Category: PRESS RELEASES

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MDS Global conclut un partenariat stratégique avec PlatformX Communications (PXC)

WARRINGTON, Royaume-Uni, 26 mars 2025 (GLOBE NEWSWIRE) — MDS Global, l’un des principaux fournisseurs de systèmes de soutien aux entreprises (BSS) pour les opérateurs de télécommunications numériques, est ravi d’annoncer la conclusion d’un nouveau partenariat stratégique avec PlatformX Communications (PXC), premier fournisseur en gros de solutions de connectivité, de voix, de cloud et de sécurité au Royaume-Uni. Grâce à cet accord historique, MDS Global continuera de proposer sa plateforme de monétisation convergée (CMP) de pointe en tant que service de monétisation de bout en bout entièrement externalisé, afin d’accompagner les ambitieux objectifs de PXC en matière d’innovation et de transformation numérique.

Dans le cadre de ce partenariat, la plateforme CMP de MDS Global servira de plateforme stratégique unique de facturation de gros pour PXC. Elle soutiendra ainsi son projet de création d’une puissante plateforme d’agrégation d’altnets, tout en simplifiant l’infrastructure informatique de PXC et en fusionnant plusieurs environnements de BSS. En optimisant les opérations de PXC et en automatisant ses processus, la plateforme lui permet de réduire ses coûts opérationnels, de stimuler l’innovation et d’offrir des expériences client numériques.

La conclusion de ce partenariat témoigne de la capacité de MDS Global à générer de la valeur ajoutée et à garantir des opérations efficaces et fluides. La décision de PXC de prolonger cette relation, après un long historique de partenariat, témoigne de sa confiance dans l’engagement de MDS Global à s’aligner sur sa stratégie et à l’aider à atteindre ses ambitieux objectifs.

Phil Haslam, Directeur des techniques informatiques de PXC, a déclaré : « Notre relation avec MDS Global s’étend sur plus de 2 décennies et nous sommes ravis de renouveler notre accord afin de renforcer davantage encore notre partenariat. La plateforme de monétisation convergée de MDS nous permet de simplifier notre infrastructure technologique et de stimuler l’innovation, ce qui s’est avéré essentiel dans le parcours qui nous a amenés à devenir le premier fournisseur de connectivité de gros au Royaume-Uni. Nous sommes impatients de poursuivre notre fructueuse collaboration et de franchir ainsi de nouvelles étapes ensemble. »

John Burton, PDG de MDS Global, a commenté : « Nous sommes ravis de prolonger notre partenariat de longue date avec PXC. Non seulement la plateforme de monétisation convergée de MDS simplifiera l’architecture informatique de PXC, mais elle stimulera également l’innovation et l’efficacité au sein de l’entreprise, consolidant ainsi la position de leader de PXC sur le marché britannique des télécommunications de gros. Ce partenariat témoigne de notre engagement à collaborer de manière étroite avec nos clients afin de leur fournir des solutions fiables qui stimulent la croissance et la transformation numérique. »

À propos de PlatformX Communications (PXC)

PlatformX Communications (PXC) est le premier fournisseur britannique de solutions innovantes pour la connectivité, la voix, le cloud et la sécurité, toutes soutenues par le réseau le plus robuste, le plus sécurisé, le plus résilient et le plus fiable du Royaume-Uni.

Alimenté par un réseau national de plus de 3 000 centraux couvrant 98 % des foyers et des entreprises, PXC bénéficie d’une position unique en raison de sa clientèle élargie et de la diversité de ses partenaires d’infrastructure fibre.

Née de la combinaison des services de gros et du réseau national de TalkTalk avec Virtual1, la compréhension approfondie de PXC des problèmes auxquels sont confrontés les acteurs du marché de gros lui permet de soutenir de manière unique tous les types d’entreprises.

Rendez-vous sur : www.PXC.co.uk

À propos de MDS Global

MDS Global accompagne les opérateurs de télécommunications numériques dans la croissance de leurs revenus, l’amélioration de leur satisfaction client, et la réduction de leurs coûts. Nous proposons des systèmes de soutien aux entreprises (BSS) de pointe, avec notamment des solutions de monétisation, d’expérience client, d’eSIM et d’intelligence décisionnelle basée sur l’IA, conçues pour les modèles économiques B2B, B2C, B2B2X et IoT.

