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Nyxoah BETTER SLEEP Trial Reaches its Primary Endpoints

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Nyxoah BETTER SLEEP Trial Reaches its Primary Endpoints

Mont-Saint-Guibert, Belgium – 7 June 2021, 7:00 am CET / 1:00 am ET – Nyxoah SA (Euronext Brussels: 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 BETTER SLEEP trial reached its primary safety and performance endpoints.

The BETTER SLEEP trial was designed to assess the long-term safety and performance of the Genio® bilateral hypoglossal nerve stimulation system (the “Genio® system”) in 42 adult OSA patients with and without Complete Concentric Collapse (CCC) of the soft palate.

Top-line results from the BETTER SLEEP study showed:

  •  A statistically significant mean reduction in Apnea Hypopnea Index (AHI) from baseline to six months post implantation in the whole cohort (CCC and non-CCC patients)
  •  A statistically significant mean reduction in AHI from baseline to six months post implantation in the CCC patient subgroup
  •  42.9% of the study population had CCC

The Company expects to announce additional data with respect to the study as further analyses are conducted.

Dr. Richard Lewis, MBBS, FRACS, Principal Investigator of the BETTER SLEEP study, from Royal Perth Hospital and the University of Western Australia commented: “The top-line results of the BETTER SLEEP study are extremely encouraging. The most impressive aspect of the results is the responder rate of the CCC patient subgroup. These patients are excluded from unilateral hypoglossal nerve stimulation, but the BETTER SLEEP results showed a significant reduction in AHI in these patients following treatment with the Genio® system, which is the first device designed to deliver bilateral stimulation of the hypoglossal nerve. Overall, we have achieved a very high responder rate in both CCC and non-CCC patients, and the treatment with the Genio® system was well tolerated. We look forward to publishing this data in a leading medical journal.”

Olivier Taelman, CEO of Nyxoah, stated: “We are excited by the top-line data, with the primary performance and safety endpoints met, supporting our belief that the Genio® system’s bilateral stimulation of the hypoglossal nerve, has the potential to provide positive clinical outcomes for patients with CCC. We already engaged with the EU Notified Body to review these study data, with the goal of expanding the CE-marked indication to include CCC patients. In parallel, we plan to initiate dialogue with the FDA to further discuss the Genio® system as a potential treatment option for patients with CCC.” Mr. Taelman continued, “Additionally, we observed a 70% responder rate in the non-CCC patient subgroup based on the Sher criteria, which strengthens our confidence in ongoing study outcomes.”

About BETTER SLEEP Trial
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea, or BETTER SLEEP, is a multicenter, prospective, open-label, two-group clinical trial, designed to assess the safety and performance of the Genio® system for the treatment of OSA in adult patients with and without CCC. The BETTER SLEEP trial includes a subgroup of CCC patients who are currently contraindicated for unilateral hypoglossal nerve stimulation. The trial was authorized by the Australian and New Zealand regulatory authorities and is being conducted in nine local medical centers. The primary safety endpoint was the incidence of device-related serious adverse events six months post-implantation. The primary performance endpoint was the change in the AHI score from baseline to six months post-implantation measured by counting the number of events (apnea or hypopnea) that occur per hour collected during an overnight sleep study. Patients with moderate to severe AHI scores between 15 and 65 and aged between 21 and 75 years were eligible for enrollment if they failed, refused, or did not tolerate PAP treatment. Patients with a body mass index above 32 kg/m² were excluded.

About Nyxoah
Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat OSA. Nyxoah’s lead solution is the Genio® system, a CE-marked, patient-centered, minimally invasive, next generation hypoglossal neurostimulation therapy for treatment of moderate to severe OSA. OSA is the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and comorbidities including cardiovascular diseases, depression and stroke.

Following the successful completion of the BLAST OSA study in patients with moderate to severe OSA, the Genio® system received its European CE Mark in 2019. The Company is currently conducting the BETTER SLEEP study in Australia and New Zealand for potential CE-mark indication expansion, the DREAM IDE pivotal study for potential FDA approval and the post-marketing EliSA study in Europe to evaluate the long-term safety and efficacy of the Genio® system.

