Aesyra Advances a Therapy Product - AesyBiteTM Active - To Clinical Trials for Bruxism Management
Aesyra SA is a private company based in Lausanne (Switzerland) that is developing a medical device able to accurately monitor and relieve sleep bruxism (nocturne teeth grinding), a highly prevalent condition without therapy that has negative impact on patient’s life and is associated with serious sleep disorders such as sleep apnea. The company has already secured the IP, obtained regulatory approval in EU for its first product and obtained clinical data.
Caused by anxiety, stress accumulated during the day, obesity and sleep apnea, bruxism affects 66milion of people in US and EU. Short-term symptoms comprise headache, facial pain and drowsiness. In the long run, bruxism provokes severe damage to teeth and dental implants, causes severe sleep disruption, and poor quality of life.
For decades, sleeping bruxism has been managed with dental appliances produced by dentists. Such appliances protect the teeth without treating the condition. Although with poor clinical benefits, this solution was the predominant solution proposed by specialists. In US and EU, 7.5M people receive this treatment every year. Leveraging on this existing market, Aesyra has developed AesyBiteTM a smart oral appliance that reduce bruxism by relaxing muscles during sleep. AesyBiteTM would replace traditional dental splints, which are ineffective to treat this condition.
Clinical data obtained by the company in collaboration with the Federal Institute of Technology of Lausanne (EPFL), the San Gerardo Hospital (Monza, Italy) and Clinique Universitaire De Médecine Dentaire (CUMD) demonstrated the ability of the Aesyra technology to reduce the bruxism activity by 70% in subjected affected by this condition after 3 nights of use.
Marco Letizia (CEO) commented: “This is fundamental to mitigate symptoms, preserve teeth and dental implants and improve the quality of life of millions of people every year. In addition, the technology developed by the company has several applications in dentistry and sleep medicine at various stages of development, all of which offer significant partnering opportunities.”
Pietro Maoddi (CTO) added: “After having CE marked the first bruxism monitoring device (AesyBite Discover), is preparing to initiate clinical trials on a bruxism treatment device (AesyBite Active) with the aim of launching this disruptive solution on the market in 2022”.
Paolo Orsatti (Board member, Investor) commented: “We are convinced that Aesyra solution has a very large potential because it addresses an unmet medical need, it can positively impact the quality of life of millions of patients and potentially prevent other sleep disorders. We are delighted to support the company in the next phases”.