Technology

Nyxoah Announces Pivot DREAM US Study Meets Primary Endpoints

2024-03-19 20:08:21

Class in: Science and technology, Sant
Topics: Miscellaneous, Miscellaneous

Nyxoah Announces Pivot DREAM US Study Meets Primary Endpoints

The response rate to the apne-hypopne index (AHI) was 63.5% by intention to treat (ITT) (p=0.002).
Oxygen desaturation index (ODI) response rate of 71.3% by intention to treat (ITT) (p<0.001)
Median reduction in 12-month AHI of 70.8%.

Mont-Saint-Guibert, Belgium? March 19, 2024, 9:05 p.m. CET / 4:05 p.m. ET? Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (Nyxoah or the Company) operates in the medical technology sector and focuses on the development and commercialization of innovative solutions to treat Obstructive Sleep Apne Syndrome (OSAS). The Company announced today that the pivotal DREAM study in the United States demonstrated a statistically significant reduction in the co-primary endpoints, namely the rate of responders to the 12-month AHI, according to the Sher criterion, and the IDO responder rate, both based on the ITT.

The DREAM study is a pivotal trial, conducted under an Investigational Device Exemption (IDE) and designed to support marketing authorization of the Hypoglossal Nerve Stimulation System ( HGNS) Genio in the United States. This multicenter, prospective, open, interventional study recruited 115 patients and its co-primary efficacy endpoints are the response rate to the apne-hypopne index (AHI), according to the Sher criterion, and the response rate the oxygen desaturation index (ODI), both measured following 12 months*. Subjects were also required to sleep supine for at least 60 minutes during their 12-month polysomnographic (PSG) test. Further information regarding the study is available in section 1.5.4 of the Company’s Annual Report for the financial year 2022, which can be viewed on the Company’s website using the following link: Nyxoah Annual Report 2022 EN.pdf.

Participants in the DREAM study had a mean AHI of 28.0, a mean ODI of 27.0, and a mean body mass index of 28.5. 12 months, 73 subjects were considered AHI responders, according to the Sher criterion, i.e. an ITT rate of AHI responders of 63.5% (p=0.002), and 82 subjects were considered AHI responders. IDO, i.e. an IDO responder rate of 71.3% (p<0.001). Subjects had a median reduction in AHI at 12 months of 70.8%, with similar improvements in AHI in the supine and side sleep positions. The safety results of the experimental treatment were favorable, with 11 serious adverse events, or SAEs, in ten subjects, for an SAE rate of 8.7%. Of the 11 SAEs, three were related to the device and there were three explants.

“DREAM is a pivotal, multicenter, international study of Genio, a next-generation HGNS technology offering patients bilateral stimulation with a non-implanted battery solution, powered and controlled by an external device. With data from DREAM, Genio demonstrated the positive efficacy results that OSA patients who have failed traditional medical therapies have the right to expect. In particular, Genio’s unique bilateral stimulation offers the potential to improve outcomes for more people of patients suffering from OSA. I am delighted that Nyxoah and Genio are working to expand the options and advance HGNS therapy for OSA, and I look forward to offering it to my patients once it is approved by the FDA”, how did B Tucker Woodson, MD, Chief, Professor? Medical College of Wisconsin and principal investigator of the DREAM study.

“I am very pleased to announce the positive results of DREAM, as they pave the way for Genio to change the paradigm of OSA treatment in the United States. With Genio’s patient-centered design, robust clinical data and With the commercial lessons learned from Europe, we are convinced that Nyxoah can become a leading company in the field of OSA”, commented Olivier Taelman, CEO of Nyxoah. “We are finalizing the fourth and final module of the Marketing Authorization Application and I look forward to launching Genio in the United States, awaiting FDA approval.”

Telephone conference and webcast presentation

Company Management will host a conference call to discuss DREAM’s results today from 9:30 p.m. CET / 4:30 p.m. ET. The broadcast of the conference will be accessible via the Investor Relations page of the Nyxoah website or via this link: DREAM Results Webcast. For those who do not intend to ask Management a question, the Company recommends listening to the webcast.

If you intend to ask a question, please use the following link: DREAM Results Call. After registration, an email will be sent including connection details and a unique conference call access code required to join the live call. To ensure you are connected before the call begins, the Company suggests registering at least 10 minutes before the call begins.

About Nyxoah
Nyxoah operates in the medical technology sector. It focuses on the development and marketing of innovative solutions intended to treat Obstructive Sleep Apne Syndrome (OSAS). Nyxoah’s primary solution is the Genio System, a CE-marked, patient-centered, leadless, battery-free hypoglossal nerve neurostimulation therapy intended to treat Obstructive Sleep Apne Syndrome (OSAS), the disorder the most common sleep respiratory system in the world. The latter is associated with an increased risk of mortality and comorbidities, including cardiovascular diseases. Nyxoah’s vision is that OSA patients should be able to enjoy restful nights and live their lives to the fullest.

following the conclusive finalization of the BLAST OSA study, the Genio system received the European CE marking in 2019. Nyxoah successfully completed two IPOs: one on Euronext Brussels in September 2020 and the other on the NASDAQ in July 2021. Thanks to the positive results of the BETTER SLEEP study, Nyxoah received CE marking for the extension of its therapeutic indications to patients suffering from complete concentric collapse (CCC), for whom competing therapies are currently contraindicated. Additionally, the Company announced positive results from the pivotal DREAM IDE study in preparation for FDA approval and commercialization in the United States.

For more information, please see theThe company’s annual report for the 2023 financial year which will be filed on March 20, 2024 and visit the site http://www.nyxoah.com/.

Attention ? CE marking since 2019. Research device in the United States. Restricted to experimental use in the United States by US federal law.

Forward-looking Statements
Certain statements, beliefs and opinions contained in this press release are forward-looking in nature and reflect the current expectations of the Company or, where applicable, the directors or management of the Company regarding the Genio System and ongoing clinical studies. on the Genio 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 the clinical data in potentially obtaining FDA approval for the Genio system; the communication of data from the pivotal DREAM US trial of Nyxoah; filing an application for approval with the FDA; and entry into the American market. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that might cause actual results or events to differ materially from those expressed or implied in the statements. forward-looking statements. These risks, uncertainties, assumptions and factors might adversely affect the financial results and effects 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 fiscal year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, and subsequent reports the Company files with the SEC. A multitude of factors, including but not limited to changes in demand, competition and technology, may cause actual events, performance or results to differ materially from any anticipated developments. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be relied upon as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, such results or developments may not be representative of results or developments in future periods. No representation or warranty is made as to the accuracy or appropriateness of these forward-looking statements. Accordingly, the Company expressly disclaims any obligation or undertaking to publicly release any updates or revisions to any forward-looking statements contained in this press release as a result of a change in expectations or a change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, unless expressly required by law or regulation. Neither the Company, its advisors or representatives, nor any of its affiliates, nor the officers or employees of such persons guarantee that the assumptions underlying these forward-looking statements are free from errors and accept no responsibility for the accuracy future of the forward-looking statements contained in this press release or as to the actual occurrence of anticipated developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contact :
Nyxoah
David DeMartino, Chief Strategy Officer
[emailprotected]
+1 310 310 1313

FRENCH_DREAM Press Release_FINAL

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