Periodic Reporting for period 1 - EDOR BOX (Electrodermal Orienting Reactivity-based Safeguard System for Early Detection of Suicide Propensity)
Periodo di rendicontazione: 2016-03-01 al 2016-06-30
Sintesi del contesto e degli obiettivi generali del progetto
Suicide is a global phenomenon and an alarming public health problem resulting from mental/mood disorders. According to the WHO, 800,000 people commit suicide yearly. Suicide is the 3rd leading cause of death among the most economically productive age group (15-44) and the 2nd among 15-29 years old. Moreover, there are 10 million suicide attempts globally and 0.5 million in Europe. The costs of treatment and rehabilitation of patients who have attempted suicide reach an overall of €50 billion.
Suicide is preventable by timely interventions, provided that the patient is accurately identified as an at-risk-patient. Yet, there is no reliable solution to distinguish depressed patients not at risk, from those patients at risk of committing suicide. Due to the lack of effective and accurate diagnostic tools, very few at-risk patients are promptly identified and protected by effective preventive actions.
Emotra has developed EDOR-BOX, a first-of-its-kind system for non-subjective diagnosis of suicide risk. The system uses a cost-effective and non-invasive biomarker-based solution to ensure the early detection of patients at risk of attempting suicide. Based on the assessment of electrodermal reactivity as a biomarker, hyporeactive or at-risk patients can be accurately detected and properly managed with preventive measures. The test is conducted in 15 minutes and the technology is user-friendly with short training.
EDOR-BOX will be launched within the market of diagnostic medical devices, which includes biomarkers. The global biomarkers market is expected to grow from $8.09 to $18.30 billion at a 14.6% compound annual growth rate (CAGR) from 2014 to 2020. The field of diagnostic devices for mental disorders is likely to grow in the coming years due to the high incidence of depression, alcohol or drug abuse and suicide.
We have estimated that after 5 years from launch, we will be able to sell 3,125 units, perform 408,000 tests and hire 50 employees. We will obtain total revenues of €56.4 M and generate a R.O.I. of 2.43 with the commercializing of this technology.
EDOR-BOX will help to overcome the limitations in our healthcare system due to a lack of non-subjective diagnostic tools, as well as the economic burden incurred by suicide cases. With EDOR-BOX, Emotra seeks to become a leading player in the market of mental health diagnosis and suicide-risk detection.
Suicide is preventable by timely interventions, provided that the patient is accurately identified as an at-risk-patient. Yet, there is no reliable solution to distinguish depressed patients not at risk, from those patients at risk of committing suicide. Due to the lack of effective and accurate diagnostic tools, very few at-risk patients are promptly identified and protected by effective preventive actions.
Emotra has developed EDOR-BOX, a first-of-its-kind system for non-subjective diagnosis of suicide risk. The system uses a cost-effective and non-invasive biomarker-based solution to ensure the early detection of patients at risk of attempting suicide. Based on the assessment of electrodermal reactivity as a biomarker, hyporeactive or at-risk patients can be accurately detected and properly managed with preventive measures. The test is conducted in 15 minutes and the technology is user-friendly with short training.
EDOR-BOX will be launched within the market of diagnostic medical devices, which includes biomarkers. The global biomarkers market is expected to grow from $8.09 to $18.30 billion at a 14.6% compound annual growth rate (CAGR) from 2014 to 2020. The field of diagnostic devices for mental disorders is likely to grow in the coming years due to the high incidence of depression, alcohol or drug abuse and suicide.
We have estimated that after 5 years from launch, we will be able to sell 3,125 units, perform 408,000 tests and hire 50 employees. We will obtain total revenues of €56.4 M and generate a R.O.I. of 2.43 with the commercializing of this technology.
EDOR-BOX will help to overcome the limitations in our healthcare system due to a lack of non-subjective diagnostic tools, as well as the economic burden incurred by suicide cases. With EDOR-BOX, Emotra seeks to become a leading player in the market of mental health diagnosis and suicide-risk detection.
Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti
TECHNICAL FEASIBILITY
Objective 1: To define and design the protocol for clinical validation of EDOR-BOX in younger patients (EUDOR-Y) in addition to our EUDOR-A clinical study conducted in adult patients. Key Findings: We have defined the parameters of the clinical study and detailed the set-up procedure. A multi-centre study will be performed in 23 centres with 1,150 patients. We will recruit patients of ages 12 to 20. Specifications have been detailed in the Report.
