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AesyBite Custom smart nightguard by Aesyra SA.

The clinical investigation demonstrated that AesyBite? Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity, exceeding the predefined performance target.

Strong and robust clinical outcomes

In the study (Identifier: NCT06153810), involving 26 adult patients with confirmed sleep bruxism, activation of the AesyBite Active biofeedback system resulted in a 60.6% reduction in total sleep bruxism duration per hour compared to baseline (95% CI: 55.8%-64.9%, p < 0.001). This reduction exceeded the study's predefined efficacy threshold, confirming the device's ability to meaningfully reduce bruxism activity during sleep.

In addition to the primary endpoint, statistically significant improvements were observed across multiple secondary measures, including:

-- Reduced number of bruxism episodes per hour

-- Shorter bruxism episode duration

-- Lower intensity of bruxism episodes

-- No negative impact on sleep duration

The therapeutic effect was consistent regardless of baseline bruxism severity and independent of the timing of biofeedback activation.

Positive safety and usability profile

No adverse events were reported during the investigation. Patient-reported outcomes showed progressive improvements in orofacial pain, as well as improved comfort and acceptance of the device over time, supporting its suitability for long-term nightly use.

A differentiated approach to treating sleep bruxism

Unlike conventional passive splints, AesyBite? Active combines a customized oral appliance with embedded sensors and active biofeedback, enabling real-time detection and reduction of bruxism activity without disturbing sleep.

"These results represent a major milestone for Aesyra," said Marco Letizia, co-founder and CEO of Aesyra SA. "Demonstrating a consistent and robust reduction in sleep bruxism activity, together with an excellent safety profile, strongly supports the clinical value of AesyBite Active and its potential to change how sleep bruxism is treated."

"The magnitude and consistency of the effect observed in this investigation are particularly encouraging," added Prof. Marcello Maddalone, Principal Investigator, University of Milano-Bicocca."The data support AesyBite Active as an effective and well-tolerated therapeutic option for patients suffering from sleep bruxism."

Next steps

The study results will support global regulatory submissions and future commercialization efforts. FDA submission has been initiated and regulatory approval in the USA is targeted for 2026.European regulatory approval is planned thereafter. In 2026 Aesyra plans to initiate go-to-market activities with existing partners and will seek additional partners for other commercial activities and to expand clinical indications of its platform technology.

About Aesyra SA

Aesyra SA is a Swiss spin-off from EPFL (École Polytechnique Fédérale de Lausanne) focused on developing smart, data-driven oral medical devices for the diagnosis and treatment of sleep-related dental conditions using its proprietary platform technology.

Its flagship product, AesyBite? Active, integrates digital sensing and biofeedback to address sleep bruxism in a novel and clinically validated way.

Building on the same technological platform, Aesyra is also developing AesyBite? Custom, a next-generation digital dentistry solution that leverages patient-specific intraoral 3D scans and additive manufacturing to enhance personalization and wearing comfort in bruxism therapy.

For more information, visit: www.aesyra.com

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