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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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

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N2Growth Executive Search

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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

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Image 1: Art of The Order of the Tormented Souls

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Timor-Leste lauds Indonesia for its support in development

President of the Democratic Republic of Timor-Leste, José Ramos-Horta, expressed his gratitude for Indonesia’s support in the development of Timor-Leste.

“We are very grateful for Indonesia’s support for the development in Timor-Leste, including in the fields of education and human resources,” Ramos-Horta noted in a joint press statement at the Bogor Presidential Palace, West Java, on Tuesday.

Ramos-Horta paid a state visit to the Bogor Presidential Palace in West Java, Tuesday, and was greeted by Indonesian President Joko Widodo (Jokowi).

Ramos expressed gratitude that at the meeting, Indonesian President Jokowi had agreed to provide support for strengthening water sources in Timor-Leste through the border area.

President Jokowi, in his statement, conveyed the commitment of State-Owned Enterprises (BUMN) and companies in Indonesia to partake in development in Timor-Leste, including in the infrastructure sector.

President Jokowi urged the two countries to immediately complete an investment treaty.

President Jokowi said Indonesia’s investment value in Timor-Leste currently reached US$818 million, chiefly in the banking, oil and gas, and telecommunications sectors.

President Ramos-Horta arrived at the Bogor Presidential Palace at around 9:54 a.m. local time. He was greeted with a series of official state welcoming ceremonies.

Marching band troops, cavalry, and troops wearing traditional Indonesian attire escorted Ramos-Horta’s arrival at the Bogor Palace.

President Jokowi greeted President Ramos-Horta in the courtyard of the Bogor Presidential Palace.

In a series of activities for receiving state guests, President Jokowi also invited President Ramos-Horta to plant trees.

Currently, the two state leaders were still engaged in informal conversations on the back porch of the Bogor Presidential Palace.

President Ramos-Horta is planning to stay in Indonesia for eight days. Before arriving at the Bogor Presidential Palace, the Timor-Leste president and his entourage first visited the Kalibata Heroes Cemetery to lay a wreath honoring the fallen soldiers.

Meanwhile, delegations from Timor-Leste that accompanied President Ramos-Horta comprised Minister of Foreign Affairs and Cooperation Adaljiza Albertina Xavier Reis Magno, Minister of Transport and Communications José Agustinho da Silva, Minister of Agriculture and Fisheries Pedro dos Reis, and Ambassador of Timor-Leste to Indonesia Filomeno Aleixo da Cruz.

Source: Antara News

Indonesia, Timor-Leste to boost bilateral trade value

Indonesia and Timor-Leste have agreed to continue to raise the value of bilateral trade between the countries, Indonesian President Joko Widodo (Jokowi) stated after attending a bilateral meeting with President of Timor-Leste José Ramos-Horta.

“Considering the current trend of trade affairs (between the two countries) that continues to show positive development, I believe that it can continue to be improved,” Jokowi stated during a joint press conference along with Ramos-Horta at the Bogor Presidential Palace, West Java Province, on Tuesday.

The Indonesian president remarked that at the meeting, discussions focused on bilateral economic cooperation.

Furthermore, he highlighted the commitment of Indonesian state-owned enterprises (SOEs) and private companies to become involved in the development activities in Timor-Leste, especially in the infrastructure sector.

He also encouraged the two countries to immediately conclude their bilateral investment treaty.

Jokowi stated that the value of Indonesia’s investment in Timor Leste had reached US$818 million (Rp12.3 trillion) in the banking, oil and gas, as well as telecommunications sectors.

“We also spoke about the completion of border negotiations, and I emphasized the importance of resolving the two remaining segments of the two countries’ land border soon,” he stated.

Moreover, at the bilateral meeting, the delegations of both nations inked four memoranda of understanding on agriculture, cross-border transportation, standardization and metrology, as well as trade cooperation.

