Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones


INSIDE INFORMATION
REGULATED INFORMATION

Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones
All 115 patients implanted in DREAM U.S. pivotal study
First DREAM PMA module submitted
First patient implanted in ACCCESS U.S. pivotal study

Mont-Saint-Guibert, Belgium – March 6, 2023, 7:30am CET / 1:30am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the Company has completed all 115 implants in its DREAM U.S. pivotal study, submitted the first module in the modular PMA submission and implanted the first patient in the ACCCESS U.S. pivotal study. 

The DREAM study is a pivotal, investigational device exemption (IDE) trial designed to support the marketing authorization of the Genio® hypoglossal nerve stimulation system (HGNS) in the United States. This multicenter, prospective, open-label, observational study enrolled 115 patients and has co-primary efficacy endpoints of the Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria, and the Oxygen Desaturation Index (ODI) responder rate, both at 12 months.

In the ACCCESS trial, Nyxoah will implant 106 complete concentric collapse (CCC) patients with co-primary efficacy endpoints of Apnea-Hypopnea Index (AHI) responder rate, per the Sher criteria, and Oxygen Desaturation Index (ODI) responder rate, both assessed at 12 months post-implant.  

“The achievement of these key clinical and regulatory milestones brings us closer to offering our patient centric Genio solution to all OSA patients in the U.S. The DREAM and ACCCESS studies demonstrate Nyxoah’s mission of providing Genio to patients regardless of CCC status and without the requirement for a CCC diagnosis,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. 

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.

For more information, please visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements 
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company's or, as appropriate, the Company directors' or managements' current expectations regarding the Genio® system; future financial performance and market position; planned and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; and the Company's results of operations, financial condition, liquidity, performance, prospects, growth and strategies. 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 effects of the plans and events described herein. Additionally, 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, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2022, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken 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, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:
David DeMartino
Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313


Attachment

  • ENGLISH_Nyxoah Announces a Clinical Update


Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones

TIN LIÊN QUAN

ONWARD Receives New FDA Breakthrough Device Designations

The company has now been awarded a total of eight FDA Breakthrough Device Designations for its innovative SCI therapies...

New Clinical Studies Demonstrate that Sword Health Improves

The studies are the first to evaluate how underserved patient populations progress when given access to a digital care program- In Study #1 Black and...

Y-mAbs Therapeutics, Inc. (YMAB) Class Action Notice:

SAN DIEGO, March 08, 2023 (GLOBE NEWSWIRE) -- The Class: Robbins LLP reminds investors that a shareholder filed a class action on behalf of all...

Axiom Exhibiting at Outsourcing in Clinical Trials West

TORONTO, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Axiom Real-Time Metrics ('Axiom'), a premier provider of unified eClinical solutions and services focused on...

NeuroMetrix, Inc. Announces Date for Fourth Quarter and

WOBURN, Mass., Feb. 16, 2023 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) announced today that it plans to issue its 2022 fourth quarter and year...

Agenus Schedules Conference Call to Discuss the Company’s

Conference Call on Monday, March 13, 2023 at 8:30 a.m. ET...

THỦ THUẬT HAY

Đề xuất những quà tặng người yêu độc đáo nhất cho các cặp đôi

Mua một món quà tặng người yêu độc đáo thay vì hai món quà nghe có vẻ dễ dàng hơn, nhưng để tìm được thứ mà cả hai thực sự thích có thể khó khăn. Web trangcongnghe.vn xin đề xuất những món quà tốt nhất dành cho cặp đôi

Hướng dẫn cách cắt ghép Video bằng Camtasia Studio

Yên tâm đã có Camtasia Studio ! Phần mềm này không những giúp bạn quay Video màn hình, mà còn có thể cắt ghép hay chỉnh sửa Video thành một Video hoàn hảo.

Cách format thẻ nhớ trực tiếp trên điện thoại Android

Sau một thời gian sử dụng nếu bạn muốn làm mới lại chiếc thẻ SD về trạng thái ban đầu thì hãy nghĩ tới việc format (định dạng) lại mọi thứ. Và bài viết sau đây sẽ hướng dẫn các bạn cách format thẻ nhớ trực tiếp trên

Làm thế nào để phân biệt chính xác iPhone 6 hay iPhone 6s?

Hiện nay trên thị trường bắt đầu xuất hiện thêm nhiều iPhone 6S giả được độ từ iPhone 6. Rất nhiều người dùng đã mua phải iPhone 6S giả được độ từ iPhone 6. Đặc biệt Tết Nguyên Đán lại đang đến gần, giá iPhone cũng

iCloud Photo Library: Công cụ hữu ích để quản lý ảnh hiệu quả

Hệ thống quản lý ảnh đồng bộ trên đám mây của Apple dành cho Mac và iPhone, iCloud Photo Library cung cấp rất nhiều công cụ hữu ích. Dưới đây là tất cả những điều bạn cần biết để quản lý ảnh hiệu quả nhất trên iCloud

ĐÁNH GIÁ NHANH

Xe Mazda 6 2016 – Dòng sedan mang phong cách thể thao với giá dưới 1 tỷ đồng.

Thiết kế KODO mang lại những kiểu dáng quyến rũ tựa như của một con mãnh thú đang phóng về phía trước. KODO được áp dụng cho dòng Mazda 6 nên mẫu xe sedan phân khúc D này mang phong cách thể thao, năng động.

Trên tay iMac Pro: Cấu hình siêu mạnh trong thân máy mỏng nhẹ, ít tốn điện

Bằng cách sử dụng CPU được Intel tùy biến riêng, SSD được chế tạo độc quyền cho iMac Pro hay các giải pháp nhà làm như con chip bảo mật T2, Apple đã có thể 'nhét' được một cấu hình siêu mạnh vào một thân máy mỏng nhẹ,

Đánh giá thông số kỹ thuật Honda Winner 150 và Yamaha Exciter 150

Chiếc xe underbone côn tay của Honda cũng chính thức ra mắt. Honda Winner 150 được cho là sẽ cạnh tranh với Yamaha Exciter 150 hay Suzuki Raider 150 ở phân khúc này. Đây đều là những chiếc xe 150 phân khối mạnh mẽ,