Objective 2: To define the plan for optimization and scale up manufacturing of the technological system. Key Findings: We have designed a plan in collaboration with the company Prevas, defining the parameters that will be improved to reach the ultimate marketable product.
Objective 3: To define the terms of scaling-up production with our manufacturer Norautron AB (Sweden). Key Findings: The terms have been agreed with Norautron, so that we can build the estimated 33 EDOR-BOX units that we need to complete the Project and reach TRL9.
Objective 4: To define a mitigation plan and risk contingency measures within the production protocol. Key Findings: The risk assessment and mitigation measures are provided on page 12 of the Feasibility Study Report.
Objective 5: To define the specifications and user manual of the device, ensuring user-friendly condition. Key Findings: The specifications of the ultimate EDOR-BOX system, as well as the content of the user manual, have been defined and will materialize in WP1 (page 11 of the report).
Objective 6: To design an additional cloud-based communication platform to transfer and store test data for a better medical intercommunication. Key Findings: The specifications of the updated global cloud-based communication platform have been detailed on page 10 of the Feasibility Study Report.
COMMERCIAL FEASIBILITY
Objective 1: To ensure compliance with EU regulatory demands on clinical devices and their approval. Key Findings: The EDOR-BOX system encloses a de-risked and non-invasive device that will be classified as a Class I medical device before being allowed to affix the CE-mark. In these cases, the company needs to present a declaration of conformity with safety, quality and efficiency.
Objective 2: To secure EDOR-BOX’s market viability by confirming it’s expected demand in Europe and US. Key Findings: The market analysis that we have conducted in this Feasibility Study confirms the potential of EDOR-BOX in the market. There are no other alternatives to objectively detect suicide risk using a biomarker-based diagnostic device. Suicide is a major concern globally, not only in Europe/North America but also Asia. Along the EU, the market is promising with 140,000 cases/year and 4,000 psychiatric centers. In the US, there are 43,000 cases/year. Asia (East Asia specifically) is where most cases of suicide occur yearly worldwide.
Objective 3: To carry out a detailed economic analysis on suicide risk diagnosis and prevention by country. Key Findings: The market on diagnostic devices is expected to grow and reach $25 billion in 2020. The segment on mental health diagnosis is promising for Emotra, since there are no other companies providing effective biomarker solutions. When studying the different countries, higher possibilities have been found in Germany, France, Norway, UK and Ireland since they have reported higher suicide rates and high healthcare investment.
Objective 4: To assess the public/private health sector particularities within our main EU-target countries. Key Findings: We have analysed the types of healthcare systems in force in the EU and other markets of interest, as well as the commercial implications for EDOR-BOX in terms of dissemination and commissioning, including reimbursement from insurances.
Objective 5: To analyze the requirements for the routine use of EDOR-BOX in the EU healthcare system. Key Findings: The EU healthcare system periodically issues calls for tenders to attract applicants with novel solutions to be applied in healthcare and diagnosis of the most prevalent diseases.
Objective 6: To secure our “freedom to operate” and further assess the patentability of our device. Key Findings: IPR analysis showed that there are no other patents protecting technologies comparable to EDOR-BOX’s diagnostic purpose. Five similar devices have been protected, but 2 patents have been abandoned. We also have an active patent at Emotra, which supports our FTO in Europe.
Objective 7: To define our exploitation and commercialization strategy, initially involving already approached specialized psychiatric centers in Germany, Italy, France, Spain, UK and the Nordic countries. Key Findings: Our exploitation strategy will be based on a sales plan combining EDOR-BOX units and Tests provided. Dissemination will take place through Emotra’s website, social networks, international dealers, and communication of EDOR-BOX’s results at International Psychiatric Meetings and Medical Devices Conventions.
Objective 8: To secure our distribution by defining alliances with end users in targeted psychiatric facilities. Key Findings: Psychiatric centres participating in the clinical validations conducted in adults and youngsters will ensure initial distribution. Participation has been secured with 23 European centres. We also have agreements with patient associations.
