- Limitations of Currently Available Therapies and Lack of
Consensus Guidelines Lead to Suboptimal Treatment of Iron
Deficiency Anemia -
- Most Survey Respondents Expressed a Preference for an
At-Home Infusion Versus a Visit to an Outpatient Infusion Center
-
- Survey Highlights to be Presented at the NHIA 2022 Annual
Conference -
WIXOM, Mich. and NASHVILLE, Tenn., March
15, 2022 /PRNewswire/ -- 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 presented survey
findings in oral and poster presentations at the National Home
Infusion Association's (NHIA) 2022 Annual Conference, taking place
March 12 through 16, 2022 in
Nashville, Tennessee.
In collaboration with NHIA and other professional and patient
organizations, Rockwell Medical surveyed a total of 202 physicians,
dieticians, pharmacists, and home parenteral nutrition (HPN)
patients to identify opportunities for improving the management of
iron deficiency anemia (IDA) in home parenteral nutrition (HPN)
patients, specifically around understanding current diagnosis,
treatment and practice patterns. IDA is a serious comorbidity for
many sub-groups of patients who are receiving longer-term home
infusion therapy. If left untreated IDA can lead to serious health
risks including immune system compromise, severe fatigue and heart
failure. The risk of IDA is particularly high in the HPN
population, where prevalence rates in the range of 36-55% have been
reported1,2.
A copy of the poster presentation with survey highlights can be
accessed on the Investors section of the Company's website at
https://ir.rockwellmed.com once the presentation has
concluded.
Results from the survey confirmed that there was no clear
consensus among healthcare providers (HCPs) as to the hemoglobin
level that should trigger therapeutic intervention for IDA.
Inconsistent treatment patterns for IDA and limitations with
current therapies were confirmed by both HCPs and HPN patients.
Patients who have been treated for IDA reported issues with
efficacy and tolerability, and most expressed a preference for an
at-home infusion versus a visit to an outpatient infusion
center.
"Access to medications best infused at home is an emerging
frontier for healthcare, and we believe treatment of IDA with an IV
iron suitable for home infusion presents a significant opportunity
to benefit multiple afflicted patient populations," said
Marc Hoffman, M.D., Chief Medical
Officer of Rockwell Medical and co-author of the poster
presentation. "The survey results confirmed our initial assumptions
that a lack of consistency exists in the diagnosis, treatment and
management of IDA in HPN patients. Findings show a clear need for a
standard of care for IDA in this patient population and
improvements in defining the thresholds for intervention and the
targets for treatment are required if one is to be established. The
development of evidence-supported clinical practice guidelines
could be beneficial, and the availability of new anemia drugs
suitable for home infusion may also increase the likelihood of
successful, timely and consistent therapeutic intervention."
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. 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.
About Home Health and IDA in Home Infusion
Therapy
Home health is an area of medicine experiencing
explosive growth – a trend that will likely continue over the next
decade due to an aging US population, the need to control costs,
the desire to improve patient outcomes, and the convenience of home
healthcare.
Home infusion therapy, an important part of some home care
regimens, allows patients with diseases requiring regular infusions
of intravenous medications to be treated in the comfort of their
home and has been proven to be a cost-effective, safe, and
efficacious alternative to inpatient care for a variety of
therapies and disease states, both acute and chronic.
Treating IDA as part of an existing home infusion regimen more
effectively, calls for an innovative approach. Rockwell Medical is
developing a technology to manage iron in the home infusion
setting. Ferric Pyrophosphate Citrate (FPC) is Rockwell's novel
next-generation parenteral iron is anticipated to enter a Phase II
study for the treatment of IDA in the home infusion setting in the
first half of the year.
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 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 are more fully discussed in the
"Risk Factors" section of our Quarterly Report on Form 10-Q for the
period ended September 30, 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
Rockwell@argotpartners.com
Media:
David Rosen
Argot Partners
212.600.1902
david.rosen@argotpartners.com
1 Hwa YL, et al. Iron Deficiency in Long-Term
Parenteral Nutrition Therapy. JPEN 2016 Aug;40(6):869-76.
2 Khaodhiar L, et al. Iron deficiency anemia in
patients receiving home total parenteral nutrition. JPEN. 2002
Mar;26(2):114-119.
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SOURCE Rockwell Medical, Inc.