LAUSANNE, Switzerland — Jan 26, 2026 — Swiss medtech company Aesyra SA announced the successful completion of a clinical study evaluating AesyBite™ Active, its intelligent oral appliance for treating sleep bruxism. The device combines a customized splint with embedded sensors and real-time biofeedback to detect and reduce teeth grinding during sleep.
The study (NCT06153810) involved 26 adults with confirmed sleep bruxism. Activation of the AesyBite™ Active system led to a 60.6% reduction in total sleep bruxism duration per hour compared to baseline (95% CI: 55.8%–64.9%, p < 0.001). This exceeded the study’s predefined efficacy target, demonstrating both statistical significance and clinical relevance.
Secondary outcomes also showed significant improvements, with consistent therapeutic effects observed regardless of baseline bruxism severity or timing of biofeedback activation.
Unlike conventional passive splints, AesyBite™ Active actively monitors and reduces bruxism events without disturbing sleep.
“These results mark a major milestone for Aesyra,” said Marco Letizia, co-founder and CEO. “The consistent reduction in sleep bruxism activity, coupled with an excellent safety profile, highlights the clinical value of AesyBite Active and its potential to transform bruxism treatment.”
Prof. Marcello Maddalone, principal investigator at the University of Milano-Bicocca, added, “The magnitude and consistency of the effect are particularly encouraging. AesyBite Active emerges as an effective and well-tolerated option for patients suffering from sleep bruxism.”
Looking ahead, Aesyra plans to use the study results to support global regulatory submissions, including an FDA submission in the United States in 2026, with European approval to follow. The company will also pursue commercialization with existing and new partners and explore expanded clinical applications for its platform technology.