FINANCIAL FEASIBILITY
Objective 1: To conduct a full cost/benefit analysis, taking into account regulatory issues on medical devices. Key Findings: Costs/benefit analysis is favourable at €5,000 selling cost per full EDOR-BOX unit and €100 selling cost per test. We have taken into account our production costs for each unit and the cost to provide each test. We have also considered the number of tests expected to be conducted per year. The cost/benefit analysis is detailed on page 17 of the Report.
Objective 2: To estimate our financial projections for the 5 years upon commercialization and the expected profitability. Key Findings: Projections and profitability were estimated based on our current production costs and considering the cost-benefit analysis. The figures are positive and favourable for Emotra. They have been detailed on page 18 of the Report. After 5 years we will have €56.4M in revenues and earn €17.17M in net profit. In 5 years, we will have 50 more employees, and manage 100% of the market on diagnostic devices for suicide risk detection.
Objective 3: To evaluate the total investment required to bring the global EDOR-BOX system to the market. Key Findings: Total investment required is close to €5M, from which we estimate possible to cover €1.4M from our own financial capabilities. A detailed description of the funding requirements can be found on page 20 of the Report.
Objective 4: To define a business plan that realistically represents the development of project. Key Findings: We have defined our business plan in accordance to the favourable findings of this Feasibility Study. The plan is described on page 19 of the presented Report.
Objective 1: To define and design the protocol for clinical validation of EDOR-BOX in younger patients (EUDOR-Y) in addition to our EUDOR-A clinical study conducted in adult patients. Key Findings: We have defined the parameters of the clinical study and detailed the set-up procedure. A multi-centre study will be performed in 23 centres with 1,150 patients. We will recruit patients of ages 12 to 20. Specifications have been detailed in the Report.
Objective 2: To define the plan for optimization and scale up manufacturing of the technological system. Key Findings: We have designed a plan in collaboration with the company Prevas, defining the parameters that will be improved to reach the ultimate marketable product.
Objective 3: To define the terms of scaling-up production with our manufacturer Norautron AB (Sweden). Key Findings: The terms have been agreed with Norautron, so that we can build the estimated 33 EDOR-BOX units that we need to complete the Project and reach TRL9.
Objective 4: To define a mitigation plan and risk contingency measures within the production protocol. Key Findings: The risk assessment and mitigation measures are provided on page 12 of the Feasibility Study Report.
Objective 5: To define the specifications and user manual of the device, ensuring user-friendly condition. Key Findings: The specifications of the ultimate EDOR-BOX system, as well as the content of the user manual, have been defined and will materialize in WP1 (page 11 of the report).
Objective 6: To design an additional cloud-based communication platform to transfer and store test data for a better medical intercommunication. Key Findings: The specifications of the updated global cloud-based communication platform have been detailed on page 10 of the Feasibility Study Report.
COMMERCIAL FEASIBILITY
Objective 1: To ensure compliance with EU regulatory demands on clinical devices and their approval. Key Findings: The EDOR-BOX system encloses a de-risked and non-invasive device that will be classified as a Class I medical device before being allowed to affix the CE-mark. In these cases, the company needs to present a declaration of conformity with safety, quality and efficiency.
Objective 2: To secure EDOR-BOX’s market viability by confirming it’s expected demand in Europe and US. Key Findings: The market analysis that we have conducted in this Feasibility Study confirms the potential of EDOR-BOX in the market. There are no other alternatives to objectively detect suicide risk using a biomarker-based diagnostic device. Suicide is a major concern globally, not only in Europe/North America but also Asia. Along the EU, the market is promising with 140,000 cases/year and 4,000 psychiatric centers. In the US, there are 43,000 cases/year. Asia (East Asia specifically) is where most cases of suicide occur yearly worldwide.
Objective 3: To carry out a detailed economic analysis on suicide risk diagnosis and prevention by country. Key Findings: The market on diagnostic devices is expected to grow and reach $25 billion in 2020. The segment on mental health diagnosis is promising for Emotra, since there are no other companies providing effective biomarker solutions. When studying the different countries, higher possibilities have been found in Germany, France, Norway, UK and Ireland since they have reported higher suicide rates and high healthcare investment.
Objective 4: To assess the public/private health sector particularities within our main EU-target countries. Key Findings: We have analysed the types of healthcare systems in force in the EU and other markets of interest, as well as the commercial implications for EDOR-BOX in terms of dissemination and commissioning, including reimbursement from insurances.
