Rockwell Medical Adds Single-Use Bicarbonate Cartridge to Hemodialysis Concentrates Product Portfolio

Rhea-AI Summary

Rockwell Medical (RMTI) has entered into a distribution services agreement to add single-use bicarbonate cartridges to its hemodialysis product portfolio. The agreement enables RMTI to distribute 510(k) approved bicarbonate cartridges in two sizes (720g and 900g) to dialysis centers, hospital-based outpatient centers, and skilled nursing facilities.

The single-use bicarbonate disposables market represents an approximate $100 million opportunity and is one of the fastest-growing segments within the hemodialysis concentrates market. The company plans to launch the product in late February 2025, leveraging its existing distribution network and transportation subsidiary.

Positive

• Access to $100 million market opportunity in fast-growing segment
• Leverages existing distribution infrastructure without additional investment
• Product diversification into single-use disposables segment
• Partnership with established manufacturer reduces development costs

Negative

• Product launch not until February 2025
• Dependent on partner for regulatory compliance and approvals

Insights

Medical Industry Analyst

This strategic distribution agreement marks a pivotal expansion for Rockwell Medical into the rapidly growing single-use bicarbonate cartridge segment. The $100 million market opportunity represents a substantial revenue potential, particularly given RMTI's established distribution network and transportation infrastructure that can be leveraged at minimal additional cost.

The partnership structure is particularly advantageous as it minimizes regulatory risks and development costs. The partner maintains FDA compliance responsibilities, while RMTI capitalizes on its core strengths in distribution and customer relationships. The two size options (720g and 900g) ensure comprehensive market coverage, addressing various dialysis machine compatibility requirements.

From a market dynamics perspective, the timing is optimal. The dialysis industry's shift toward single-use solutions is driven by several factors:

• Increased focus on infection control and safety
• Growing preference for convenience and standardization in dialysis centers
• Rising demand for compatible solutions across different dialysis machines

The agreement positions RMTI to capture market share in one of the fastest-growing segments while maintaining operational efficiency. By leveraging existing infrastructure and customer relationships, the company can achieve faster market penetration with controlled operational costs. The planned February 2025 launch allows adequate time for inventory building and customer education.

WIXOM, Mich.--(BUSINESS WIRE)-- 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250204131161/en/

Heather R. Hunter

SVP, Chief Corporate Affairs Officer

(248) 432-1362

IR@RockwellMed.com

Source: Rockwell Medical

FAQ

What is the market size for single-use bicarbonate cartridges that RMTI is targeting?

The single-use bicarbonate disposables market represents approximately $100 million opportunity, according to the press release.

When will RMTI launch its new bicarbonate cartridge products?

Rockwell Medical plans to launch the bicarbonate cartridge in late February 2025.

What sizes of bicarbonate cartridges will RMTI distribute?

RMTI will distribute two sizes of bicarbonate cartridges: 720 grams and 900 grams, both FDA 510(k) approved.

Where will RMTI distribute its new bicarbonate cartridges?

RMTI will distribute the cartridges to dialysis centers, hospital-based outpatient centers, and skilled nursing facilities.

How does this new product align with RMTI's existing business?

The product leverages RMTI's existing reliable distribution network, transportation subsidiary, commercial infrastructure, and established customer relationships.