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The company has developed two proprietary platforms—SAMI targeting the acute renal replacement therapy market, and DIMI targeting the chronic/home hemodialysis market. DIMI has received FDA 510(k) clearance for clinical settings and Health Canada approval for both clinical and home use. Usability trials are ongoing to support U.S. in-home regulatory submission. The company aims to expand access to home hemodialysis with user-friendly technology that addresses key barriers of current systems.
No drug or biologic programs; focus exclusively on medical devices.
Joint venture with Infomed SA formed in December 2022 to accelerate North American commercialization of SAMI/DIMI devices.
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