Day: April 8, 2025

Nyxoah Provides Update on FDA Approvable Letter for Genio System
Expects to meet final FDA requirements for full PMA approval in the second quarter

Mont-Saint-Guibert, Belgium – April 8, 2025, 07:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), which develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced an update on the FDA approval process for the Genio system.

On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company’s Pre-Market Approval (PMA) application for the Genio® system.

The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. FDA has accepted all other data provided with the PMA submission, including most importantly the clinical study that demonstrates the safety and effectiveness of the Genio® system.

Nyxoah is actively addressing one remaining item before FDA approval may be granted which is the validation of one process used with a component of the Genio system at its U.S. manufacturing site. The Company is confident that it will be able to successfully complete this validation in the near term. As such, Nyxoah anticipates that its application could potentially be approved in the second quarter and intends to provide an update on the review process on its first quarter 2025 earnings call to be held in May.

“We are pleased to share that the Approvable Letter from FDA confirms that we are very close to PMA approval,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We believe the final remaining step is completing a process validation at our U.S. manufacturing site – action taken in response to the last set of specific validation questions sent by the FDA – which we are confident we can address swiftly and successfully. We look forward to launching Genio in the U.S. upon receipt of FDA approval.”

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. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. 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 announced positive outcomes from the DREAM IDE pivotal study.

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; receipt of FDA approval; satisfactory completion of a manufacturing facilities, methods and controls review, and the anticipated timing of the foregoing; entrance to the U.S. market; 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, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, 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
John Landry, CFO
[email protected]

For Media
In United States
FINN Partners – Alyssa Paldo
[email protected]

In International/Germany
MC Services – Anne Hennecke
[email protected]

In Belgium/France
Backstage Communication – Gunther De Backer
[email protected]

Attachment

• ENGLISH_Update on FDA Approvable Letter_FINAL

GlobeNewswire Distribution ID 1001078888

NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) — Marc Mysterio’s legal team, led by attorney Michael H. Joseph, will serve Amazon Music’s counsel with a letter of preservation of evidence imminently—as noted in Marc’s 3-Part YouTube Series exposing the Shadow-ban placed on his music using the IF/THEN protocol employed by Amazon Music— escalating the Irish-Canadian artist’s lawsuit against Amazon Music and DistroKid (Case No. 1:25-cv-01705).

Filed in the U.S. District Court for the Southern District of New York on Feb. 27, 2025, the suit claims damages “in excess of $75,000,” with losses in the millions to date, alleging Amazon employed a shadow-ban on Mysterio’s songs by deploying an “IF/THEN” filter—essentially a simple “if this, then that” command, like telling a computer, “If it’s Marc’s music, then mark it with a dash (‘-’)”—rendering his tracks “artist-less” and unable to reach his 1.25 million fans, play on Amazon Stations, connect to related artists’ fans, or be considered for AI features normally available to all artists, even the below-mentioned, unheralded Neon Tom.

Mysterio, a 20-year music veteran and one of Amazon’s top global stars with over 80 million streams from September 2023 to August 2024—55% from Amazon Stations—saw his music blocked by the shadow-ban starting Sept. 10, 2024. The ban also threatens chart integrity, notably the Billboard Hot Dance and Electronic Songs Chart, where Mysterio charted based solely on Amazon streams..

Marc Mysterio Streams/Listeners from 2024 Amazon Music For Artists

By arbitrarily shadow-banning a charting artist for reasons known only to Amazon, the company can manipulate positions on independent charts like Billboard in the U.S. and the UK Official Charts, undermining the credibility of Billboard Magazine’s staff, artists, and their teams. “Amazon’s playing god with data that charts like Billboard Magazine—totally independent with no business ties to Amazon beyond collecting stream stats—rely on for calculations, for charts that Billboard’s readers and paying subscribers rely on,” Joseph said.

A 3-part YouTube series strengthens Mysterio’s case: Video 1 (March 19, 2025) shows “streaming errors” across his profile; Video 2 reveals “My Sabrina Carpenter Mix” with 17 of 50 songs by Carpenter, while “My Marc Mysterio Mix” has zero of 50 by Mysterio, contrasting Amazon Music Stations—algorithm-driven streams, not playlists—where Neon Tom, an artist with zero Amazon fans (equivalent to followers), lands two of the first 10 songs on his station, while Mysterio’s station played nearly 50 songs with none of his own. Video 3 details his station’s 225,463 streams and 57,453 listeners from the noted calendar year, and the Taylor Swift station’s 3,698,968 streams and 742,696 listeners of Mysterio’s songs from the noted calendar year, both bottoming out to zero on Sept. 25, 2024.

Marc Mysterio’s 3-Part YouTube Series expose Amazon’s IT backend, for example: Mysterio’s artist page URL (https://music.amazon.com/artists/B0041A1P4U/marc-mysterio) works without “/marc-mysterio” (https://music.amazon.com/artists/B0041A1P4U/), proving the 10-digit code “B0041A1P4U” drives identification—a key for discovery subpoenas. Amazon’s partial restore of Mysterio’s “Related Artists” to their pre-shadow-ban state in March 2025, post-complaint, without removing the shadow-ban itself, fueled the fight. “They showed they could fix it but didn’t,” Joseph said. “It’s more foolish than a 4th down trick play gone wrong.”

