Periodic Reporting for period 8 - CUCUMBER (Bringing to market the world’s first integrated medical cooling system for minimizing brain damage in stroke patients.)
Período documentado: 2024-06-01 hasta 2024-11-30
CLINICAL:
Significant progress was made during this period, focusing on the initiation of the COTTIS-2 trial and site activation. Challenges included site activation, protocol deviations, and contract finalization. By July, Freiburg was ready, with the first patient treated using RhinoChill® and BrainCool™ Systems. Recruitment progressed, reaching 13 patients by December. Gießen and Erlangen were activated in November, with recruitment starting in December and January, respectively. An investigator meeting on September 25 in Frankfurt addressed protocol updates, logistics, training, and device distribution. Attendees included key investigators, CRO monitors, and BrainCool representatives.
TECHNICAL:
BrainCool identified defects in systems from Innokas and developed protocols for inspecting and releasing incoming goods for clinical studies. Catheter testing revealed performance discrepancies, leading to the establishment of inspection protocols to meet performance criteria. Discussions with SHL and Innokas are ongoing, with SHL initiating tooling setup for increased catheter production.
DEVIATION:
Several factors, including the need for a safety trial (COTTIS-1), contract changes, ethics amendments, and a sponsor change, caused delays. Three centers are now active, with a fourth (Essen) starting by January’s end. To establish this innovative cooling treatment for severe stroke patients, an 18-month project extension to November 2026 is requested without additional budget or costs.
Significant progress was made during this period, focusing on the initiation of the COTTIS-2 trial and site activation. Challenges included site activation, protocol deviations, and contract finalization. By July, Freiburg was ready, with the first patient treated using RhinoChill® and BrainCool™ Systems. Recruitment progressed, reaching 13 patients by December. Gießen and Erlangen were activated in November, with recruitment starting in December and January, respectively. An investigator meeting on September 25 in Frankfurt addressed protocol updates, logistics, training, and device distribution. Attendees included key investigators, CRO monitors, and BrainCool representatives.
TECHNICAL:
BrainCool identified defects in systems from Innokas and developed protocols for inspecting and releasing incoming goods for clinical studies. Catheter testing revealed performance discrepancies, leading to the establishment of inspection protocols to meet performance criteria. Discussions with SHL and Innokas are ongoing, with SHL initiating tooling setup for increased catheter production.
DEVIATION:
Several factors, including the need for a safety trial (COTTIS-1), contract changes, ethics amendments, and a sponsor change, caused delays. Three centers are now active, with a fourth (Essen) starting by January’s end. To establish this innovative cooling treatment for severe stroke patients, an 18-month project extension to November 2026 is requested without additional budget or costs.
Work Package 2: Technical Integration
This work package has been finalized and the report has already been uploaded.
Work Package 3: Manufacturing
Key achievements include:
RoHS reporting completion for all components.
Final design files uploaded to the manufacturer.
Technical follow-up of prototype systems to resolve any unclarity or issues.
Work Package 4: Clinical Validation
Sponsor of the clinical study COTTIS-2 has been changed from UKLFR to BRAINCOOL due to legal concerns.
Required protocol updates and amendments have been approved by the relevant authorities.
Clinical trial sites have been prepared and patient recruitment has begun.
The matched pair analysis manuscript is under review.
Work Package 5: Market Access and Regulatory
BrainCool has initiated activities related to CE marking.
A comprehensive response to the FDA's comments regarding the pre-submission request is being prepared.
Work Package 6: Commercialization and Marketing
BrainCool is actively working on commercializing their thrombectomy solution in multiple markets.
Partnerships are being formed to navigate regulatory hurdles and access new markets.
Data from the Freiburg site of the COTTIS-2 trial has been presented at scientific meetings.
This work package has been finalized and the report has already been uploaded.
Work Package 3: Manufacturing
Key achievements include:
RoHS reporting completion for all components.
Final design files uploaded to the manufacturer.
Technical follow-up of prototype systems to resolve any unclarity or issues.
Work Package 4: Clinical Validation
Sponsor of the clinical study COTTIS-2 has been changed from UKLFR to BRAINCOOL due to legal concerns.
Required protocol updates and amendments have been approved by the relevant authorities.
Clinical trial sites have been prepared and patient recruitment has begun.
The matched pair analysis manuscript is under review.
Work Package 5: Market Access and Regulatory
BrainCool has initiated activities related to CE marking.
A comprehensive response to the FDA's comments regarding the pre-submission request is being prepared.
Work Package 6: Commercialization and Marketing
BrainCool is actively working on commercializing their thrombectomy solution in multiple markets.
Partnerships are being formed to navigate regulatory hurdles and access new markets.
Data from the Freiburg site of the COTTIS-2 trial has been presented at scientific meetings.
Stroke is the most common cause of disability in Europe and was estimated to cost healthcare over €45 billion in 2020, a cost that is expected to increase by nearly 44% until 2040, according to the European stroke organization Stroke Alliance for Europe (SAFE). The COTTIS-1 study confirms the neuroprotective properties of very early hypothermia combined with thrombectomy as 95% of the penumbra tissues were salvaged by this approach. 64% of patients are within 0-2 on the mRS scale already at discharge from the hospital (approx. 8-9 days after treatment), and 68% at 3 months. Retrospective studies of treated normothermic patients with thrombectomy at the University Hospital of Freiburg show a result of only 32-42% (mRS 0-2), and metaanalysis of randomized trials reported independency after 3 months (mRS 0-2) of 46%. Health economics data available show the influence of patient’s degree of neurological disability on the overall costs that will be incurred in the following years. Publications show that the mean 5-year cumulative costs differed significantly according to the 3-month mRS score; the costs for a 3-month mRS score of 0 or 5 were $53,578 and $257,486 USD, respectively. Three-month mRS score was an independent determinant of long-term costs after stroke. Therefore, it is expected that RhinoChill can significantly reduce the cost of stroke for patients and society.