Nyxoah הודיעה כי המחקר המכריע בארה"ב, ACCCESS, עמד ביעדים העיקריים של בטיחות ויעילות בקרב מטופלים הסובלים מקריסה קונצנטרית מלאה
מון-סן-גיבר, בלגיה – 2 בספטמבר 2026, GLOBE NEWSWIRE:
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 מחקר המרכזי של ACCCESS בארה"ב השיג תוצאות משמעותיות סטטיסטית בנקודות הסיום העיקריות שלו ליעילות של שיעור תגובה ל-AHI לאחר 12 חודשים, לפי קריטריוני Sher*, ושיעור תגובה למדד הרוויה בחמצן (ODI) לאחר 12 חודשים, ועמד בנקודות הבטיחות שלו, בחולים עם קריסה קונצנטרית מלאה (CCC) של החיך הרך. מחקר ACCCESS תוכנן לתמוך בהרחבת ההתוויה של מערכת Genio®בארה"ב עבור חולי CCC, אשר כיום התווית נגד לטיפול בגירוי עצב היפוגלוסלי חד-צדדי הזמין מסחרית באזור גיאוגרפי זה.
REGULATED INFORMATION INSIDE INFORMATION
Nyxoah Announces ACCCESS U.S. Pivotal Study Meets Primary Safety and Efficacy Endpoints in Complete Concentric Collapse Patients
Reports an Apnea-Hypopnea Index (AHI) responder rate of 77.2% on a Full Analysis Set basis (p<0.001)
Zero device-related serious adverse events through 12 months
Mont-Saint-Guibert, Belgium – September 2, 2026, GLOBE NEWSWIRE:
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 ACCCESS U.S. pivotal study achieved statistically significant outcomes on its co-primary efficacy endpoints of 12-month AHI responder rate, per the Sher criteria*, and 12-month Oxygen Desaturation Index (ODI) responder rate, and met its safety endpoints, in patients with Complete Concentric Collapse (CCC) of the soft palate. The ACCCESS study was designed to support the expansion of the Genio® system’s U.S. indication for CCC patients, who are today contraindicated for commercially available unilateral hypoglossal nerve stimulation in this geography.
As announced in August 2025, the Company closed enrollment ahead of the planned maximum of 106 patients, reflecting its confidence that the enrolled population would deliver statistically significant results. Today’s results confirm that confidence.
At 12 months, patients demonstrated an AHI responder rate, per the Sher criteria, of 77.2% (p<0.001) and an ODI responder rate of 87.7% (p<0.001), both on a Full Analysis Set basis. On safety, zero device-related serious adverse events were reported through 12 months post-implant.
The results were generated in line with the prespecified statistical analyses planned in the study protocol as approved by the U.S. Food and Drug Administration (FDA). The primary analysis was performed on the Full Analysis Set of 47 patients, being all patients who were implanted, activated and completed at least one in-study sleep test (polysomnography). Missing data points were addressed through a multiple imputation model, the recognized statistical method prespecified as primary analysis in the protocol and statistical analysis plan.
"A significant number of patients with OSA are found to have CCC and, until this point, hypoglossal nerve stimulation has not been an option for this population. The ACCCESS results demonstrate that Genio delivers a strong responder rate with an excellent safety profile in patients with this pattern of airway collapse. These findings could give U.S. physicians a new treatment option for the vast number of OSA patients with CCC who have struggled with positive airway pressure," commented Colin Huntley, MD, Professor, Department of Otolaryngology Head & Neck Surgery, Thomas Jefferson University, and Co-principal Investigator of the ACCCESS study.
"ACCCESS delivers on the promise we made to CCC patients. With a 77.2% AHI responder rate and zero device-related serious adverse events, Genio demonstrated both the efficacy and the safety this underserved patient population deserves. We are preparing our FDA submission to bring Genio to CCC patients in the United States, as we already do in Europe, and to deliver on our mission to make sleep simple," commented Olivier Taelman, Nyxoah’s Chief Executive Officer.
The complete 12-month dataset and detailed results are expected to be presented at the upcoming International Surgical Sleep Society (ISSS) annual meeting in Los Angeles, October 15-16, 2026.
Nyxoah is preparing a premarket approval (PMA) supplement submission to the FDA to expand Genio’s indication to CCC patients under FDA Breakthrough Device Designation.
*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.
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. 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, following the positive outcomes of the BETTER SLEEP study, 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.
Contacts:
Nyxoah John Landry, CFO [email protected]
Rémi Renard, Head of Investor Relations & Corporate Communication [email protected]
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Nyxoah הודיעה כי המחקר המכריע בארה"ב, ACCCESS, עמד ביעדים העיקריים של בטיחות ויעילות בקרב מטופלים הסובלים מקריסה קונצנטרית מלאה