Nyxoah Announces 2024 Strategic Priorities

Nyxoah Announces 2024 Strategic Priorities

Mont-Saint-Guibert, Belgium – January 17, 2024, 10:05pm CET / 4:05pm 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, in anticipation of upcoming investor meetings, its strategic priorities for 2024.

2024 Strategic Priorities

  • Complete patient follow up in the DREAM U.S. pivotal study and report efficacy and safety data by early April. 12-month efficacy data1 on the first 34 DREAM patients and safety data on all DREAM patients were presented at SLEEP 2023, demonstrating a 65% AHI responder rate, a 76% ODI responder rate and safety in-line with expectations. These data are preliminary and not conclusive of final DREAM success.
  • File the fourth and final module in the modular PMA submission. Anticipate submitting the final module shortly after announcing DREAM results.
  • Accelerate investments in the U.S. commercial organization in preparation for a late 2024 launch. Recently hired Francis Kim as Chief Regulatory and Quality Officer and expanded market access to secure reimbursement at launch.
  • Complete enrollment in the ACCCESS complete concentric collapse (CCC) U.S. pivotal study. Recently announced investigator-sponsored data in Europe demonstrating Genio’s® success in treating CCC patients.
  • Increase hypoglossal nerve stimulation (HGNS) market penetration and Genio market share in Europe. For 2024, we expect continued sales growth driven by an increasing benefit from direct-to-consumer (DTC) initiatives, initial contribution from the ResMed commercial partnership in Germany and geographic expansion.

“Since Nyxoah’s founding we have been guided by the mission to improve the lives of OSA patients. This led to the development of the patient-centric Genio HGNS system. Genio’s single-incision, leadless, upgradable design powered and controlled by a wearable resonated with clinicians and patients and led to a strong European launch. Genio’s bilateral stimulation enables treatment of CCC, and the label was subsequently expanded to include these patients, whose only treatment option after failing CPAP up until then was major palate surgery,” commented Olivier Taelman, Chief Executive Officer.

“In our ongoing effort to provide patients greater control over their therapy, thereby making sleep simple again, we then received approval for Genio 2.1. Genio 2.1 offers patients daily feedback on therapy usage and autonomy to adjust stimulation amplitude within pre-defined boundaries, improving patient comfort and compliance without the need for a surgical procedure to replace the implantable component.”

“We are now on the cusp of the most significant milestone in the Company’s history with the reporting of DREAM results in the coming months. We expect to complete the PMA submission shortly after and are accelerating manufacturing and commercial investments to ensure we are fully prepared to replicate our European success in the U.S. With an approaching U.S. launch and continued growth in Europe, we are excited for the coming years.”

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 is currently conducting the DREAM IDE pivotal study for FDA and U.S. 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; 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; reporting data from Nyxoah’s DREAM US pivotal trial; filing for FDA approval; entrance to the US market, contributions from the ResMed commercial partnership in Germany; 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, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 22, 2023, 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


1 For the trial to be successful, of the 115 patients, at least 63% of patients need to be AHI and ODI responders at the 12-month follow-up.

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Revolution leader: America’s classification and raids have no meaning


The Leader of the Revolution,al-Sayeed Abdul-Malik Badr al-Din al-Houthi, renewed the call for the Yemeni people to bring out million in Sabaeen Square in the capital, Sana’a, and the governorates in marches ‘steadfast with Palestine… and America the mother of terrorism.’

In his speech today regarding the latest developments, the Leader of the Revolution considered the people of million exit as part of the firm Yemeni position and jihad for the sake of Allah and an honorable position.

He expressed hope that people would move and continue their activity with demonstrations in various countries, including Western countries.

He said, “The Arab and Islamic communities can lead those who still have conscience and humanity in those societies in pressing demonstrations in support of the Palestinian people.”

Al-Sayeed called on the members of the Yemeni communities in America and Europe to take effective, active and distinguished action to support of the Palestinian people.

Al- Sayyed Abdul-Malik Al-Houthi re
viewed the latest development in the American classification of the Ansar Allah component as a terrorist, describing it as funny.

He said, “The American sponsors the Zionist crime of killing children and women in Gaza every day and night.”

He added, “The American morally and humanely bankrupt, his practices and policies are criminal, and his tendencies are tyranny and arrogance.”