President Ramos-Horta is scheduled to stay in Indonesia for eight days. He arrived at the Bogor Presidential Palace at 9:54 a.m. Western Indonesian Standard Time (WIB, UTC+7) and was greeted with a series of official welcoming ceremonies.

Before conducting the bilateral meeting, the two state leaders planted an agarwood tree (Aquilaria sp.) in the backyard of the palace and engaged in brief talk on the palace veranda.

It was Ramos-Horta’s first visit to Indonesia after being inaugurated as the 7th president of Timor-Leste on May 20, 2022.

Earlier, President Jokowi assigned Coordinating Minister of Political, Legal, and Security Affairs Mahfud MD to attend the inauguration ceremony of the president of Timor-Leste.

Source: Antara News

Jokowi urges Timor-Leste to open Kupang-Dili-Darwin shipping route

Indonesian President Joko Widodo (Jokowi) urged the Democratic Republic of Timor-Leste to boost sea lane connectivity by opening a shipping route between Kupang, Dili, and Darwin.

President Jokowi made this request in a press statement on the state visit of President of the Democratic Republic of Timor-Leste, José Ramos-Horta, and his delegation to the Bogor Presidential Palace, West Java, Tuesday.

“For sea connectivity, I see the importance of opening the Kupang-Dili-Darwin shipping route,” President Jokowi noted in a press statement as witnessed virtually via the Presidential Secretariat’s YouTube account.

President Jokowi revealed that the two countries agreed to improve both land and sea connectivity.

Jokowi expressed hope that the Kupang-Dili bus route would be launched soon to improve land connectivity.

The cooperation on land connectivity was strengthened with the inking of a memorandum of understanding on cross-border bus movement by Indonesian Minister of Transportation Budi Karya Sumadi and Minister of Transport and Communications of Timor-Leste José Agustinho da Silva.

During a bilateral meeting between Indonesia and Timor-Leste, President Jokowi said that strengthening economic cooperation was the focus of discussion between the two parties.

In addition to connectivity, Indonesia and Timor-Leste agreed to boost trade between the two countries.

“By looking at the trend in the development of trade relations that continues to be positive, I believe that trade between the two countries can continue to be increased,” President Jokowi affirmed.

Jokowi also invited SOEs and Indonesian companies to partake in development in Timor-Leste, including in the infrastructure sector.

Currently, the value of Indonesia’s investment in Timor-Leste reaches US$818 million, with the main sectors being banking, oil and gas, and telecommunications.

The four memoranda of understanding signed between the two countries pertained to cooperation in agriculture, bus cross-border movement, standardization and metrology, as well as technical cooperation in the trade sector.

President Ramos-Horta arrived at the Bogor Presidential Palace at around 9:54 a.m. local time. He was greeted with a series of official state welcoming ceremonies.

Marching band troops, cavalry, and troops wearing traditional Indonesian attire escorted the arrival of Ramos-Horta at the Bogor Palace.

President Jokowi then greeted President Ramos-Horta in the courtyard of the Bogor Presidential Palace.

During a series of activities for receiving state guests, President Jokowi also invited President Ramos-Horta to plant trees.

Currently, the two state leaders were still engaged in informal conversations on the back porch of the Bogor Presidential Palace.

President Ramos-Horta is planning to stay in Indonesia for eight days. Before arriving at the Bogor Presidential Palace, the Timor-Leste president and his entourage first visited the Kalibata Heroes Cemetery to lay a wreath honoring the fallen soldiers.

Source: Antara News

Experts: Seoul, Tokyo Maintain Ties Despite Possible Japanese Military Expansion

WASHINGTON — As South Korea and Japan agree to improve bilateral ties, experts say the latter’s possible constitutional revision allowing military expansion should be in line with the Biden administration’s effort to forge a strong Washington-Seoul-Tokyo trilateral front against the threats of China and North Korea.