Des MVNO performants, comme iD Mobile, aux opérateurs de premier plan, comme BT, nos solutions cloud hautement évolutives sont au service des MVNO, des MVNE, des opérateurs de réseau et des fournisseurs de services de gros pour les services mobiles, fixes et convergents.

Après avoir initialement exercé nos activités en tant que MVNO B2B, nous faisons à présent bénéficier nos clients de plus de 35 années d’excellence dans le domaine de la facturation. Nos équipes internationales et conviviales s’engagent à établir des partenariats à long terme fondés sur la collaboration afin d’assurer la réussite de nos clients. MDS Global est une société de Lumine Group (TSXV : LMN).

Rendez-vous sur mdsglobal.com et suivez-nous sur linkedin.com/company/mdsglobal.

Contact pour tout complément d’information

Corine Suscens
Responsable du marketing mondial
[email protected]

Les photos jointes au présent communiqué sont disponibles aux adresses suivantes :

https://www.globenewswire.com/NewsRoom/AttachmentNg/6fa94b87-7250-4c03-9be7-25e33ce798c8

https://www.globenewswire.com/NewsRoom/AttachmentNg/9efca876-29d9-4ac7-99bd-f703d62b148b

GlobeNewswire Distribution ID 1001076232

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Bitget Maintains 213% Reserve Ratio in March 2025 Proof-of-Reserves Update

Ratio in March 2025 Proof-of-Reserves Update

Ratio in March 2025 Proof-of-Reserves Update

VICTORIA, Seychelles, March 26, 2025 (GLOBE NEWSWIRE) — Bitget, the leading global cryptocurrency exchange, has released its latest proof-of-reserves report for March 2025, reaffirming its asset transparency and user fund security with a reserve ratio of 213%. The report, timestamped at 10:30 AM (UTC+8) on March 17, shows that the exchange holds more than double the users’ total assets across BTC, ETH, USDT, and USDC.

The audit, supported by a 27-layer Merkle tree comprising over 37.8 million records, verifies that Bitget possesses sufficient assets to cover all user balances. This month’s report highlights reserve ratios of 332% for BTC, 173% for USDT, 161% for ETH, and 198% for USDC, each significantly exceeding the 100% threshold required to meet user liabilities.

A reserve ratio exceeding 100% indicates that the platform holds more crypto assets in custody than its users collectively own, acting as a real-time solvency signal. The publication of this data follows increasing calls from both regulators and users for more frequent, mathematically verifiable disclosures from centralized exchanges.

By adopting cryptographic techniques such as the Merkle tree structure, Bitget enables users to independently verify their balances within the total liabilities without exposing personal account data. This method strengthens user trust by enabling public verification of platform solvency while preserving user privacy.

“Transparency must be consistent, not occasional. Exchanges carry an obligation to provide users with tools to verify that their funds are held securely and fully accounted for. Bitget’s latest reserve ratio is not just a metric—it’s a signal of operational clarity and a standard the industry should continuously uphold,” said Gracy Chen, CEO at Bitget.

As regulatory scrutiny intensifies and users become more discerning, frequent and transparent solvency proofs are becoming integral to the survival of centralized platforms. The latest data places Bitget ahead of many major exchanges in terms of capital buffers, offering a substantial margin of security in volatile market conditions.

With over 20,500 BTC, 197,500 ETH, 2 billion USDT, and 106 million USDC held in custody, Bitget’s holdings remain aligned with its broader objective to provide users with uninterrupted access to their digital assets. The latest Merkle root hash for March 2025—37a20f806f400dcd—can be used by users to confirm their account’s inclusion in the reserve audit.

The March disclosure continues a monthly cycle of transparent reporting introduced by Bitget following industry-wide failures in 2022. With this sustained publication, the exchange reinforces its operational visibility and bolsters user confidence in custodial safety.

To view Bitget’s Proof-of-Reserves, please visit here.

About Bitget

Established in 2018, Bitget is the world’s leading cryptocurrency exchange and Web3 company. Serving over 100 million users in 150+ countries and regions, the Bitget exchange is committed to helping users trade smarter with its pioneering copy trading feature and other trading solutions while offering real-time access to Bitcoin price, Ethereum price, and other cryptocurrency prices. Formerly known as BitKeep, Bitget Wallet is a world-class multi-chain crypto wallet that offers an array of comprehensive Web3 solutions and features including wallet functionality, token swap, NFT Marketplace, DApp browser, and more.

