Clinical trials
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Pilot randomized controlled trials for the VentFree Respiratory Muscle Stimulator showed reduced duration of mechanical ventilation and ICU stay compared to placebo. The pivotal PREVENT trial aims to confirm these findings. The device has received FDA Breakthrough Device Designation, Emergency Use Authorization during COVID, and CE marking in the EU. Clinical data for SecondBreath show significant reduction in static hyperinflation and breathlessness during exercise for COPD patients.
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