Periodic Reporting for period 1 - SN-marker (Secretoneurin (SN): the first blood biomarker to accurately stratify mortality risk in patients with cardiac arrhythmia)
Reporting period: 2019-10-01 to 2020-02-29
What is the problem/issue being addressed?
Cardiovascular disease (CVD) is the leading cause of death worldwide. A large proportion of these patients ultimately die from sudden cardiac death (SCD). The predominant causes of SCD - ventricular tachycardia and ventricular fibrillation (VT/VF) – have been shown to be key determinants of survival in patients both with CVD and the general population.
Thus, there is an urgent need to better target and select patients who will benefit from an ICD. As none of the other biomarkers allow risk stratification due to risk of ventricular arrhythmias, SN will be the only currently available biomarker that has a potential to meet this medical need.
Why is it important for society?
As an example, as many as 70% of patients with an ICD (implantable cardioverter-defibrillator) will never need the device. Conversely, a large proportion of sudden cardiac death patients do not fulfil current criteria for ICD implantation. The arrhythmia- ICD market is massive: It is estimated that > 30 million people suffer from arrhythmias and >100.000 ICDs are implanted in the EC alone with yearly device treatment costs exceeding €2 billion.
What are the overall objectives?
Objectives:
1. Develop a comprehensive business plan, including market analysis of primary segments & global roll-out strategy for the various SN assays
2. Gather market intelligence via primary research, incl. detailed analysis of requirements from players across the value chain to establish final features of the tests
3. Plan the Phase 2 project, namely by securing clinical demonstrations sites, as well as engaging with target end-users and KOLs.
Summary of results and conclusions
• Feedback from survey strongly indicate that our technology is well suited and potentially can be used by large IVD companies
• Our planned clinical trial to document our biomarker blood test has a good design but needs to be expanded to gain marked acceptance and KOL support
• Potential distributors in key European markets have been identified and contacted. Discussion are ongoing with several of them
• Partners (3) for innovative project have been identified and has agreed to participate in the project, for which we have applied for funding though EU Fast Track Innovation program
• Project will continue
Cardiovascular disease (CVD) is the leading cause of death worldwide. A large proportion of these patients ultimately die from sudden cardiac death (SCD). The predominant causes of SCD - ventricular tachycardia and ventricular fibrillation (VT/VF) – have been shown to be key determinants of survival in patients both with CVD and the general population.
Thus, there is an urgent need to better target and select patients who will benefit from an ICD. As none of the other biomarkers allow risk stratification due to risk of ventricular arrhythmias, SN will be the only currently available biomarker that has a potential to meet this medical need.
Why is it important for society?
As an example, as many as 70% of patients with an ICD (implantable cardioverter-defibrillator) will never need the device. Conversely, a large proportion of sudden cardiac death patients do not fulfil current criteria for ICD implantation. The arrhythmia- ICD market is massive: It is estimated that > 30 million people suffer from arrhythmias and >100.000 ICDs are implanted in the EC alone with yearly device treatment costs exceeding €2 billion.
What are the overall objectives?
Objectives:
1. Develop a comprehensive business plan, including market analysis of primary segments & global roll-out strategy for the various SN assays
2. Gather market intelligence via primary research, incl. detailed analysis of requirements from players across the value chain to establish final features of the tests
3. Plan the Phase 2 project, namely by securing clinical demonstrations sites, as well as engaging with target end-users and KOLs.
Summary of results and conclusions
• Feedback from survey strongly indicate that our technology is well suited and potentially can be used by large IVD companies
• Our planned clinical trial to document our biomarker blood test has a good design but needs to be expanded to gain marked acceptance and KOL support
• Potential distributors in key European markets have been identified and contacted. Discussion are ongoing with several of them
• Partners (3) for innovative project have been identified and has agreed to participate in the project, for which we have applied for funding though EU Fast Track Innovation program
• Project will continue
Market research with major IVD companies and Key Opinion Leaders, key findings:
1)There is an urgent medical need for the product we do develop
2) The technology we use is the technology of choise
3) Our plans for documenting clinical use is appropriate but furthere studies are required for KOL support
Engage with ELISA distributors for the commercialisation of the RuO assay
1) Identification of and contact with potential distributors and discussions are ongoing
B2B business plan
1) Business plan updated based on input from market search performed through this project
Planning of Phase 2 innovation project
1) KOLs and potential partners for innovation project identified and contacted
2) several agreements made for their participation in such a project
1)There is an urgent medical need for the product we do develop
2) The technology we use is the technology of choise
3) Our plans for documenting clinical use is appropriate but furthere studies are required for KOL support
Engage with ELISA distributors for the commercialisation of the RuO assay
1) Identification of and contact with potential distributors and discussions are ongoing
B2B business plan
1) Business plan updated based on input from market search performed through this project
Planning of Phase 2 innovation project
1) KOLs and potential partners for innovation project identified and contacted
2) several agreements made for their participation in such a project
This project has reveiled the urgent medical need of the product we are developing. It has the potential to impact treatment of heart failure patients and thus save lives and cost for society