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

Attachment

N2Growth Expanding Operations in Asia, Opens Location in South Korea

Firm Appoints Financial Services Executive as Managing Partner to Lead Seoul Office

N2Growth South Korea Logo

N2Growth South Korea Logo

PHILADELPHIA, July 18, 2022 (GLOBE NEWSWIRE) — N2Growth, a global leadership consulting and executive search firm, announced today the firm’s expansion in Asia with the appointment of Gene W. Oh as Managing Partner and Country Head, who will be leading the firm’s newest location in South Korea and reporting directly to the firm’s CEO, Kelli Vukelic.

N2Growth is pleased to welcome Gene, who will run the Korea office out of Seoul; we look forward to his innovative approach to the industry. The Korea practice aligns with our partners worldwide to deliver our differentiated solutions to the market, finding and developing innovative, visionary, and highly agile executives in the world’s leading companies for our clients.

“Gene is a proven business leader passionate about exceptional leadership and building teams across the boardroom and C-Suite,” said Kelli Vukelic, CEO. “His addition in the region is at the ideal moment for our clients who are seeking a differentiated approach to the selection and development of leaders who will be transformational to their organizations in Korea. Gene’s broad business perspective and intimate knowledge of leadership challenges in Korea make him a powerful resource for our clients. I am so pleased to have his leadership opening our office in Korea for N2Growth.”

Before joining N2Growth, Mr. Oh’s career spanned two decades in financial services, marked by increasingly challenging roles in quantitative analysis, trading, derivative sales, and relationship management. Throughout his professional career, he has assumed leadership roles in financial services and served as the executive director of the American Chamber of Commerce Korea (AMCHAM). He is a member of the Korea Blockchain Association (KBCA) and the Global Finance Society (GFS) of Korea. He is also a non-executive board member of a prominent Korean fintech start-up and an advisor to BioMagnetic Solutions LLC, a U.S.-based biotech firm.

“I am excited to join the N2Growth family, whose values perfectly align with mine. The opportunity to identify and develop leaders in Korea as well as at Korean firms globally is a privilege,” said Gene.

In 2021, the firm opened a location in Singapore, led by Mr. Steve Manning, Managing Partner, focused on serving clients in Southeast Asia. N2Growth’s new site in South Korea builds on the firm’s presence and capabilities to support our clients throughout Asia and globally. The new Seoul-based office expands the firm’s global reach and talent network across Asia.

N2Growth’s expansion to South Korea solidifies the firm’s commitment to building and establishing permanent operations throughout Asia and supporting our vast global network of premiere talent through retained search engagements, executive coaching, and leadership assessments.

About N2Growth

N2Growth is a global leadership consulting and executive search firm, consistently ranked in the Top 10 Best Executive Recruiting Firms by Forbes, serving more than 50 markets across the Americas, EMEA, and APAC. Visit www.n2growth.com.

Media Inquiries:

Dan Evans, CMO

press@n2growth.com

Related Images

Image 1: N2Growth South Korea Logo

N2Growth Executive Search

This content was issued through the press release distribution service at Newswire.com.

Attachment

RiotMinds to Publish First Coffee-Table Book With AI-Only Generated Pictures

Art of The Order of the Tormented Souls

Art of The Order of the Tormented Souls

STOCKHOLM, July 18, 2022 (GLOBE NEWSWIRE) — RiotMinds, awarded fantasy and horror publisher, announced today a new project with AI-only generated pictures, all embedded in a fantastic story about a long-forgotten order.

Art of The Order of the Tormented Souls is the first complete coffee-table artbook with AI-only generated art. The book was launched as a Kickstarter Campaign in July and will include hundreds of AI-generated pictures together with an immersive story about a long forgotten religious order.

https://www.kickstarter.com/projects/riotminds/art-of-the-order-of-the-tormented-souls

“This book is interesting from two perspectives. One is that everyone has said that Artificial Intelligence will never be able to generate art and second that human and technology will work hand in hand as one creative force in this project. I think we will prove them wrong on the first point and surprise them how well this will work on the second,” said Magnus Malmberg, co-founder of RiotMinds.

