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Diagnosing platform for neurological and mental disorders based on the analysis of ocular and oculocephalic movements.

Periodic Reporting for period 1 - OSCANN (Diagnosing platform for neurological and mental disorders based on the analysis of ocular and oculocephalic movements.)

Reporting period: 2017-01-01 to 2017-06-30

Progressive aging of the population is a worldwide phenomenon. Neurodegenerative disorders affect primarily older people, so their incidence will only grow, and it is already becoming one of the most pressing problems faced by health systems around the world, specially in western countries where total population is shrinking whilst cohorts of those over 65 years old are increasing in size.

OSCANN, AURA’s value proposal, will provide neurologists and doctors in general with decisive assistance to perform early, fast and reliable diagnosis for more than 200 different disorders, both neurodegenerative like Alzheimer or Parkinson´s Disease and non-neurodegenerative like Essential Tremor or Vertigo.

AURA has decided to focus initially on Parkinson’s Disease based on the following factors:

¥ It is the second neurodegenerative disorder in terms of prevalence and incidence rates, after Alzheimer.
¥ There is a lack of reliable diagnosis methods.
¥ Early diagnosis of the disease considerably improves quality life score of patients.

The feasibility study conducted refers mainly to this limited “beachhead market” although the market potential for OSCANN is highly scalable as the pool of diseases susceptible to be diagnosed with it is very ample.

The specifications of OSCANN have been defined to ensure that the resulting hardware / software device presents a series of differential characteristics that make it highly competitive in the market. A detailed analysis of the competition proposals has been conducted, and the most important conclusion that derives from it is that none of the potential rivals working in the field of ocular movement monitoring has a proposal comparable to that of AURA’s: portable, low cost, easy to use and with results simple to interpret.

OSCANN has been designed to maximize its spread in health systems, and not only in the so-called first world; for this, its cost will be extraordinarily competitive, at least an order of magnitude cheaper than competitive proposals.

Additionally, another source of OSCANN's competitive advantage will be the progressive creation of a cloud-based knowledge database with data generated by all the devices that are operational, which will be exploited using artificial intelligence techniques to find biomarkers for neurological diseases able to assist physicians in their diagnostic tasks.
AURA was incorporated as a limited liability company in February 2015. Its main project since its inception has been OSCANN.
Thus, 26 months of intense work have been dedicated so far to OSCANN, focused on:

¥ R&D on ocular and oculocephalic movements and their relation with neurological conditions, focusing on the research of scientific sources to lay ground to the design principles and specification of a device able to monitor and interpret those movements to assist in the diagnostic process.
¥ Research on similar devices already in the market (mainly for medical research purposes in large hospitals) and definition of the data set and performance objectives of the OSCANN device to comply with AURA’s vision of how medical diagnosis, processes and treatments should be: accessible to everyone.
¥ Design of a fixed version of the device, both hardware and software (OSCANN d100), and in-depth testing of its capabilities, with special emphasis on the precision of eye movements tracking. From initial prototypes to first industrial grade series.
¥ Scouting, negotiating and eventual liaison with reference hospitals in Spain to prepare a battery of clinical trials, with emphasis on PD.
¥ Definition of the functional and operational specification of a portable version of OSCANN (w300), and initial prototypes.
¥ Definition of a procedure to search for biomarkers within the realm of data gathered by OSCANN.

Results achieved are:

¥ Industrial grade device OSCANN d100, being used for pre-clinical testing (TRL 8) and clinical trials in hospitals to obtain CE mark (first series of 25 units). OSCANN d100 has been classified as a Class IIa medical device; this means that clinical trials have to be performed to attain TRL 9.
¥ Pre-clinical trials successfully completed for OSCANN d100: electromagnetic compatibility, electric security, and photoluminescence.
¥ Agreements signed with 9 reference hospitals to conduct clinical trials of OSCANN for different neurological conditions; some of them are ongoing and all are expected to finish by late 2017.
¥ First prototype of portable version of OSCANN already in place and evolving swiftly; first industrial grade version expected for early 2018.
Main progress attributable to OSCANN is to make available to clinics, hospitals and physicians an affordable and easy to use device providing assistance in early diagnosis of neurological conditions, not only for neurologists and psychiatrists, but also for non-specialists in broad levels of national health systems. Currently, alternatives to OSCANN are complex and expensive devices aimed at big hospitals with limited capabilities of attending large numbers of prospective patients. Moreover, OSCANN’s software is made of two parts: OSCANN Capture and OSCANN Viewer. The former allows medical staff to select and perform tests with two different human-machine interfaces (one for patient and one for medical staff) and the later is a powerful tool aiding in the analysis of the results and allowing a speedier generation of medical records.

After clinical trials, OSCANN will also make it possible to effectively pursue the identification of biomarkers that will complement and enhance diagnostic processes for many illnesses contributing to the betterment of patients (early diagnoses conducing to early, more effective treatments), physicians (productivity, accuracy) and national health systems (costs, services).

For the moment, main impact has been felt by the medical professionals that are working with OSCANN in clinical trials in hospitals; feedbacks from them is encouraging, and value the potential of the device and besides and foremost of the biomarkers that can be discovered.

Human-machine interfaces of OSCANN Capture and OSCANN Viewer have been developed with end-user requirements in mind, thus improving OSCANN's acceptability and enhancing market impact. Furthermore, easy to use interfaces will open new markets for this kind of technology beyond neuroscience.

From a technological point of view, device and method got qualification of “A” in the European Research Report, ratifying the innovation content of both.

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[2] Saccadic eye movements in Parkinson's disease. Anshul Srivastava, Indian J Ophthalmol. 2014 May; 62(5): 538–544. doi: 10.4103/0301-4738.133482
[3] Validation of mobile eye-tracking as novel and efficient means for differentiating progressive supranuclear palsy from Parkinson's disease. Svenja Marx, Front Behav Neurosci. 2012; 6: 88. Published online 2012 Dec 13. doi: 10.3389/fnbeh.2012.00088
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