Nyxoah Announces CE Mark Approval for Genio® 2.1

Nyxoah Announces CE Mark Approval for Genio 2.1

The next generation external activation chip leverages Nyxoah's scalable platform to continuously enhance patient comfort and therapy efficacy

Mont–Saint–Guibert, Belgium "" July 18, 2022, 10:30pm CET / 4:30pm 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 DEKRA Notified Body has approved the use of Nyxoah's next generation Genio 2.1 system for patients in Europe. As with the recent approval of Genio 2.1 by the U.S. FDA for use in the DREAM U.S. IDE pivotal study, this CE mark pertains entirely to the external components of the Genio system and will be available to all patients who have received Genio implants.

Genio 2.1 is designed to improve patient comfort and compliance with a new smartphone application and upgraded external activation chip. Genio 2.1 offers patients daily feedback on therapy usage and the autonomy to adjust stimulation amplitude within pre–defined boundaries. Physicians can fine–tune stimulation amplitude to determine the optimal level of comfort for patients without compromising therapy efficacy. Additional embedded sensors will allow physicians to further tailor therapy stimulation parameters based on patient position and throughout the night.

"Genio 2.1 embodies the patient–centric design and the scalability of the Genio platform with features that allow for greater customization of therapy to meet individual patient's needs," commented Olivier Taelman, Nyxoah's Chief Executive Officer. "Importantly, these additional features are made available without the need for a surgical procedure to replace the implantable component. We are excited to launch Genio 2.1 in Europe, strengthening our vision to address the needs of OSA patients with and without Complete Concentric Collapse (CCC) and further accelerating market share gains."

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 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.

Contacts:
Nyxoah
Loic Moreau, Chief Financial Officer
corporate@nyxoah.com
+32 473 33 19 80

Jeremy Feffer, VP IR and Corporate Communications
jeremy.feffer@nyxoah.com
+1 917 749 1494

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Triller Calls for Immediate Ban of TikTok Dubbing it Greatest Existential Threat to the Fabric of America

LOS ANGELES, July 18, 2022 (GLOBE NEWSWIRE) — Triller calls on CFIUS, President Joe Biden, Congress the Department Of Defense to ban TikTok calling it the largest security threat to America today in open letter by CEO and Chairman of Triller Mahi De Silva.

As the CEO of a global company whose mission is to help creators take control of their destiny in the creator economy, leveraging transformative adaptive technology, I stand with a growing chorus of elected officials, regulators, intelligence officials, other global executives, and consumers who recognize the enormity of the devastating impact of TikTok on our society. The danger signs abound from the leaders of our intelligence community to the most versatile and connected technology journalists. Every American parent needs to ask what this social video app knows about their children and how those signals are used to get a deeper understanding of the location, preferences, and habits of their parents and the entire family. The petaflops of data sent from American TikTok users start with content preferences and location information that can quickly lead to the determination of home ownership, work, and vacation schedules and a host of much more granular data on every aspect of our American lives.

Today, we call for every American to remove TikTok from their devices immediately. Additionally, Triller calls on the U.S. government to take immediate action and ban TikTok and its Chinese–owned parent ByteDance. The stakes have never been higher.

Professor Scott Galloway's recent piece, TikTok: Trojan Stallion, illustrated this deftly:

"The Chinese government has the power to access the data of private– sector companies whenever it wants. A wide range of laws makes this possible, including the Law of Guarding State Secrets: If you're suspected of harboring sensitive state information, you must grant access. The state takes small ownership positions known as golden shares (that typically come with board seats) in businesses deemed strategic to the state. One of those golden share arrangements is with ByteDance. And though TikTok is not accessible to Chinese consumers, Chinese access to TikTok's data is not in dispute. In June, Buzzfeed obtained over 80 audio recordings of internal TikTok meetings, confirming that Chinese management at ByteDance had unfettered access to TikTok's data. A TikTok manager refers to an engineer in Beijing, known as the "Master Admin,' who "has access to everything."

This creates some meteoric concerns around TikTok in the United States.

The AI systems that drive the recommendation of short–form videos will be expanded to influence e–commerce and its associated supply chain, which, in turn, will shape and influence the future of American commerce. The Chinese–owned ByteDance and its agent in the United States, TikTok, already have the lion's share of digital attention, where Americans spend up to 90 minutes a day scrolling through AI– recommended content, far more than the time spent on platforms like Google, Facebook, or Amazon.

