Periodic Reporting for period 2 - Jane (Harmless Respiration for Intensive Care Patients decreasing mortality and shortening stays – including COVID-19 patients)
Période du rapport: 2021-05-01 au 2022-10-31
The outbreak of COVID-19 underlined the importance of optimal mechanical ventilation at the Intensive Care Unit (ICU). It confirmed that improving mechanical ventilation saves lives. Conventional mechanical ventilation relies on providing inspiration followed by uncontrolled, passive expiration. This uncontrolled expiration causes sudden collapse of the lungs, that may occlude distal lung parts, reducing functional lung volume over time. Moreover, sudden collapse causes shear stress in the lung tissue, leading to an inflammatory response in the already vulnerable body. Both effects cause longer ICU stays or even death.
Ventinova has developed a breakthrough solution: FCV is the only ventilation method available to control the expiratory flow, resulting in a smooth and natural respiration pattern. Currently, 12 small (randomized controlled) clinical trials and over 3,500 cases were performed, showing Ventinova’s new ventilation principle is potentially the best method to keep the lung open and to prevent lung damage.
We are convinced that new FCV ventilator, with working name ‘Jane’, will benefit all patients that require ventilation, as the patient’s body is better oxygenated and no longer has ventilation-induced damage to repair, allowing it to focus on healing the primary trauma / the lungs itself in case of lung-illness.
Pre-clinical and clinical data indicate that FCV technology has a more efficient oxygenation and CO2 removal, with less application of mechanical power, and does not cause Ventilator Induced Lung Injury (VILI). Incremental innovations iof the gold standards PCV and VCV have already reduced the mortality rate at ICU by 20% over the last 15 years. However, the quick wins are already won. To further reduce ICU mortality related to ventilation, a new disruptive principle is needed. FCV promises to fulfill this need. This does not only saves lives, but also obviously would result in considerably lower healthcare costs and improved day-to-day patient care.
At the start of the project FCV was available for use in the operating room and in selected ICU patients with required continuous direct supervision of an intensivist / anaesthesiologist. This project aimed to bring disruptive ventilation technology FCV to the ICU globally. The project consists of technological development, creating an ICU ventilator, and clinical validation, including observational data collection and comparative studies. Also, CE marking and dissemination to reach KOLs and medical doctors were part of the plan.
The following objectives were defined for the project:
• ICU prototype device shows potential benefit in various ICU patients in observational data
• Field demonstrator units available for studies
• CE marked (MDR) for 3 days of ICU ventilation
• Clinical benefits shown in distinct ICU patient groups
• CE mark (MDR) for ICU ventilation without undivided attention
Ventinova has developed a breakthrough solution: FCV is the only ventilation method available to control the expiratory flow, resulting in a smooth and natural respiration pattern. Currently, 12 small (randomized controlled) clinical trials and over 3,500 cases were performed, showing Ventinova’s new ventilation principle is potentially the best method to keep the lung open and to prevent lung damage.
We are convinced that new FCV ventilator, with working name ‘Jane’, will benefit all patients that require ventilation, as the patient’s body is better oxygenated and no longer has ventilation-induced damage to repair, allowing it to focus on healing the primary trauma / the lungs itself in case of lung-illness.
Pre-clinical and clinical data indicate that FCV technology has a more efficient oxygenation and CO2 removal, with less application of mechanical power, and does not cause Ventilator Induced Lung Injury (VILI). Incremental innovations iof the gold standards PCV and VCV have already reduced the mortality rate at ICU by 20% over the last 15 years. However, the quick wins are already won. To further reduce ICU mortality related to ventilation, a new disruptive principle is needed. FCV promises to fulfill this need. This does not only saves lives, but also obviously would result in considerably lower healthcare costs and improved day-to-day patient care.
At the start of the project FCV was available for use in the operating room and in selected ICU patients with required continuous direct supervision of an intensivist / anaesthesiologist. This project aimed to bring disruptive ventilation technology FCV to the ICU globally. The project consists of technological development, creating an ICU ventilator, and clinical validation, including observational data collection and comparative studies. Also, CE marking and dissemination to reach KOLs and medical doctors were part of the plan.
The following objectives were defined for the project:
• ICU prototype device shows potential benefit in various ICU patients in observational data
• Field demonstrator units available for studies
• CE marked (MDR) for 3 days of ICU ventilation
• Clinical benefits shown in distinct ICU patient groups
• CE mark (MDR) for ICU ventilation without undivided attention
This project consists of five work packages (WPs) that interact with each other:
WP1 Technological Development
Engineering work on several aspects was performed to make the current FCV device ICU ready. This entails a.o. work to interface with patient monitoring systems, make it splash proof (IP21) and reduce noise levels. During the project the device was prepared to be used in clinical studies with a short duration and to collect clinical ICU data.
Due to delays in a.o. review at Notified Body DEKRA the CE mark for 3 days of ICU ventilation was received after the project. Therefore the next step in product improvement, being ventilation without the need for undivided attention, was not achieved. Though this remains a Company objective and work is being done for this purpose.
WP2 Clinical validation and demonstration
This WP aims to demonstrate a proof of concept that FCV is beneficial for ICU patients, regarding improved ventilation efficiency and reduced lung damage.
