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The First In Vitro Diagnostic Device for the Early Detection of Cardiac Ischemia

Periodic Reporting for period 1 - AGLYC (The First In Vitro Diagnostic Device for the Early Detection of Cardiac Ischemia)

Reporting period: 2018-07-01 to 2018-09-30

Cardiovascular diseases (CVD) are the leading cause of death/morbidity across the globe, accounting for 31% of all deaths in 2015. Ischemic events are the most common manifestation of CVD. Early detection of ischemia is essential to prevent the progression of heart damage and the irreversible tissue damage that can lead to heart failure. However, there are no available biomarkers for the early detection of cardiac ischemia. In fact, almost 90% of the available in vitro diagnostic (IVD) methods are based on the quantification of markers of necrosis, an advanced stage of organ damage, and are not effective for the early detection of ischemic damage.

AGLYC is an IVD device for the quantification of Apo J-Glyc blood levels as an early biomarker of ischemia (<30 mins from event onset) in the absence of the irreversible necrosis of the tissue. AGLYC demonstrates a 97% sensitivity in detecting the presence of cardiac ischemia. Our main competitive advantages are high sensitivity, early detection, and cost effectiveness. The Global IVD market accounted for $61,103 m in 2016 and is estimated to reach at $84,647 m by 2023, growing at a CAGR of 4.6% from 2017 to 2023. We have estimated a lab-based target market of >70M patients (USA+5EU) and Point of Care (POC) target market of >36M patients (USA+5EU).

Our main business model will be a sublicense model based on the development of a laboratory-based test that we will develop and then sublicense to either a medical device company (MedTech) in the cardiac diagnostic testing market or to a pharmaceutical company with drugs for CVD in its portfolio for the co-development of the POC device for the rapid quantification of Apo J-Glyc for its commercialization. With this model and the successful completion of the SMEI Phase 1 and 2 we estimate an EBITDA of around €19m, creating 10 new jobs by 2024.

The Feasibility Study for this project has taken 3 months and has focussed on an in-depth market study, technical testing and the development of final business plan to take us to market.
The work performed within the Feasibility Study is divided into four tasks:
Task 1: Management and Coordination of the study
Task 2: Market Feasibility Study
Task 3: Technical Feasibility Study
Task 4: Financial and Organizational Feasibility Analysis and Business Plan update

These tasks have been carried out to attain the three specific objectives of the project:
1. To demonstrate the market viability of the project by quantifying the level of market demand and willingness to pay by main users.
2. To carry out the technical testing of the improved AGLYC prototype.
3. To update the business plan according to the obtained results.

After the completion of the Feasibility Study during the execution of the SME Instrument Phase 1 we have identified the key activities to be accomplished in the next phases of the project:
1. To develop clinical evidence studies with the improved AGLYC prototype.
2. To develop cost-effectiveness studies.
3. To design and implement an awareness campaign.
4. To work on the business development strategy.
5. To incorporate new roles with complementary skills in the company.
6. To initiate applications for CE mark and reimbursement plan as per go-to-market objectives.

Thus, the final recommendation is to apply for the SME Instrument Phase 2 as soon as possible in order to cover the next activities of the AGLYC project and to shorten the time-to-market of our solution.
Nearly 90% of the available methods for the detection of cardiac events (troponins, CK-MB and myoglobin) are based on the quantification of markers of necrosis (cellular death) that determines the presence of an advanced and irreversible stage of heart damage. Furthermore, there is a need to identify novel biomarkers to improve current classification of patients’ risk, as the only accepted tool for risk stratification and prediction of recurrent ischemic events and mortality in ACS is the Global Registry of Acute Coronary Events (GRACE) risk score.

In this context, the use of AGLYC will detect ischemia early, improving patients’ prognosis and reducing the impact of the disease. In addition, due to the added prognostic value of Apo J-Glyc, besides improving patients’ management in the acute setting, it will be useful in carrying out risk stratification strategies in secondary prevention. This would be crucial to ensure an adequate categorization of chronic patients suffering from ischemia according to their risk, reducing the impact of the disease and improving their quality of life, contributing to the sustainability of healthcare systems.
Apo J-Glyc: Early and specific marker for the detection of cardiac ischemia