הוגשה ל-FDA תוספת לבקשת אישור שיווק (PMA) במטרה להרחיב את התוויית השימוש ב-Genio למטופלים הסובלים מ-CCC
Nyxoah SA (נאסד"ק/יורונקסט בריסל: NYXH), חברת טכנולוגיות רפואיות המתמקדת בפיתוח פתרונות חדשניים לטיפול בדום נשימה חסימתי בשינה (OSA), באמצעות נוירומודולציה, הודיעה היום כי התוצאות המלאות לאחר 12 חודשים מהמחקר המרכזי שנערך בארה"ב, ACCCESS, הוצגו בכנס השנתי של האגודה הבינלאומית לכירורגיה של השינה (ISSS), שהתקיים ב-15-16 באוקטובר 2026 בלוס אנג'לס, קליפורניה. הנתונים הוצגו על ידי ד"ר קולין האנטלי (Colin Huntley), חוקר ראשי משותף במחקר ACCCESS. ממצאים אלה מאששים את התוצאות העיקריות עליהן דווח ב-2 בספטמבר 2026, ומצביעים על יעילות ובטיחות גבוהות בשימוש במערכת Genio® לגירוי דו-צדדי בקרב מטופלים הסובלים מקריסה קונצנטרית מלאה (Complete Concentric Collapse – CCC) של החך הרך – אוכלוסייה שעבורה לא קיימת כיום בארצות הברית אפשרות טיפול מבוססת נוירוסטימולציה (גירוי עצבי) הזמינה באופן מסחרי.
Full 12-Month Data from the ACCCESS U.S. Pivotal Study in Complete Concentric Collapse Patients Presented at ISSS 2026
Genio® bilateral stimulation delivered a 74.3% median reduction in AHI at 12 months, with no device- or procedure-related serious adverse events
PMA supplement submitted to the FDA to expand Genio’s indication to CCC patients
Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the complete 12-month results of the ACCCESS U.S. pivotal study were presented at the International Surgical Sleep Society (ISSS) annual meeting, taking place October 15-16, 2026, in Los Angeles, California. The data were presented by Colin Huntley, MD, Co-principal Investigator of the ACCCESS study. They confirm the top-line results announced on September 2, 2026, and show strong efficacy and safety outcomes with Genio® bilateral stimulation in patients with Complete Concentric Collapse (CCC) of the soft palate, a population with no commercially available neurostimulation option in the United States today.
Key Highlights
- Efficacy
- Both co-primary efficacy endpoints were met: Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria1, of 77.2% and Oxygen Desaturation Index (ODI) responder rate of 87.7%, both on a Full Analysis Set basis (p<0.001).
- In the per protocol population, mean AHI decreased from 33.6 to 10.4 events per hour, a median reduction of 74.3% from baseline. Mean ODI decreased from 32.6 to 10.9 events per hour, a median reduction of 71.9% (both p<0.001).
- Safety
- No device- or procedure-related serious adverse events (SAEs) were reported through 12 months. Four SAEs were reported, all unrelated to the device or the procedure (overall SAE rate of 7.5%).
- Quality of life and patient-reported outcomes
- Mean Epworth Sleepiness Scale (ESS) score improved by 5.3 points and mean Functional Outcomes of Sleep Questionnaire (FOSQ-10) score improved by 2.3 points (both p<0.001).
- 94.7% of patients reported an improvement, and 97.4% were satisfied and would choose the implant again.
Patients evaluable in the ACCCESS study2 had a mean baseline AHI of 33.1 events per hour, and close to two thirds (63.8%) presented with severe OSA. CCC was confirmed by an independent Drug-Induced Sleep Endoscopy (DISE) core laboratory, sleep tests were scored by an independent core laboratory, and adverse events were adjudicated by an independent Clinical Events Committee.
Today, Nyxoah has submitted a premarket approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) to expand Genio’s indication to CCC patients. Patients in the ACCCESS study will continue to be followed for three years post-implant.
“In our daily practice, we regularly identify CCC patients for whom we currently have no commercially available hypoglossal nerve stimulation option to offer in the United States. The 12-month ACCCESS data show that Genio can address this need. Statistically significant reductions were reported in AHI and ODI, with no device- or procedure-related serious adverse events, and patients reported reduced daytime sleepiness and improved quality of life. This could give U.S. physicians an additional therapeutic approach for OSA patients with CCC,” commented Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute (Miami, Florida), and Co-principal Investigator of the ACCCESS study.
“We are pleased that ACCCESS delivered a 74.3% median reduction in AHI at 12 months, with no device- or procedure-related serious adverse events, in OSA patients with CCC. These patients have no commercially available neurostimulation option in the U.S. today, and this remains an important unmet clinical need. We have submitted our PMA supplement to the FDA, and we remain confident in our ability to bring Genio to more OSA patients and to deliver on our mission to make sleep simple,” commented Liam Kelly, Nyxoah’s Chief Executive Officer.
About the ACCCESS study
ACCCESS is a multicenter, prospective, open-label pivotal study conducted in the United States, designed to assess the safety and efficacy of the Genio system in adult patients with moderate to severe OSA and CCC of the soft palate who have failed, do not tolerate, or refused positive airway pressure treatment. The study’s co-primary efficacy endpoints are the AHI responder rate, per the Sher criteria, and the ODI responder rate, both assessed at 12 months post-implant, with patients followed for three years post-implant. CCC patients are currently contraindicated for unilateral hypoglossal nerve stimulation in the United States. Genio has been approved for CCC patients in Europe since 2021, while in the United States, no commercially available neurostimulation treatment option exists for this population today.
About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.
Following the successful completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study in 2024 and received approval from the FDA in August 2025, with the treatment of CCC patients included in the warning section of our indications for use.
For more information, please visit http://www.nyxoah.com.
Caution – CE marked since 2019. FDA approved in August 2025 as prescription-only device.
1 An AHI responder, per the Sher criteria, is defined as a subject with an AHI reduction of at least 50% from baseline and an AHI score of less than 20 events per hour on the 12-month polysomnography (PSG). An ODI responder is defined as a subject which demonstrates an ODI reduction of at least 25% from baseline on the 12-month PSG.
2 An evaluable patient is defined as a patient that was implanted, activated and had at least one in-lab polysomnography post-activation.