For more information, please visit 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
This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding Nyxoah’s 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; and the utility of prior clinical data, including data from the BETTER SLEEP study, in potentially obtaining FDA approval of the Genio® system. Forward-looking statements are based on Nyxoah’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and could cause actual results to differ.  Forward-looking statements contained in this announcement are made as of this date, and Nyxoah undertakes no duty to update such information except as required under applicable law.

Contacts:
Nyxoah
Fabian Suarez, Chief Financial Officer
fabian.suarez@nyxoah.com
+32 10 22 23 55

Gilmartin Group
Vivian Cervantes
vivian.cervantes@gilmartinir.com

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BitMEX receives prestigious ISO information security certification

MAHE, Seychelles, June 7, 2021 /PRNewswire/ — 100x Group, the holding structure for the BitMEX platform – the world’s leading cryptocurrency derivatives trading platform – today announced that it had received the prestigious International Organisation for Standardisation (ISO) information security certification ISO/IEC 27001.

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The ISO is an independent global body that establishes and assesses important standards for a wide variety of industries and functions. ISO/IEC 27001 provides the requirements for establishing a top-flight information security management system including safeguards for customer and partner data, a particularly important aspect for leading financial services companies.

Alex Höptner, CEO of 100x, said: “It’s difficult to overstate the importance of information security for a platform like BitMEX. Traders trust us because of our track record on security – we have never lost a single Satoshi through intrusion or hacking. But security is never a static process and in order to continue to set the bar as high as possible, we sought – and were awarded – one of the most rigorous certifications: ISO/IEC 27001.”

The award of the ISO/IEC 27001 certification requires an extremely thorough audit of IT systems but goes much further. It is a thorough examination of an organisation’s information security risks including potential threats, vulnerabilities and impacts of both. The certification process also requires an assessment of a bespoke, comprehensive set of information security controls and risk mitigation protocols and the implementation of a complete management process to ensure information security standards continue to evolve and improve.

Brian Rankin, Head of Security at 100x Group, said: “Data security is a cornerstone of our business and the ISO certification shows just how seriously we take that commitment. Working with BSI, the organisation that developed these exacting standards, the certification process has taken nearly a year and hundreds of hours of detailed audits. However, as pleased as we are, we recognise that this is just part of our ongoing obligation to keep our customers as safe as possible.”

About 100x Group

100x Group explores, incubates, and pursues opportunities and investments as part of its mission to reshape the modern digital financial system into one which is inclusive and empowering. It was created by the founders of HDR Global Trading Limited, the company behind the cryptocurrency derivatives trading platform, BitMEX.

For media inquiries, please contact Ruder Finn:

 

Winky Chow/Jess Lo

(+852)22016474/(+852)22016473

100xGroup@RuderFinnAsia.com / BitMEX@RuderFinnAsia.com

Logo – https://mma.prnewswire.com/media/1344559/100x_Profile_Photo__2_Logo.jpg

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Antaisolar Launched SPACE, the World’s Longest Solar Tracker at SNEC 2021

SPACE, the 1P Multi-Slew solar tracker, can be extended to 240m in length.

XIAMEN, China, June 7, 2021 /PRNewswire/ — Antaisolar, the leading supplier of the whole industry chain in PV mounting system, celebrated its 15th anniversary by launching its latest SPACE solar tracker at SNEC.   Featuring with “Unique, Intelligence, Efficiency, Infinity”, this world’s longest 1P independent single-axis tracking system can be extremely extended to more than 4 strings, maximum 240m in length and up to 18% solar mounting system cost reduction, which made it become best choice for large scale solar plant in flat terrain and matches better for cleaning robots.

The key features of the new tracker include:

1: Unique Multi-point Drive

Approved by authoritative CPP and multiple tests and certifications and effectively solves the instability problem under extreme weather.

2: Unique drive through electric synchronously

Free from the transmission bar, electrical synchronization is quick to installation, convenient for maintenance and low consumption, which effectively reduces labor costs.

3: Unique Brushless Direct Current Motor

The industry’s first BLDC system with a more than 30 years’ maintenance-free serviced life.

4: AI Tracking Mode

Massive data analysis of weather, terrain, scattered light conditions, together with the deep machine learning method to generate the optimized tracking path, increasing power generation by 10% compared with the conventional tracking.

5: ANTAI SPACE CLOUD Monitoring O&M system

The cloud monitoring system can provide a monitoring service globally on both O&M and system protection.

