Accepted 2026 presentations highlight clinical experience with AIO Breathe® oral appliance therapy in 6-17-year-old children with obstructive sleep apnea
TYLER, TX, UNITED STATES, April 15, 2026 /EINPresswire.com/ — AIOMEGA® today announced that multiple pediatric-focused scientific presentations related to the AIO Breathe® platform have been accepted for presentation at national meetings in 2026, including the American Academy of Sleep Medicine (AASM), the American Academy of Dental Sleep Medicine (AADSM), and the Southern Sleep Society.
The accepted presentations highlight clinical experience with oral appliance therapy in children with obstructive sleep apnea (OSA), including approaches to airway assessment, treatment planning, and interdisciplinary care.
Focus on Pediatric Obstructive Sleep Apnea Management
Obstructive sleep apnea in pediatric patients presents unique clinical considerations, including changes in dentition over time and the need for coordinated care across specialties. Oral appliance therapy is one treatment option that may be incorporated into patient-specific management plans under the supervision of qualified healthcare professionals.
AIO Breathe® Pediatric (PDS) (FDA 510(k) K252525) is an oral appliance indicated for the treatment of mild to moderate obstructive sleep apnea (OSA) and snoring in appropriate pediatric patients ages 6–17. The device is prescribed by a sleep physician and fitted by a trained dentist as part of coordinated clinical care.
Mechanism-Based Design to Support Airway Patency During Sleep
AIO Breathe® Pediatric is a custom-fabricated mandibular repositioning device designed to advance the mandible and associated soft tissues during sleep. This repositioning supports the maintenance of upper airway patency by increasing pharyngeal airway space and facilitating airflow.
The device incorporates design features that allow for vertical opening and lateral movement of the jaw, enabling use in both open and closed mouth positions during sleep. These features are intended to support patient comfort and consistent use as prescribed.
Each device is fabricated based on dental impressions or digital scans and is individualized to the patient’s dentition and clinical presentation.
Clinical Management in Growing Patients
In pediatric patients, oral appliance therapy is managed through ongoing evaluation by the treating dentist in coordination with the prescribing sleep physician. As dentition changes over time, device replacement may be required to maintain appropriate fit and function.
AIO Breathe® Pediatric is part of a coordinated care pathway designed to support patients over time, with ongoing clinical evaluation and device replacement as appropriate to maintain therapy during periods of dental transition. This longitudinal approach reflects how oral appliance therapy may be incorporated into pediatric care as patients grow and clinical needs evolve.
Accepted Presentations to Explore Clinical Experience and Care Pathways
The accepted presentations will include topics such as:
• Airway assessment approaches using imaging modalities, including CBCT
• Clinical experience with oral appliance therapy in pediatric populations
• Patient-reported experience measures related to device use
• Interdisciplinary care coordination between dental and medical providers
• Treatment workflows in real-world clinical settings
These presentations are intended to support scientific exchange and clinical discussion and do not establish new or expanded indications for use.
Important Safety Information
As with any oral appliance therapy, some patients may experience temporary side effects including excessive salivation, tooth discomfort, or mild jaw soreness during initial use. Patients should be monitored by a trained dentist in coordination with their prescribing sleep physician. Consult prescribing information for full safety details.
“As a company committed to advancing airway and sleep health across the lifespan, we are thrilled to make AIO Breathe available to pediatric patients” said Dr. Raghavendra V. Ghuge, MD, MBA, DABSM, FAASM, the Founder and Chief Executive Officer of AIOMEGA. “Obstructive sleep apnea in children is often under‑recognized yet carries profound implications—from impaired neurocognitive development and growth delays to cardiovascular and metabolic disturbances.”
Studies estimate prevalence in the general pediatric population at approximately 1 %–4 %. (Frontiers) In practice, the risks are even higher among children with craniofacial abnormalities, neuromuscular disorders, or obesity. (Dove Medical Press).
Dr. Ghuge continued, “With clearance of the pediatric version of AIO Breathe, we are now positioned to offer a new, non‑invasive airway enhancement solution that may fill a critical gap in pediatric sleep‑disordered breathing management. Our goal is to support improved sleep, growth, behavior, and cardiovascular wellness for children impacted by OSA.”
Clinical and Market Implications
Pediatric OSA is associated with a spectrum of adverse conditions, including impaired cognitive performance, behavioral dysfunction, growth faltering, and elevated cardiovascular risk. (MDPI) Historically, treatment options have centered on surgery (e.g., adenotonsillectomy) and positive airway pressure modalities such as CPAP; yet a significant portion of children either fail first‑line therapy, are non‑adherent, or remain untreated. With FDA clearance for pediatric use, AIO Breathe provides sleep medicine specialists, otolaryngologists, pediatric pulmonologists, and dentists a new therapeutic option for children with obstructive sleep apnea.
About AIOMEGA®
AIOMEGA is a medical device company focused on oral appliance technologies for the management of obstructive sleep apnea. The company develops FDA-cleared devices designed to support airway patency during sleep through mandibular repositioning, within established clinical care pathways.
The company was founded by Raghavendra Ghuge, MD, DABSM, a board-certified pediatric and adult sleep medicine physician, whose clinical experience informs the development of the AIO Breathe® platform.
Raghavendra V Ghuge
AIOMEGA LLC
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