Periodic Reporting for period 1 - Luncolive (Saving Cardiac Arrest Patients with Hypothermic Lung Conservative Liquid Ventilation)
Reporting period: 2023-05-01 to 2024-04-30
Orixha offers a major clinical breakthrough in Critical Care with its unique LUNg COnservative LIquid VEntilation (hence LuncoLive) technology. It powers the Vent2Cool medical device to induce ultra-rapid protective cooling of heart and brain of resuscitated cardiac arrest patients. Vent2Cool will increase their survival rate by tackling the reperfusion injury of Post Cardiac Arrest Syndrome.
LuncoLive project will enable clinical validation of Vent2Cool as a new gold standard for post-resuscitation care. Orixha will industrialize and miniaturize the technology to increase usability as well as reduce costs and environmental impact, in particular through reprocessing of the Liquid2Breathe breathable liquid.
The goal of the LuncoLive Project is to obtain CE Mark of the Vent2Cool device in 2026 and subsequent commercial launch in the EU. Once validated clinically and adopted in most cardiac arrest centers, Vent2Cool holds the potential to save 10,000 cardiac arrest patients / year in Europe by the end of the decade.
LuncoLive project will enable clinical validation of Vent2Cool as a new gold standard for post-resuscitation care. Orixha will industrialize and miniaturize the technology to increase usability as well as reduce costs and environmental impact, in particular through reprocessing of the Liquid2Breathe breathable liquid.
The goal of the LuncoLive Project is to obtain CE Mark of the Vent2Cool device in 2026 and subsequent commercial launch in the EU. Once validated clinically and adopted in most cardiac arrest centers, Vent2Cool holds the potential to save 10,000 cardiac arrest patients / year in Europe by the end of the decade.
In the first 12 months of the project, the Orixha team achieved the following technical milestones:
- Development and pre-clinical validation of Vent2Cool v2.1 system, which includes an improved liquid ventilator and breathable circuit.
- Identification of the process at pilot and industrial scale for recycling the Liquid2Breathe breathable liquid.
- Obtention of biocompatibility status on Liquid2Breathe and the Breathable Circuit.
- Set up and filing of the Vent2Cool technical file to the French and Belgian authorities for the OverCool first in human feasibility clinical trial.
Another major event was the 4 M€ pre-Series A fund raising led by the EIC Fund and BPI France which strengthens the balance sheet and the governance or the company.
- Development and pre-clinical validation of Vent2Cool v2.1 system, which includes an improved liquid ventilator and breathable circuit.
- Identification of the process at pilot and industrial scale for recycling the Liquid2Breathe breathable liquid.
- Obtention of biocompatibility status on Liquid2Breathe and the Breathable Circuit.
- Set up and filing of the Vent2Cool technical file to the French and Belgian authorities for the OverCool first in human feasibility clinical trial.
Another major event was the 4 M€ pre-Series A fund raising led by the EIC Fund and BPI France which strengthens the balance sheet and the governance or the company.
Two Vent2Cool v2 devices are being assembled and will be delivered to Orixha by end of July with improved usability features and reliability related to volume and pressure management. These devices will be used by the medical teams at Hospital Cochin, Paris and Hospital Erasme, Brussels, on cardiac arrest patients by end of year.
This will represent a world premiere for total liquid ventilation.
This will represent a world premiere for total liquid ventilation.