Nyxoah Advances Patient Access Strategy through Partnership with the American Association of Otolary

FirstmedicaldevicecompanytobecomeacorporatechampionattheENTerpriseCirclelevelMont-Saint-Guibert,Belgium–March25,2024,7:05amCET/2:05amET–NyxoahSA(EuronextBrussels/Nasd...

First medical device company to become a corporate champion at the ENTerprise Circle level

Mont-Saint-Guibert, Belgium – March 25, 2024, 7:05am CET / 2:05am 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 signed a strategic partnership to become a Corporate Champion at the ENTerprise Circle level with the American Association of Otolaryngology – Head & Neck Surgery Foundation (AAO-HNSF). Nyxoah is the first medical device company to partner with the AAO-HNSF at this level.

The AAO-HNSF is committed to identifying and combating harmful coverage policies that threaten access to quality otolaryngology-head and neck services. The Academy’s Advocacy team, in collaboration with its dedicated members and strategic industry partners like Nyxoah, actively engage with payers to achieve this goal.

The ENTerprise Circle is the top-tier partnership experience and the collaboration will focus on improving patient access to new breakthrough treatments for OSA by:

• Navigating the CMS and Private Payers prior authorization requirements pathway
• Preparing for interaction with the FDA and AMA CPT to expand patient access to appropriate care
• Advocating for reducing the hurdles to new, bilateral hypoglossal nerve stimulation (HGNS) therapy with clinical guidelines to be used by CMS and commercial insurance payers
   

"We are thrilled to partner with Nyxoah, the maker of Genio,” said Dr James Denneny III, Executive Vice President & CEO, AAO-HNSF. “With the rapid growth of HGNS, ENTs are playing an increasingly important role in treating OSA. Genio represents the next generation of HGNS technology and the AAO-HNSF looks forward to working closely with Nyxoah to ensure all patients in the U.S. have access to the system.”

“We are honored to be the first medical device company to partner with the AAO-HNSF as a Corporate Champion at the ENTerprise Circle level,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “Nyxoah and the AAO-HNSF share the common goal of putting patients first and making sure they have access to HGNS therapy. We look forward to working closely with the AAO-HNSF as we prepare for our U.S. launch.”

About the AAO-HNS
The American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) is one of the world’s largest organizations representing specialists who treat the ears, nose, throat, and related structures of the head and neck. Otolaryngologist–head and neck surgeons diagnose and treat medical disorders that are among the most common affecting patients of all ages in the United States and around the world. Those medical conditions include chronic ear disease, hearing and balance disorders, hearing loss, sinusitis, snoring and sleep apnea, allergies, swallowing disorders, nosebleeds, hoarseness, dizziness, and tumors of the head and neck as well as aesthetic and reconstructive surgery and intricate micro-surgical procedures of the head and neck. The Academy has approximately 13,000 members.

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. 

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; 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, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, 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:
Nyxoah
David DeMartino, Chief Strategy Officer
david.demartino@nyxoah.com
+1 310 310 1313