Obstructive sleep apnea (OSA) is characterized by repetitive narrowing and collapse of the upper airway during sleep, which leads to oxygen desaturation and fragmented sleep. Approximately two million people are diagnosed suffering from OSA each year. Significant co-morbidities are indentified, such as hypertension, obesity, diabetes and cardiac disease, imposing high chronic healthcare costs and burden to society.
Standard of care OSA therapy in Western markets is continuous positive airway pressure (CPAP), which provides a constant flow of pressurized air to keep the airway from collapsing during sleep. While CPAP is highly effective, about 40% of patients are unable to tolerate therapy, leaving a significant number untreated, and in search of a solution that fits their lifestyle. Surgery is an alternative and is the firstline OSA therapy in Asia. Current surgical options have drawbacks, including low effectiveness. While obstruction commonly occurs at multiple airway levels, a collapse at the tongue base contributes to OSA in the majority of cases. No minimally invasive, adjustable, reversible surgery exists to effectively address tongue-based obstruction.
Philips has developed Respiosa; a simple, minimally invasive surgically implanted solution to provide optimal therapy for tongue-based OSA.
Respiosa prevents the tongue from collapsing into the airway when patients sleep on their backs. Designed and tested by world-class developers with ENT surgeons, the novel Respiosa implant system promises to deliver effective, durable and adjustable therapy. The implant can be placed with a 30-minute procedure, offering low trauma and quick recovery. Respiosa’s effect is optimized with an in-office adjustment procedure post-surgery. Since Respiosa is natural and unobtrusive, patients don’t feel the implant, or interact with it, thus adherence is not an issue.
Respiosa’s design is frozen, having been refined with robust bench testing, KOL feedback, and extensive preclinical (animal and cadaver) studies. Manufacturing process and supply chain are established. Next steps are to complete design verification, execute a human clinical study, complete the regulatory approvals and develop and execute the commercial strategy.