Bitget is at the forefront of driving crypto adoption through strategic partnerships, such as its role as the Official Crypto Partner of the World’s Top Football League, LALIGA, in EASTERN, SEA and LATAM markets, as well as a global partner of Turkish National athletes Buse Tosun Çavuşoğlu (Wrestling world champion), Samet Gümüş (Boxing gold medalist) and İlkin Aydın (Volleyball national team), to inspire the global community to embrace the future of cryptocurrency.

For more information, visit: Website | Twitter | Telegram | LinkedIn | Discord | Bitget Wallet

For media inquiries, please contact: [email protected]

Risk Warning: Digital asset prices are subject to fluctuation and may experience significant volatility. Investors are advised to only allocate funds they can afford to lose. The value of any investment may be impacted, and there is a possibility that financial objectives may not be met, nor the principal investment recovered. Independent financial advice should always be sought, and personal financial experience and standing carefully considered. Past performance is not a reliable indicator of future results. Bitget accepts no liability for any potential losses incurred. Nothing contained herein should be construed as financial advice. For further information, please refer to our Terms of Use.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0f1afe99-dee9-403a-a014-543d1c47fd84

GlobeNewswire Distribution ID 1001076212

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Saudi National Pavilion at London Design Biennale 2025: “Good Water” Invites Us to Rethink Our Relationship With Water

Closeup of the sabeel fountain, 2025. Photo by Aziz Jamal. Courtesy of the Architecture and Design Commission.

Closeup of the sabeel fountain, 2025. Photo by Aziz Jamal. Courtesy of the Architecture and Design Commission.

RIYADH, Saudi Arabia, March 26, 2025 (GLOBE NEWSWIRE) — Saudi Arabia returns to the London Design Biennale 2025 with an exhibition entitled Good Water, from 5–29 June 2025 at Somerset House. Commissioned by Saudi Arabia’s Architecture and Design Commission, this year’s pavilion is curated by design collective including Alaa Tarabzouni, Aziz Jamal, Dur Kattan and Fahad bin Naif, who bring together their multidisciplinary backgrounds in architecture, design and the arts, for an exhibition that questions, disrupts, and reimagines systems of access and distribution of water, and our relationship with it.

The curatorial concept of Good Water responds to this year’s theme for the London Design Biennale, ‘Surface Reflections’, which explores how ideas are fuelled by our internal experiences, external influences and personal histories. The Saudi Pavilion is defined by a sabeel – a free water fountain, a symbol of hospitality deeply rooted in the Saudi Arabian tradition. Traditionally, these fountains are scattered across the country, providing water to passersby embodying a communal ethos of generosity. Yet, within the context of this exhibition, the sabeel is no longer just a gesture of goodwill, but a question: Who pays for ‘free’ water? What does it truly cost? And, crucially, if the burden falls on someone else, does it not, in some form, cost everyone?

The sabeel, as a concept, carries a deep contradiction: while it offers water freely, the reality is that the water is not free at all. Every sip is made possible by a complex system of labour, energy, and economics. Potable water is extracted through costly processes, imported in plastic bottles, or transported through networks that demand maintenance and oversight. The cost is distributed across various actors – governments, corporations, workers – but ultimately, it is a cost that all must bear. Even those who do not pay for water directly still share in its long-term consequences. The sabeel in the pavilion, therefore, is more than a functional object: it is a symbol of interdependence. It highlights the tension between generosity and cost, between access and consequence.

The Saudi National Pavilion is a flagship initiative of the Architecture and Design Commission, supported by the Ministry of Culture, reflecting Saudi Arabia’s commitment to contributing to international design discourse and promoting sustainable, innovative solutions.

The press kit is HERE.

