BrainCool AB has announced the expansion of its COTTIS 2 clinical study with the addition of two German hospitals in Giesen and Erlangen. These hospitals will begin enrolling patients to evaluate the efficacy of BrainCool's cooling systems in treating ischemic stroke.
The COTTIS 2 trial (Combination of Targeted temperature management and Thrombectomy after acute Ischemic Stroke) is designed to assess the outcomes of 400 acute stroke patients with large vessel occlusion. These patients will be treated using a combination of hypothermia, induced by the RhinoChill® System and BrainCool™ System, and thrombectomy. The primary endpoint is the evaluation of neurological function three months post-treatment.
"With three hospitals now participating in the COTTIS 2 study, we will be able to expand patient recruitment," said Jon Berg, CEO of BrainCool. "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".
The trial aims to provide robust clinical data to support a market approval application for RhinoChill® as a hypothermic treatment for ischemic stroke patients. Interim analyses are planned during the study to monitor progress and document the benefits of the combined treatment approach.
Significance of the Study
Ischemic stroke accounts for approximately 90% of the several million stroke cases reported annually. The COTTIS 2 trial is designed to further explore the potential benefits of combining cooling therapy with thrombectomy, addressing a significant unmet need in stroke treatment.
Cooling Technology
The RhinoChill® System is a unique cooling technology developed by BrainCool. The BrainCool™ System is used for post-treatment of stroke patients, representing another commercial opportunity for the company.
Expert Commentary
"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," commented Prof. Dr. Jürgen Bardutsky at the University of Freiburg, Principal Investigator in the COTTIS 2 study. "The progress we've made so far strengthens our confidence in the value of combining cooling therapy with thrombectomy."
