Post-Market Clinical Evaluations of Onera STS I Polysomnography System Initiated

Onera Health announces enrollment of first patients into post-market validation studies of its patch-based Onera STS I system. The data of the ongoing clinical studies will be presented at upcoming sleep conferences.

EINDHOVEN, the Netherlands--(BUSINESS WIRE)--Onera Health, a leader in transforming sleep medicine and remote monitoring, announced that it had enrolled the first 50 patients into post-market clinical evaluations of its patch-based PSG solution by the beginning of February, with continuous enrollment of more subjects.

The first part of the studies will assess the diagnostic accuracy of Onera STS I in comparison with in-lab polysomnography administered by a technician. Additionally, the second part will evaluate the usability and reliability of Onera STS I for ambulatory PSG, in which patients apply the patches themselves at their homes.

“We are pleased to see Onera’s solution used on a routine basis in an in-lab setting as well as the comfort of the patient’s home. We are eager to collect further evidence that Onera STS I not only meets the gold-standard set by traditional PSG systems but, through its user-centric and compact design, brings additional benefits for doctors and patients alike. We are excited to contribute to a future where this comprehensive diagnostic solution can be delivered to many patients with sleep disorders, whether in a clinical or non-clinical setting”, said Ruben de Francisco, Founder and CEO of Onera.

“Technological innovations like Onera’s patch-based PSG system are essential to helping end the delays in identifying various sleep disorders. I’m delighted to see such a seamless integration in our day-to-day clinical practice. The signal quality we have seen with Onera STS I meets our requirements for a comprehensive assessment of sleep disorders. Compared to the commonly used technology, the reduction of hook-up time is remarkable; it literally takes minutes! Additionally, the patients voice positive feedback, which indicates to us a high patient satisfaction, something that we shouldn’t underestimate when it comes to our field”, adds Hartmut Schneider, MD, PhD, retired Associate Professor of Pulmonary and Critical Care Medicine at the John Hopkins University (Baltimore, US) and Onera Co-Founder.

With the ongoing enrollment of more subjects in different centers in Europe, the studies are scheduled to complete enrollment in Q2 2022. Clinical study results will be presented in leading medical conferences later this year.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 960826.

About Onera

Onera Health is a leader in transforming diagnostics and monitoring. Their breakthrough products and technologies are poised to help millions of people struggling with health ailments and chronic conditions in a variety of medical fields, including sleep, neuro, cardiac and respiratory care, ultimately improving the health and quality of life for patients around the world. The company’s innovative solutions provide comprehensive physiological and health-related data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs. Onera has offices in the Netherlands and the US. For more information, go to www.onerahealth.com