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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

GlobeNewswire Distribution ID 1000796325

The launch of the Charter by the Coalition for Fisheries Transparency lays out a new roadmap to advance marine governance around the world.

PANAMA CITY, Panama, March 02, 2023 (GLOBE NEWSWIRE) — The Coalition for Fisheries Transparency – a new international community of civil society organizations – today launched the Global Charter for Fisheries Transparency. The Charter pinpoints the most essential policy priorities needed to combat fisheries mismanagement, illegal fishing, and human rights abuses at sea. Experts, ministers, and delegates from international organizations and companies around the world discussed the benefits of the Global Charter for Fisheries Transparency at Our Ocean conference in Panama this Thursday and Friday – an annual meeting for countries, civil society and industry to announce significant actions to safeguard the world’s oceans.

“Ghana recognizes the critical role that transparency plays in the fight against illegal fishing to protect livelihoods and provide food security to our coastal communities,” said Hon. Mavis Hawa Koomson, Ghana’s Minister of Fisheries and Aquaculture Development. “With the significant progress Ghana has made in the last year on ending harmful fishing practices that have encouraged illegal fishing in our waters, we are now working towards making greater efforts towards sustaining fisheries transparency in Ghana.”

Prof. Maxine Burkett, Deputy Assistant Secretary for Oceans, Fisheries and Polar Affairs at the U.S. Department of State, highlighted how the U.S. plays a leading role in increasing transparency in global fisheries.

“Last year, President Biden released a National Security Memorandum that recognizes the importance of transparency for combating illegal, unreported, and unregulated (IUU) fishing and associated forced labor abuses,” she said. “By enhancing productive information-sharing, the Global Charter for Fisheries Transparency will serve as an important complement to the U.S. government’s activities to end IUU fishing through improving fisheries and ocean governance, increasing enforcement efforts, and raising ambition to end IUU fishing globally.”

Additionally, global partnership initiatives, like the Fisheries Transparency Initiative (FiTI), emphasized the importance of equal, multi-stakeholder collaboration to increase transparency in coastal countries for achieving sustainably managed marine fisheries.

“Given the complexity of fisheries governance, multiple transparency efforts are needed to address the various challenges of unsustainable marine fisheries, such as overfishing, IUU fishing, unequal access to fisheries resources, and unfair benefit sharing,” said Dr. Valeria Merino, Chair of the International Board of the Fisheries Transparency Initiative (FiTI). “The 10 principles of the Global Charter for Fisheries Transparency recognize the need for a comprehensive and coordinated approach to fisheries transparency, and has the potential to support existing global endeavors, such as the FiTI, through a much-needed mobilization of civil society organizations to ensure that marine fishing activities are legal, ethical, and sustainable.”

Finally, the role of the civil society to maximize collective impact to improve transparency has been underlined by Mr. Wakao Hanaoka, Chief Executive Officer of Seafood Legacy (Japan), and a steering committee member of the Coalition for Fisheries Transparency. “Our membership in the Coalition for Fisheries Transparency represents a voice of an international community that allows us to strengthen and amplify our efforts amongst the seafood industry and government towards achieving our goal of making Japan a global leader in environmental sustainability and social responsibility,” he explained.

The Global Charter for Fisheries Transparency lays out a new roadmap to advance marine governance internationally, by providing a set of advocacy principles that are both effective and achievable by all stakeholders involved in fisheries governance and management.

“Continuous advocacy efforts by civil society organizations are critical to improving fisheries governance internationally as well as protecting the ocean and the people who depend on its resources,” commented Maisie Pigeon, Director of the Coalition for Fisheries Transparency. “The Coalition’s mission to deliver an urgent shift towards greater transparency in fisheries will be achieved through supporting our members in developing joint strategies, harmonizing and strengthening efforts, and finally – closing transparency policy gaps in fisheries governance,” she concluded.

Through civil society organizations from around the world, the Coalition for Fisheries Transparency calls on governments to apply the Charter’s principles in legislation and practice.

Press contact: Agata Mrowiec agata@fisheriestransparency.net +34 608 517 552

GlobeNewswire Distribution ID 8780726

VILNIUS, Lithuania, March 02, 2023 (GLOBE NEWSWIRE) — Avia Solutions Group, the leading aviation business group, has become an Irish-based company. Following the transfer of its controlling headquarters to Ireland, Dublin, the group also became the second largest Irish-registered aviation business behind aviation giant Ryanair.

