2022-11-006 - mHealth - System for Early Assessment of Sleep Disorders and Healthy Sleep

mHealth

2022-11-006

Novel approach for OSA diagnostic and monitoring, based on the analysis of signals captured by mobile phone devices. Our asset can provide, using a multi-parameter analysis, which is not common with the competitors, and the positional therapy

The institution has a clear commitment towards the inclusion and diversity,employee engagement, human rights and wellbeing. Furthermore, the project has a commitment towards reducing environmental impact, engaging citizenship, and overseed ethical aspects and gender equality, regarding the widespreading of the technology.

Digital health infrastructures help healthcare institutions to advance towards the integration of digital modelling, the advanced processing of objective information aligned to a clinical use case, and the ability to better understand or even draw significant clinical insigh. We expect our technology to change or benefit in the economy, society, culture, policies or public services, health, environment or well-being, beyond the academic field.

Obstructive sleep apnea (OSA) is one of the most common sleep disorders, with a prevalence ranging from 9% to 38% in the overall population. Most patients (~80%) remain undiagnosed and untreated. The gold-standard for OSA diagnosis is polysomnography (PSG), requiring very specific equipment and patient hospitalization. mHealthySleep which allows diagnose, monitoring and screeening of sleep disorders relying on mobile phone signals, in asimpler, unobtrusive, and cheapert way than PSG. It has higher sensitivity than PSG in the determination of sleep position, allows multi-night recording and will offer personalized positional treatment. It will imply a reduction of diagnostic costs, and a increase of diagnosed patients who wilñl potentially benefit from positional therapy.

5300000000

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Customers will be contacted through the healthcare system. Primary care doctors will prescribe the diagnostic device setup to patients with suspected OSA and will prescribe the personalized therapeutic setup to patients with AHI between 12 and 30 (moderate disease). This system is compatible with screening processes, in which all population from a certain age will have to take this test.Clients: Primary healthcare centers, hospitals, sleep units, sleep patients that need positional tratment ; Payors: Public Health System, sleep patients that download the therapy app ; End-Users: healthcare professionals giving assistance sleep disease patients; sleep patients under positional treatment . Seller: Digital health pharma company specialized in sleep disorders.

The market needs cheap, cutting-edge, portable devices that patients undergoing diagnosis or tratment for the condition can use at home. Those reliable portable devices would allow screening strategies and implementation of Health Continuum.

Market of Sleep Apnea devices

450K €

Investments for funding a spin-off to perform the required activities (regulatory preclinical, early clinical validation) to accelerate market readyness of the tecnology

Technical development of the app, validation of the app+mobile phone in clinical settings, market study, stakeholder involvement, business plan, detailed regulatory roadmap assessment to reach the market through spin-off creation in 2-3 years

mHealthySleep technology offers a diagnostic power comparable to PSG results, based on analysis of multimodal signals, offering even higher sensitivity at the determination of sleep angles. It has the added value of being based on smartphone sensors and wireless devices, and allowing the delivery of personalized positional treatment.

Further integration of all the functionalities within an app. Integration of the data collection within a telemedicine platform to connect data with the physician. Further clinical studies in patients and healthy volunteers for validation.

Clinical validation in patients with sleep apnea (2025-2026) - Clinical trial in patients with sleep apnea and pilot implementation of the platform - spin-off launching (2026- 2027) Scale-up, regulatory action, CE mark (2028)- Clinical validation completed (2029) CE mark for different mobile phone devices (2030) product comercialization [8% over total sells]

Patent pending. Entered National phases in the beginning of 2025. Territories in which protection was pursued: Australia, Brasil, Canada, China, EU, Japan, Mexico, USA.

The project is available for investors interested in supporting an early-stage spin-off developing cell therapy products.

Talented team, a Severo Ochoa acredited institution with 23 research teams , that count on the support of management and research facilities. The institution offers mentoring programs and trainings on innovation, open science, research management, etc. A skilled research team with know-how regarding the technology, and expertise in non-invasive monitoring, diagnosis, disease prevention and pathology treatment.

A quality management system is used for management of innovation, and will be implemented in all the steps of the product life. The quality system is based on leadership, enganement of team members and stakeholders, in improvement, evidence-based decision making, excellence, transparency and talent retention.

Patents: EP22187174.2 - Date: Jul 29th, 2022

Sleep disorders are significant public health problems, whose burden affects both patientsand the public health system. Among different sleep disorders, prevalence of obstructive sleep apnea (OSA) has dramatically increased during the last years. Current strategies for diagnosis and monitoring of OSA disorders rely on Polysomnography (PSG), a technique that limits patient movement and comfort, and has a very high cost, which makes it inaccessible for many hospitals, limiting the diagnostic capability of the health system. Some initiatives had been taken in order to generate clinically useful portable devices for OSA diagnostic and monitoring, but they remain as unsolved medical needs. On this regard, mobile health (mHealth) solutions have become more and more interesting for the clinical community, as they represent and affordable and user-friendly source of medical data. Efforts on exploding the potential clinical utility of mHealth products mark a clear trend towards quality remote monitored medicine. Overall, OSA diagnostic and monitoring deserve innovative solutions to overcome current limitations, taking advantage on current medical technologies.