Periodic Reporting for period 4 - CAtALySt (NeurescueTM: Computer- controlled aortic occlusion device for the treatment of cardiac arrest)
Período documentado: 2021-08-01 hasta 2023-01-31
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 – 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 – 384 696 deaths per year (just for the initial 10 target countries). This represents a potential saving of €1,6 - €5 billion in lost GDP just in the 10 primary regional markets. Furthermore, the healthcare systems will have a 44% cost reduction equivalent to €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- CE labelling clinical validations in hospitals in Germany and the US involving a total of 20 SCA patients (hospital selection is based on available high rates of non-traumatic SCA patients and solid cardiology units) - Heidelberg University Hospital in Germany and Long Beach Medical Center in USA.
b) 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 or 510(k) approval for Neurescue, given verified and matured device specs and sufficient documentation.
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 NEUR business plan.
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 – 384 696 deaths per year (just for the initial 10 target countries). This represents a potential saving of €1,6 - €5 billion in lost GDP just in the 10 primary regional markets. Furthermore, the healthcare systems will have a 44% cost reduction equivalent to €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- CE labelling clinical validations in hospitals in Germany and the US involving a total of 20 SCA patients (hospital selection is based on available high rates of non-traumatic SCA patients and solid cardiology units) - Heidelberg University Hospital in Germany and Long Beach Medical Center in USA.
b) 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 or 510(k) approval for Neurescue, given verified and matured device specs and sufficient documentation.
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 NEUR business plan.
NEUR has completed crucial activities for project objectives. Throughout the project, a main theme has been for the NEUR team to complete complete technical and regulatory documentation tasks in order to execute clinical activities. The technical and clinical activities are continuously supported by commercial research and diligence activities, in order to ensure optimal market uptake, once clinical evidence and regulatory approvals are reached. A summary of the work carried out in the project is listed below:
- Project management: Project leader NEUR has organized the periodic review meetings, working to carry out tasks according to plans to the best ability, and keeping an overview of potential risks and mitigation measures for the project. NEUR furthermore corresponds with the assigned EASME officer regarding overall project planning when necessary.
- Data management and clinical activities: Clinical activities has been at the core of this project since the beginning. However due the COVID19 pandemic in the middle of this project, the clinical activities have had to be altered multiple times during the project. After NEUR had trained and initiated a clinical trial with Odense Universitets Hospital (OUH) in Denmark, the COVID19 pandemic changed thepriorities for OUH, and the trial therefore had to be cancelled. This led to a larger change in clinical activities, and these were rescoped to two clinical studies in Germany and USA. NEUR then worked to complete the prerequisite documentation to initiate the new clinical trials in Germany and USA. In the final reporting period, NEUR has commenced and enrolled cardiac arrest patients in both the German and US trials. The trials have not managed to enroll all intended patients at the time of project termination, but they will continue to enroll irrespective of the termination of SME Instrument co-financing.
- Regulatory planning and work: After NEUR completing verification and validation activities required for FDA submission, NEUR obtained a 510(k) clearance from the FDA in May 2021, where the first cleared indication for use of the device is for hemorrhage control and traumatic cardiac arrest. NEUR still needs to obtain more clinical evidence to pursue an expanded indication for use with the FDA for non-traumatic cardiac arrest, as well as CE mark in Europe. In the final reporting period, NEUR obtained the necessary regulatory approvals to start the trials in Germany and USA. The US trial was especially complex to obtain approval for as it required a "community consultation", which involved hosting townhall meeting, and publishing notifications about the trial in local radio and newspapers. It all was completed and approved however.
- Exploitation, Dissemination and Communication: Due to the COVID19 delays in trials, NEUR did not have much reason to attend conferences, as the trials have not yet produced the desired scientific evidence to present publicly. The FDA 510(k) clearance entitles NEUR to market the device commercially in the US. Since obtaining the clearance, NEUR entered into a distribution agreement with the distributor aimed at the US military. This agreement will generate sales of 1 000 devices per year and marks the first commercial milestone for NEUR. During the fourth reporting period NEUR has also pursued distribution agreements in other territories which are also covered by the FDA 510(k) clearance including Israel, the Gulf countries, Singapore and Australia. These activities will be continued. NEUR has also finalized planned tasks focused on mapping out Key Opinion Leaders, reimbursement codes and market entry strategies for the most relevant future markets.
A trial data is not yet available, NEUR will not publish clinical evidence in any leading peer-reviewed scientific journals within the timeline of the project. NEUR has however worked closely with the investigative teams at both clinical sites in terms of monitoring and continuously updating clinical evidence documentation for the future scientific publications about the trials, thereby preparing as much of the scientific work as possible within the scoped time of the project.
- Project management: Project leader NEUR has organized the periodic review meetings, working to carry out tasks according to plans to the best ability, and keeping an overview of potential risks and mitigation measures for the project. NEUR furthermore corresponds with the assigned EASME officer regarding overall project planning when necessary.
- Data management and clinical activities: Clinical activities has been at the core of this project since the beginning. However due the COVID19 pandemic in the middle of this project, the clinical activities have had to be altered multiple times during the project. After NEUR had trained and initiated a clinical trial with Odense Universitets Hospital (OUH) in Denmark, the COVID19 pandemic changed thepriorities for OUH, and the trial therefore had to be cancelled. This led to a larger change in clinical activities, and these were rescoped to two clinical studies in Germany and USA. NEUR then worked to complete the prerequisite documentation to initiate the new clinical trials in Germany and USA. In the final reporting period, NEUR has commenced and enrolled cardiac arrest patients in both the German and US trials. The trials have not managed to enroll all intended patients at the time of project termination, but they will continue to enroll irrespective of the termination of SME Instrument co-financing.
- Regulatory planning and work: After NEUR completing verification and validation activities required for FDA submission, NEUR obtained a 510(k) clearance from the FDA in May 2021, where the first cleared indication for use of the device is for hemorrhage control and traumatic cardiac arrest. NEUR still needs to obtain more clinical evidence to pursue an expanded indication for use with the FDA for non-traumatic cardiac arrest, as well as CE mark in Europe. In the final reporting period, NEUR obtained the necessary regulatory approvals to start the trials in Germany and USA. The US trial was especially complex to obtain approval for as it required a "community consultation", which involved hosting townhall meeting, and publishing notifications about the trial in local radio and newspapers. It all was completed and approved however.
- Exploitation, Dissemination and Communication: Due to the COVID19 delays in trials, NEUR did not have much reason to attend conferences, as the trials have not yet produced the desired scientific evidence to present publicly. The FDA 510(k) clearance entitles NEUR to market the device commercially in the US. Since obtaining the clearance, NEUR entered into a distribution agreement with the distributor aimed at the US military. This agreement will generate sales of 1 000 devices per year and marks the first commercial milestone for NEUR. During the fourth reporting period NEUR has also pursued distribution agreements in other territories which are also covered by the FDA 510(k) clearance including Israel, the Gulf countries, Singapore and Australia. These activities will be continued. NEUR has also finalized planned tasks focused on mapping out Key Opinion Leaders, reimbursement codes and market entry strategies for the most relevant future markets.
A trial data is not yet available, NEUR will not publish clinical evidence in any leading peer-reviewed scientific journals within the timeline of the project. NEUR has however worked closely with the investigative teams at both clinical sites in terms of monitoring and continuously updating clinical evidence documentation for the future scientific publications about the trials, thereby preparing as much of the scientific work as possible within the scoped time of the project.
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.