“Moving the company’s controlling headquarters to Ireland was a strategically important step for us in terms of our further development plans,” explains Jonas Janukenas, CEO of Avia Solutions Group. “Ireland is known as the hub of aviation. A large number of aviation companies are located here, hence, being closer to the aviation community we will be able to implement the group’s development plans faster and maintain market leadership.”

According to Janukenas, the company’s financial instruments on the Dublin Stock Exchange have been purchased by the world’s largest institutional investors from the USA and Europe, so this was also one of the reasons for choosing Ireland.

The group has offices spanning all across the world: Ireland, Lithuania, the US, United Arab Emirates, South Africa, Australia and Asia Pacific.

Avia Solutions Group is the world’s leading and largest ACMI (aircraft leasing, maintenance and insurance) services group with a fleet of more than 165 aircraft. The group also provides various aviation services, such as aircraft maintenance, pilot and crew training, ground handling, and others. Avia Solutions Group employs more than 11,000 highly skilled aviation professionals across different regions of the world.

About Avia Solutions Group

Avia Solutions Group is the largest global ACMI (aircraft, crew, maintenance, and insurance) provider with more than 165 aircraft fleet, and a parent company of SmartLynx Airlines, Avion Express, BBN Airlines, KlasJet, Magma Aviation and more operating in all continents in the world. The Group also provides various aviation services such as MRO (maintenance, repair, and overhaul), pilots and crew trainings, ground handling and other interconnected solutions. Avia Solutions Group is backed by over 11,000 highly skilled aviation professionals worldwide.

For more information, please visit www.aviasg.com

Media contact:
Silvija Jakiene
Chief Communications Officer
Avia Solutions Group
silvija.jakiene@aviasg.com
+370 671 22697

GlobeNewswire Distribution ID 1000795760

LONDON, March 01, 2023 (GLOBE NEWSWIRE) — The world’s latest investment migration option — and Africa’s second — the Namibia Residence by Investment Program has been launched by Henley & Partners, the global leaders in residence and citizenship planning.

The Namibian government is actively seeking foreign investment to boost the country’s economic growth and diversify the economy. The program provides numerous opportunities for international investors seeking a foothold and growth on the African continent, including tax incentives, financing, and a one-stop bureau service for international companies. For a minimum real estate investment of USD 316,000 in the new luxury golf and eco-friendly President’s Links Estate in Walvis Bay, successful investors will receive a five-year, renewable work permit which gives them the right to live, do business, and study in Namibia.

Group Head of Private Clients at Henley & Partners, Dominic Volek, says, “We are delighted to announce this innovative new residence by investment offering in Africa. Namibia’s stunning landscape, attractive tax system, and business-friendly environment make it an ideal option for international entrepreneurs, high-net-worth individuals, or retirees. There are fewer than 600 real estate units available in this exclusive coastal estate that qualifies for residence, so investors need to move quickly if they want to take advantage of this limited opportunity to secure residence rights in one of the most nature- and wildlife rich countries in the world.”

One of Africa’s fastest growing private wealth markets

The total private wealth currently held on the African continent is USD 2.1 trillion and is expected to rise by 38% over the next 10 years, according to the Africa Wealth Report, published by Henley & Partners in partnership with New World Wealth. Namibia is expected to be one of Africa’s fastest growing markets going forward, with high-net-worth individual (those with wealth of USD 1 million or more) growth of over 60% forecast for the next decade (until 2032). According to New World Wealth’s December 2022 statistics, Namibia holds USD 26 billion in total investable wealth. The average wealth of a resident of Namibia (wealth per capita) is USD 10,050, ranking as the third highest in Africa after Mauritius and South Africa. The nation is home to around 2,100 high-net-worth individuals and three centi-millionaires (with wealth of USD 100 million or more).

To attract inward investment, the government has made major improvements to its tax system in recent years. Namibia operates a source-based tax system, which means that foreign residents are generally only taxed on the income they generate in the country. What is more, tax rates are relatively competitive compared with many other emerging markets and particularly with neighboring countries such as South Africa. The top rate of income tax in Namibia is a modest 37%, but perhaps most notably there are no capital gains, estate, gift, inheritance, or net wealth/worth taxes.

