Nyxoah Begins US Commercial Rollout of Genio Sleep Apnea Implant
First patients implanted with the novel neurostimulator marks a key step in challenging market leader Inspire Medical after recent FDA approval.
Nyxoah (NASDAQ: NYXH) has initiated its U.S. commercial launch for the Genio® system, announcing that the first American patients have been successfully implanted with the device for treating Obstructive Sleep Apnea (OSA). The milestone is a critical step for the Belgium-based medical technology company, transitioning it from regulatory approval to revenue generation in the largest global market for sleep apnea devices.
The announcement follows the device's , positioning Genio as a new contender in the hypoglossal nerve stimulation space. According to the company, the and successful payor coverage, validating its market access strategy.
Nyxoah enters a lucrative and rapidly expanding field. The U.S. sleep apnea implants market was valued at over $800 million in 2024 and is , driven by low patient adherence to traditional CPAP machines. Genio aims to capture a significant share of this growth by differentiating itself from the current market leader, Inspire Medical Systems (NYSE: INSP).
Unlike existing treatments, Nyxoah's Genio system is leadless, battery-free, and requires only a single incision for implantation. The device stimulates the hypoglossal nerve bilaterally to prevent airway collapse during sleep and is controlled by a small, wearable patch, which also allows for future technology upgrades without requiring further surgery. This design contrasts with .
The successful implantation of its first U.S. patients is a crucial proof point for Nyxoah as it begins the challenging process of scaling its commercial operations. The company's ability to compete with Inspire's established network of implant centers and navigate the complex landscape of insurance reimbursement will be closely watched by investors. The two companies are also engaged in an ongoing patent infringement lawsuit, adding another layer of risk and competition to the market dynamics.