Nyxoah Receives IDE Clearance from FDA to Initiate ACCCESS Study of Genio® in Patients With Complete Concentric Collapse – Form 6-K
Nyxoah Receives IDE Approval from the FDA to Initiate the ACCCESS Study of Genio® in Patients With Complete Concentric Collapse
The first ACCCESS patient is expected to be implanted in the fourth quarter of 2022
Mont-Saint-Guibert, Belgium – July 11, 2022, 8:00 a.m. CET / 2:00 a.m. ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on developing and commercializing innovative solutions to treat obstructive sleep apnea (OSA), today announced that the Food and Drug Administration ( FDA) of the United States has approved an Investigational Device Exemption (IDE) to allow Nyxoah to initiate a clinical trial, called ACCCESS, to evaluate the use of the Genio® System for the treatment of adult patients with moderate to severe OSA and complete concentric collapse (CCC) of the soft palate. The FDA previously granted Breakthrough Device Designation to Genio® to treat CCC patients.
In the ACCCESS trial, Nyxoah will implant up to 106 patients with co-primary efficacy endpoints of Apnea-Hypopnea Index (AHI) responder rate, per Sher criteria, and responder rate oxygen desaturation index (ODI), both assessed 12 months post-implant. The first patient is expected to be implanted in the fourth quarter of 2022, in accordance with previous guidelines.
“The ACCCESS IDE approval is an important first step in unlocking a huge patient population, as over 30% of OSA patients in the United States have CCC. Nyxoah is the only hypoglossal nerve stimulation company ( HGNS) with a positive CCC clinical trial and CCC approval in Europe, and the ACCCESS study further strengthens our leadership position in meeting the needs of these patients,” commented Olivier Taelman, CEO of Nyxoah. CPAP-refractory patients have no choice but major palate surgery to treat their OSA. demonstrated that Genio® can provide these patients with a minimally invasive solution for their disorder.Nyxoah is already the only HGNS company with European CCC approval, bilateral stimulation and 1.5 T and 3.0 T whole body MRI compatibility, and the ACCCESS trial further demonstrates Nyxoah’s mission to provide HGNS solutions for all patients with CCC. We are seeing outstanding results in CCC patients treated with Genio® in Europe and are excited to begin the ACCCESS study and make Genio® available to as many patients as possible.
“Patients with complete concentric soft palate collapse, who have failed CPAP, represent a significant unmet need in the treatment of OSA since, currently, the only FDA-approved hypoglossal nerve stimulation therapy is contraindicated. -indicated for these patients”, commented Dr. Maria Suurna. , an otolaryngologist and director of sleep surgery at the University of Miami Health. “The ACCCESS study gives hope to these patients and their referring physicians that there may soon be a minimally invasive surgical solution to treat their OSA. Together with the entire sleep community, I commend Nyxoah for developing Genio® with bilateral hypoglossal nerve stimulation and for conducting the ACCCESS trial to provide a treatment alternative to this underserved population.”
Nyxoah is a medical technology company focused on developing and commercializing innovative solutions to treat obstructive sleep apnea (OSA). Nyxoah’s leading solution is the Genio® System, a patient-centric, lead-free, battery-free hypoglossal neurostimulation therapy for OSAS, the world’s most common sleep-disordered breathing disorder, associated with an increased risk of mortality and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel empowered to live their lives to the fullest.
Following the success of the BLAST OSA study, the Genio® system received its European CE marking in 2019. Nyxoah has completed two successful IPOs: on Euronext Brussels in September 2020 and on NASDAQ in July 2021. Following the positive results from the BETTER SLEEP study, Nyxoah has received CE Mark approval for the extension of its therapeutic indications to patients with complete concentric collapse (CCC), currently contraindicated in the treatment of competitors. Additionally, the Company is currently conducting the pivotal DREAM IDE study for marketing approval by the FDA and the United States.
For more information, please visit http://www.nyxoah.com/.
Caution – CE marked since 2019. Experimental device in the United States. Restricted by US Federal Law to experimental use in the United States.
Loïc Moreau, Chief Financial Officer
+32 473 33 19 80
Jeremy Feffer, Vice President IR and Corporate Communications
+1 917 749 1494
|ENGLISH_ACCESS Approval IDE PR _FINAL|