University of Milano-Bicocca

LAUSANNE, Switzerland--(BUSINESS WIRE)--Aesyra SA, a Swiss medtech company developing innovative digital therapeutics for dental and sleep-related disorders, today announced the successful completion of its clinical investigation evaluating the efficacy and safety of AesyBite™ Active, an intelligent oral appliance designed to treat and prevent sleep bruxism through biofeedback. The clinical investigation demonstrated that AesyBite™ Active achieved a statistically significant and clinically meaningful reduction in sleep bruxism activity. 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

TUESDAY, Jan. 20, 2026 -- Common blood biomarkers can predict multimorbidity, according to a study published online Jan. 2 in Nature Medicine . Alice Margherita Ornago, from the University of Milano-Bicocca in Italy, and colleagues analyzed 54 blood biomarkers reflecting inflammatory, vascular, metabolic, and neurodegenerative processes in 2,247 individuals aged 60 years and older from the Swedish National Study on Aging and Care in Kungsholmen to examine the biological underpinnings of multimorbidity. Three measures were used to assess multimorbidity: baseline total disease count, baseline multimorbidity patterns identified through latent class analysis, and 15-year rate of disease accumulation. The researchers found consistent and positive associations for growth differentiation factor 15, hemoglobin A1c, cystatin C, leptin, and insulin with all multimorbidity measures. Specific associations with distinct multimorbidity patterns were demonstrated for additional biomarkers. A direct association was seen for faster disease accumulation with gamma-glutamyl transferase, while an inverse association was seen with albumin. External validation of longitudinal results was performed in 522 participants from the Baltimore Longitudinal Study of Aging, with comparable predictive accuracy. "Our study suggests that disturbances in metabolism, stress responses, and energy regulation are among the main drivers of multimorbidity in older people," principal author Davide Liborio Vetrano, M.D., Ph.D., from Karolinska Institutet and Stockholm University, said in a statement. "This opens up the possibility of using simple blood tests to identify high-risk individuals, enabling earlier intervention in the future." Abstract/Full Text

FRIDAY, Jan. 9, 2026 -- Maternal influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccinations are associated with a lower risk for influenza- and pertussis-related hospitalization or emergency department (ED) visits in infants younger than 6 months, according to a study published online Jan. 8 in JAMA Network Open . Gabriella Morabito, from the National Centre for Healthcare Research and Pharmacoepidemiology at the University of Milano-Bicocca Milan in Italy, and colleagues conducted a population-based cohort study using health care utilization databases from the Lombardy region of Italy to examine the association of maternal influenza and Tdap vaccinations with influenza- and pertussis-related hospitalizations and ED visits among infants aged younger than 6 months. A total of 53,448 pregnant individuals who received the Tdap vaccine and 5,347 who received the influenza vaccine were included in the study. Maternal vaccination coverage was 6.4 and 41.0 percent for influenza and Tdap, respectively. The researchers found that the risk for hospitalization or ED visits for influenza and pertussis was lower among infants born to mothers who received the influenza and Tdap vaccines (vaccine effectiveness, 69.7 and 88.6 percent, respectively). "These results support the current recommendations for administering these vaccines during pregnancy and highlight the urgent need to implement strategies aimed to increase their acceptance," the authors write. One author disclosed ties to the pharmaceutical industry. Abstract/Full Text