Objective 5: To analyze the requirements for the routine use of EDOR-BOX in the EU healthcare system. Key Findings: The EU healthcare system periodically issues calls for tenders to attract applicants with novel solutions to be applied in healthcare and diagnosis of the most prevalent diseases.
Objective 6: To secure our “freedom to operate” and further assess the patentability of our device. Key Findings: IPR analysis showed that there are no other patents protecting technologies comparable to EDOR-BOX’s diagnostic purpose. Five similar devices have been protected, but 2 patents have been abandoned. We also have an active patent at Emotra, which supports our FTO in Europe.
Objective 7: To define our exploitation and commercialization strategy, initially involving already approached specialized psychiatric centers in Germany, Italy, France, Spain, UK and the Nordic countries. Key Findings: Our exploitation strategy will be based on a sales plan combining EDOR-BOX units and Tests provided. Dissemination will take place through Emotra’s website, social networks, international dealers, and communication of EDOR-BOX’s results at International Psychiatric Meetings and Medical Devices Conventions.
Objective 8: To secure our distribution by defining alliances with end users in targeted psychiatric facilities. Key Findings: Psychiatric centres participating in the clinical validations conducted in adults and youngsters will ensure initial distribution. Participation has been secured with 23 European centres. We also have agreements with patient associations.
FINANCIAL FEASIBILITY
Objective 1: To conduct a full cost/benefit analysis, taking into account regulatory issues on medical devices. Key Findings: Costs/benefit analysis is favourable at €5,000 selling cost per full EDOR-BOX unit and €100 selling cost per test. We have taken into account our production costs for each unit and the cost to provide each test. We have also considered the number of tests expected to be conducted per year. The cost/benefit analysis is detailed on page 17 of the Report.
Objective 2: To estimate our financial projections for the 5 years upon commercialization and the expected profitability. Key Findings: Projections and profitability were estimated based on our current production costs and considering the cost-benefit analysis. The figures are positive and favourable for Emotra. They have been detailed on page 18 of the Report. After 5 years we will have €56.4M in revenues and earn €17.17M in net profit. In 5 years, we will have 50 more employees, and manage 100% of the market on diagnostic devices for suicide risk detection.
Objective 3: To evaluate the total investment required to bring the global EDOR-BOX system to the market. Key Findings: Total investment required is close to €5M, from which we estimate possible to cover €1.4M from our own financial capabilities. A detailed description of the funding requirements can be found on page 20 of the Report.
Objective 4: To define a business plan that realistically represents the development of project. Key Findings: We have defined our business plan in accordance to the favourable findings of this Feasibility Study. The plan is described on page 19 of the presented Report.
Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)
The major novelty of EDOR-BOX is to bring to market a first-of-its-kind diagnostic system for non-subjective diagnosis of suicide risk. It aims at the stratification of suicide risk associated with depression. Through this project we aim to introduce a non subjective tool for detection of suicide risk, EDOR-BOX, using which clinicians and psychiatric care personnel will be able to distinguish depressed patients at-risk of committing suicide from those non-at-risk.
EDOR-BOX’s technology encloses a series of key innovative features. It is non-subjective and reproducible, since patients cannot direct and control the biomarkered response. Also, it is a reliable alternative to the subjective questionnaire –based evaluations. Additionally, it is able to perform an early detection of suicide risk, enabling timely application of suicidal preventive measures and interventions. Moreover, we provided a non-invasive diagnosis since it does not require taking blood samples or electrical stimulation. Our technology is user-friendly, since EDOR-BOX has been specially designed to offer the highest simplicity in all operations and it is highly intuitive. The use of EDOR-BOX for the front line clinical staff takes only 4 hours. Importantly, EDOR-BOX Test requires only 10 minutes of testing for the patient plus 15 minutes of clinical data documentation. Finally, it works through a cloud-based communication system for the transmission of Test Results to/from the clinical setting to Emotra’s servers. Transmission is conducted through a secure protocol integrated in EDOR-BOX’s Software.