Due to the corona pandemic, the initially planned multi-centre observational study was cancelled. Collection of Real World Data and (pre-)clinical studies were started at several academic hospitals. Results (incl. user feedback) is and will be used to 1) improve the device, 2) gather clinical evidence, and 3) for publication and communication (if ethically allowed). A FCV symposium was organized by the Erasmus MC in Rotterdam (NL) in order to share knowledge and data, and to start discussion on designing a Multi- Centre study .
WP3 Exploitation and Dissemination
To create awareness of FCV and to enlarge exposure, results of WP2 were shared with relevant stakeholders and decision makers through (scientific) publications in journals and showcasing at conferences. Due to the pandemic congresses, networking events and demonstrations were cancelled. Therefore we developed the Ventinova Academy: an online training facility in order to train KOLs, distributors and users of the FCV ventilator. In order to disseminate results we organized webinars in which experts shared their clinical experience of using the FCV ventilator. In 2022 congresses were organized again and Ventinova exhibited at the ESAIC (Milan) and EAC2022 (Antalya). At various international congresses FCV was presented. Further, one case report (Spraider et al crit care 2020), two comparative studies (Van Dessel et al ICMx 2022 and Grassetto et al Pulmonology 2022) and two pig studies (Schranc et al Front Pediatrics 2022, Spraider et al EJA in press) are (being) published in scientific journals.
WP4 Regulatory compliance
This WP governs required activities to ensure that relevant project approvals are obtained and maintained for using the FCV ventilator in ICUs. Ventinova received CE mark acc. MDR for ventilation in ICU for 3 days in November 2022. Next submissions are being prepared.
WP5 Project management
This WP takes care on project management.
WP1 Technological Development
Engineering work on several aspects was performed to make the current FCV device ICU ready. This entails a.o. work to interface with patient monitoring systems, make it splash proof (IP21) and reduce noise levels. During the project the device was prepared to be used in clinical studies with a short duration and to collect clinical ICU data.
Due to delays in a.o. review at Notified Body DEKRA the CE mark for 3 days of ICU ventilation was received after the project. Therefore the next step in product improvement, being ventilation without the need for undivided attention, was not achieved. Though this remains a Company objective and work is being done for this purpose.
WP2 Clinical validation and demonstration
This WP aims to demonstrate a proof of concept that FCV is beneficial for ICU patients, regarding improved ventilation efficiency and reduced lung damage.
Due to the corona pandemic, the initially planned multi-centre observational study was cancelled. Collection of Real World Data and (pre-)clinical studies were started at several academic hospitals. Results (incl. user feedback) is and will be used to 1) improve the device, 2) gather clinical evidence, and 3) for publication and communication (if ethically allowed). A FCV symposium was organized by the Erasmus MC in Rotterdam (NL) in order to share knowledge and data, and to start discussion on designing a Multi- Centre study .
WP3 Exploitation and Dissemination
To create awareness of FCV and to enlarge exposure, results of WP2 were shared with relevant stakeholders and decision makers through (scientific) publications in journals and showcasing at conferences. Due to the pandemic congresses, networking events and demonstrations were cancelled. Therefore we developed the Ventinova Academy: an online training facility in order to train KOLs, distributors and users of the FCV ventilator. In order to disseminate results we organized webinars in which experts shared their clinical experience of using the FCV ventilator. In 2022 congresses were organized again and Ventinova exhibited at the ESAIC (Milan) and EAC2022 (Antalya). At various international congresses FCV was presented. Further, one case report (Spraider et al crit care 2020), two comparative studies (Van Dessel et al ICMx 2022 and Grassetto et al Pulmonology 2022) and two pig studies (Schranc et al Front Pediatrics 2022, Spraider et al EJA in press) are (being) published in scientific journals.
WP4 Regulatory compliance
This WP governs required activities to ensure that relevant project approvals are obtained and maintained for using the FCV ventilator in ICUs. Ventinova received CE mark acc. MDR for ventilation in ICU for 3 days in November 2022. Next submissions are being prepared.
WP5 Project management
This WP takes care on project management.
Next to the high-grade ICU in academic hospitals, FCV ventilation can also be of great relevance for the smaller, regional ICUs. For example, the influenza epidemic of 2018 hit specifically young people between 20-49 years old, in the midst of their productive working life. Both high and lower grade ICUs in Europe were filled with flue patients having respiratory issues. An Austrian intensivist of a small regional hospital told us that he lost a 47-year old mother of young children that winter, who was fully healthy before being struck by this flue. His ICU is lacking expertise to operate a heart-lung machine and all surrounding high-grade ICUs having such devices were already fully occupied. When he would have had our FCV device – this ventilator does not need special additional expertise to be operated - he believed he could have saved this young woman. The COVID-19 crisis is an even much stronger example of (rapidly) overloaded hospitals due to an epidemic. Further, we have case data that in case the patient is transferred to a heart-lung machine (called ‘ECMO’), using FCV may enhance recovering and shorten the so-called weaning period.
We are convinced that bringing FCV into the ICU is of significant value for all ICUs including the small and the big academic ones as FCV may prevent further deterioration of ventilated patients and reduce the need for and time of ECMO.
Also, a global success of FCV shall lead to growth of Ventinova and of its collaborators (production partners, development partners, distributors etc).
We are convinced that bringing FCV into the ICU is of significant value for all ICUs including the small and the big academic ones as FCV may prevent further deterioration of ventilated patients and reduce the need for and time of ECMO.
Also, a global success of FCV shall lead to growth of Ventinova and of its collaborators (production partners, development partners, distributors etc).