More importantly, our concerns as Americans should extend beyond our wallets to the very backbone of our society: representative democracy and free speech. The AI systems controlled by Chinese– owner ByteDance and delivered via TikTok are the penultimate tool to influence our youth by shaping content and perceptions favoring a pro–China agenda.

It is clear that in the lexicon of technology, the signal–to–noise ratio for TikTok and its Chinese–owned parent ByteDance is all signal. It has become unavoidable that TikTok's overweight position in the marketplace is not simply a threat within the creator ecosystem but a threat to our entire economy, because its Chinese owners don't have to abide by the same rules as other platforms in this space. These present and future dangers threaten the whole of the American innovation economy.

We understand that some may counter that Google, Facebook, and Triller also collect a myriad of digital grains of sand on users; however, like every other U.S. company, Triller operates under the laws of the United States. It also may seem convenient for a company to call for the ban of the biggest company in its space. But at our core, Triller is about giving creators complete control over their content and their fan data "" and ultimately " complete control of their destiny.

As Professor Galloway rightly concluded, we have, as a society, welcomed a foreign actor to seduce our children and dominate this market, and we have done so without objection.

Triller believes that must end.

As Triller has expanded to build the platform for creators and to lay the foundation for its first–of–its–kind Creator Platform, we have developed a far more profound understanding of the creator economy. Through our lens, which watches over 175 billion social media content items per quarter, covering over 2 million creators and 25,000 brands, we have witnessed that TikTok suppresses the content and contributions from Black creators, making that content invisible to its audiences. It is indisputable that the TikTok AI algorithm designed by ByteDance is the ultimate propaganda tool "" and it is why India has banned the app from its citizens. Another example is TikTok's role in the recent Philipino elections for Bong Bong Marcos, as detailed by Bloomberg. As the article expertly assigns culpability to TikTok's role in rewriting the history of the Philippines, it should also be a clarion call for each of us to understand that exact mechanism is in each of our homes.

There is no doubt that TikTok plays a central role in enabling surveillance networks inside and outside China. The avenues that these technologies can access our lives are almost unlimited. This is a clear and present danger and a national security issue.

Look at the breadth of data that TikTok has access to and understands. Then, marry it with the broader concerns that our political leaders, intelligence community, and business leaders are raising "" where there is smoke, there is fire.

Triller is pulling the fire alarm today.

We do not have time to waste.

Triller, the platform for creators by creators, has built a network of creator–first services and products. It has assembled a revolutionary ecosystem to serve the immediate and long–term needs of those who seek to share their passions with the world. While our focus is on the creator and the future of the creator economy, we believe the broader future of American innovation is at risk because of our continued indifference to this threat that is literally in our hands.

Join us today and take action. Join us and all clear–thinking, freedom– loving Americans who believe in free markets, creative freedom, innovation, and a future where we can direct our lives unhindered by dark forces.

Mahi de Silva
CEO
Triller, Inc.

About Triller:

Triller is the AI–powered open garden technology platform for creators. Pairing music culture with sports, fashion, entertainment, and influencers through a 360–degree view of content and technology, Triller encourages its influencers to post the content created on the app across different social media platforms and uses proprietary AI technology to push and track their content virally to affiliated and non–affiliated sites and networks, enabling them to reach millions of additional users. Triller additionally owns VERZUZ, the live–stream music platform launched by Swizz Beatz and Timbaland; Amplify.ai, a leading customer engagement platform; FITE, a premier global PPV, AVOD, and SVOD streaming site; and Thuzio, a leader in B2B premium influencer events and experiences. Triller recently filed for an IPO expected to occur later this year.

About TikTok:

TikTok is a Chinese communist party trojan horse weapon of war disguised as a short form app that 80 percent or American children have downloaded on their phone. It can read, download, watch, copy, track and control any and all aspects of the phone the information of the owner and those close to it and sends the information back to America's greatest enemy the China Communist Party. Make no mistake about it, TikTok is not a toy but one of the most advanced weapons of war to ever invade America.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ca8bb25e–7e18–4071–846d–6d75cf7bfbe9