Onera Health

Executive Summary

Onera Health, a Dutch digital health company founded in 2016, has developed a novel patch-based polysomnography (PSG) system that enables clinical-grade sleep diagnostics from the comfort of patients' homes. By eliminating the need for conventional sleep lab visits with cumbersome wired equipment, Onera's solution addresses a critical bottleneck in sleep medicine: access to timely and convenient diagnosis. The system is designed to capture the same physiological signals as traditional PSG—including brain activity, eye movements, muscle tone, and respiratory parameters—through a single, wireless patch, significantly reducing patient burden and operational costs for healthcare providers. With a growing global prevalence of sleep disorders such as obstructive sleep apnea and insomnia, Onera Health is well-positioned to capture a share of the expanding home sleep testing market, valued at over $5 billion. The company has attracted attention from investors and strategic partners in the medtech space, though it remains in a growth phase pending regulatory clearances and commercial scaling. If successful, Onera's technology could disrupt the sleep diagnostics industry by shifting care from specialized centers to primary care and home settings, improving patient outcomes and healthcare efficiency.

Upcoming Catalysts (preview)

• Q2 2026FDA 510(k) clearance for home polysomnography system65% success
• Q3 2026CE marking under EU MDR for commercial launch in Europe70% success
• Q4 2026Strategic partnership with a national sleep clinic chain for market access50% success