New Survey from Rockwell Medical Reveals Management of Iron Deficiency Anemia in Home Infusion Patients Does Not Adequately Address Medical Need

- 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
[email protected] 

Media:
David Rosen
Argot Partners
212.600.1902
[email protected] 

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.

SOURCE Rockwell Medical, Inc.