The Magazine for Sleep Professionals
Wednesday, September 9, 2026
Nyxoah SA announced that the first patient has been implanted in BREATHE, the Company’s U.S. post-approval study of the Genio® system. The procedure was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates. Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute […]
Nyxoah announced the pricing of an underwritten public offering in the United States, which includes shares sold in a private offering to certain qualified or institutional investors outside the United States, including within the European Union, of 55,232,558 of its ordinary shares at an offering price of $1.72 (EUR 1.48) […]
Nyxoah SA has announced an important investment in Belgium to further scale its manufacturing capacity to support its continued growth in the United States and international markets. In addition to its existing contract manufacturing operations in the United States, the Company will expand its manufacturing footprint in Wallonia, reflecting Nyxoah’s […]
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system (hypoglossal nerve stimulation) for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. Genio is […]
Nyxoah SA, which develops breakthrough treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation, announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company’s Pre-Market Approval […]
Nyxoah SA today announced the appointment of Dr. Maurits S. Boon, MD as Chief Medical Officer. Dr. Boon joins Nyxoah from Thomas Jefferson University, where he will continue part-time as a professor and Vice Chairman, Education. He is dual board-certified in otolaryngology – head and neck surgery, as well as […]
Nyxoah SA has announced the DREAM U.S. pivotal study achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an ITT basis. The DREAM study is a pivotal trial being conducted under an investigational device exemption […]
Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah’s next-generation Genio® 2.1 system for use in the Company’s DREAM U.S. IDE pivotal study. Genio® 2.1’s upgrades are entirely related to the external components of the Genio® system, as the implantable stimulator remains […]
Nyxoah SA has announced that the U.S. Food and Drug Administration has granted the Genio® bilateral hypoglossal nerve stimulation system Breakthrough Device Designation for the treatment of adult patients with moderate to severe OSA and Complete Concentric Collapse (CCC) of the soft palate. The FDA’s Breakthrough Designation Program was created […]
