Nyxoah Reports Q1 2025 Financial Results and FDA Progress

Nyxoah Sa ( (NYXH) ) has released its Q1 earnings. Here is a breakdown of the information Nyxoah Sa presented to its investors.

Nyxoah SA is a medical technology company specializing in innovative treatments for Obstructive Sleep Apnea (OSA) through neuromodulation, with its flagship product being the Genio® system, a unique leadless and battery-free therapy.

In its first-quarter earnings report for 2025, Nyxoah highlighted significant progress towards obtaining FDA approval for its Genio® system, having received an Approvable Letter from the FDA and completing necessary validation requirements. However, the company reported a slight decline in revenue compared to the previous year.

Key financial metrics for the quarter included a revenue of €1.1 million, down from €1.2 million in the same period last year, and an increased operating loss of €20.6 million, driven by higher research and development expenses and preparations for U.S. market entry. The company also reported a decrease in cash reserves, with €63.0 million in cash and financial assets as of March 31, 2025.

Looking ahead, Nyxoah remains optimistic about receiving FDA approval in the second quarter of 2025, which would allow for the commercialization of the Genio® system in the U.S. market. The company continues to focus on expanding its market presence and advancing its innovative solutions for OSA treatment.