For information contact:

Anastasia Lander
Pelham Communications
[email protected] 

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f11301a5-c6f1-4cba-81d8-65b5bfcd50d3

GlobeNewswire Distribution ID 9411242

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Two Hong Kong Restaurants Achieve Top 3 Status in Asia’s 50 Best Restaurants 2025

Together with No.1 Ranking at Asia’s 50 Best Bars, Hong Kong Shines as a Culinary Powerhouse

Celebrated chefs from Hong Kong who made it to the 50 Best Restaurants

Celebrated chefs from Hong Kong who made it to the 50 Best Restaurants

Celebrated chefs from Hong Kong who made it to the list of Asia’s 50 Best Restaurants 2025, with The Chairman and WING ranked 2nd and 3rd on the list. (Credit: The Forks & Spoons, Forklore)

HONG KONG, March 26, 2025 (GLOBE NEWSWIRE) — Hong Kong has solidified its position as a culinary powerhouse in Asia, boasting three spots in the top three of both Asia’s 50 Best Restaurants 2025 and Asia’s 50 Best Bars 2024. Asia’s 50 Best Restaurants 2025 were revealed at a ceremony in Seoul last night, Gaggan in Bangkok was named the best restaurant, while Hong Kong’s The Chairman and WING secured second and third places, respectively, each improving their standings from last year. Vicky Cheng, Chef and Owner of WING, also secured the coveted peer-voted Inedit Damm Chefs’ Choice Award. The achievement caps a remarkable 12 months for Hong Kong’s gastronomy scene, which began when Hong Kong’s Bar Leone stunned the hospitality world by debuting at number 1 on Asia’s 50 Best Bars 2024, the first ever bar to do so.

Danny Yip, owner of The Chairman (Credit: Asia’s 50 Best Restaurant)

Danny Yip, owner of The Chairman (Credit: Asia's 50 Best Restaurant)

Danny Yip, owner of The Chairman, elevates Chinese cuisine to fine dining, showcasing its rich flavours and artistry. (Credit: The Chairman & Asia’s 50 Best Restaurants)

Danny Yip, owner of The Chairman, said: “I would like to dedicate this recognition to everyone in Chinese restaurants who harness the beauty of Chinese cuisine to connect with friends from all corners of the globe. We’re thrilled to share our culinary journey on the international stage, inspiring others to explore the richness of our cuisine and the vibrant essence of Hong Kong’s dining scene.”

WING_Chef Vicky Cheng

WING_Chef Vicky Cheng

Vicky Cheng, Executive Chef and Owner of WING, invites diners to experience the perfect fusion of flavours, where Chinese culinary art meets French fine dining. (Credit: WING)

Vicky Cheng, Chef and Owner of WING, said: “Being recognised among the best restaurants in Asia is an incredible honour for our team and a reflection of our commitment to pushing culinary boundaries, and we are proud to contribute to Hong Kong’s rich culinary tapestry. We are excited to share our culinary story on such a prestigious stage, and this recognition fuels our passion to explore new gastronomic horizons.”

Hong Kong has long been renowned by global gourmands and culinary tastemakers as one of the world’s great gastronomic cities, known for its incredible breadth and depth of restaurants and cuisines. This latest recognition underscores Hong Kong’s position as one of the world’s best cities for food and drink enthusiasts, with a hospitality scene that continues to go from strength to strength and that remains at the forefront of creativity and innovation.

Hong Kong’s success at Asia’s 50 Best Restaurants and Bars firmly establishes the city as a premier destination for gastronomic excellence. With The Chairman, WING and Bar Leone leading the way, the city showcases an unparalleled richness in culinary artistry and innovation. Food and beverage enthusiasts from around the world are encouraged to immerse themselves in the city’s vibrant dining scene, exploring the celebrated establishments that make Hong Kong a true gastronomic haven.

Looking ahead, Hong Kong will also host the World’s 50 Best Bars 2025 for the first time on 8 October, at the iconic Kai Tak Cruise Terminal, ensuring that this extraordinary year will further elevate the city’s reputation in the hospitality world.

Key points at a glance:

  • Top Rankings for Hong Kong Establishments: 3 establishments from Hong Kong are currently ranked in the top 3 of Asia’s 50 Best Restaurants 2025 and Asia’s 50 Best Bars 2024: The Chairman at no. 2 and WING at no. 3 for restaurants, along with Bar Leone, which holds the top spot at no. 1 for bars. This remarkable achievement solidifies the city’s reputation as one of the world’s great gastronomy hubs.
  • Additional Honorees in Asia’s 50 Best Lists: A number of the city’s other establishments hold spots on current Asia’s 50 Best lists. Asia’s 50 Best Restaurants 2025 includes 7 Hong Kong Restaurants: The Chairman (no. 2), WING (no. 3), Caprice (no. 18), Neighborhood (no. 21), MONO (no. 24), Estro (no. 32) and Andō (no. 41) while the 51–100 long list features VEA (no. 53), Xin Rong Ji (no. 56), Testina (no. 60), Ta Vie (no. 64), Feuille (no. 93), and 8 1/2 Otto E Mezzo Bombana (no. 94).
  • Recognition of Hong Kong Bars: Including the top-ranked Bar Leone, Asia’s 50 Best Bars 2024 includes 9 Hong Kong bars: three-time number one COA (no. 4), ARGO (no. 9), The Aubrey (no. 10), Darkside (no. 17), The Savory Project (no. 19), Penicillin (no. 24), Quinary (no. 26), and Mostly Harmless (no. 45).
  • About 50 Best: 50 Best is one of the world’s leading authorities on international hospitality, showcasing worldwide trends and highlighting great restaurants and bars from all corners of the globe. The annual lists are compiled by votes by local industry tastemakers, and celebrate excellence in gastronomy, from innovative dishes to exceptional beverages.

