phone: 248 960 9009
    Address:0142 South Wixom Avenue Suite 501
    City: Wixom
    State: MI 48393
    Country: United States
    Website: https://www.rockwellmed.com/

    View Full Article Hide Full Article
  3. RMTI)" src="https://www.getnews.info/wp-content/uploads/2021/07/1625504602.png" alt="Next Generation BioPharma with Advanced Treatments for Anemia & FDA-Approved Therapies: Rockwell Medical (NASDAQ:RMTI)" width="225" height="57" />
    • Commercial Stage Developer of Advanced Treatments for Anemia. 

    • Major Supplier of Hemodialysis Concentrate Products to Kidney Dialysis Clinics in the United States.

    • Pre-IND Meeting Request with FDA for Proposed Clinical Trial of Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion. 

    • Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates – Minimum Value $11.4 Million. 

    • Exclusive License Agreement with Drogsan Pharmaceuticals in Turkey. 

    RMTI)" src="https://www.getnews.info/wp-content/uploads/2021/07/1625504602.png" alt="Next Generation BioPharma with Advanced Treatments for Anemia & FDA-Approved Therapies: Rockwell Medical (NASDAQ:RMTI)" width="225" height="57" />
    • Commercial Stage Developer of Advanced Treatments for Anemia. 

    • Major Supplier of Hemodialysis Concentrate Products to Kidney Dialysis Clinics in the United States.

    • Pre-IND Meeting Request with FDA for Proposed Clinical Trial of Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion. 

    • Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates – Minimum Value $11.4 Million. 

    • Exclusive License Agreement with Drogsan Pharmaceuticals in Turkey. 


    Rockwell Medical (NASDAQ:
    RMTI) is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients’ lives. 

    RMTI has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. RMTI is developing FPC for the treatment of iron deficiency in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting, a large and rapidly growing segment of healthcare, and where these patients suffer from chronic diseases associated with high incidence of iron deficiency and anemia. In addition, RMTI is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States.

    THE ROLE OF IRON IN MAINTAINING HEALTH

    Iron is very important in maintaining many body functions, including the production of hemoglobin, the molecule in the blood that carries oxygen. If the body doesn’t have sufficient hemoglobin, tissues and muscles don’t get enough oxygen to function effectively. This leads to a condition called anemia.

    Iron deficiency is very common, and approximately 10 million people are iron deficient in the United States. Inadequate iron intake due to poor diet or restrictive diets can lead to iron deficiency, as well as numerous other underlying diseases and risk factors.

    Anemia affects more than 1.6 billion people globally and over 3 million people in the U.S. Iron deficiency is the most common cause of anemia worldwide, afflicting several hundred million people. Severe iron-deficiency anemia may cause fatigue or tiredness, shortness of breath, or chest pain.

    • RMTI Works to Manage Iron in a New Way 

    The RMTI ferric pyrophosphate citrate (FPC) product is a novel complex iron salt, developed to replace iron losses in patients with anemia in an entirely new way. This unique and differentiated molecule consists of an iron atom complexed to one pyrophosphate and two citrate anions. This RMTI formulation has been shown to allow for rapid donation of iron to transferrin, protein in the blood that binds to iron and transports it through the body, including to the bone marrow. This mechanism uses the body’s own means to transport iron safely to tissues that need iron (i.e. red blood cells and muscle).

    The RMTI FPC product is a form of protected iron in which citrate and pyrophosphate are tightly complexed to the iron. The molecule is water soluble, making the iron completely bioavailable. FPC has the ability to deliver iron directly and completely to transferrin. This transferrin-bound iron is immediately delivered to the bone marrow to be incorporated into hemoglobin.

    The structure of FPC minimizes the potential for the iron to be taken up into the body’s storage cells, such as those present in the liver and other tissues. Iron release from body storage cells can be slowed or blocked when inflammation is present. Because of its Mechanism of Action, FPC increases bioavailable iron without excessively increasing body iron stores or causing inflammation, iron toxicity, or oxidative stress.

    In addition, FPC iron is delivered regardless of other underlying conditions which might otherwise block the release of iron. Some of the challenges of managing iron in sick patients, including inflammation, hepcidin block, and functional iron deficiency, can be overcome with FPC due to its ability to provide bioavailable iron.

    • RMTI Files Pre-IND Meeting Request with FDA for its Proposed Clinical Trial of FPC as a Treatment for Iron Deficiency Anemia in Patients Receiving Home Infusion 

    On June 28thRMTI announced that it has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.

