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Nyxoah BETTER SLEEP Trial Reaches its Main Endpoints
Mont-Saint-Guibert, Belgium – 7 June 2021, 7:00 am CET / 1:00 am ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Firm”), a medical expertise firm targeted on the event and commercialization of revolutionary options to deal with Obstructive Sleep Apnea (OSA), in the present day introduced that the BETTER SLEEP trial reached its main security and efficiency endpoints.
The BETTER SLEEP trial was designed to evaluate the long-term security and efficiency of the Genio® bilateral hypoglossal nerve stimulation system (the “Genio® system”) in 42 grownup OSA sufferers with and with out Full Concentric Collapse (CCC) of the taste bud.
Prime-line outcomes from the BETTER SLEEP examine confirmed:
- A statistically vital imply discount in Apnea Hypopnea Index (AHI) from baseline to 6 months put up implantation in the entire cohort (CCC and non-CCC sufferers)
- A statistically vital imply discount in AHI from baseline to 6 months put up implantation within the CCC affected person subgroup
- 42.9% of the examine inhabitants had CCC
The Firm expects to announce extra knowledge with respect to the examine as additional analyses are performed.
Dr. Richard Lewis, MBBS, FRACS, Principal Investigator of the BETTER SLEEP examine, from Royal Perth Hospital and the College of Western Australia commented: “The highest-line outcomes of the BETTER SLEEP examine are extraordinarily encouraging. Essentially the most spectacular side of the outcomes is the responder fee of the CCC affected person subgroup. These sufferers are excluded from unilateral hypoglossal nerve stimulation, however the BETTER SLEEP outcomes confirmed a big discount in AHI in these sufferers following remedy with the Genio® system, which is the primary system designed to ship bilateral stimulation of the hypoglossal nerve. Total, we have now achieved a really excessive responder fee in each CCC and non-CCC sufferers, and the remedy with the Genio® system was properly tolerated. We sit up for publishing this knowledge in a number one medical journal.”
Olivier Taelman, CEO of Nyxoah, said: “We’re excited by the top-line knowledge, with the first efficiency and security endpoints met, supporting our perception that the Genio® system’s bilateral stimulation of the hypoglossal nerve, has the potential to supply constructive scientific outcomes for sufferers with CCC. We already engaged with the EU Notified Physique to overview these examine knowledge, with the purpose of increasing the CE-marked indication to incorporate CCC sufferers. In parallel, we plan to provoke dialogue with the FDA to additional talk about the Genio® system as a possible remedy possibility for sufferers with CCC.” Mr. Taelman continued, “Moreover, we noticed a 70% responder fee within the non-CCC affected person subgroup primarily based on the Sher standards, which strengthens our confidence in ongoing examine outcomes.”
About BETTER SLEEP Trial
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea, or BETTER SLEEP, is a multicenter, potential, open-label, two-group scientific trial, designed to evaluate the protection and efficiency of the Genio® system for the remedy of OSA in grownup sufferers with and with out CCC. The BETTER SLEEP trial features a subgroup of CCC sufferers who’re at present contraindicated for unilateral hypoglossal nerve stimulation. The trial was approved by the Australian and New Zealand regulatory authorities and is being performed in 9 native medical facilities. The first security endpoint was the incidence of device-related critical hostile occasions six months post-implantation. The first efficiency endpoint was the change within the AHI rating from baseline to 6 months post-implantation measured by counting the variety of occasions (apnea or hypopnea) that happen per hour collected throughout an in a single day sleep examine. Sufferers with average to extreme AHI scores between 15 and 65 and aged between 21 and 75 years have been eligible for enrollment in the event that they failed, refused, or didn’t tolerate PAP remedy. Sufferers with a physique mass index above 32 kg/m² have been excluded.
About Nyxoah
Nyxoah is a medical expertise firm targeted on the event and commercialization of revolutionary options to deal with OSA. Nyxoah’s lead resolution is the Genio® system, a CE-marked, patient-centered, minimally invasive, subsequent era hypoglossal neurostimulation remedy for remedy of average to extreme OSA. OSA is the world’s most typical sleep disordered respiration situation that’s related to elevated mortality threat and comorbidities together with cardiovascular illnesses, despair and stroke.
Following the profitable completion of the BLAST OSA examine in sufferers with average to extreme OSA, the Genio® system acquired its European CE Mark in 2019. The Firm is at present conducting the BETTER SLEEP examine in Australia and New Zealand for potential CE-mark indication growth, the DREAM IDE pivotal examine for potential FDA approval and the post-marketing EliSA examine in Europe to judge the long-term security and efficacy of the Genio® system.
For extra data, please go to www.nyxoah.com.
Warning – CE marked since 2019. Investigational system in the US. Restricted by U.S. federal
regulation to investigational use in the US.
Ahead-Wanting Statements
This press launch consists of sure disclosures that include “forward-looking statements,” together with, with out limitation, statements relating to Nyxoah’s expectations relating to the Genio® system; deliberate and ongoing scientific research of the Genio® system; the potential benefits of the Genio® system; Nyxoah’s targets with respect to the event, regulatory pathway and potential use of the Genio® system; and the utility of prior scientific knowledge, together with knowledge from the BETTER SLEEP examine, in doubtlessly acquiring FDA approval of the Genio® system. Ahead-looking statements are primarily based on Nyxoah’s present expectations and are topic to inherent uncertainties, dangers and assumptions which are troublesome to foretell and will trigger precise outcomes to vary. Ahead-looking statements contained on this announcement are made as of this date, and Nyxoah undertakes no responsibility to replace such data besides as required underneath relevant regulation.
Contacts:
Nyxoah
Fabian Suarez, Chief Monetary Officer
fabian.suarez@nyxoah.com
+32 10 22 23 55
Gilmartin Group
Vivian Cervantes
vivian.cervantes@gilmartinir.com
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