Harmless Respiration for Intensive Care Patients decreasing mortality and shortening stays - including COVID-19 patients

The current outbreak of COVID-19 is incisively pointing towards the importance of optimal mechanical ventilation in Intensive Care. Improved mechanical ventilation saves lives. Last year, we have seen multiple cases in which our mechanical ventilator suited only for the Operating Room (OR), was used off-label in ICU to ventilate severely lung-ill patients. Doctors claim patients would have died if our device would not have been used. These case reports are supported by more fundamental evidence published in March 2020: in-vivo studies on pigs having similar lung-illness as with the current COVID-19 outbreak (called Acute Respiratory Distress Syndrome) have shown superior result with our disruptive ventilation method, called FCV®. Half of all patients on higher grade Intensive Care Units need mechanical ventilation. However, current ventilation methods are known to damage the lungs in these vulnerable patients. This significantly prolongs ICU stay and increases mortality. The damages relate to the passive expiratory phase during mechanical respiration, which is fast and uncontrolled resulting in shear stress and collapse of the distal lung parts. Prolonged ventilation then initiates inflammatory responses in the lungs. We have developed a new ventilation method controlling the expiration, preventing lung damage. In 2017 our innovative OR ventilator (Evone) was brought to the market. Having performed over 1,000 OR patient cases and 5 small clinical studies till date, clear superior ventilation and improved lung mechanics has been shown. However, the largest unmet medical need related to ventilation is on ICU. The objective of this proposal is to bring this superior ventilation technology to ICUs in Europe, the Middle East and in 2nd phase the USA and by that, lower ICU mortality by 20% and ICU stay with 15%. This means 44,800 lives to be saved in European ICUs, each year (valued at € 90 billion) and a reduction of €2 billion in annual European healthcare costs.