Media can download photos at the following link:

Asia’s 50 Best Restaurants 2025 Asia’s 50 Best Bars 2024
Restaurant Photos:
https://drive.google.com/drive/folders/1D7Iks5GeE7N9O-aEIXmSG5y4wRBwAQLO?usp=sharing		 Bars Photos:
https://drive.google.com/drive/folders/1u6Gyzyssrbt0UsQICkgmOz4cYuq8VYNv?usp=sharing
Ceremony Photos and Press Materials from 50 Best:
https://mediacentre.theworlds50best.com/#/hierarchies/Media%20Centre/Asia’s%2050%20Best%20Restaurants		 Ceremony Photos and Press Materials from 50 Best: https://mediacentre.theworlds50best.com/#/hierarchies/Media%20Centre/Asia’s%2050%20Best%20Bars


For media enquiries, please contact:

Ms. Holly Chan
Tel: 2807 6206
Email: [email protected]		 Ms. Natalie Chan
Tel: 2807 6216
Email: [email protected]

Photos accompanying this announcement are available at:
https://www.globenewswire.com/NewsRoom/AttachmentNg/bab98761-0ce8-410f-b083-ad5103315369

https://www.globenewswire.com/NewsRoom/AttachmentNg/d7424af8-5479-483f-95ef-498542df94bb

https://www.globenewswire.com/NewsRoom/AttachmentNg/5d71b189-dbb0-4269-a49e-46b47debaabd

GlobeNewswire Distribution ID 9411213

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Bitget Shifts Gears with Porsche Cup Brasil Sponsorship with Driver Flávio Sampaio

Bitget Shifts Gears with Porsche Cup Brasil Sponsorship with Driver Flávio Sampaio

Bitget Shifts Gears with Porsche Cup Brasil Sponsorship with Driver Flávio Sampaio

VICTORIA, Seychelles, March 26, 2025 (GLOBE NEWSWIRE) — Bitget, the leading global cryptocurrency exchange, is set to accelerate its presence in the motorsport world as the official sponsor of Driver Flávio Sampaio for the Porsche Cup Brasil 2025. The partnership, which kicks off with the season’s opening race in April 2025, symbolizes the convergence of the on-going financial evolution, and the adrenaline-fueled world of motorsport.

The collaboration sets Bitget with Porsche’s legacy of precision and speed, creating a partnership that resonates with both crypto enthusiasts and motorsport fans. The sponsorship of driver Flávio Sampaio in the 2025 Porsche Carrera Cup Brazil season is supported by Bitget’s mission of bringing together sports and crypto.

The championship kicked off on March 22nd and 23rd at the Velocitta in Mogi Guaçu and will continue through November, with the final stage scheduled for the 8th and 9th in Interlagos, São Paulo. With its support for Flávio, Bitget becomes the first crypto exchange to participate in the competition and will have its own car in Latin America’s largest Grand Touring category.

In the past, Bitget also had a successful partnership with Argentina’s star Lionel Messi from 2022 to 2024 and previously sponsored Juventus’ women’s football team in Italy. Currently, it also supports other major sports projects, such as Turkish athlete Buse Tosun Çavuşoğlu (world wrestling champion), Samet Gümüş (gold medalist in boxing), and İlkin Aydın (national volleyball team athlete).

Flávio Sampaio, commented on the partnership, saying, “I am very excited about this partnership with Bitget and hope to help spark interest among motorsport fans in the world of cryptocurrencies. The profile of sports fans often has similarities with that of crypto investors. I believe we can create an interesting connection between these two worlds.”

