Rockwell Medical partners with a medical equipment manufacturer to distribute an FDA-cleared single-use bicarbonate cartridge.
Summary:
Rockwell Medical has entered into a distribution services agreement to supply an FDA-cleared single-use bicarbonate cartridge for hemodialysis. The agreement allows Rockwell to leverage its existing distribution network and transportation subsidiary to deliver the cartridges to dialysis centers, hospital-based outpatient centers, and skilled nursing facilities. The partner manufacturer will supply the cartridges in two sizes (720 grams and 900 grams) and maintain all regulatory approvals. Rockwell Medical plans to launch the product in late February 2025, aiming to meet the growing demand for machine-compatible, single-use dialysis solutions.
Key Takeaways:
- Expanding the Single-Use Dialysis Market – The single-use bicarbonate cartridge market is valued at $100 million, representing a rapidly growing segment within hemodialysis concentrates.
- Regulatory and Distribution Strategy – The cartridges will be supplied by a partner manufacturer, with Rockwell Medical handling distribution through its established network of dialysis providers.
- Product Launch in February 2025 – Rockwell Medical will begin distributing the single-use bicarbonate cartridges to dialysis centers, outpatient facilities, and skilled nursing homes in late February.
Rockwell Medical Inc, a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, announced it entered into a distribution services agreement with a manufacturer of medical equipment including hemodialysis machines, disposable products, and automated fluid balance systems.
Leveraging the company’s existing 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, according to a release from Rockwell Medical. 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 US Food and Drug Administration.Â
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,” says Tim Chole, chief commercial officer at Rockwell Medical, in a release. “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.”
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