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 announced
that two abstracts have been accepted for poster presentation at
the American Society of Nephrology (ASN) Virtual Kidney Week
2020, which will occur from October 20 to 25, 2020.
Title: Use of Triferic and Outcomes of HDD
Patients: Initial Analysis Using 2016-2017
USRDSPresenter: Yi Zhang, Ph.D., Sr. Research
Associate, Medical Technology and Practice Patterns
InstituteSession Title: Hemodialysis and Frequent
Dialysis - 4E-Poster Number:
PO1213Abstract Number: 3450928
Title: Triferic (ferric pyrophosphate citrate,
FPC) Maintains Hemoglobin and Reduces IV Iron: Results from a
Single-site 2 Year Observational
AnalysisPresenter: Marc Hoffman, M.D., Chief
Medical Officer, Rockwell MedicalSession Title:
Anemia and Iron ManagementE-Poster Number:
PO0225Abstract Number: 3440944
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company
dedicated to transforming iron deficiency and anemia management in
a wide variety of therapeutic areas and across the globe, improving
the lives of very sick patients. The Company’s initial focus is the
treatment of anemia in end-stage kidney disease (ESKD). Rockwell
Medical's exclusive renal drug therapies, Triferic (ferric
pyrophosphate citrate) Dialysate and Triferic AVNU, are the only
FDA-approved therapeutics indicated for iron replacement and
maintenance of hemoglobin in hemodialysis patients. Rockwell
Medical is also an established manufacturer, supplier and leader in
delivering high-quality hemodialysis concentrates/dialysates to
dialysis providers and distributors in the U.S. and abroad.
About Triferic
Dialysate and Triferic
AVNU
Triferic Dialysate and Triferic AVNU are the
only FDA-approved therapies in the U.S. indicated to replace iron
and maintain hemoglobin in hemodialysis patients during each
dialysis treatment. Triferic Dialysate and Triferic AVNU have a
unique and differentiated mechanism of action, which has the
potential to benefit patients and health care economics. Triferic
Dialysate and Triferic AVNU represent a potential innovative
medical advancement in hemodialysis patient iron management – with
the potential to become the future standard of care.
Triferic Dialysate and Triferic AVNU both
deliver approximately 5-7 mg iron with every hemodialysis treatment
to the bone marrow and maintain hemoglobin without increasing iron
stores (ferritin). Both formulations donate iron immediately and
completely to transferrin (carrier of iron in the body) upon entry
into the blood which is then transported directly to the bone
marrow to be incorporated into hemoglobin, with no increase in
ferritin (stored iron and inflammation) and no reports of
anaphylaxis in over 1,200,000 patient administrations, addressing a
significant medical need in overcoming Functional Iron Deficiency
(FID) in ESKD patients.
Important Safety Information
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.
The most common adverse reactions (≥3% and at
least 1% greater than placebo) in controlled clinical studies
include: procedural hypotension (21.6%), muscle spasms (9.6%),
headache (9.2%), pain in extremity (6.8%), peripheral edema (6.8%),
dyspnea (5.8%), back pain (4.5%), pyrexia (4.5%), urinary tract
infection (4.5%), asthenia (4.1%), fatigue (3.8%), arteriovenous
(AV) fistula thrombosis (3.4%), and AV fistula site hemorrhage
(3.4%).
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, statements
relating to the abstract accepted for poster presentations. 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:
market and other conditions, the impact of the COVID-19 pandemic
(including federal or state orders) on business and operating
results; and those risks more fully discussed in the “Risk Factors”
section of our Quarterly Report on Form 10-Q for the period ended
June 30, 2020 and of our Annual Report on Form 10-K for the year
ended December 31, 2019, 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.
Triferic® is a registered trademark of Rockwell
Medical, Inc. Triferic AVNU is pending with the U.S. Patent and
Trademark Office. All other product names, logos, and brands
are property of their respective owners in the United
States and/or other countries. All company, product and
service names used on this website are for identification purposes
only. Use of these names, logos, and brands does not imply
endorsement.
CONTACTS
Investors:Argot
Partners212.600.1902Rockwell@argotpartners.com
Media:David RosenArgot
Partners212.600.1902david.rosen@argotpartners.com
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