Rockwell Medical, Inc. Appoints Dr. Allen R. Nissenson to Board of Directors
Rockwell Medical, Inc. (Nasdaq: RMTI) (“Rockwell Medical” or the
“Company”), a biopharmaceutical company dedicated to transforming
anemia management and improving outcomes for patients around the
world, today announced the appointment of industry leader and
renowned authority on kidney disease, Allen R. Nissenson, M.D.,
F.A.C.P., to its Board of Directors, effective June 11, 2020. Dr.
Nissenson serves as an Emeritus Professor of Medicine at the David
Geffen School of Medicine at University California Los Angeles,
Emeritus Chief Medical Officer of DaVita Kidney Care, and a member
of the Board of Directors of Angion Biomedica Corp.
“We are pleased to welcome Allen to the Board of
Directors,” said John P. McLaughlin, Chairman of the Board of
Directors of Rockwell Medical. “We expect Allen’s clinical,
regulatory and public policy expertise, combined with his senior
executive experience at a large dialysis organization, will make
him a valuable advisor as we seek to expand the reach and impact of
Triferic® (ferric pyrophosphate citrate) in End-Stage Renal
"I am delighted to join Rockwell Medical’s Board
of Directors at this exciting time for the Company," said Dr.
Nissenson. "I look forward to working with the Board and Executive
Team to help transform the treatment of kidney patients and create
value for patients and shareholders."
In addition to his current roles, Dr. Nissenson
is the immediate past Chair of Kidney Care Partners, immediate past
Co-Chair of the Kidney Care Quality Alliance, and he served as
Director of the Dialysis Program and Associate Dean at the David
Geffen School of Medicine. He is a former President of the Renal
Physicians Association and current member of the Government Affairs
Committee. Dr. Nissenson also previously served as President of the
Southern California End-Stage Renal Disease Network, as well as
Chair of the Medical Review Board. He earned his M.D. from
Northwestern University Medical School.
About Rockwell Medical
Rockwell Medical is a biopharmaceutical company
dedicated to transforming 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 renal disease (ESRD). 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
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 1,000,000 patient administrations, addressing a
significant medical need in overcoming Functional Iron Deficiency
(FID) in ESRD patients.
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
Triferic® is a registered trademark of Rockwell Medical,
Inc. Triferic AVNU is pending with the U.S. Patent and
Media:David Rosen Argot Partners