For more than 20 years, RiotMinds has published fantasy and horror games and literature for a global audience releasing award-winning games and books. Art of The Order of the Tormented Souls is the first in a series of exclusive coffee-table books that will be launched under its new label Alternate Publishing.

“We are in the forefront of creativity with this project, and we are really excited to see where we can take it. If we are successful, this will be a new way of creating art”, concluded Magnus Malmberg.

About RiotMinds and Alternate Publishing

Headquartered in the domains between fantasy and horror RiotMinds is a games publisher, managed by a small team of creative talent to serve the international market with role-playing games and board games. The company has a long success of acclaimed and award-winning games and the main intellectual properties.

Alternate Publishing is a newly founded label under RiotMinds focusing on coffee-table artbooks.

Press Contact Information:
info@riotminds.com

Related Images

Image 1: Art of The Order of the Tormented Souls

This content was issued through the press release distribution service at Newswire.com.

Attachment

Taipei mayor airs grievances with China at twin-city forum

Taipei Mayor Ko Wen-je (???) referenced the war in Ukraine and blamed China's military sorties near Taiwan for harming cross-strait ties in a speech at the final Taipei-Shanghai twin-city forum of his tenure on Tuesday.

The annual forum, which has taken place alternately in Taipei or Shanghai since 2010, was held virtually for the third consecutive year on Tuesday due to the COVID-19 pandemic.

In his keynote speech at the event, Ko, who will leave office in December after eight years as Taipei mayor, warned that the ongoing Russia-Ukraine war should give both sides "cause for reflection" with regards to the current state of the cross-Strait relationship.

In spite of the two sides' close economic and trade ties and frequent people-to-people interactions, Ko said, in recent years, the broader relationship has been caught in a deepening "spiral of malice."

Issues such as Taiwan's participation in the World Health Assembly (WHA), the incursions of Chinese military aircraft near Taiwan, and Chinese import bans on some of Taiwan's agricultural products have become major points of contention and harmed relations between people from the two sides, he said.

Ko warned that if the two sides continue to quarrel, ignore each other, or engage in "political manipulation," the situation will only get worse.

"We can diverge politically, but [our] people should not see each other as enemies," he said, instead advocating for a process of "building goodwill through exchanges" in order to minimize the potential for conflict or war.

In his own remarks, Shanghai Mayor Gong Zheng (??) said that the cross-strait points of contention raised by Ko "have already found satisfactory resolutions in the past."

He appeared to be referring to the 2008-2016 period under Taiwan's Kuomintang (KMT) government, when relations between Taipei and Beijing were warmer, allowing for Taiwan's participation in organizations such as the WHA as an observer.

"These problems demonstrate once again that cross-Strait exchanges cannot be removed from a shared foundation in politics," he said.

Instead, Gong reaffirmed the notion that "the two sides of the Taiwan Strait are one family," and praised the forum as an opportunity for the sides to better understand each other and build goodwill.

After the forum concluded, media coverage in Taiwan centered on the perception that Ko had taken a stronger, more confrontational stance against China than in previous years.

When asked about this by local media later on Tuesday, Ko said that because the meeting was conducted virtually, "a lot of things had to be said in the open" that could otherwise have been discussed in private.

"My purpose today was to express some of the grievances of the Taiwanese people," said Ko, who has been open about the fact that he is considering a presidential run in 2024, likely as the nominee of his centrist Taiwan People's Party.

Ko was also asked to respond to criticism from Taipei mayoral candidate Chen Shih-chung (???), who had earlier dismissed as "sophistry" Ko's complaint, made last week, that the government's frequent characterization of Chinese warplanes as "harassing Taiwan" lacked a clear definition.

"If Chen Shih-chung wants, he can just say directly that he'll stop holding the forum," Ko said, possibly implying that Chen's criticism reflected a hard stance against China. "If he's up to it, he can even chase all the Chinese businesspeople in Taipei back [to China]!"

Chen, who is running for mayor in November's local government election in the capital city as the nominee of the ruling Democratic Progressive Party (DPP) after having served as health minister until this month, said Tuesday that he was not opposed in principle to the forum, as long as it was "necessary" and "meaningful."