6: Smart Commissioning

With the ANTAI unique Smart Commissioning, system could be fast located and operated via smart phone QR code scanning.

“At the beginning phase of R&D for SPACE, Antaisolar has paid attention to the application trend of mainstream large-format module. All products of Antaisolar solar tracker have completed the CPP wind test report. SPACE is just one of them,” said Amy Kou, Vice General Manager of Antaisolar.

About Antaisolar:

Antaisolar, established in 2006, has a vast expertise in Solar Mounting & Tracking System with over 800 employees including a R&D team composed of 80 specialists. Antaisolar has been continuously optimizing the global service by globally setting up over 20 branches and offices.

Up to now, its cumulative solar racking shipments have reached 15GW and ranked No.1 of export volume to Japan for seven consecutive years and ranked top 1 in Australian and Vietnam distribution market.

Video – https://mma.prnewswire.com/media/1527045/Antaisolar.mp4

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Vice President of Human Rights Commission Receives President of Independent Democratic Union and Senator of the Republic of Chile

Riyadh, Vice President of the Human Rights Commission Abdulaziz bin Abdullah Al-Khayyal received here today President of the Independent Democratic Union and Senator of the Republic of Chile Jacqueline Rysselberghe and her accompanying delegation, currently visiting the Kingdom of Saudi Arabia.

During the meeting, Al-Khayyal stressed the depth of the Saudi-Chilean relations and the importance of strengthening them in various fields, especially in the field of the human rights, highlighting the Kingdom of Saudi Arabia’s efforts in this regard.

For her part, the President of the Independent Democratic Union praised the bilateral relations between the two friendly countries in all fields.

Source: Saudi Press Agency

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Syrian community in South Africa celebrates winning of Dr. Bashar al-Assad in presidential election

Pretoria, Members of the Syrian community in South Africa have celebrated the success of the presidential elections and the wining of Dr. Bashar al-Assad in them during a massive national event held at the headquarters of the Syrian Embassy in Pretoria, with the participation of South African political figures and activists.

Participants in the celebration expressed their happiness over President al-Assad’s winning, reiterating their confidence in Syria’s leadership ability to achieve safety and the reconstruction of what was destroyed by terrorism, and expressing their support for their country in confronting terrorism and its supporters.

Syria’s Ambassador to South Africa, Onfouan Naeb, affirmed that the achievement of the presidential elections on time is a victory for the Syrian national decision and the will of the Syrians, and an explicit expression of their rejection of Western countries’ attempts to disrupt the elections, influence their results, or interfere in the internal affairs of a member state of the United Nations.

“The Syrians’ choice of President al-Assad is a clear message sent by the people of Syria worldwide, that just as their wills were united with the Syrian state in the face of terrorism, their wills are united with their state and leadership to rebuild the future of Syria,” Naeb said.

In turn, Head of the Syrian Expatriates Association, Dr. Omar al-Adel, expressed in a speech on behalf of the Syrian community, the pride in President al-Assad’s winning in the presidential elections, pointing out that the next stage aims to rebuild Syria.

Mohammad Desai, a member of the National Youth Committee of the South African Communist Party, congratulated the Director of Africa for Palestine Organization in a speech during the celebration of the Syrian people on the success in the presidential election, praising the steadfastness of the Syrians in the face of the terrorist conspiracy against their homeland.

Desai affirmed his party’s support for Syria in confronting terrorism and Western schemes targeting it, denouncing the unilateral coercive economic measures imposed by Western countries on the Syrian people which target them through their livelihood and basic needs.

Desai hailed Syria’s “honorable” stances towards South Africa and its solidarity with his country against the racial regime and its rejection of imperialism and colonialism, saying that “The South Africans appreciate the sacrifices and steadfastness of the Syrian people,” noting that South Africa stands by Syria in the face of the fierce campaign targeting it by the United States and some western countries and their tools.

Source: Syrian Arab News Agency

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Turkish regime continues Turkification of occupied Syrian regions

Damascus, The Turkish regime went ahead in its practices and crimes against the Syrians that aim to Turkify areas which it occupies in Syrian territories.

Local sources in Idleb revealed that the Turkish occupation and its mercenaries intends to establish the so-called “General Secretariat of the Civil Registry” in the province which will be directly affiliated to the occupation authorities in addition to establishing local councils in the cities, towns and villages which are still under the control of terrorists.

