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Regulatory press release

Redsense Clamp CE marked and introduced across key markets

Redsense Medical
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Redsense Medical is pleased to announce that the clamp is CE marked and has been introduced in the UK, Canadian, and German markets. We have been working closely with our distribution partners and dialysis providers, with the first demonstrations performed and pilot study discussions started.

"Being able to place the CE mark on our device was a defining moment, but the real progress is happening now as we work alongside our partners and clinical contacts to ensure a smooth introduction," said Sebastien Bollue, CEO at Redsense Medical. "We're also developing optimised visuals, marketing materials, and instruction videos in applicable languages to support both providers and patients in adopting the device."

The Clamp is currently available through authorized partners in the UK and Canada, while in Germany the first efforts have been made directly. Prior distribution partners in other EU markets have also been approached, while additional translations may be required as a next step to support these opportunities.

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