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Bringing to market the world’s first integrated medical cooling system for minimizing brain damage in stroke patients.

Periodic Reporting for period 2 - CUCUMBER (Bringing to market the world’s first integrated medical cooling system for minimizing brain damage in stroke patients.)

Reporting period: 2021-06-01 to 2021-11-30

Stroke-related disabilities remains a major challenge faced by patients, their families and healthcare systems worldwide and is estimated to cost healthcare systems over €45B per year. In Europe, there are over 1.1M new incidences of stroke per year, a third of which will result in permanent disabilities such as limited mobility and affected cognitive function. These handicaps are a result of the brain damage caused by blocked blood flow to the brain, as well as the further damage following recanalization of an arterial blockage.

Targeted temperature management (TTM), also known as 'brain cooling', is a method that has proven effective in reducing brain injury in sudden cardiac arrest patients. Extrapolation of TTM to stroke will have tremendous impact on patient outcomes, however, the limited functionalities of current cooling technologies prevent this realization.The CUCUMBER consortium, whose expertise range from engineering, manufacturing, clinical neurology and stroke, are working to change this paradigm by developing CoolConnect, the world's first cooling device that accommodates the needs of stroke treatment to improve patient’s outcome, survival and neurological outcome. CoolConnect is an integrated device composed of 3 components (RhinoChill, BrainCool, and BrainTemp sensor), which come together to address the 3 critical phases of brain cooling, 1)Early cooling, 2)Cooling during reperfusion and 3)maintenance cooling. CoolConnect is the only solution in development designed for this purpose.

To achieve the main objective of CUCUMBER, which is to accelerate the wide-spread market adoption of CoolConnect and to ensure market launch as the CUCUMBER project finalizes, the following objectives are envisioned:
1. To finalize the technical development
2. To scale-up manufacturing procedures
3. To demonstrate the efficacy of CoolConnect in a large, multicentred clinical trial
4. To prepare the market for the wide-spread uptake ensure commercial readiness
The project has been procceded according to plan. See current status per WP below:

WP 1&2:
• Performed DFA (design for assembly), DFA (design for testability) analysis of the RhinoChill® system
• Finalized the setup production organization: purchasing, planning, incoming inspection, warehouse, quality control, production engineering, locate and setup new production facility .
• Investigated regulatory and 3rd party impact and requirements on production according to MDR.
• Finalize the documentation for the first design review
• Initiated activities for the validations and verification of processes and test equipment
WP 3

WP 4
• Initiated updating the documents to submit for regulatory certification of RhinnoChill version 2.0 according to MDR regulations

WP 5: None

WP 6
• According to plan - Monitor progress of the project towards the project’s objectives, milestones and deliverables have been performed.
Impact on patients: CUCUMBER will reduce the incidence and severity of brain damage that accompanies stroke. In the current situation, 22% of ischemic stroke patients die following treatment, whereas 95% of the surviving patients report some form of disability. Of the surviving patients, 35% experience ‘Moderately severe disability – Unable to walk or attend to common bodily needs without assistance’ and ‘Severe disability – Bedridden, incontinent and requiring constant nursing attention’, aligning with Scores of 4 and 5 on the Rankin stroke-related disabilities Score scale. As it is estimated that reperfusion injury and fever contribute to 38% of stroke-related brain damage, CUCUMBER will:
• Reduce the overall incidence of stroke-related disabilities from 95% to 62%.
• Reduce the percentage of patients experiencing level 4 and 5 of disabilities from 35% to 23%.
• Reduce the number of stroke-related deaths from 22% to 14%.
Impact on health sector and society: The incidence rate of ischemic stroke is increasing at an alarming rate of 8%/year (approximate to 8,000 new patients/ year in Europe), and with it comes an increasing economic burden that is experienced at the national, healthcare payer and the family level. Specifically, CUCUMBER will impact the following:
• Reduction of the physical, financial and emotional burden on family members to provide informal care. 35% of ischemic stroke patients are left with disabilities that require daily assistance, provided in most cases by family members.
• In Europe, healthcare costs associated with stroke are €45B, €16B of which are related to informal care costs, and €5.4B to loss-in-productivity, two cost burdens that are incurred as a result of long-term disabilities. With CoolConnect, we estimate these costs can be reduced by at least 50%, thereby reducing the overall cost burden of stroke in Europe by ~€11B per year.
• Improved patients’ outcomes and reduce burden on family: By bringing CoolConnect, the consortium will contribute to the improvement in the quality of life of over 100,000 patients and their families per year in Europe.
• Reduced Europe-wide healthcare costs: With CoolConnect, it is estimated that the cost burden of stroke can be reduced by €10.7B per year (see above).
• Leadership in the treatment for stroke: CoolConnect will demonstrate that Europe puts on tackling major health issues and will highlight European innovators as global leaders in the field of therapeutic hypothermia for stroke treatment.
• Employment generation: CUCUMBER will generate over 25 new hires during the project, which 9 more recruited after the first year as the project finishes. FTE growth will be in field of engineering and manufacturing and business development (at BRAINCOOL and INNOKAS), regulatory affairs (at BRAINCOOL and sub-supplier E&E) and clinical management (at BRAINCOOL, FREIBURG).
Cucumber vision