Inspire Medical Systems’ neurostimulation device has been approved by the US Food and Drug Administration (FDA) for treating obstructive sleep apnoea (OSA).
The company plans to soft launch the Inspire V therapy system in the US later this year, with a full launch scheduled for 2025.
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The Inspire V device consists of a neurostimulator that delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles, along with a Bluetooth patient remote and physician programmer.
OSA is a sleep disorder where the walls of the throat relax and narrow during sleep, interrupting normal breathing and leading to interrupted sleep. Common treatments include using a continuous positive airway pressure (CPAP) device and a mandibular advancement device (MAD) – both prevent airway closure.
The OSA market has seen volatility in recent months. As the market leader in the space, Philips has issued several recalls for CPAP machines. The company issued a Class I recall for its DreamStation 2 CPAP machines after reports emerged that the polyester-based polyurethane (PE-PUR) foam used in these devices broke down to release toxic chemicals.
Philips’ troubles have made way for other companies in the field to increase their OSA treatment market share. The global annual market for OSA detection and treatment is worth approximately $10bn, as per GlobalData analysis.
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By GlobalDataMultiple companies are developing novel treatments for OSA. StimAire is developing an injectable stimulator device for treating the disorder. The device was designed to modulate peripheral nerves such as the hypoglossal, utilising a tiny, battery-free, injectable receiver/stimulator that is activated by a small wearable.
In January 2023, Vivos Therapeutics received 510(k) clearance from the FDA for its DNA oral appliance (daytime-nighttime appliance) for treating mild to moderate OSA.
The device acts similar to a MAD by opening the airway by extending the palate and training the tongue to rest in the proper position as well as converting patients to nasal instead of oral breathing. The device trial showed OSA resolution in 28% of patients, with 63% of patients showing improvement by one AHI classification and 86% of patients improving their airway size.
