DREAM pivotal research data presented at the International Surgical Sleep Society 2024 Educational Update

DREAM pivotal study data presented at the International Surgical Sleep Society 2024 Educational Update

Additional clinical data on patients suffering from Obstructive Sleep Apnea (OSA) demonstrate a clinically significant median reduction of 71.0% in Apnea-Hypopnea Index (AHI) while sleeping in the supine position
after 12 months compared to baseline.

82.0% of patients who completed polysomnography at 12 months had an AHI less than 15, and 67.4% of patients who completed polysomnography at 12 months had an AHI less than 10.

Mont-Saint-Guibert, Belgium – September 27, 2024, 10:30 PM CET / 4:30 PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company developing breakthrough treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation, announced that data from the pivotal DREAM US study was presented during an oral session at International Surgical Sleep Society (ISSS) 2024 Educational Update, taking place September 26-27 in Miami, Florida.

Additional data were presented for the reduction of AHI in supine and non-supine positions. Genio bilateral stimulation resulted in a clinically meaningful median reduction of 71.0% in supine AHI at 12 months compared to baseline. This reduction compares with an average 12-month AHI reduction of 70.8% for all sleeping positions.

Regarding the secondary endpoints reported in the ISSS, subjects showed significant improvements in quality of life outcomes. Specifically, a mean increase of 2.3 points was observed when assessing the Functional Outcomes of Sleep Questionnaire (FOSQ). In addition, the Epworth sleepiness score was reduced by an average of 3.4 points from baseline.

The presentation included previously announced data demonstrating that the study met the co-primary endpoints of 12-month AHI responder rate, per Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both on an Intent-To Treat (ITT) base. basic. In the pivotal DREAM US study, 115 patients received the Genio® implant and were included in the safety analysis. These patients had a mean AHI of 28.0, a mean ODI of 27.0, and a mean body mass index of 28.5 at baseline. At 12 months, 73 subjects were determined to be AHI responders, per Sher criteria*, resulting in an ITT AHI responder rate of 63.5% (p=0.002), and 82 subjects were ODI responders, resulting in an ODI responder. rate of 71.3% (p

“The DREAM study demonstrated the efficacy of bilateral hypoglossal nerve stimulation using Genio for the treatment of obstructive sleep apnea. Clinically significant improvements in primary and secondary endpoints were observed,” said B. Tucker Woodson, MD, Chief, Professor – Medical College of Wisconsin and Principal Investigator of the DREAM Study “Genio has the potential to help us advance neuromodulation therapy for the treatment of OSA.”

“Achieving meaningful AHI reductions regardless of sleep position is a clinical validation of our patient-centered approach,” said Olivier Taelman, CEO of Nyxoah. “Bidelateral stimulation by Genio has also enabled more than 80% of patients to reach 12 months with an AHI of less than 15 months. , which positively impacts their overall quality of life and reduces drowsiness. Nyxoah is now entering the final regulatory phase and progressing towards FDA approval. This will be a huge milestone in our mission to make Genio available to OSA patients in the US.”

About Nyxoah

Nyxoah reinvents sleep for the billion people suffering from obstructive sleep apnea (OSA). We are a medical technology company developing groundbreaking treatment alternatives for OSA through neuromodulation. Our first innovation is Genio®, a battery-free hypoglossal neuromodulation device that is inserted through a single incision under the chin and controlled by a wearable device. Through our commitment to innovation and clinical evidence, we have demonstrated best-in-class results for reducing the burden of OSA.

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 positive results from the BETTER SLEEP trial, Nyxoah received CE Mark for expanding its therapeutic indications to Complete Concentric Collapse (CCC) patients , which are currently contraindicated in competitor therapy. In addition, the company announced positive results from the pivotal DREAM IDE trial for FDA and US commercialization approval.

For more information, please refer to the company’s annual report for fiscal year 2023 and visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Research device in the United States. Restricted by US federal law to research use in the United States.

Forward-Looking Statements

Certain statements, beliefs and opinions contained in this press release are forward-looking and reflect the current expectations of the Company or, as applicable, the Company’s directors or management regarding the Genio® System and ongoing clinical trials of the Genio® System system; the potential benefits of the Genio® system; Nyxoah’s objectives regarding the development, regulatory pathway and potential use of the Genio® System; the usefulness of clinical data in potentially obtaining FDA approval for the Genio® System; reporting data from Nyxoah’s pivotal DREAM US study; filing for FDA approval; and access to the US market. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial consequences of the plans and events described herein. In addition, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023 filed with the Securities. and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports the Company files with the SEC. A variety of factors, including but not limited to changes in demand, competition and technology, could cause actual events, performance or results to differ materially from those anticipated. Forward-looking statements in this press release regarding past trends or activities are not guarantees of future performance and should not be construed as a representation that such trends or activities will continue in the future. Furthermore, even if actual results or developments are consistent with the forward-looking statements in this press release, these results or developments may not be indicative of results or developments in future periods. No representations or warranties are made as to the accuracy or fairness of such forward-looking statements. Accordingly, the company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements contained in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which such forward-looking statements are based , unless specifically required by law or regulation. Neither the Company, nor its advisors or representatives, nor any of its subsidiaries or the officers or employees of any such person warrants that the assumptions underlying such forward-looking statements will be free from errors nor accept any responsibility for their future accuracy of the forward-looking statements. statements in this press release or the actual occurrence of the predicted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
Loïc Moreau, financial director
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For media
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In Belgium/France
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