The preservation letter targets 17 evidence categories tied to “B0041A1P4U,” including metadata logs proving the shadow-ban’s scope from Sept. 10, 2024, backup snapshots showing Amazon’s restore capability, algorithm trails pinning intent, station logs quantifying damages—225,463 streams on Mysterio’s station and 3,698,968 on Taylor Swift’s, both zeroed by Sept. 25, 2024—and user metrics revealing 1.25 million fans cut off, per the YouTube series—all of which are dispositive to Marc’s claims contained in his lawsuit.

“Amazon’s half-fix—restoring Mysterio’s ‘Related Artists’ to their pre-shadow-ban state without removing the shadow-ban itself—is their 4th down fumble; they have essentially handed us the win by fixing and restoring the related artists portion of Marc Mysterio’s Amazon Music Artist Page but not simultaneously removing the IF/THEN code responsible for the shadow-ban when Amazon’s IT Staff could easily have done so—it shows clear and convincing intent to cause undue harm to Marc Mysterio, and the logs sought will show this” Joseph said, eyeing punitive damages.

Mysterio, known for collaborations with David Guetta, Crash Test Dummies, Flo Rida, Samantha Fox, and Trailer Park Boys—where he composed, appeared as a guest star DJ, and earned an IFPI Gold Award for the anthem from the Netflix Series entitled “L&W” (an abbreviation of the song title due to the explicit song title)—also scored a Gold Award with Alexandra Stan for “Balans.” He holds IBA boxing recognition as a contender for a vacant world title against Jake Paul.

“I was a top Amazon star who entrusted them as a voluntary exclusive artist, pulling my catalog from Spotify and Apple—if they’ll mistreat me like this, they could and likely would do it to any star, no matter how successful globally or how much you do for the community, including assisting terrorist victims” Mysterio concludes.

Marc Mysterio’s 3-part YouTube series exposing the Amazon Music shadow-ban can be viewed at www.alexaemail.com which links directly to the playlist.

For More Information

Attorney for Plaintiff Marc Mysterio:
Law Office of Michael H. Joseph
18 West 33rd Street, Suite 400
New York, NY 10001
Tel: +1-212-858-0503
www.newyorktriallawyers.org
[email protected]

Marc Mysterio on X – Full Grok Bio Available
@marc_mysterio

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/18c6a56a-fe32-4ec8-8188-e9c47a51f0b4

https://www.globenewswire.com/NewsRoom/AttachmentNg/6bb0652d-f74e-4e88-b03f-5390fde0325d

A video accompanying this announcement is available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/072f47e8-1a23-4801-b1ea-b5e332438388

GlobeNewswire Distribution ID 1001079052

TAMPA, Fla., April 08, 2025 (GLOBE NEWSWIRE) — AACSB International, the global leader in business education, proudly announces the launch of the AACSB Academy, a transformative learning platform designed to upskill business school faculty, staff, administrators, and leaders. The Academy offers competency-based, technical learning programs that focus on building excellence, success, and quality, all directly aligned with AACSB standards.

“This launch represents a major expansion of our professional learning portfolio, enabling us to provide even more impactful development opportunities for business education professionals,” said Carrie Summerlin, Executive Vice President, Chief Learning & Engagement Officer.

The AACSB Academy is distinguished by:

Competency-Based Curriculum: Structured learning built around real-world leadership, pedagogy, and accreditation skills.
Flexible Formats: In-person, virtual, hybrid, and asynchronous options to suit individual and institutional needs.
Recognized Credentials: Certificates and digital badges that validate professional growth and global readiness.
Customizable Learning Paths: Tailored experiences for a range of roles and career stages.
Mentorship & Community: Cohort-based programs that foster collaboration and shared growth.

“With the launch of the Academy, we are not only responding to the evolving needs of business education professionals, but we are also raising the bar,” said Lily Bi, president and CEO of AACSB. “The Academy ensures that institutions and individuals alike can access rigorous, competency-based programs that enhance leadership, faculty excellence, and long-term institutional impact.”

In addition to its accreditation curriculum, AACSB Academy introduces new offerings such as leadership cohorts, on-demand modules, seminars, and certificates on the topics of assurance of learning, AI, professional excellence, and business simulation. Many programs will be accessible to emerging markets, underscoring AACSB’s commitment to global, inclusive development.

Media Contact:
Andrew Thriffiley, Public Relations Manager
[email protected]

About AACSB International

Established in 1916, AACSB International (AACSB) is the world’s largest business education association, connecting educators, learners, and businesses to create the next generation of great leaders. With members in over 100 countries and territories, AACSB elevates the quality and impact of business schools globally. Learn how AACSB and business schools from around the world are leading boldly in business education at aacsb.edu.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/759d0b91-b7df-410d-9267-b49e96cc8b6d

GlobeNewswire Distribution ID 9417380