    Home infusion represents a large and rapidly growing segment of healthcare. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue and can result in serious health risks, such as, poor immune function and heart failure.

    • Extension of Multi-Year Distribution Agreement with Nipro Medical Corporation for Dialysis Concentrates – Minimum of Approximately $11.4M in Purchases Over 3-year Period

    On June 11thRMTI announced that it extended its distribution agreement with its long-term distribution partner, Nipro Medical Corporation (NMC), for a period of three years through May 2024. The agreement was originally initiated in 2008. With the extension of the agreement, NMC will continue to distribute dialysis concentrates manufactured by RMTI to numerous countries in Latin America and the Caribbean. NMC is a leading renal, medical, surgical and interventional radiology products manufacturer and a major distributor of renal products in these regions.

    • RTIMand Drogsan Pharmaceuticals Enter into Exclusive License Agreement for the Rights to Commercialize TRIFERIC® in Turkey


    With approximately 65,000 patients receiving hemodialysis annually, Turkey represents a significant and expanding market opportunity

    On June 8thRMTI and Drogsan Pharmaceuticals, a leading pharmaceutical company in Turkey with an established presence in the nephrology space having launched the first locally manufactured biosimilar in 2014 and building it to be the leader in the Epoetin Alfa market in Turkey, announced that the Companies entered into an exclusive license agreement for the rights to commercialize the RMTI Triferic AVNU (ferric pyrophosphate citrate injection) product in Turkey.

    Under the terms of the license agreement, Drogsan will be the exclusive development and commercialization partner for Triferic in Turkey and RMTI will supply the product to Drogsan. The agreement also allows for Drogsan to negotiate further geographic expansion into the surrounding region. In consideration for the license, RMTI will receive an upfront fee and will be eligible for milestone payments based on reimbursement price approval.

    For more information on Rockwell Medical (RMTI) visit: https://www.rockwellmed.com

    DISCLAIMER:

    CAP/FrontPageStocks/CorporateAds.com (CA) is a third-party publisher and news dissemination service provider. CAP/FPS/CA is NOT affiliated in any manner with any company mentioned herein. CAP/FPS/CA is a news dissemination solutions provider and is NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. CAP/FPS/CA’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release or opinion of the writer. CAP/FPS/ CA is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. CAP/FPS/CA has been compensated $500 by a third party for dissemination of this article.

    Disclaimer/Safe Harbor:

    These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur.

    Media Contact
    Company Name: Rockwell Medical, Inc.
    Contact Person: Dr. Russell H. Ellison M.Sc., M.D., MSc. Pres, CEO & Director
    Email: Send Email
    Phone: 248 960 9009
    Address:0142 South Wixom Avenue Suite 501
    City: Wixom
    State: MI 48393
    Country: United States
    Website: https://www.rockwellmed.com/

    View Full Article Hide Full Article
  4. WIXOM, Mich., June 28, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.

    Home infusion represents a large and rapidly growing segment of healthcare. Many patient groups requiring home infusion therapies…

    WIXOM, Mich., June 28, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of its proposed Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC), designed for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting.

    Home infusion represents a large and rapidly growing segment of healthcare. Many patient groups requiring home infusion therapies suffer from chronic diseases that are associated with a high incidence of iron deficiency and anemia. For example, it is estimated that 40%-55% of all home parenteral nutrition patients are iron deficient. Current treatment patterns can be inadequate for patients on home infusion therapy with iron deficiency anemia, causing them to suffer extreme fatigue and can result in serious health risks, such as, poor immune function and heart failure.

    "This is an important step for Rockwell Medical and home infusion patients as we believe that FPC is uniquely suited to address this important unmet clinical need," said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. "We expect to finalize our Phase 2 clinical study design and protocol with the advice and guidance of the FDA."

    About Rockwell Medical

    Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients' lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. The Company is developing FPC for the treatment of iron deficiency in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting, a large and rapidly growing segment of healthcare, and where these patients suffer from chronic diseases associated with high incidence of iron deficiency and anemia. In addition, Rockwell Medical is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States. For more information, visit www.RockwellMed.com.

