Nyxoah SAs Desire US pivotal analyze, made to assist the advertising and marketing authorization of the Genio hypoglossal nerve stimulation procedure for obstructive sleep apnea in the United States, achieved a statistically substantial reduction in the co-key endpoints of 12-month apnea-hypopnea index (AHI) responder amount, the company declared.
This multicenter, prospective, open-label, interventional review enrolled 115 sufferers and has co-major efficacy endpoints of the AHI responder level, for every the Sher standards, and the oxygen desaturation index responder fee, both equally calculated at 12 months.
Subjects also have been essential to rest supine for at least 60 minutes at their 12-thirty day period polysomnography check.
Analyze members entered the Desire review with a indicate AHI of 28, indicate oxygen desaturation index of 27, and mean body mass index of 28.5. At 12 months, 73 subjects had been decided to be AHI responders, for each the Sher requirements, ensuing in an ITT AHI responder charge of 63.5% (p=.002), and 82 topics have been identified to be oxygen desaturation index responders, ensuing in an oxygen desaturation index responder fee of 71.3% (p<0.001).
Subjects demonstrated a median 12-month AHI reduction of 70.8%, with similar AHI improvements in supine and non-supine sleeping positions. The safety results for the investigational treatment were favorable, with 11 serious adverse events, or SAEs, in 10 subjects resulting in an SAE rate of 8.7%. Out of the 11 SAEs, three were device-related, and there were three explants.
The Genio system has been CE-marked since 2019.
With the DREAM data, Genio has demonstrated positive efficacy results that OSA patients, having failed traditional medical therapies, have come to expect. Notably, Genios unique bilateral stimulation provides the potential for improved outcomes for a wider spectrum of OSA patients. I am excited that Nyxoah and Genio are working towards expanding options and advancing [hypoglossal nerve stimulation system] therapy for OSA, and I look forward to offering it to my patients upon FDA approval, says B Tucker Woodson, MD, chief, professor at Medical College of Wisconsin and principal investigator of the DREAM study, in a release.
Olivier Taelman, Nyxoahs chief executive officer, adds in a release, I am excited to report the positive DREAM results, as they pave the way for Genio to shift the OSA treatment paradigm in the US. With Genios patient centric design, strong clinical data, and commercial learnings from Europe, we are confident Nyxoah can become a leading OSA company.
Nyxxoah is finalizing the fourth and final module submission in the premarket approval application to submit for US Food and Drug Administration approval.
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