Replacing sleep labs: The first clinical grade home-based diagnostic of sleep disorders

Informations projet

SOMNIO

N° de convention de subvention: 960826

DOI

10.3030/960826

Projet clôturé

Date de signature de la CE 7 Juillet 2020

Date de début 1 Novembre 2020

Date de fin 30 Avril 2023

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 3 788 320,25

Contribution de l’UE

€ 2 499 999,00

Coordonné par

ONERA BV
Netherlands

Periodic Reporting for period 2 - SOMNIO (Replacing sleep labs: The first clinical grade home-based diagnostic of sleep disorders)

Période du rapport: 2022-02-01 au 2023-04-30

Résumé du contexte et des objectifs généraux du projet

Onera is the next generation of medical grade sleep diagnostics and monitoring. Alarmingly, 80% of people who suffer from a sleep disorder remain undiagnosed due to the high costs, time and specialized resources required by current clinical solutions. In recent years, innovations have focused on developing simple screening devices such as smart watches or mattress sensors that provide limited and inaccurate information about sleep quality. Onera is set to change this, by redefining the ‘gold standard’ with our proprietary diagnostic solution. Onera’s clinical-grade wearable consists of adhesive patches as simple and non-intrusive as applying a band-aid, with maximum wearing comfort. The technology is valuable for remote respiratory monitoring to reduce burden on the healthcare system following the COVID-19 pandemic. Commercializing such innovative wireless sensors and machine learning algorithms is made possible by Onera’s team leveraging >10 years of experience at IMEC, a world-leading research institute in nanoelectronics and digital technologies. Our solution is designed for use at home. Our vision is to transform sleep medicine by redefining sleep diagnostics as a service. Capitalizing on the major market hype for sleep trackers and push from healthcare payors to move to home diagnoses, Onera is disrupting the field with a new service model that replaces overnight in-lab studies and allows for user-friendly, cost-effective, and scalable sleep diagnostics globally.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

Onera’s patch-based polysomnography (PSG) device, under the commercial name Onera STS, is cleared for market access for both the European market as well as for the US market. As part of the process of obtaining regulatory clearance as a medical device, the safety and effectiveness of the device has been demonstrated by (external) compliance testing as well as (clinical) validation studies. Onera continues to carry on clinical studies and commercial pilots to generate additional economic and clinical evidence, driving further clinical adoption of its unique self-applied home PSG technology. The company launched in 2022 its end-to-end solution for clinical-grade home sleep studies, Onera PSG-as-a-Service, in EU and US. In the meantime, the company has set up its first customers and commercial pilots in both geographies, as well as several strategic partnerships

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

Onera’s easy-to-use and clinical-grade device and software platform in combination with its PSG-as-a-Service business model will enable reach to a group of undiagnosed patients that would otherwise never arrive in the diagnostic pathway for sleep disorders. Onera will make gold-standard diagnostics possible wherever the patient is, also at home, overcoming the current limitations in healthcare systems regarding scarcity of medical facilities and access to qualified personnel.

Onera STS