BrainCool today announces that two additional German hospitals in Giesen and Erlangen are in the next wave to start enrolling patients in the company’s clinical study, COTTIS 2, with one of the hospitals already having included its first patient. The hospitals have been equipped, the staff have been appropriately trained and shortly after training, Giesen included its first patient. COTTIS 2 is a potentially transformative study that aims to provide clinical data to support an application for market approval of RhinoChill® in as a hypothermic treatment of ischemic stroke patients.

The COTTIS 2 (Combination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke) clinical trial intends to measure the outcome in 400 acute stroke patients with large vessel occlusion treated with the combination of hypothermia and thrombectomy. The study will evaluate neurological function three months after a stroke patient has been treated with thrombectomy, combined with cooling using the RhinoChill® System and BrainCool™ System. The study aims to further document the benefits of this combined treatment, and interim analyses are planned during the study.

“With three hospitals now participating in the COTTIS 2 study, we will be able to expand patient recruitment. We have seen an increase in the number of patients in the past couple of weeks. It is clear from the bi-weekly study team meetings that additional investigators and nurses provide a positive boost to the overall project, as the Freiburg team is joined by colleagues from other hospitals. We are also in the process of including additional hospitals to ensure that we can accelerate the inclusion rate in 2025, with the aim of providing sufficient data for market approval of our unique cooling technology, RhinoChill® System” said Jon Berg, CEO of BrainCool.

The market potential for RhinoChill® System is significant as several million people suffer from stroke every year, of which close to 90 per cent are ischemic strokes. Further, the post-treatment of stroke patients using BrainCool™ System constitutes another significant commercial opportunity for BrainCool.

“We are very happy that the COTTIS 2 trial is expanding. More hospitals are joining, which means that more patients can take part in this important study. The progress we've made so far strengthens our confidence in the value of combining cooling therapy with thrombectomy,” comments Prof. Dr. Jürgen Bardutsky at the University of Freiburg, Principal Investigator in the COTTIS 2 study.

 

Contact
For more information
Jon Berg - CEO
+46 722 50 91 19
E-mail: jon.berg@braincool.se

About Us
BrainCool AB (publ) is an innovative medical device company that develops, markets, and sells leading medical cooling systems for indications and areas with significant medical benefits within the healthcare sector. BrainCool AB (publ) is based in Lund, Sweden, and its share is listed on Nasdaq First North Growth Market, named “BRAIN”.
Eminova Fondkommission AB is the company’s Certified Adviser.

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BrainCool AB (publ) adds two centers to the COTTIS 2 clinical study of its cooling systems in stroke patients