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BrainCool AB (publ): International clinical study with RhinoChill®System of patients with sudden cardiac arrest obtain ethical approval
Kurs & Likviditet
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BrainCool AB (publ) has been notified by Karolinska Institutet about the clinical study, PRINCESS 2, has now have received ethical approval both from the ethical committee and the national body (Swedish Medical Agency (Svenska Läkemedelsverket – LMV),
The clinical trial is to study the neuroprotective effect of ultra-early cooling on cardiac arrest.
On the 28th of March 2023, BrainCool announced that the company will supply Karolinska with its product RhinoChill®System for the study. The order is worth 3 million SEK over a three-year period.
Karolinska Institutet will now be able to start recruiting patients for the study that will cover up to 924 patients.
The approval should then automatically apply to other EU-states after or in parallel with applications for ethical approval of the clinical study. The ethical approval application is made by the specific hospital implementing the trial and approved by a regional agency in each EU-state.
The sponsor of the study has also published a web page for the clinical study https://ki.se/en/kisos/princess-2 which provides further information about the steering group of the study, the complete study protocol, and initial participating sites.