Unprecedented interest in domicile diversification

Currently, the President’s Links Estate is the only investment route for the Namibia Residence by Investment Program. Group Head of Real Estate at Henley & Partners, Thomas Scott, says international real estate has always been a reliable asset class for global investors due to its long-term staying power. “Real estate–linked investment migration programs such as the offering in Namibia have the additional advantages of enhancing your global mobility and expanding your personal access rights as a resident or citizen of additional jurisdictions, creating optionality in terms of where you and your family can live, work, study, retire, and invest. The potential gains over the lifetime of this investment include the core value of the asset, rental yields, and global access as an ultimate hedge against both regional and global volatility.”

Volek points out that there has been significant and ongoing growth in the demand for residence and citizenship by investment options over the past few years. “The appeal of investment migration for affluent families is truly universal due to its many benefits, ranging from domicile diversification to global mobility enhancement, to accessing world-class education and healthcare, to having a plan B in times of turmoil. No matter where you were born, or where you currently reside, wealthy investors can futureproof themselves and their families for whatever might lie ahead through investment migration options such as the new Namibia Residence by Investment Program.”

Media Contact

Sarah Nicklin
Group Head of PR
sarah.nicklin@henleyglobal.com
Mobile: +27 72 464 8965

GlobeNewswire Distribution ID 1000795319

New Awards Categories for Achievements in Sustainability

FAIRFAX, Va., Feb. 22, 2023 (GLOBE NEWSWIRE) — The Stevie Awards are now accepting nominations for The 20th Annual International Business Awards®, the world’s premier business awards competition, which attracts nominations from organizations in more than 60 nations and territories each year.

All individuals and organizations worldwide – public and private, for-profit and non-profit, large and small – may submit nominations to The International Business Awards. The early-bird entry deadline, with reduced entry fees, is 12 April. The final entry deadline is 10 May, but late entries will be accepted through 14 June with payment of a late fee. Entry details are available at www.StevieAwards.com/IBA.

Juries featuring more than 150 executives around the world will determine the Gold, Silver, and Bronze Stevie Award winners. Winners will be announced on 11 August and celebrated at a gala banquet in Rome, Italy this October.

The International Business Awards recognize achievement in every facet of the workplace. Categories include:

• Management Awards
• Sustainability Awards
• Entrepreneur of the Year Awards
• Company of the Year Awards
• Customer Service Awards
• Human Resources Awards
• Information Technology Awards
• Marketing Awards
• New Product Awards
• Public Relations Awards
• Web Site, App, Event, Video and other media awards
• Social Media Awards
• Thought Leadership Awards

There are many new and revised features of The International Business Awards for 2023:

• There’s an entirely new group of five categories to recognize achievement in Sustainability.  Each of the five categories is split into six geographic sub-categories.
• There are new categories sprinkled throughout many of the category groups, especially in the categories for Achievement, Events, Marketing, Mobile Site & App, New Products & Services, Public Relations, Video, and Websites.
• The category group formerly known as Information Technology has been renamed Technology, to better reflect that all types of technology-related achievements are welcome to be nominated in these categories.
• The COVID-19 categories have been eliminated.

Stevie Award winners in the 2022 IBAs included Anexa BPO (Mexico), Abu Dhabi Ports Group (UAE), DHL Express (worldwide), Filinvest Alabang Inc. (Philippines), Halkbank (Turkey), IBM (USA), LLYC (Spain), Lotte Duty Free (South Korea), MDI Ventures (Indonesia), Megaphone (Australia), MetLife China, Octopus Energy (UK), Ooredoo (Singapore), Sleepm Global Inc. (Canada), Unicef Cambodia, Viettel Group (Vietnam), Wolters Kluwer Legal & Regulatory U.S., and many more.

About the Stevie Awards
Stevie Awards are conferred in eight programs: the Asia-Pacific Stevie Awards, the German Stevie Awards, the Middle East & North Africa Stevie Awards, The American Business Awards®, The International Business Awards®, the Stevie Awards for Great Employers, the Stevie Awards for Women in Business, and the Stevie Awards for Sales & Customer Service. Stevie Awards competitions receive more than 12,000 entries each year from organizations in more than 70 nations. Honoring organizations of all types and sizes and the people behind them, the Stevies recognize outstanding performances in the workplace worldwide. Learn more about the Stevie Awards at http://www.StevieAwards.com.

Contact:
Nina Moore
+1 (703) 547-8389
Nina@StevieAwards.com

GlobeNewswire Distribution ID 8752852