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A precision, computer-vision measurement system for the early diagnosis of schizophrenia

Periodic Reporting for period 1 - Gazelab (A precision, computer-vision measurement system for the early diagnosis of schizophrenia)

Reporting period: 2015-05-01 to 2015-10-31

The goal of this SME Instrument Phase 1 project was to elaborate a Business Plan for the commercialization of GazeLab, a computer vision-based system that accurately measures two known biomarkers, ocular motility (the movement of the muscles surrounding the eye) and pupillary dynamics (pupillography) for the early diagnosis of mental illnesses. In particular, we have gathered and processed the required information to plan the clinical validation of ocular motility as an indicator for schizophrenia. GazeLab, our all-in-one solution can be deployed as a point-of-care diagnostic tool, leading to quicker and more effective treatments for a variety of disorders.

The main objective was to determine if BCNINNOVA’s GazeLab precision biomechanical ocular measurement tool was a viable and sustainable business opportunity. It has been proven, thanks to an comprehensive market analysis, that there is a hopeful market waiting for biomarker as the abnormal eye movements existance is known by the mental health sector experts and there is no accurate way currently to measure it. The health sector is awaiting a biomarker that provides objective results for the diagnosis of squizofrenia, thus calming down the current need of the health market for an objective diagnostic tool that could be use as substitute of the current state of the art.

As it was proven that there is an interest in Gazelab device in the mental health scetor, the elaboration of a business plan took place as well as a clinical validation roadmap. It was also studied, that further technological refinement of the current device will be needed in order to launch it to the market, however GAZELAB for the health sector have proven to be commercially feasible as its the current GAZELAB for the ophtalmological sector.From an internal point of view, we have defined a concise, realistic, executable and clear clinical validation and technological adpatacion that will provide Gazelab for the mental health (GMH) with the sufficient push to become the gold standard for the diagnosis of squizofrenia.

BCNINNOVA has the adequate capacity to reorganize its workload and assimilate its organizational, cultural and market growth necessary to reach the objectives of GAZELAB for the health sector with great success. Thus, BCNINNOVA aspires at becoming an international leader of the objective diagnosis of order to achieve this goal, BCNINNOVA will seek further funding from the commission and will aply for further funding under the SME instrument programme (SME phase 2).
"In this feasibility study we have examined the capability of BCNINNOVA to reposition the current product Gazelab for support on ophthalmology diagnostics as a measure of efficient biomarker for early detection of schizophrenia by means of abnormal eye movements (ABEM). By such reason it has been analyzed:

•Market interest and impact.Base on comments from psychiatrist in the field it has been concluded that there is a hopeful market due to the knowledge of ABEM existance for more than a 100 years and yet not a single biomarker objective has been made.An easy acceptance of the technology is expected as a result of the wide differential value provided by the device.

•Volume and Market Share.A volumen of 35,366 potential buyers is estimaded, segregated between Menthal Heath Hospital and Outpatients Facilities. With 50% and 30% market share respectively. Resulting in target sales of 11,376 units in 10 years.

•Need for Technological Refinement. Technical (test type) and new final user (psychotic patients) requirements have been studied. A slight redesign necessity over the current Gazelab product has been appointed to overcome the suspicions of schizophrenic patients and their low stress tolerance.The refinement cost has been evaluated as it raises 7% the overall cost of the possible SME phase 2 project.Hence it is considered feasible due to its low cost.

•Clinical Validation Project.6 leading hospitals in the menthal disease treatment field have shown their interest and commitment to the project. Along with them a two type detailed study plan has ben defined.The first one is a longitudinal study to asses either the evolution of patients with the first episodes of the disease or at risk of developing the disease to come by an early diagnosis.And a second study to pull apart patients that have already been diagnosed as schizophrenics from patients either with other menthal diseases that also exhibit AEBMor mentally healthy.Once the project has been documented it is estimated that BCNINNOVA has suficient capabilities to carry it to term.

•Economic feasibility. It is estimated that the total cost of the validation and commercialization of GAZELAB for the mental health sector ascends to 3.719.011 €.

•Furthermore, we have studied the regulatory requirements, intellectual property and the risks of the project to ensure the overall feasibility of the GAZELAB as a mental health diagnostic device.

This project will catapult BCNINNOVA to organizational and market growth. Thus a restructuring of the company will be required to absorb 16 new jobs (of qualified staff) and achieve sells in 28 different countries on 4 continents. We aim to be international leaders in the objective diagnosis of schizophrenia taking advantage of the lack of technology to cover this need and the technologicalboom effect in the mental health field expected for the upcoming years.

Finally, we concluded that Gazelab in Mental Health (GMH) has an identified market, with a significant volume, that BCNINNOVA will be able to successfully attain. Technically it has a clear understanding of what should be done and how. This is ""the time"" and ""the opportunity"" for BCNINNOVA to break through the market anticipating future competitors (possibly from outside the EU)."
Mental Health of the European population is an increasing concern. One of every four citizens will suffer from a mental health problem during their life span, resulting in huge economic and social impacts. Schizophrenia is not an exception with an index of around 1 %. In other words, schizophrenia affects more than 24 million people worldwide . Moreover, while basic neurosciences have provided significant advances in the understanding of the brain,these have not translated into the psychiatric practice. Gazelab is a possible solution to this increasing concern of citizens around Europe.

Gazelab would bring objectivity in the early diagnosis of schizophrenia thanks to mathematical model that his software is built on. The current subjective diagnostic system purely based on interviews and tests that are applied to the patients will slowly disappear. In this manner Gazelab would become a homogeneous model of diagnosis. The system would keep record of evidences and videos of the patient's eyes in the PC to provide a clear and precise monitoring throughout the patient's disease. The data base would be of legal value thanks to the clinically validated biomarker and bring a lot of confidence to the professionals.

The purpose of the device Gazelab in Mental Health (GMH) is to reach an early diagnosis of schizophrenia by capturing abnormal eye movements after a series of tests to be undertaken with GMH. A slight technological refinement of hardware and software will be performed in order to adjust the current device to the new end-user, psychotic patients.The target is to prevent the patient's suffering during the disease by detecting it in advance.

Moreover, it has been proven through this feasibility study that the health sector is awaiting a biomarker that provides objective results for the diagnosis of squizofreni. Thus, calming down the current need of the health market for an objective diagnostic tool that could be use as substitute of the current state of the art.
Gazelab Device