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Berlin Heals’ C-MIC device has shown significant and rapid improvements in heart function and quality of life for patients with advanced heart failure. First-in-human pilot studies demonstrated strong efficacy and safety. The pivotal European CE trial was recommended to end early due to clear benefit; long-term data show sustained improvement even after the device was turned off. The company expects CE approval by late 2025 and has received FDA Breakthrough Device Designation for its US program.
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