Panthera Dental has expanded its line of obstructive sleep apnea (OSA) therapies by acquiring an oral appliance designed for the pediatric population. Previously named SomNyx, the appliance will be rebranded as D-SAD|Myo within Panthera Dental’s digital sleep appliance range.
The oral appliance combines elements of myofunctional therapy (MFT) with physiological mandibular advancement. Panthera will collaborate with pediatric sleep and orthodontic expert Michèle Hervy, the inventor of the appliance, who will lend her expertise to its enhancement and international roll out.
Myofunctional therapy alone has shown some promise in the treatment of OSA, but it typically requires parental involvement, which can be difficult to sustain over time. The D-SAD|Myo provides the means for the child to independently perform the tongue exercises with the device in place.
It incorporates two key elements:
- patient-tailored mandibular appliance; and
- a rolling-ball mechanism.
The ball promotes forward tongue movement, which stimulates the genioglossus muscle responsible for tongue protrusion and tone, while preventing its posterior displacement and upper airway closure. Clinical trial data from several international studies have demonstrated significantly improved breathing during sleep in children with OSA. There was a concomitant increase in nasopharyngeal airway space with improved nasal breathing, and an increase in the mandibular counter clockwise growth. While the impact on growth is only possible in children, adults may benefit from this appliance’s myofunctional training as well.
Panthera Dental will apply its expertise in CAD/CAM and its medical-grade nylon to the design and manufacture of this appliance.
At the upcoming World Sleep Congress in Rome, Italy, in a symposium dedicated to orthodontic treatments of sleep disorders for children, Hervy will present the latest results from clinical studies evaluating this oral appliance therapy.
Hervy says in a release, “This therapy is designed to change the shape of a child’s oral cavity, avoiding the need for OSA treatment later in life. It stimulates tongue activity during light stages of sleep, improving tongue function and tongue position at rest, which has been shown to promote maxillary arch expansion and improve nasal breathing.”
Laurent Viviani, co-founder of the company that developed the appliance, says in a release, “The level of compliance for MFT has often been low in children. By developing a nighttime treatment, we aim to improve outcomes for children, so they do not suffer serious health consequences later in life. We are delighted to partner with Panthera Dental to further develop our appliance and to produce it with their trademark digital precision and robust medical-grade materials.”
Gabriel Robichaud, president of Panthera Dental, says in a release, “Children with OSA are under diagnosed and under treated. It gives us enormous pleasure to add a pediatric therapy to our current range of oral appliance therapies designed for adults.”
The D-SAD|Myo is planned for launch in the European Union and United States in 2023, pending regulatory authorizations.