Nyxoah Initiates BREATHE Study to Evaluate Genio Hypoglossal Nerve Stimulation for Sleep Apnea
Nyxoah (NASDAQ:NYXH) has initiated the BREATHE study, a U.S. post-approval clinical trial evaluating its FDA-approved Genio hypoglossal nerve stimulation system in patients with moderate to severe obstructive sleep apnea who have not responded well to standard treatments. The single-arm prospective study will enroll up to 229 participants across 25 centers and follow them for five years, focusing on effectiveness endpoints such as the apnea-hypopnea index (AHI) and oxygen desaturation index at 12 months. The trial aims to generate real-world evidence that could support Genio's adoption by physicians and payers. The device uses a battery-free implant powered externally, offering an alternative approach compared to existing treatments. However, the study lacks a control group, limiting its ability to demonstrate comparative superiority over other therapies or devices in the market. Investors are watching whether BREATHE can translate clinical credibility into sustained commercial success for Nyxoah. While positive results may build physician confidence and support reimbursement discussions, challenges remain around enrollment retention, insurance coverage variability, and operational execution that could affect long-term adoption.
Tickers: $NYXH
Topics: FDA_approval_follow-up hypoglossal-nerve_stimulation sleep_apnea