Inspire obtains FDA approval for obstructive sleep apnea neurostimulator therapy

Inspire Medical Systems has received FDA approval for its Inspire V neurostimulator therapy for obstructive sleep apnea (OSA). A soft launch is planned for late 2024, with a full launch in 2025.

This update follows preliminary second-quarter results, where Inspire forecasted a 30% increase in year-over-year revenue. Consequently, the company has raised its annual revenue guidance.

The Inspire V offers a mask-free alternative to continuous positive airway pressure therapy. The implant delivers pulses to move the tongue and prevent airway blockages, allowing patients to breathe more easily during sleep. The new device includes enhanced sensing capabilities and a software platform for future updates, while maintaining the same mechanism as its predecessor.

For Q2, Inspire expects $195.9 million in revenue, with a 30% increase in U.S. sales and a 27% rise internationally. The company has revised its full-year revenue forecast to $788 million to $798 million.