    Rockwell Medical Forward-Looking Statements

    Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates, expectations and beliefs and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), that could cause actual results to differ materially from those described in the forward-looking statements. Actual results could be materially different. Risks and uncertainties include, but are not limited to statements regarding the therapeutic benefits, plans and objectives for regulatory approval of the Company's product(s); ability to obtain FDA approval and advance our product to market; risks associated with our development work, including delays, or changes to the timing, cost and success of our product development activities and clinical trials; risks of delay in the FDA approval of FPC; risks inherent in the marketing, sales and commercializing a new product; risks relating to the size and growth of the home infusion market and acceptance of FPC; risks of sufficient capital and cash resources, including access either debt or equity financing to fund such product development; and the risk of compliance with all FDA and other government requirements relating to the development and manufacturing of our product; the impact of the COVID-19 pandemic (including, applicable international or domestic orders) on our ability to operate Rockwell's manufacturing facilities in a manner that avoids any disruptions, expected financial performance, including cash flows, revenues, growth, margins, funding, liquidity and capital resources, and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and of our Annual Report on Form 10-K for the year ended December 31, 2020, as such descriptions may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

    ROCKWELL MEDICAL CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

     



    Primary Logo

    View Full Article Hide Full Article
  5. WIXOM, Mich., June 11, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it extended its distribution agreement with its long-term distribution partner, Nipro Medical Corporation (NMC), for a period of three years through May 2024. The agreement was originally initiated in 2008. With the extension of the agreement, NMC will continue to distribute dialysis concentrates manufactured by Rockwell Medical to numerous countries in Latin America and the Caribbean. NMC is a leading renal, medical, surgical and interventional radiology products manufacturer…

    WIXOM, Mich., June 11, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it extended its distribution agreement with its long-term distribution partner, Nipro Medical Corporation (NMC), for a period of three years through May 2024. The agreement was originally initiated in 2008. With the extension of the agreement, NMC will continue to distribute dialysis concentrates manufactured by Rockwell Medical to numerous countries in Latin America and the Caribbean. NMC is a leading renal, medical, surgical and interventional radiology products manufacturer and a major distributor of renal products in these regions.

    "We have a longstanding relationship with Nipro Medical Corporation, a partner of choice, and are pleased to extend our distribution agreement to continue to bring important dialysate concentrate products to patients," said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. "We look forward to working with Nipro to optimize sales of Triferic in numerous countries in Latin America and the Caribbean."

    "We welcome the opportunity to extend our relationship with Rockwell Medical and to distribute their important renal products to dialysis clinics in Latin America and the Caribbean," said Manny Zapata, Renal Division Manager Latin America, Nipro Medical Corporation. "The region provides a significant market opportunity, and we expect to see continued growth in the number of patients undergoing hemodialysis in the coming years. We look forward to working with Rockwell Medical to grow our business in this region."

    About Rockwell Medical's Hemodialysis Concentrates Business

    Rockwell Medical is the second largest supplier of hemodialysis concentrates in the United States, with core capabilities in the manufacture of hemodialysis concentrates under cGMP conditions in three U.S. facilities, as well as in the logistics of delivering these products to dialysis clinics throughout most of the United States. The Company's reputation is based on more than 25 years of service to U.S. kidney dialysis centers. This business segment generates about $60 million in annual revenue. Rockwell Medical also supplies dialysis concentrates to distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim.

    About Rockwell Medical

    Rockwell Medical is a commercial-stage biopharmaceutical company developing and commercializing its next-generation parenteral iron technology platform, Ferric Pyrophosphate Citrate (FPC), which has the potential to lead to transformative treatments for iron deficiency in multiple disease states, reduce healthcare costs and improve patients' lives. The Company has two FDA-approved therapies indicated for patients undergoing hemodialysis, which are the first two products developed from the FPC platform. Rockwell Medical is also advancing its FPC platform by developing FPC for the treatment of iron deficiency anemia in patients outside of dialysis, who are receiving intravenous medications in the home infusion setting. In addition, Rockwell Medical is one of two major suppliers of life-saving hemodialysis concentrate products to kidney dialysis clinics in the United States. For more information, visit www.RockwellMed.com.

    Rockwell Medical Forward-Looking Statements

    Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, the sales of Rockwell Concentrates in foreign jurisdictions, the ability of NMC to market and distribute Rockwell's products, and the ability to reach certain minimums set forth within the contract. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend" or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include, but are not limited to: the impact of the COVID-19 pandemic (including, applicable international or domestic orders), the ability to operate Rockwell's manufacturing facilities in a manner that avoids any disruptions, on the ability to of RMC to secure necessary government tenders in applicable jurisdictions; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended March 31, 2021 and of our Annual Report on Form 10-K for the year ended December 31, 2020, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



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