South Korean Foreign Minister Park Jin and Japanese Foreign Minister Yoshimasa Hayashi held talks Monday in Tokyo, agreeing to mend frayed relations stemming from the Japanese colonization of 1910-1945 and to improve their ties to bolster defense against North Korea.

Park’s meeting with Hayashi comes as talks of revising the Japanese constitution to fill out its military have accelerated since the assassination on July 8 of former Japanese Prime Minister Shinzo Abe, who strongly advocated for the agenda.

Japan’s conservative ruling Liberal Democratic Party (LDP) and its junior coalition partner, the Komeito, won a majority in the parliament’s upper house in elections on July 10, giving Prime Minister Fumio Kishida enough political support to change the constitution.

Kishida, the LDP leader, said on July 11 he will push for a constitutional revision to build on Abe’s legacy.

Talks of reforming Japan’s constitution — mainly the “no war” clause of Article 9 that formally renounced war and banned use of Japan’s military to settle international disputes — involve doubling its defense spending to 2% of its gross domestic product and creating counterstrike capabilities to preemptively destroy incoming missiles, according to NPR.

Japan’s possible expansion of its military has raised concerns in South Korea, where some are concerned it will pose challenges to President Yoon Suk Yeol’s desire to improve Seoul’s ties with Tokyo — a goal that dovetails with Washington’s vision of strong trilateral security cooperation in East Asia.

During the G-20 foreign ministers’ meeting in Bali, Indonesia, on the same day Abe was assassinated, Park, Hayashi, and U.S. Secretary of State Antony Blinken held talks in which they agreed to bolster cooperation against challenges posed by China’s aggression and North Korea’s missile threats.

The talk of a Japanese constitutional reform “understandably” causes concern in South Korea, said Daniel Sneider, a Stanford University expert on Japan-Korea relations.

South Korea’s historical grievances stem from the Japanese occupation of the Korean Peninsula in the first half of the 20th century. Koreans accuse Japan of forcing women to work in wartime brothels for the Japanese military and using forced labor, among other abuses. Japan says it has apologized for its World War II activities and for what Prime Minister Naoto Kan in 2010 called “the enormous damage and suffering” caused by colonization.

Experts said that in the current security environment, a Japanese military expansion would support the Biden administration’s effort to counter Chinese or North Korean threats through trilateral cooperation.

Christopher Johnstone, who recently served as director for East Asia on President Joe Biden’s National Security Council, said, “Japan’s defense modernization and a close trilateral relationship are not mutually exclusive.”

Johnstone continued: “There’s nothing to be concerned about in Seoul about Japan’s defense modernization. And there’s nothing to be concerned about in Japan about the defense investments that (South) Korea is making. Both help strengthen deterrence against North Korea. Both help to make us stronger in dealing with China.”

VOA’s Korean Service contacted the South Korean Embassy in Washington for comment on how a Japanese constitutional revision would affect Seoul’s efforts to improve ties with Tokyo. On Monday, the embassy referred the inquiry to the Foreign Ministry in Seoul, which has yet to respond.

South Korea’s defense budget, set to reach $48.3 billion in 2022,

is expected to grow more than 6% between 2023 and 2027, according to the website, Global Data.

“There is expectation for Japan to boost its defense capabilities in light of growing threats from China as well as North Korea,” said Shihoko Goto, deputy director of the Asia Program at the Wilson Center. “Revising the constitution to allow Japan to play a more active role in regional security would be part of that strategy, which is in line with Washington’s expectations.”

Goto added, “The need for both Tokyo and Seoul to be on the same page in assessing regional threats will be critical so the increasing expenditure and commitment are not seen as a threat to South Korea.”

