Periodic Reporting for period 6 - CUCUMBER (Bringing to market the world’s first integrated medical cooling system for minimizing brain damage in stroke patients.)
Reporting period: 2023-06-01 to 2023-11-30
The project is now entering the final phase, in which the effect of this procedure will be evaluated in the randomized COTTIS-2 trial. At the Congress NeuroRad on October 13, 2022, very convincing results from an initial study called COTTIS-1 were presented. The clinical study was stopped after 22 patients in consultation with the German Medicines Agency as the primary objectives of the study had already been met.
An ethics application to be able to carry out a more comprehensive study (COTTIS-2) based on the results of the COTTIS-1 trial has now been submitted in 1/2023 and will be likely received by end of Q1. COTTIS-2 will enroll 400 patients, aiming to show a statistically significant difference of 14% or more in survival with good neurological function. In the study, cooling treatment with BrainCool's products combined with thrombectomy will be compared with today's standard treatment. A first interim review of the results will take place already after the inclusion of 100 patients, when the input from the first study shows a significantly greater improvement than 14%. A positive outcome of the study will be the basis for market registration of cooling treatment as a medical indication, i.e. an improved stroke survival with preserved neurological function.
WP1 ETHICS REQUIREMENTS
• Ethical committee approval submitted for COTTIS-2 trial (a pivotal trial). BrainCool and University of Freiberg will be closely worked with EE CRO during the process.
WP2 FINALIZING TECHNICAL INTEGRATION
• Completed verification of the HW, SW of BrainCool system
• Update the technical documentation
• Completed all tests in notified body (Intertek) for the certification for BrainCool system
WP3 MANUFACTURING OF COOLCONNECT
• Finalizing all verification and validation activities.
• Finalizing all Work Instructions.
• Planning to manufacture additional 12 units following CB certificate
WP4 CLINICAL VALIDATION
• COTTIS-1: 3-months visit of all patients included in the study from 12/21-5/22. Analysis of all results (clinical and radiological parameters, temperature, outcome, complications, laboratory analyses). Writing the draft of the manuscript, review of the manuscript by all authors, submission to Journal STROKE 1/2023.
• An ethics application for the randomized-controlled COTTIS-2 trial to the ethics committee of the University of Freiburg has been prepared and submitted in 1/2023 (Study protocol; information and written informed consent for patient/relatives/independent physician; Case Report Form, financing plan; patient insurance)
WP5 MARKET ACCESS & REGULATORY AFFAIRS
• Finalize the technical file according MDR
• Working closely with NEMKO (3RD party testing house) for CB-certification
• Prepare a breakthrough designation request for the FDA.
WP6 COMMERCIALIZATION & MARKETING
• Up-dated COTTIS-trials-website on IGNITE/DGNI-homepage since 4/2022
• Workshop investigators at IGNITE meeting 6/2022 at the University of Gießen
• Personal visit by Prof. Bardutzky to the participating centers of COTTIS-2 on side
(29.9.-30.9.22: Hospital in Erlangen, Heidelberg, Darmstadt; 11.7.-15.7.22: Hospital in Bielefeld, Minden, Gießen)
• The results of the clinical study of COTTIS-1 were presented on October 13, 2022, at the NeuroRad 2022 scientific meeting in Kassel, German
• Workshop and presentation of the final COTTIS-1 results and of the protocol of the COTTIS-2 study at the IGNITE meeting in Munich on 18.11.2022
WP7 PROJECT MANAGEMENT
• According to plan - Monitor progress of the project towards the project’s objectives, milestones and deliverables have been performed. University of Freiberg and BrainCool organized meetings within the project group