BrainCool AB Clinical trial agreement with Center for Resuscitation Science at Karolinska Institute and dep. of cardiology Södersjukhuset in Sweden.

BrainCool AB (publ), a Swedish medical device company with focus on medical cooling and temperature management, has signed a clinical trial to carry out a clinical study of pre-hospital cooling of cardiac arrest patients. The agreement with the Center for Resuscitation Science at Karolinska Institute for the BrainCool product RhinoChill® - a CE marked medical device enabling rapid, catheter based cooling of nasal cavity and brain to minimize brain injury associated with cardiac arrest.

The effects of prehospital cooling of cardiac arrest victims with RhinoChill® are currently under clinical investigation in the PRINCESS trial (http://bmcemergmed.biomedcentral.com/articles/10.1186/1471-227X-13-21) (https://www.clinicaltrials.gov/ct2/show/NCT01400373?term=Princess&rank=3).

The PRINCESS trial is an ongoing multicentre study in Sweden, Belgium, Spain, Czech republic, UK and France with the RhinoChill® device used rapid cooling of cardiac arrest patients in the ambulance and emergency room.

The trial will answer the question whether more patients survive with good neurologic function after cooling with the RhinoChill® device. Currently 550 patients, out of a total of 700, are included in the trial.

Martin Waleij, CEO BrainCool AB comments:

-          We are happy to announce the agreement on the PRINCESS trial so soon after our acquisition of the RhinoChill device. It means that the study can be finished by the end of 2017 in accordance with the previous time schedule.

Results from a previous European multicenter clinical trial of 200 patients (The PRINCE trial, published in Circulation, 2010) showed that the RhinoChill™ IntraNasal Cooling System, applied at the scene of the cardiac arrest, enabled brain temperature to reach protective levels several hours earlier than in patients cooled with traditional methods in the intensive care units.

Although the PRINCE trial was not designed to detect a survival benefit, it showed clear positive signals with early cooling, encouraging further research and vouching for a larger trial.

Among patients surviving to hospital admission, 44 percent of patients who were cooled with the RhinoChill® device left the hospital alive, compared with 31 percent of those who had not been cooled with RhinoChill®. Survival rates for patients who received early cardiopulmonary resuscitation were even better, 57% and 29% respectively.

The objective of the ongoing PRINCESS trial is to obtain further evidence and answers to the benefits of early cooling with RhinoChill® in patients after cardiac arrest.

Per Nordberg, Principal Investigator, Karolinska Institutet, comments ;

-          One key issue is the potential benefit of cooling started already during the cardiac arrest, before the heart re-starts. Experimental data suggest a benefit of early cooling, with cooling started during the cardiac arrest being clearly superior to cooling started after the arrest. In clinical practice initiation of cooling has often been delayed up to several hours after the cardiac arrest, a time when the window of opportunity may have been closed. Thus, when moving from very early cooling in the experimental setting to several hours of delay in clinical practice, one might miss the time when cooling is most effective.

Rapid cooling with the RhinoChill® system can be initiated in field conditions during ongoing resuscitation efforts by emergency crews. The method induces continuous cooling, primarily to the brain, without side effects on the heart recently seen in a trial where cold saline was infused to reduce body temperature. A method of inducing cooling simply and rapidly, while avoiding excessive fluid overload to patients with compromised heart function, may in this respect be of advantage.

Martin Waleij:

-          With a combination of our two synergistic products, the RhinoChill® and the BrainCool Systems, we will offer a possibility to initiate brain protective cooling early after the cardiac arrest, and maintain cooling and provide tight temperature control throughout the intensive care period. 

Per Nordberg el LEIF, comments;

-          We are very positive to be able to continue and complete the study in agreement with the new owners, BrainCool, and we will also explore further ways of collaboration within the field of braincooling.

For further information contact

Martin Waleij – CEO BrainCool AB (publ)

Telephone: +46 (0)733 -93 70 76

E-mail:   martin.waleij@braincool.se     

Per Nordberg, MD, PhD

Dept. of Cardiology, Södersjukhuset. Center for Resuscitation Science, Karolinska Institutet

Stockholm, Sweden

+46 70 280 25 79

This press release is submitted both in English and Swedish, in case of any discrepancies, the English version will apply.