A spokesperson for the Japanese Embassy in Washington told VOA’s Korean Service on Friday that Tokyo would continue to communicate with Seoul to mend their ties, which is urgent considering North Korean threats. Pyongyang conducted 19 rounds of weapons tests this year, including artillery firing drills on July 10. [[ https://www.voanews.com/a/n-korea-likely-fired-artillery-rounds-amid-us-s-korea-drills-/6652758.html ]]

“We have no time to spare in improving Japan-ROK relations,” wrote Japanese Embassy spokesperson Masashi Mizobuchi in an email, using the acronym for the Republic of Korea, South Korea’s official name. “The Japanese government will continue to communicate closely with the Korean government in order to restore the Japan-ROK’s extremely severe[d] relations to a healthy state, based on Japan’s consistent position.”

On trilateral cooperation, Mizobuchi said, “Japan, the U.S., and ROK seek to enhance collaboration at multiple levels in various areas including strengthening security cooperation, given the strategic importance of coordination among the three countries for regional stability including responding to North Korea’s nuclear and missile threat.”

Mizobuchi declined to comment on how a possible constitutional revision could impact Tokyo-Seoul relations, stating it is “ultimately for the Japanese people to decide” in a special referendum after a concurring vote of two-thirds or more in each house of the Diet, Japan’s bicameral legislature.

Stanford’s Sneider said such a revision, which would take some time to realize, should not hinder efforts to improve bilateral ties that impact the national security interests of Tokyo and Seoul, although a revision could be “a little bit of a troubling idea” for South Koreans “if it’s not accompanied by a clear and sincere expression, an apology and regret for its wartime aggression.”

James Zumwalt, former deputy assistant secretary of state in the Bureau of East Asia Affairs and now the chair of the Japan-America Society of Washington DC, said similarly, “It will be very important for Japan to communicate clearly and closely with neighbors in the region, including South Korea, about its intentions in order to assuage those concerns.”

South Korea’s Supreme Court ordered Japan’s Nippon Steel Corporation and Mitsubishi Heavy Industries to compensate some wartime forced laborers in a 2018 decision. The court is expected to make a final decision in August or September on whether to liquidate the companies’ assets, according to Reuters, and Tokyo is warning of serious repercussions if the orders are enforced.

Source: Voice of America

US House Speaker Nancy Pelosi to Visit Taiwan in August

Nancy Pelosi, the speaker of the U.S. House of Representatives, plans to visit Taiwan next month, amid tension with China, the Financial Times said on Tuesday, citing six people familiar with the matter.

Pelosi and her delegation will also visit Indonesia, Japan, Malaysia and Singapore, and spend time in Hawaii at the headquarters of U.S. Indo-Pacific command, the paper added.

Her office and the U.S. State Department did not immediately respond to a Reuters request for comment, however. The Taiwan embassy in the United States could not immediately be reached.

The Democratic leader’s visit to Taiwan had been postponed from April, after she tested positive for COVID-19. At the time, China said such a visit would severely affect Chinese-U.S. relations.

Taiwan faces mounting pressure from China, which considers the democratically ruled island its own territory. The issue is a constant irritant in ties between Beijing and Washington.

Taiwan, however, has been heartened by continued support offered by the Biden administration, which has repeatedly talked of its “rock-solid” commitment to the island.

Pelosi, a long-time critic of China, held an online meeting with Taiwan Vice President William Lai in January as he wrapped up a visit to the United States and Honduras.

The White House had expressed concern about the trip, the Financial Times said, citing three people familiar with the situation.

There were divisions in the U.S. administration over whether Pelosi should visit Taiwan, the paper quoted two sources as saying.

Some officials believed it had been easier to justify a visit in April, as that was just after the start of Russia’s invasion of Ukraine, it added.

China sent fighters across the Taiwan Strait this month in what the latter described as a provocation. The incident came during a visit to Taipei by U.S. Senator Rick Scott, a senior Republican and member of the Senate’s Armed Services Committee.

News of Pelosi’s August visit comes after China asked the United States on Monday to immediately cancel a potential sale of military technical assistance to Taiwan worth an estimated $108 million.

Source: Voice of America