Therefore, the implementation of EDOR-BOX’s technology will be able to save lives and decrease the suffering related to suicide and suicide attempts. It will also serve to save large sums in hospital care since at-risk patients will be identified at an early stage. EDOR-BOX will be able to offer an objective instrument to support clinicians in the decision-making process, thus facilitating the selection of the appropriate management to intervene on depressed patients. Through this technology, we enable a fast response of the front-line clinicians when detecting an at-risk patient and we allow early interventions in patients diagnosed with severe depression. Support caregivers will be able to avoid unnecessary preventive actions on patients not at-risk. Additionally, we will contribute to reduce the number of unnecessary referrals for risk assessment from the primary care level to psychiatric specialist care. Importantly, we will be enabling implementation of personalized care for patients, eliminating the default prescription of anti-depressants.
EDOR-BOX would be the only system in the market capable of providing an objective biomarker-based diagnosis of suicide risk with close to 100% sensitivity. This will be highly relevant for our stakeholders, including psychiatric care clinicians and key-opinion leaders who will believe in our solution and ensure our fast market uptake. Also, healthcare commissioners and hospital managers will be willing to acquire EDOR-BOX to improve their healthcare services and save costs on unnecessary hospitalizations and lengthy suicide prevention procedures on patients that are not at risk. Health policy makers will benefit from having an instrument such as EDOR-BOX, which provides a tool to organize health management measures through its medical database. EDOR-BOX will allow them to study suicide cases, rates, and conduct risk stratification on cases of depression. More importantly, patients and suicide advocacy associations will profit from a new tool that will serve to bring hope to those individuals and families affected by suicide. They will benefit from a new non-invasive diagnostic device that accurately detects suicide risk and that will be able to prevent its occurrence in the short term.
EDOR-BOX’s technology encloses a series of key innovative features. It is non-subjective and reproducible, since patients cannot direct and control the biomarkered response. Also, it is a reliable alternative to the subjective questionnaire –based evaluations. Additionally, it is able to perform an early detection of suicide risk, enabling timely application of suicidal preventive measures and interventions. Moreover, we provided a non-invasive diagnosis since it does not require taking blood samples or electrical stimulation. Our technology is user-friendly, since EDOR-BOX has been specially designed to offer the highest simplicity in all operations and it is highly intuitive. The use of EDOR-BOX for the front line clinical staff takes only 4 hours. Importantly, EDOR-BOX Test requires only 10 minutes of testing for the patient plus 15 minutes of clinical data documentation. Finally, it works through a cloud-based communication system for the transmission of Test Results to/from the clinical setting to Emotra’s servers. Transmission is conducted through a secure protocol integrated in EDOR-BOX’s Software.
Therefore, the implementation of EDOR-BOX’s technology will be able to save lives and decrease the suffering related to suicide and suicide attempts. It will also serve to save large sums in hospital care since at-risk patients will be identified at an early stage. EDOR-BOX will be able to offer an objective instrument to support clinicians in the decision-making process, thus facilitating the selection of the appropriate management to intervene on depressed patients. Through this technology, we enable a fast response of the front-line clinicians when detecting an at-risk patient and we allow early interventions in patients diagnosed with severe depression. Support caregivers will be able to avoid unnecessary preventive actions on patients not at-risk. Additionally, we will contribute to reduce the number of unnecessary referrals for risk assessment from the primary care level to psychiatric specialist care. Importantly, we will be enabling implementation of personalized care for patients, eliminating the default prescription of anti-depressants.
EDOR-BOX would be the only system in the market capable of providing an objective biomarker-based diagnosis of suicide risk with close to 100% sensitivity. This will be highly relevant for our stakeholders, including psychiatric care clinicians and key-opinion leaders who will believe in our solution and ensure our fast market uptake. Also, healthcare commissioners and hospital managers will be willing to acquire EDOR-BOX to improve their healthcare services and save costs on unnecessary hospitalizations and lengthy suicide prevention procedures on patients that are not at risk. Health policy makers will benefit from having an instrument such as EDOR-BOX, which provides a tool to organize health management measures through its medical database. EDOR-BOX will allow them to study suicide cases, rates, and conduct risk stratification on cases of depression. More importantly, patients and suicide advocacy associations will profit from a new tool that will serve to bring hope to those individuals and families affected by suicide. They will benefit from a new non-invasive diagnostic device that accurately detects suicide risk and that will be able to prevent its occurrence in the short term.