Source: Focus Taiwan News Channel

Ex-U.S. defense chief calls on Taiwan to extend military service

Visiting former U.S. Secretary of Defense Mark Esper on Tuesday called on Taiwan's government to extend its existing four-month mandatory military training for conscripts to at least one year and to include women in such training in order to build a stronger defense against possible Chinese invasion.

"I believe that Taiwan needs to lengthen and toughen its conscription. That means to have young Taiwanese boys and girls serve at least one year if not longer, in their nation's military," Esper told reporters in Taipei.

Esper made the remarks during a press conference when asked to comment on how Taiwan can beef up its defense capabilities to better deter Beijing.

Currently, only Taiwanese men over 18 have to serve four months of military training.

Taiwanese women can choose to join the armed forces. The latest numbers show that of the over 180,000 military personnel in Taiwan, 15 percent are female.

Asked if he was suggesting both Taiwanese men and women should undergo compulsory military training, Esper told CNA that it is a decision for Taiwan's political leaders to make but he believes it is a necessary move.

"Women made tremendous contributions in our [U.S.] military and so I'm just articulating my view that I think you should probably make the best of your population," he said.

Citing the ongoing Russian invasion of Ukraine as an example, "Russians are making no discrimination between men and women, between children and seniors," he stressed.

Should China invade, it will be a matter of national survival and "it's going to be every man, woman and child fighting not just to preserve their country but their lives," he added.

Esper's comments coincide with recent calls made by Taiwanese lawmakers across party lines amid the ongoing Russian invasion of Ukraine after having seen Ukrainians put up a strong resistance.

Taiwanese men initially had to serve two to three years in the military as part of a conscription system adopted by the Republic of China government after it relocated to Taiwan in 1949.

Conscription in Taiwan was reduced to one year in 2008.

During the previous Kuomintang (KMT) administration under President Ma Ying-jeou (???), who was in power from 2008-2016, the government announced it would turn the nation's armed forces into a fully voluntary one in which conscripts are only required to undergo four months of military training starting in 2013.

The nation's military is currently a mainly volunteer force, with conscripts serving in a supporting role.

Meanwhile, Esper on Tuesday also called on Taiwan to significantly increase its defense budget, to procure and/or produce the capabilities consistent with an asymmetric warfare approach, including buying javelin, anti-tank system Stinger anti-air systems, and to revitalize and activate its reserve mobilization, as a stronger deterrent to China.

Asked by CNA how big an increase in the defense budget he believed was necessary, the former U.S. official said he hesitated to throw out a number without seeing what the strategy looks like.

However, he said that Taiwan should at least match U.S. defense expenditure, which stands at 3.2 percent of annual GDP, "to send a very powerful message about the seriousness of Taiwan's commitment."

Taiwan's annual defense spending is currently about 2 percent of GDP.

Esper said it seems like a lot of money to spend on defense, but national survival is at stake.

"It may not be done in one year. So that's what it means to grow, grow serve, so that you can make sure that you can address the conventional capabilities you need, particularly the asymmetrical capabilities that you need," he added.

Esper served as U.S. defense chief from 2019 to 2020 under former U.S. President Donald Trump.

Leading a delegation from the Atlantic Council, Esper arrived in Taipei on Monday for a four-day visit that will include discussions with Taiwan government officials and politicians about trade, economic, diplomatic and security issues.

He is joined by Barry Pavel, senior vice president and director of the Atlantic Council, and Stefano Stefanini, former permanent representative of Italy to NATO and currently a nonresident senior fellow at the think tank.

Source: Focus Taiwan News Channel

MOFA rebukes incoming EU-China envoy for ‘reunification’ remark

The Ministry of Foreign Affairs (MOFA) reiterated Tuesday that "only the people of Taiwan can determine its future," after the European Union's incoming ambassador to China indicated support for "peaceful reunification" in an interview with a Spanish newspaper.

Jorge Toledo Albignana, who previously served as Spain's ambassador to Japan, told La Vanguardia in an interview published Sunday that the EU would support "peaceful reunification" instead of independence for Taiwan.

