Karolinska expands PRINCESS 2 with BrainCool's product RhinoChill® System to additional countries, first patient outside of Sweden included
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | First North Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BrainCool AB (publ) announces that Karolinska Institutet/University Hospital has expanded the groundbreaking clinical study PRINCESS 2 to three additional countries outside Sweden. Germany, Spain and Slovenia are now ready to start including patients and the first patient outside of Sweden was recently included by the University Hospital of Freiburg, Germany. This means that for the first time, emergency vehicles outside Sweden are equipped with BrainCool's product RhinoChill® System. When an equipped emergency vehicle reaches a patient with cardiac arrest, the patient could immediately be treated with RhinoChill® System implying more lives may be saved.
The interest to join PRINCESS 2 from countries outside Sweden has been overwhelming with multiple countries attending and showing great enthusiasm at a recently held investigator meeting. Karolinska has to date included as many as 36 patients since the study started in the spring of 2024. The inclusion rate is expected to significantly accelerate with multiple countries and sites now joining.
Dr. Per Nordberg, senior consultant at Karolinska University Hospital and principal investigator of PRINCESS 2, comments:
- With PRINCESS 2, we have the potential to transform the outcome for patients with cooling already at the site of the cardiac arrest. The interest to participate in the study has been extensive. We have met a lot of enthusiasm as we have travelled to new sites. We look forward to welcoming additional countries to the study in 2025 and providing more patients the opportunity to participate.
BrainCool's CEO Jon Berg comments:
- We are impressed with the great progress made by Dr. Per Nordberg and his study team colleagues at PRINCESS 2. It is with great pleasure we collaborate on a daily basis with the study team to support the accelerated progress in the best way possible. The significant interest to participate in the study confirms that we are at the forefront of medical cooling and technological expertise. The cooling with RhinoChill® System has the potential to change practice when treating cardiac arrest.
ABOUT THE PRINCESS 2 STUDY
PRINCESS 2 is a randomized international clinical trial involving approximately 1,000 patients. The study is led by Karolinska Institutet/University Hospital. A further 20 or so European clinics in Italy, Spain and Germany, among others, will participate. The aim of the study is to evaluate the effect of early and ultrafast cooling in the treatment of patients who have suffered cardiac arrest. Efficacy is measured as survival and recovery of neurological function.
ABOUT RHINOCHILL® SYSTEM
RhinoChill® System is a portable cooling system for cooling the brain via the nasal cavities. Early and ultra-fast cooling of the brain is achieved, which, according to the study's hypothesis, significantly reduces the risk of the patient dying or suffering from neurological impairments as a result of the cardiac arrest.
The system includes disposable products in the form of coolants and catheters, which means great potential for ongoing sales for each treated patient.
RhinoChill® System can also be used in hospitals for the treatment of stroke associated with thrombectomy (i. e. removal of a blood clot in the brain), within the framework of another study, COTTIS 2. Thus, RhinoChill® System has two different areas of use that are now being evaluated in the studies PRINCESS 2 (cardiac arrest) and COTTIS 2 (stroke).
ABOUT CARDIAC ARREST
Approximately five million people globally suffer from cardiac arrest annually, of which about 20 percent survive. Direct health and care costs are estimated at SEK 1.2 million per patient in the United States, according to a study "Health Care Costs After Cardiac Arrest in the United States | Circulation: Arrhythmia and Electrophysiology" (ahajournals.org). With early and ultra-fast cooling, survival rates can increase and lead to fewer or no neurological impairments, which means reduced suffering for the patient while there are significant health economic gains.