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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - CoaguPOC (SMART POINT-OF-CARE DEVICE FOR SELF-PATIENT MANAGEMENT OF THE ORAL ANTICOAGULANT THERAPY)

Teaser

Summary

The ultimate goal we seek in the CoaguPOC project is to develop a point-of-care device for patientâ€™s self-testing of the Oral Anticoagulant Therapy (OAT). This therapy is aimed at reducing the risk of stroke for patients diagnosed with Atrial Fibrillation (AF), mechanical heart valve replacement, and other conditions with high risk of thrombosis. Since most oral anticoagulants interfere with other drugs, food and patientâ€™s lifestyle, this therapy requires regular tests to determine the coagulation level, called INR, and confirm or adjust dose levels. Moreover, the most used oral anticoagulants have a narrow therapeutic window and anticoagulation levels too low or too high may cause dangerous adverse events (stroke, bleeding). The current model for INR monitoring is based on patients visiting clinics once a month to measure their INR. However, at this frequency, a large portion of patients spend much time with dangerous anticoagulation levels. However, it is not feasible to increase the frequency of INR monitoring because, at the current growth of cardiovascular diseases, the cost of INR monitoring for healthcare services would soon become unsustainable.
The use of POC coagulometers for INR self-testing entail a new model of home INR monitoring which may lead to more frequent INR monitoring. Several studies have proved that this new model is more cost-effective and enables a better anticoagulation management, leading to important reductions on adverse events. It has also a substantial impact on patientsâ€™ quality of life, and important cost savings on the healthcare system.
Approximately 2% of the population are prescribed long-term oral anticoagulants (blood thinners), meaning that more than 10-12 million people are treated in Western Europe. On the other hand, stroke is currently the second cause of death in Europe, with 1 million strokes per year.
CoaguPOC will be an integral solution to help OAT patients and doctors in self-monitoring and self-managing their therapy. Our device is based on sensors that determine the INR by an accurate and innovative technique to measure blood viscosity.
During the SME-Phase 1, we have elaborated a detailed Business Innovation Plan to make us ready for Phase 2 and market uptake following these main objectives: Market study and Validation activities, New Product Development, deeply studying relevant regulation, monitoring a very dynamic market and IPR integral strategy.

Work performed

During the phase 1, we have attained great advances towards product termination, running fruitful LEAN-based processes with reference figures of our main stakeholders:
- 4 patient associations: AEPOVAC, AMAC, FEASAN, AVAC,
- 1 pharmaceutical laboratory specialized in generic drugs,
- 10 specialist physicians,
- 10 pharmacies,
- 5 primary care centers,
- 1 hospital.
This has allowed us refining our product concept and market uptake strategy, as well as shaping our revenue model. Our IPR protection is advancing, the strategy is completely defined and we are preparing the documentation to file a patent request. We are also having success establishing relevant partnerships.

Final results

CoaguPOC aims to bring to the market the first low-cost POC INR device for OAT patients to self-monitor and self-manage their chronic condition. Ultimately, it will improve INR management, increasing the time patients are within target therapeutic ranges, reducing major adverse events and increasing patientâ€™s satisfaction and quality of life.
The overall plan is to commercialize CoaguPOC first in Spain and speed scalability at the international level through a network of allies. Thanks to this strategy, we expect to grow to reach a turnover of â‚¬28 million and 72 employees by the year 2022.