Asked to comment on Albignana's remarks, MOFA spokeswoman Joanne Ou (???) underlined Taiwan's right to self-determination, adding that it was "a sovereign and democratic country and has never been part of the People's Republic of China (PRC)."

It is unclear whether Albignana, who had been asked how the EU would react in the event of a Chinese attack on Taiwan, was reflecting official policy or speaking in a personal capacity.

The EU did not issue an immediate response to the incoming envoy's remarks.

Despite underlining the bloc's commitment to a "one China" policy, Albignana said that any resort to force by Beijing would result in the EU introducing "the same or even more serious measures" than those imposed on Russia following its invasion of Ukraine.

During a previous phone call with Chinese Foreign Minister Wang Yi (??) on Sept. 28, 2021, the EU's foreign policy chief Josep Borrell stressed that the bloc had always had and would maintain a "One China" policy, without clarifying if this included support for reunification.

At the same time, Borrell said the EU and its member states had an interest in developing cooperation with Taiwan, a like-minded and important economic partner in the region, "without any recognition of statehood."

Source: Focus Taiwan News Channel

Scholarships to be offered to Japanese for study in Taiwan

Taiwan's newly formed Friends of Shinzo Abe Association will establish a scholarship for young Japanese people to study in Taiwan to enhance their understanding of the country and experience Taiwanese culture, the group said in a statement issued Tuesday.

Under the association's current plan, it will offer scholarships to 10 young Japanese people per year to study at universities in Taiwan for at least one year, with the annual scholarship capped at 1 million Japanese yen (US$7,258.72) for each person, according to association head Mark Chen (???).

Chen served as Taiwan's foreign minister from 2004-2006 under President Chen Shui-bian (???) from the Democratic Progressive Party.

The scholarship scheme aims to encourage more Japanese youths to study in Taiwan and enhance their knowledge and understanding of the country, according to the association, which was founded in June.

The plan was formulated after the association raised funds from Taiwanese businesses for a full-page advertisement in the Japanese newspaper Sankei Shimbun on July 15 paying tribute to former Japanese Prime Minister Shinzo Abe.

Abe, known for his pro-Taiwan stance, was shot dead July 8 at the age of 67 during a campaign speech on a street in Nara, near Osaka ahead of the Diet's upper house elections in Japan, which took place July 10.

The association said that from a national security perspective, Taiwan should depend not only on the government but also the private sector to help advance relations with Japan.

Source: Focus Taiwan News Channel

CORONAVIRUS/Transportation, economic deputy ministers named as CECC’s deputies

Taiwan's Central Epidemic Command Center (CECC) is seeing yet another change in its top positions, as two deputy ministers of government were appointed Tuesday to replace its second-in-command.

Transportation and economic deputy ministers Chen Yen-po (???) and Chen Cherng-chyi (???) will fill the post left vacant after the resignation of Chen Tsung-yen (???) on Monday, the CECC said.

The replacement of Chen Tsung-yen (???), who is deputy interior minister, followed the appointment of Victor Wang (???) as the new head of the CECC on July 15.

In announcing his two new deputies on Tuesday, Wang said Chen Yen-po will oversee the CECC's tourism policies, hotel management, border controls, and logistics, while Chen Cherng-chyi will handle the acquisition of medical supplies and coordinate the center's efforts to boost the economy.

On the question of whether the new deputy appointments signaled a change in the CECC's direction, Wang did not give a direct answer, saying only that the CECC's charter allows for the appointment of one to three deputies to meet changing responses as the COVID-19 situation evolves.

Tourism and economic stimulus measures are central to Taiwan's efforts to alleviate the negative effects of the pandemic on the domestic economy, Wang said.

The new CECC deputies have practical experience in those two areas, and their many years of public service make them ideal choices to lead the CECC's efforts in that regard, he said.

Wang was appointed last week as head of the CECC, replacing then Health Minister Chen Shih-chung (???), who resigned from both posts on July 14 to run for the Taipei mayoral seat in the November local government elections.

Source: Focus Taiwan News Channel