Al-Houthi stressed that America is the source of terrorism, crime and tyranny, pointing out that the American does not have any right to classify others in any classification, because it is in an inhumane and immoral situation and does not possess any values.

He reiterated Yemen’s continued firm position in targeting Israeli ships linked to the entity.

The leader of the revolution added, “The Americans want the seas to be safe for the arrival of the support and capabilities they provide to the Zionist enemy.”

He pointed out that the Yemeni people will confront the American-British aggression in support of Israel.

He continued,
“We will classify America and Britain among the countries that sponsor and protect Zionist terrorism.”

Al-Sayyed Abdul-Malik Al-Houthi also renewed the call to all countries to beware of getting involved with America and Britain in the aggression against the Yemeni and Palestinian peoples.

He added, “The tragedy in Gaza worsening, and with it the responsibility on the Arab and Islamic nation doubles, stressing the necessity of boycotting American and Israeli goods.”

The revolution leader asked the Arab peoples to activate the weapon of boycott of American and Israeli products and goods.

Al-Sayyed explained that the Zionist Jewish crime committed more than two thousand massacres and genocides against the Palestinian people in 104 days.

The leader of the revolution pointed out that the United Nations, the Organization of Islamic Cooperation and the Arab League content with statements and condemnations regarding what was happening in Palestine that did not rise to the level of responsibility.

He said, “The
re is negligence on the part of most Islamic countries in the Arab region and elsewhere towards the Palestinian people.”

He warned of the danger of indifference towards what the American and Zionist enemy is committing in Palestine.

He continued, “Biden did not excuse himself because he become old. Rather, after October 7, he took the initiative to occupied Palestine to directly and personally express his support for the Zionist enemy.

Al-Sayyed Al-Houthi stated that the Palestinian people suffered for decades, and in the eyes of the Americans and Europeans that they have no right to defend themselves and their land.

The leader pointed out that the Americans, the British, and the Israelis violated Yemen’s sovereignty to the point of aggression and declaring war on Yemen.

He also stressed that the American-British aggression against the Yemeni people will not change Yemen’s position in supporting the Palestinian people.

He said, “The American must understand that we are in a position of faith that cannot
be changed by intimidation, aggression, or bombing.”

Al-Sayeed expressed the great honor for Yemen to directly confront the evil trio, ‘Israeli, American, and British,’ which are the mother of terrorism, its roots, and the sources of tyranny.

He went on to say, “We proceed consciously and take pride in what al-Sayeed Hussein Badr al-Din al-Houthi said, that ‘America is straw.'”

The leader of the revolution concluded his speech by saying, “We proceed with confidence, and the American position does not intimidate us.”

Source: Yemen News Agency

UAE Press: AI can change the world but not if we leave people behind

ABU DHABI: A local newspaper has said that artificial intelligence stands as a beacon of innovation, akin to the transformative impact of the printing press – a technology that offers the promise of creating, sharing and using online information in ways previously unthought of.

‘These potential opportunities to change how we live, work and communicate rightly generate a lot of excitement, but it is vital to ensure that when it comes to the global economy, AI does not simply replicate existing inequalities that already threaten to undermine human progress,’ The National said in an editorial on Thursday.

This week, the World Economic Forum’s Chief Economists Outlook found that the experts it consulted thought generative AI will increase productivity and innovation – with the worrying caveat that this would be largely confined to the world’s richer countries.

‘Looking at the next five years,’ the report’s authors stated, ’94 percent expect these productivity benefits to become economically significant in high
-income economies, compared to only 53 percent for low-income economies.’

In the same week, the head of the International Monetary Fund, Kristalina Georgieva, issued a similar note of caution. In a blog post, she noted that ‘many of [low-income] countries don’t have the infrastructure or skilled workforces to harness the benefits of AI, raising the risk that over time the technology could worsen inequality among nations’.

The editorial added, ‘Countries like the UAE have the resources to develop comprehensive AI strategies – and have been doing so. Others face more acute problems and are not able to prioritise advanced technology. This leaves them at a serious disadvantage if we accept AI’s potential to deliver better results when it comes to issues of particular concern to emerging countries – health care, education, predicting natural disasters and managing the effects of climate change.’

So, how does the world bridge what threatens to be another gap between advanced and developing countries? At the core
of the answer is partnership: low-income countries will need help to develop national and regional AI strategies. They must also be supported when it comes to investing in AI education and nurturing local talent. This can be done in collaboration with private companies and international partners. Key to all of the above are innovative forms of international financing.

