BETTER SLEEP Achieves Primary Endpoint in All Patient Cohorts
- First clinical data demonstrating the effectiveness of hypoglossal nerve stimulation to treat CCC patients
- As previously reported, confirms achievement of primary endpoint of reductions in AHI4 for the overall population, CCC cohort, and non-CCC cohort at six months, and reports responder rates greater than 60 % for the three cohorts
- Exceeds an average 70% reduction in AHI4 among responders in CCC and non-CCC cohorts
Mont-Saint-Guibert, Belgium – March 14, 2022, 11:30 p.m. CET / 6:30 p.m. ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”) operates in the medical technology sector and is focused on developing and commercializing innovative solutions to treat Obstructive Sleep Apnea Syndrome (OSAS), today provided additional data from its clinical study BETTER SLEEP during a poster presentation to 16th World Sleep Congress – World Sleep Congress 2022. World Sleep, a global scientific congress, brings together leaders in sleep medicine and research from around the world for scientific sessions and meetings.
Forty-two (42) study patients with moderate to severe OSAS received an implant at eight research centers in Australia, of whom 18 experienced Complete Concentric Collapse (CCC) of the soft palate and 24 were classified as not -CCC. Three patients in each arm did not complete their polysomnography at six months and therefore the analysis was calculated on the basis of 36 patients (15 CCC, 21 non-CCC). Of these 36 patients, there were 23 responders (64%), including nine of 15 CCC patients (60%) and 14 of 21 non-CCC patients (67%), at six months.
The primary endpoint was achieving a reduction of at least 4 points in the apnea-hypopnea index (4% oxygen desaturation, or AHI4) after six months for all 42 patients. The overall reduction was statistically significant with a reduction of 11 points (p<0.001), with statistically significant reductions of 10 points (p=0.001) in the CCC cohort and 11 points (p<0.001) in the non-CCC cohort . In addition, the mean reduction in AHI4 exceeded 70% in responders from the CCC and non-CCC cohorts. These results are subject to final review and validation.
“BETTER SLEEP represents the first clinical study to demonstrate the efficacy of treating CCC patients with hypoglossal nerve stimulation (HGNS),” said Olivier Taelman, CEO of Nyxoah. “The results give us confidence that we will be able to provide a better treatment option for CCC patients, who represent approximately 30% of the moderate to severe OSAS population and are contraindicated for other HGNS options. These data validate our differentiated approach of delivering bilateral stimulation via an implantable device requiring only one incision, and a CCC indication would eliminate the need for patients to undergo an invasive DISE procedure. »
“We are also extremely encouraged to have generated such positive clinical results after only six months post-implantation, as the growing body of clinical data and real-world experience suggests that patient responses are improving significantly. between months six and twelve,” Mr. Taelman continued. “The achievement of an expanded CE Mark indication to treat CCC patients and US FDA Breakthrough Device designation, both based on BETTER SLEEP, as well as the high level of interest among the approximately 50 physicians present at the Nyxoah World Sleep symposium, underline the strength of the data and the enthusiasm for the Genio platform. We continue to work with the FDA on an IDE approval to conduct a clinical trial for CCC patients in the United States, which we aim to begin later this year.
About Nyxoah
Nyxoah operates in the medical technology sector. It focuses on the development and commercialization of innovative solutions intended to treat Obstructive Sleep Apnea Syndrome (OSAS). Nyxoah’s leading solution is the Genio® System, a next-generation patient-centered hypoglossal nerve neurostimulation therapy with no leads or implanted batteries to treat Obstructive Sleep Apnea Syndrome (OSAS), the respiratory disorder of the most common sleep in the world. The latter is associated with an increased risk of mortality and cardiovascular comorbidities. Nyxoah is driven by the vision that OSAS patients should enjoy restful nights and feel empowered to live life to the fullest.
Following the successful completion of the BLAST OSA study, the Genio® system received European CE marking in 2019. Nyxoah completed two successful IPOs: on Euronext in September 2020 and on NASDAQ in July 2021. More Based on the positive results of the BETTER SLEEP study, Nyxoah obtained CE Mark approval for the treatment of patients with Complete Circumferential Collapse (CCC), currently contraindicated in competing therapies. In addition, the Company is currently conducting the pivotal DREAM IDE study with a view to FDA approval and marketing in the United States.
For more information, visit http://www.nyxoah.com/
Warning – CE marked since 2019. Experimental device in the United States. Restricted by US Federal Law to experimental use in the United States.
contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
[email protected]
+32 473 33 19 80
Jeremy Feffer, VP IR and Corporate Communications
[email protected]
+1 917 749 1494
FRENCH_BETTER SLEEP Data PR Final
