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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CAtALySt (NeurescueTM: Computer- controlled aortic occlusion device for the treatment of cardiac arrest)

Teaser

Summary

With a worldwide incidence expected to increase from 9,23 million cases by 2020 to 10,89 million cases by 2030, Sudden Cardiac Arrests (SCA) episodes are today recognized as a public health problem leading to severe brain tissue damage with survival rates below 10%. Neurescue Aps (NEUR) proposes to address the SCA burden by bringing to light a game changing solution - the Neurescue Device â€“ capable of 1) increasing coronary perfusion pressure in the patient undergoing CPR, thereby increasing the likelihood for the patient to respond to defibrillation, and 2) increasing blood flow to the brain, thus extending the critical time window necessary to bring a SCA patient back to normal heart function.
In addition to the significant contribution to the decrease in brain damages and disabilities caused by SCA today, an potential increase of 20 - 40% from today\'s 10% in the SCA survival rate implies that Neurescue could contribute to the direct avoidance of 192 384 â€“ 384 696 deaths per year (just for the initial 10 target countries). This represents a potential saving of â‚¬1,6 - â‚¬5 billion in lost GDP just in the 10 primary regional markets. Furthermore, the healthcare systems will have a 44% cost reduction equivalent to â‚¬385 million yearly savings when using our solution compared to competitor to closest equivalent.

For this project CAtALySt, the four overall objectives are:
1)
a) To perform pre- and post- CE labelling clinical validations in four hospitals in Denmark, France, Germany and the US involving a total of 70 SCA patients (hospital selection is based on available high rates of non-traumatic SCA patients and solid cardiology units) - University Hospital of Grenoble Alps and Hospital SAMU de Paris CHU Necker, Odense Universitets Hospital, and two more hospital to be selected in US & Germany (c.f. Â§4, letters of support).
a) To create an open-access data platform where information collected from patients SCA assisted by Neurescue is properly organized and made available.
2) To obtain CE-mark approval for NeurescueTM. Verify and mature the device specs and prepare documentation for FDA approval.
3) To prepare the documentation required to pursue the administrative pathways required to secure reimbursement. To engage with Key Opinion Leaders (KOLs), hospital procurement managers, national reimbursement organisations and insurance companies, to devise the best and most appropriate reimbursement strategies possible.
4) To establish a distribution network in the different regional markets. To launch a communication plan for scientific, medical and commercially - oriented audiences to attract the visibility of NeurescueTM within the medical community. To strengthen NEUR IPR portfolio. New findings will either be filed as new patents, protected by trademarks or kept secret as company know-how. To continuously update NEU business plan.

Work performed

The first period of the project is contain crucial activities related to preparation and documentation for the authorities regulating our medical technology. A summary of the work carried out in the period by Neurescue in collaboration with subcontractors is listed below. A more detailed description of the work carried out in relation to each work package, can be found under â€œ1.2. Explanation of the work carried per WP.
- Project management: In the period, project leader NEUR has organized the periodic review meetings, ensured that the work has been carried out in accordance with the plan (including the updated plan post the validated amendment request), key on top of key risks and mitigation measures, as well as filing the amendment request, when this was necessary in order to reach a better outcome for the project.
- Data management for the clinical activities which are in the later stage of the project: Has been planned by the clinical director in collaboration with a biostatistician. The data management plan was an important milestone to conclude, as it is a crucial requirement for initiating the further planning and documentation of the forthcoming clinical activities.
- Regulatory planning and work: In Month 10 NEUR had a meeting with US regulatory authority FDA, which expressed verbal and written support of the idea for NEUR to follow the 510(k) athway for clearance of our device. The 510(k) pathway was a previously un-confirmed faster pathway to market clearance. With this novel information at hand, NEUR thus updated its plan to complete documentation of technical verification and validation of the device catering to both EU and US authorities, in order to achieve both EU and US market approval in one go. This meant increasing existing planned tests, which was a primary driver in the recent amendment request. Based on the updated and valid amendment and project plan accommodating both the EU and the US authorities, NEUR has initiated the above-mentioned work from Month 6, which is still ongoing during this end of the first period. Significant and successful test results have been obtained in alignment with the agreed plans (as explained in detail below in respect to individual WPs).
- Submission to Competent Authority: Given the above-mentioned update to the planed work, the increased verification and validation processes to cater to both US and EU authorities. The documentation package required for both competent authorities has been prepared but are still awaiting results from of a number of technological tests which are currently ongoing, before submission can begin.
- Ethical committee approval: In alignment with the project plan, NEUR worked and submitted our submission to the Ethical Committee, which is required to gain permission to legally enrol patients in the first clinical trial of the device. As it is typically rare to gain approval upon the first submission, especially for highly invasive device types in our classification category, we were positively surprised to not only gain approval, but additionally a supportive comment from the Danish Ethical Committee expressing their support and anticipation of the deployment of our technology. This was a significant positive milestone for NEUR, as this approval is a mandatory requirement in order to commence the planned clinical trials.
- Exploitation, Dissemination and Communication: NEUR has followed the planned activities and uncovered valuable knowledge from interviews, surveys and continuous market research with industry and medical KOLs regarding the optimal market access and reimbursement strategy for commercial adoption of the device. As will also be explained in detail below, planned deliverable have been met successfully. Finally, in the process of identifying KOLs and gaining market feedback, NEUR has been showcasing our technology at the worldâ€™s largest fair for Anaesthesiology (ASA 2018) in Month 3, as well as at a leading European symposium in Mo

Final results

Expectations for the project are the successful fulfillment of the above listed objectives and societal impact. Given above description of the work performed during the first period and reached milestones, and as the project is ongoing and the main regulatory and clinical results are generated throughout the second period of project CAtALySt is finalized, these pivotal and conclusive achievements of the project are yet to be collected for publication.