There is a growing recognition among those at the coalface of developing AI that a wise approach involves not only improving the technology but making it as accessible as possible.

Speaking at the WEF’s annual meeting in Davos, Matt Brittin, President of Google in Europe, the Middle East and Africa, told The National that it is important for the tech industry to ‘keep our eyes wide open about our responsibilities to get this right’.

Brittin also spoke about the results of a poll released by Google this week that highlighted how most people around the world recognised the benefits of AI. That awareness was particularly strong in emerging econo
mies where 71 percent of respondents thought AI was having a positive impact on how they work.

‘There is a lot of optimism around AI. If the technology is improved and used wisely, it promises to have a profoundly beneficial impact on societies around the world. It is vital not to squander this opportunity by leaving some countries and communities behind,’ concluded the Abu Dhabi-based daily.
Source: Emirates News Agency

UAE University and Seoul National University organise workshop on earth and environmental sciences

AL AIN: The UAE University (UAEU) in cooperation with Seoul National University, Korea, conducted a workshop on ‘Earth Science for a Better Stewardship of Our Planet’. The workshop aims to strengthen partnerships and improve research outcomes in geology, earth science, and environmental science to protect the planet from climate change.

Prof. Ahmed Murad, UAE Associate Provost for Research, said, ‘This workshop strengthens the strategic research partnership between the two universities. These workshops will encourage faculty members, researchers, and students to develop ideas and implement joint research in the university colleges and research centres. They also promote a student exchange programme to develop the student’s academic research skills at both universities among many other joint scientific activities.’

He added that the university attaches great importance to international cooperation to enhance its reputation and international standing. The international partnership and cooperation are among th
e university’s essential standards at the local and international levels. The UAE University will continue to expand strategic partnerships, including the partnership with the Seoul National University that will provide opportunities for researchers and scholars in various fields of environmental and earth sciences.

The Korean delegation attended several presentations in research cooperation with the UAE University. The most important areas are a presentation on seismic imaging of the deep structure, a research paper on basic understanding of the physical and chemical properties of minerals in geological processes, as well as research on rock deformation and geophysical implications and other research papers in the fields of earth and environmental sciences.

The UAE University researchers also presented several research papers addressing many cooperation areas in earth and environmental sciences and other fields. These research papers include remote sensing for regional geological mapping, seismic reservoir
characterisation, assessing the impacts of phosphate mining on the Red Sea coast, and radioactive isotopes and aquatic geochemistry for the UAE eastern region.

The researchers also presented a paper on discovering the past 500 million years of UAE fossils and many others in earth and environmental sciences.

Source: Emirates News Agency

China reveals its space exploration plan for 2024

BEIJING: Astronauts of China’s upcoming two manned space missions in 2024 are undergoing targeted trainings, said Yang Liwei, deputy chief designer of China’s manned spaceflight project, when introducing China’s plan of space missions this year.

According to China Central Television, China successfully launched the Tianzhou-7 cargo spacecraft on Wednesday night. Its purpose is to transport essential supplies for China’s orbiting Tiangong space station. This mission marks the first step in China’s manned space missions set to take place in 2024.

According to Yang, 2024 will be a busy year for China’s manned space launches, with six major missions planned, including the launch missions of the cargo craft Tianzhou-7 and Tianzhou-8 and the crewed spaceships Shenzhou-18 and Shenzhou-19, as well as the return of Shenzhou-17 and Shenzhou-18.

Yang also introduced the progress in China’s manned lunar exploration project which was set up in 2023.

Source: Emirates News Agency

Jordan’s tourism sector records 27.4% increase in 2023

Amman: The Central Bank’s preliminary data reveals a remarkable surge in tourist income for Jordan during the fiscal year 2023, marking a substantial 27.4% increase, reaching a total of $7.4 billion. This notable growth can be attributed to a surge in tourist arrivals, with a recorded 25.8% rise, totaling 6,353,800 visitors.

Analyzing the specifics, the tourist income in December 2023 amounted to JD359.3 million (equivalent to $506.8 million). Although still significant, this figure reflects a marginal 3.4% decrease compared to December 2022. The decline is primarily attributed to an 8.0% reduction in tourist numbers, totaling 416.6 thousand visitors for the month, as opposed to the corresponding period in 2022.

Source: Jordan News Agency