Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that the Company entered into a distribution services agreement (the "Agreement") with a leading manufacturer of medical equipment including hemodialysis machines, disposable products, and automated fluid balance systems (the "Partner"). Leveraging the Company's existing reliable distribution network and transportation subsidiary, Rockwell Medical will now be able to distribute a single-use bicarbonate cartridge to its customers at dialysis centers, hospital-based outpatient centers, and skilled nursing facilities.

Single-use bicarbonate disposables represent an approximate $100 million market opportunity, one of the fastest growing segments within the hemodialysis concentrates market. Under the terms of the Agreement, the Partner will supply Rockwell Medical with premium grade, single-use bicarbonate cartridges in two sizes, 720 grams and 900 grams, both of which are 510(k) approved by the U.S. Food and Drug Administration. The Partner is responsible for maintaining all regulatory approvals required to market and sell the bicarbonate cartridges throughout the United States. The Company plans to launch the bicarbonate cartridge in late February 2025.

"As the dialysis market continues to shift toward single-use bicarbonate cartridges, we believe there remains a growing unmet need for manufacturers and distributors to provide cartridges that are compatible with a range of dialysis machines," said Tim Chole, Chief Commercial Officer at Rockwell Medical. "This new agreement leverages our reliable distribution network through our transportation subsidiary, as well as our commercial infrastructure and well-established customer relationships. We believe the addition of a single-use bicarbonate cartridge to our portfolio of products represents an exciting opportunity for us to diversify our product offerings and address a rapidly growing segment in the hemodialysis space."

About Rockwell Medical

Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed at freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or in a patient’s home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Certified as a Great Place to Work^® in 2023 and 2024, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis Solutions^TM. For more information, visit www.rockwellmed.com.

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," "look forward to," "remain confident," “are determined,” “are on track,” “are resolute in our vision,” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. There can be no assurance that Rockwell Medical will use the bicarbonate cartridge to address a rapidly growing segment in the hemodialysis space. 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 those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2023, 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.

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$RMTI adds a 510k-approved single-use bicarbonate cartridge to its hemodialysis concentrates product portfolio, available in two sizes--720 grams and 900 grams.