Flávio Sampaio began his career in karting at the age of 12 and competed in major state and national championships until 2001. In 2007, he was invited to participate in Stock Jr., the feeder category for Stock Car. In 2008, he joined ATW Racing in Stock Light. In 2010, he was invited to compete in the Mini Cooper Challenge category, and in 2014, he moved to the GT3 Challenge.

This partnership is a Porsche 911 GT3 Cup wrapped in Bitget’s signature black-and-cyan livery, embodying the exchange’s commitment to speed, reliability, and performance. With a roaring 510CV engine, the car serves as a metaphor for Bitget’s high-performance trading engine, designed to deliver unmatched efficiency and results.

“This partnership isn’t just about speed on the track—it’s about accelerating innovation in the crypto space,” said Gracy Chen, CEO at Bitget. “We find that Flavio’s sportsmanship also dwells on the same principles that drive Bitget: strategy, adaptability, and high-performance execution. Aligning with a motorsport professional for a series known for its precision and competitiveness allows us to engage with an audience that values both technological advancement and calculated risk-taking.”

The Porsche Cup Brasil is the ideal setting for Bitget to engage with a discerning audience, since it draws Brazil’s top motorsport aficionados and sports-centric enthusiasts. Among the unique experiences attendees will have is access to the Paddock Terrace, where timing screens and real-time race radios provide an immersive perspective of the action. Bitget’s VIP visitors will also be able to meet drivers, tour the pit lane, and take part in Porsche Experience Rides where they will ride shotgun with professional drivers in Bitget-branded helmets.

Brazil is experiencing a notable surge in cryptocurrency adoption, with over 40 million users, which positions the country as a key market for Bitget’s expansion. By partnering with Driver Flávio Sampaio in the Porsche, Bitget strengthens its local presence and reinforces its global reputation as the top emerging crypto brand. The sponsorship shows Bitget’s ability to connect with diverse audiences, from crypto traders to motorsport enthusiasts, through shared values of innovation and performance.

As engines roar and markets surge, Bitget, and Porsche Cup Brasil are set to redefine what it means to blend speed with substance. This partnership merges excitement and anticipation, driving the future of finance and motorsport with Bitget set to lead.

About Bitget

Established in 2018, Bitget is the world’s leading cryptocurrency exchange and Web3 company. Serving over 100 million users in 150+ countries and regions, the Bitget exchange is committed to helping users trade smarter with its pioneering copy trading feature and other trading solutions while offering real-time access to Bitcoin price, Ethereum price, and other cryptocurrency prices. Formerly known as BitKeep, Bitget Wallet is a world-class multi-chain crypto wallet that offers an array of comprehensive Web3 solutions and features including wallet functionality, token swap, NFT Marketplace, DApp browser, and more.

Bitget is at the forefront of driving crypto adoption through strategic partnerships, such as its role as the Official Crypto Partner of the World’s Top Football League, LALIGA, in EASTERN, SEA and LATAM markets, as well as a global partner of Turkish National athletes Buse Tosun Çavuşoğlu (Wrestling world champion), Samet Gümüş (Boxing gold medalist) and İlkin Aydın (Volleyball national team), to inspire the global community to embrace the future of cryptocurrency.

For more information, visit: Website | Twitter | Telegram | LinkedIn | Discord | Bitget Wallet

For media inquiries, please contact: [email protected]

Risk Warning: Digital asset prices are subject to fluctuation and may experience significant volatility. Investors are advised to only allocate funds they can afford to lose. The value of any investment may be impacted, and there is a possibility that financial objectives may not be met, nor the principal investment recovered. Independent financial advice should always be sought, and personal financial experience and standing carefully considered. Past performance is not a reliable indicator of future results. Bitget accepts no liability for any potential losses incurred. Nothing contained herein should be construed as financial advice. For further information, please refer to our Terms of Use.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/aeb5ea1c-7b55-47c1-879e-64bebd0cae6d

GlobeNewswire Distribution ID 1001076125

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FDA Issues Nyxoah an Approvable Letter for its Genio® System

INSIDE INFORMATION
REGULATED INFORMATION

FDA Issues Nyxoah an Approvable Letter for its Genio® System

Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has 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. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.

“The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA’s Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are still on the right track to make Genio available to U.S. patients suffering from OSA.”

This decision does not impact Genio’s CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients.

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; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; 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]

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