Mont-Saint-Guibert, Belgium — September 7, 2026
Nyxoah announced that the first patient has been implanted in BREATHE, its U.S. post-approval clinical study evaluating the Genio® System for adults with moderate to severe obstructive sleep apnea (OSA). The milestone marks the start of what Nyxoah describes as its largest prospective Genio study to date, expanding the company’s clinical evidence program following U.S. FDA approval of the therapy in 2025. The first procedure was performed by Rolando Molina, MD, an otolaryngologist at South Florida ENT Associates, with Edward Mezerhane, MD, of PharmaDev Clinical Research Institute serving as the site principal investigator. BREATHE is designed to generate long-term clinical evidence on the safety and effectiveness of the Genio system in routine U.S. clinical practice. The prospective, multicenter, single-arm study is expected to enroll and implant up to 229 patients across as many as 25 U.S. clinical centers, with participants followed for up to five years after implantation. The launch strengthens Nyxoah’s post-market clinical development strategy and expands its real-world evidence generation for bilateral hypoglossal nerve stimulation.
BREATHE Designed to Generate Long-Term Real-World Evidence
The BREATHE study will evaluate the performance of the Genio System across a broad network of U.S. clinical centers, bringing together sleep-medicine physicians and ENT surgeons involved in the treatment of OSA. The study’s design is intended to capture how the therapy performs outside the controlled environment of a pivotal clinical trial and provide longer-term evidence from routine clinical practice. The co-primary effectiveness endpoints will assess Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) responder rates at 12 months. Safety assessments will focus on device- and procedure-related serious adverse events at 12 months and annually thereafter. Patients will remain under observation for up to five years, allowing Nyxoah to build a substantial longitudinal dataset around the Genio therapy. The company said the study will contribute to the ongoing evaluation of long-term patient outcomes and provide evidence relevant to physicians, patients and payors. From a medical-technology development perspective, the program represents an important step in expanding the evidence base supporting hypoglossal nerve stimulation in the United States.
Genio System Advances Bilateral Hypoglossal Nerve Stimulation
The BREATHE program builds on Nyxoah’s development and commercialization of the Genio System, a leadless and battery-free hypoglossal nerve stimulation technology designed to treat OSA. Rather than relying on conventional approaches to sleep-apnea management, the technology uses neuromodulation to stimulate the hypoglossal nerve and address airway obstruction during sleep. Nyxoah has developed the platform as a patient-centered alternative for individuals requiring additional treatment options. The company previously advanced Genio through European clinical development and received CE Mark approval in 2019, followed by additional European indication expansion and subsequent U.S. regulatory approval in August 2025. The launch of BREATHE now moves the technology into a broader post-approval evidence-generation phase in the U.S. market. The study’s multicenter design is intended to provide data from different clinical settings and physicians, supporting a more comprehensive understanding of the therapy’s performance as adoption expands. The resulting evidence could become an important component of Nyxoah’s efforts to establish the long-term clinical profile of Genio.
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Nyxoah Expands U.S. Clinical Evidence Program
The first BREATHE implantation represents a significant milestone for Nyxoah’s U.S. commercialization and clinical strategy, with the company now moving beyond regulatory approval toward systematic collection of long-term real-world evidence. By following patients for up to five years, the study is structured to assess both effectiveness and safety over an extended period rather than focusing solely on short-term outcomes. Nyxoah expects the program to document Genio’s performance across multiple U.S. centers and under routine clinical conditions, strengthening the evidence base available to patients, physicians and payors. The company said BREATHE will also provide an opportunity to evaluate bilateral hypoglossal nerve stimulation in everyday practice involving both sleep specialists and surgeons. The study therefore serves as an important post-approval development program for the Genio platform while supporting Nyxoah’s broader expansion in the U.S. OSA treatment market. With the first patient successfully implanted, enrollment and implantation activities can now progress across participating centers, establishing the foundation for the company’s largest prospective Genio evidence program to date.
Source: Nyxoah, press relese
