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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Site of Fire Dept’s Kuching Air Base identified

KUCHING, July 19 (Bernama) — The site for the new Malaysian Fire and Rescue Department’s Kuching Air Base here has been identified.

Deputy Housing and Local Government Minister Datuk Seri Dr Ismail Abd Muttalib said the air base in Kuching would replace the existing air base in Miri.

He added that the department is also in the process of opening another air base in Kota Kinabalu, Sabah.

“For the base in Kota Kinabalu, we are currently in the process of identifying the site and in discussions with the Sabah government.

“Currently, the department has three Air Bases in Miri, Penang and Subang,” he said after attending the Fire Science Certificate Accreditation Parade here today.

A total of 108 trainees successfully completed their training today.

Meanwhile, Ismail said the government was also open to proposals to add more air bases, especially in areas far from existing bases.

We will also consider having an air base in other zones such as in the East Coast (Peninsula) area, which does not yet have one.

“Aside from air bases, we are also committed to improving and adding equipment for the department,” he added.

Source: BERNAMA News Agency

Baling floods: Istana Negara Disaster Relief Team carries out clean-up work at school

KUALA LUMPUR, July 19 (Bernama) — The Istana Negara Disaster Relief Team today carried out clean-up work at the Sekolah Menengah Agama (Arab) Yayasan Al Kahriah in Kupang, Baling, Kedah which was affected by the recent floods.

Istana Negara, in a statement posted on its official Facebook page, said the clean-up work involved a total of 73 volunteers comprising Istana Negara officers and staff, Telekom Malaysia Reaching Out Volunteers (TMRovers) and assisted by staff from the Fire and Rescue Department, Special Malaysia Disaster Assistance and Rescue Team (SMART) as well as Baling Police headquarters.

“The aid mission today was led by His Majesty’s naval aide-de-camp First Admiral Datuk Sharum Shaim and also participated by Yang di-Pertuan Agong’s police aide-de-camp SAC Datuk Azry Akmar Ayob,” it said.

The statement said that Sharum also presented donations from Yayasan Al-Sultan Abdullah (YASA) in the form of school uniforms, stationery and school shoes to 396 students.

The TMRovers team presented donations in the form of electrical appliances to the flood victims and water spraying machines to schools affected by floods.

“His Majesty is very concerned about the plight of the flood victims and sympathised with them for the hardship they went through and expressed the hope that the assistance and donations provided by the team can help to reduce their burden,” it said.

Source: BERNAMA News Agency

Integrated digital repository system ‘Terengganu Lawnet’ launched

KUALA TERENGGANU, July 19 (Bernama) — The state government today launched Terengganu Lawnet, an integrated digital repository system for legal documents that can be accessed more easily by any party in need.

State Trade, Industry, Regional Development and Administrative Wellbeing Committee chairman Datuk Tengku Hassan Tengku Omar said Terengganu Lawnet was developed in collaboration with the Terengganu Strategic & Integrity Institute (TSIS) and a group of researchers from Universiti Sultan Zainal Abidin (UniSZA).

He said the collection of all legal documents in one integrated digital system would also make it easier for potential investors to obtain information on laws in Terengganu.

“Terengganu Lawnet can be used as a comprehensive one-stop reference to help administrators, government agencies, foreign and local investors as well as those wishing to obtain accurate and up-to-date information on Terengganu state legislation.

“Along with the development of the industrial revolution (IR 4.0), updated certified online information is very much needed. In addition, there are various laws and regulations that apply in Terengganu that are different from other states,” he said in a press conference here today.

Terengganu State Secretary Datuk Tengku Farok Hussin Tengku Abdul Jalil and Terengganu State Assembly Speaker Datuk Yahaya Ali were also present at the press conferece.

Commenting further, he said Terengganu Lawnet will be expanded in the form of an app that can be downloaded onto smartphones in the near future to be more easily accessible to anyone at any time.

“I will introduce Terengganu Lawnet to 200 investors in a seminar organised by the Malaysian Investment Development Authority (MIDA) in Kuala Lumpur on Aug 25 to attract their interest to look at the investment potential in Terengganu.

“The state government will also continue to improve such innovations and initiatives so that we remain relevant in line with rapidly changing times and environment for the good of all parties that benefit the people,” he said.

Source: BERNAMA News Agency

Strengthen cross-sector cooperation in implementation of comprehensive security – Mohd Zuki

PUTRAJAYA, July 19 (Bernama) — The civil service should be prepared to strengthen cooperation across various sectors in the country in the implementation of Comprehensive Security and Community-based Security Management, said Chief Secretary to the Government Tan Sri Mohd Zuki Ali.

He said the role of district officers and residents was key to mobilising cooperation between the government machinery and the people through the planning of programmes and activities involving the community.

He said the elements of Comprehensive Security and Community-Based Security Management needed to be strengthened so that they could be translated into all aspects of national governance, whether at the federal, state or district level, and most importantly at the community level.

“This should be the way forward in any planning and delivery of public services, to ensure that Malaysia has people who are highly resilient in facing any challenge during peaceful times and especially during crises,” he said.

Mohd Zuki said this at the closing ceremony of the National Security Conference 2022 here today organised by the National Security Council (MKN). The conference themed “National Security, Shared Responsibility” was officiated by Prime Minister Datuk Seri Ismail Sabri Yaakob in the morning.

“The conference was held in conjunction with the National Security Month 2022 celebration which aims to create a comprehensive platform involving various parties in national security management in line with the desire to strengthen national security management.

“The capacity and competence to handle security situations in the future demands that we constantly increase our preparedness in the face of crisis situations that are critical to life and property,” said Mohd Zuki.

Mohd Zuki said the comprehensive security concept introduced by the government reflected the importance of each party in taking joint responsibility to preserve the country’s sovereignty, peace and prosperity.

“I would like to request that the government machinery at the district as well as resident levels must always be prepared to face risks and security challenges in their respective places.

“Village chiefs, officers and members of the civil service who interact directly with the people in the field should understand security management mechanisms at all times,” he said.

Mohd Zuki also wanted ministry secretaries-general, department heads and state secretaries to understand the National Security Policy and components relevant to the functions of their respective ministries and agencies.

“It is the duty of every department head to increase the capacity and competence of their respective organisations, so that preparations to face any security threat can be faced smoothly,” he said.

Mohd Zuki said the prime minister’s message that national security was the common responsibility of members of Keluarga Malaysia (the Malaysian family) should be made a priority and for the trust and responsibility to be shouldered to ensure that the country remains sovereign, peaceful and prosperous.

“In this case, we can see that the concept of Keluarga Malaysia initiated by the government is very significant and has an important relationship with the concept of national security,” he said.

Source: BERNAMA News Agency