Obstructive sleep apnea (OSA) is associated with various negative health consequences including increased risk of heart disease, hypertension and daytime sleepiness causing road accidents. The economic burden of OSA is rising as almost 1 billion people worldwide are estimated to have OSA. The current diagnostic metric, however, relates poorly to these symptoms and comorbidities. It merely measures the frequency of breathing cessations without assessing OSA severity in any other physiologically relevant way. Furthermore, the clinical methods for analyzing PSG signals are outdated, expensive and laborious. Due to this, the majority of OSA patients remain without diagnosis or have an inaccurate diagnosis leading to sub-optimal treatment. Thus, it is evident that more personalized diagnostics are required including predictive and preventive health care and patient participation. The SLEEP REVOLUTION aims to develop machine learning techniques to better estimate OSA severity and treatment needs to improve health outcomes and quality of life. These techniques are implemented to high-end wearables developed in this project to alleviate the costs and increase the availability of PSGs. Finally, we aim to design a digital platform that functions as a bridge between researchers, patients and healthcare professionals. We will achieve these ambitious goals throughout extensive collaboration between sleep specialists, computer scientists and industry partners. The collaboration network consists of over 30 sleep centers working together to provide the needed retrospective data (over 10.000 sleep studies). The multi-center prospective trials involve experts and end-users to assess and validate the new SLEEP REVOLUTION diagnostic algorithms, wearables and platforms. With the commitment of the European Sleep Research Society and Assembly of National Sleep Societies (over 8000 members), we have the unique possibility to create new standardized guidelines for sleep medicine in the EU.

CLINICAL PROBLEM AND UNMET NEED There are 11,827 patients with severe structural airway disease in Europe. Even with the current standard of care, when hospitalised this group of patients has a 22% risk of dying. Patients are currently subjected to repeated surgical interventions (stent insertion) which have a high failure rate. Other therapeutic strategies under development include synthetic tracheal scaffolds seeded with patients own stem cells. Preliminary data show that these scaffolds are poorly integrated and are susceptible to infection. TETRA PROJECT Our SME-led project will address the limitations of standard clinical care and competitor products under development and will: - Build on our successful compassionate use experience using autologous stem cell seeded scaffold-tracheal transplants in 48 patients - Follow on from our Phase I 4 patient INSPIRE clinical trial which will improve on the clinical prototype used in compassionate use cases - Conduct a 48 patient Phase II pivotal clinical trial to provide robust, quality data with validated GMP manufacturing processes to support an accelerated route to market for commercial exploitation in this orphan indication - Prepare a dossier for MAA submission BENEFITS Our product, an ATMP, aims to eliminate the need for repeated surgical interventions of high risk and limited efficacy, reduce deaths and improve the quality of life for surviving patients. If treating 20% of the patients with severe structural airway disease, we estimate that in Europe our technology will improve the quality and length of patient lives and result in savings of €517 million per year. We plan to further develop our platform technology to generate other complex tissues/organs such as bowel and liver replacements for clinical applications which will impact the lives of tens of thousands of patient in the EU with bowel and liver diseases.