Nyxoah Launches BREATHE Study for Genio System in U.S

Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA) through neuromodulation, has announced the first patient has been implanted in BREATHE, a U.S. post-approval study of the Genio® system. The study, which will follow up to 229 patients at up to 25 U.S. centers for five years, aims to evaluate the long-term safety and effectiveness of the Genio therapy in real-world clinical practice.

The first implant was performed by Rolando Molina, MD, an otolaryngologist at South Florida ENT Associates, with Edward Mezerhane, MD, serving as the Site Principal Investigator from PharmaDev Clinical Research Institute. BREATHE is designed to assess the Genio system's performance in adults with moderate to severe OSA, focusing on co-primary effectiveness endpoints, including the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months. Safety endpoints will monitor device- and procedure-related serious adverse events at 12 months and annually thereafter.

Dr. Molina, an advocate for treating sleep-disordered breathing, stated, "As an otolaryngologist dedicated to the treatment of sleep-disordered breathing, I have seen firsthand the significant impact obstructive sleep apnea has on patients' health and quality of life. The BREATHE study represents an exciting milestone in the evolution of sleep surgery and neurostimulation therapy. By performing the first implant in this study, we have the opportunity to help shape the future of sleep apnea treatment while offering eligible patients access to an additional therapeutic approach."

Dr. Mezerhane emphasized the importance of the BREATHE study, saying, "Obstructive sleep apnea affects millions of people, yet many continue to struggle despite available therapies. The launch of the BREATHE study marks an exciting step forward in the evolution of sleep medicine, allowing us to evaluate an innovative bilateral hypoglossal nerve stimulation therapy in a real-world setting. Being the first site to implant a patient in this study reflects our commitment to bringing cutting-edge research and new treatment possibilities to patients who need alternatives."

Olivier Taelman, Chief Executive Officer of Nyxoah, added, "The first BREATHE implant marks the start of the largest prospective study of Genio to date and the next step in building the long-term, real-world evidence base for bilateral hypoglossal nerve stimulation in the United States. As adoption of Genio accelerates across U.S. centers, BREATHE will document how the therapy performs in everyday practice, in the hands of both sleep physicians and surgeons, over five years. This is the evidence that patients, physicians, and payors expect, and it reflects our commitment to clinical rigor beyond approval."

The Genio system, developed by Nyxoah, is a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA. Nyxoah's lead solution received its European CE Mark in 2019 and has since completed two successful Initial Public Offerings (IPOs) on Euronext Brussels and NASDAQ. The company has also received approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients and has seen positive outcomes from the DREAM IDE pivotal study in 2024.

BREATHE will contribute to the ongoing evaluation of long-term patient outcomes and provide valuable real-world evidence on the Genio system's performance. This data is crucial for healthcare providers, patients, and payors as they consider the long-term benefits of bilateral hypoglossal nerve stimulation therapy for OSA.