Nyxoah מודיעה על השתלה במטופל הראשון במסגרת BREATHE – המחקר האמריקאי שנערך לאחר קבלת האישור עבור מערכת Genio®
Nyxoah מודיעה על השתלה במטופל הראשון במסגרת BREATHE – המחקר האמריקאי שנערך לאחר
קבלת האישור עבור מערכת Genio®
מחקר BREATHE צפוי לכלול השתלה בקרב עד 229 מטופלים בעד 25 מרכזים רפואיים
בארה"ב, ומעקב אחריהם למשך עד חמש שנים, במטרה להעריך את הבטיחות והיעילות
ארוכות-הטווח של הטיפול ב-Genio במסגרת פרקטיקה קלינית בעולם האמיתי
מון-סן-גיבר, בלגיה – 7 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 הושלמה השתלת המכשיר במטופל
הראשון במסגרת BREATHE – המחקר של החברה בארה"ב
המתקיים לאחר קבלת האישור הרגולטורי עבור מערכת ה- Genio®. ההליך בוצע על ידי ד"ר
רולנדו מולינה, רופא אף-אוזן-גרון (OTL)
במרכז הרפואי South Florida
ENT Associates.
ד"ר אדוארד מזרהאן – רופא מומחה לרפואת שינה ממכון המחקר הקליני PharmaDev (מיאמי, פלורידה) – משמש כחוקר
הראשי באתר המחקר BREATHE.
Nyxoah Announces First Patient Implanted in
BREATHE, the U.S. Post-Approval Study of the Genio® System
BREATHE is scheduled to implant up to 229
patients at up to 25 U.S. centers, followed for up to five years, to evaluate
the long-term safety and effectiveness of the Genio therapy in real-world
clinical practice
First implant performed by Rolando Molina,
MD, South Florida ENT Associates, with Edward Mezerhane, MD, of PharmaDev
Clinical Research Institute as Site Principal Investigator
Mont-Saint-Guibert, Belgium – September 7, 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
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 (Miami, Florida), serves as the BREATHE Site Principal Investigator.
BREATHE is a multicenter, prospective,
single-arm post-approval study designed to assess the long-term safety and
effectiveness of the Genio system in adults with moderate to severe OSA. Up to
229 patients will be implanted at up to 25 clinical centers across the United
States and followed for up to five years after implantation. The co-primary
effectiveness endpoints are the Apnea-Hypopnea Index (AHI) and Oxygen
Desaturation Index (ODI) responder rates at 12 months. Safety endpoints assess
device- and procedure-related serious adverse events at 12 months and annually
thereafter.
BREATHE will generate real-world evidence on
how Genio performs in routine clinical practice across a broad set of U.S.
centers bringing together sleep medicine physicians and ENT surgeons and will
contribute to the ongoing evaluation of long-term patient outcomes.
“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. Advancing innovation through clinical research remains central to our
mission of improving outcomes for patients with obstructive sleep apnea,” said
Rolando Molina, MD, South Florida ENT Associates, implanting surgeon.
“Obstructive sleep apnea affects millions of
people, yet many patients 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,” said Edward Mezerhane, MD, PharmaDev Clinical Research
Institute.
“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,” said Olivier Taelman, Chief Executive
Officer of Nyxoah. “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.”
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.
For more information, please visit http://www.nyxoah.com.
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