This method and approach of Turkish regime imitates crimes of Israeli occupation authorities against Syrian citizens in the occupied Syrian Golan in a repeated attempt to usurp the Syrian identity from the occupied areas through changing the names of streets, schools and major landmarks in the occupied cities and towns.

Source: Syrian Arab News Agency

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Syrian communities in Australia and Bulgaria celebrate winning of Dr. Bashar al-Assad in Presidential election

Sydney, Members of the Syrian community in Australia celebrated the success of the presidential election and winning of Dr. Bashar al-Assad with the post of the President of the Republic during a massive national event held at the Syrian Consulate in Sydney, with the participation of a number of members of the Arab community.

Honorary Consul of Syria in Sydney, Dr.Maher Dabbagh affirmed that the Syrian people did not submit to pressures of the Western countries hostile to Syria, saluting the heroes of Syrian Arab Army who is fighting terrorism, , the martyrs who shed their blood on Syrian land to achieve victory, and the wounded army personnel whose wounds did not deter them from participating in the process of rebuilding what has been destroyed by terrorism.

The participants noted that the presidential election confirmed the Syrians’ rejection of foreign interference in their country’s affairs and that is a new victory for a new phase in which Syria will move to safety and reconstruction and complete the liberation of its entire territory from occupation and terrorism.

In the same context, Professor Tim Anderson, author of the book “The Dirty War on Syria,” said in a statement to the Syrian Consulate in Sydney that the wide popular support for President al-Assad constitutes a clear victory over the terrorism which targeted Syria with support of countries of North Atlantic Treaty Organization (NATO).

“This triumph has been achieved thanks to sacrifices of the Syrian Arab Army and its allies , and the steadfastness of the Syrian people in the fight against terrorism and foreign occupation ,”said Anderson

In the same context, members and representatives of the Syrian community in Bulgaria held a national event at the headquarter of the Syrian Embassy in Sofia , in celebration of Dr. Bashar al-Assad winning in the presidential election.

A number of representatives of Arab communities, a number of intellectual figures of Bulgaria, and the Syrian university students in the Bulgarian universities participated in the event.

The charge d’affaires of the Syrian Embassy in Bulgaria Mohammed Mohammed pointed out to the massive turnout by the Syria Expatriates in Bulgaria to ballot boxes which constituted a confirmation of their belonging to their homeland.

Source: Syrian Arab News Agency

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Saudi Central Bank Organizes Virtually its Second Quarterly Workshop on Islamic Finance for 2021

Riyadh, Deputy Governor of the Saudi Central Bank “SAMA” for Research and International Affairs Dr. Fahad bin Abdullah Al-Dossari opened SAMA’s second virtual workshop on Islamic Finance for 2021 on Thursday, June 3, under the title “The Contribution of Research and Development in the Islamic Finance Industry.” A number of participants including industry experts and those interested in the sector attended the workshop. The quarterly workshop focuses on Islamic Finance sponsored by SAMA, aimed at discussing current topics concerning the sector.

In his welcoming remarks, the Deputy Governor highlighted the importance of qualitative developments in the industry, most notably research and development as being a strategic pillar that assesses the developments and challenges for the industry with a forward looking approach to launching innovative products for future economic growth and financial stability. He also touched on the most prominent qualitative developments taking place in the Islamic financial industry in Saudi Arabia, including the joint Islamic Finance research initiative launched by SAMA. He also referred to the role of the Shariah Governance Framework for banks operating in the Kingdom of Saudi Arabia issued in February 2020 in supporting the research and development system in the Islamic banking industry. In this context, the Deputy Governor highlighted the important role of Saudi Universities in developing the research and development system and the continuous cooperation of SAMA with universities.

The workshop included three main themes in three successive sessions. The first session discussed research and development and their role in the development of the Islamic finance industry.

The second session discussed the pillar related to the pivotal areas that shape the focus of research and development in the Islamic finance industry, important achievements, and future research trends. The third and concluding session discussed recent innovations and practical applications in Islamic finance and their expected additional value.

Source: Saudi Press Agency

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Public Investment Fund Holds Partnership with E1 Series to Launch World’s First Electric Powerboats Championship

Riyadh, The Public Investment Fund (PIF) here today announced signing an agreement with Electric Sea Racing Limited (E1 Series) to create the world’s first electric powerboat racing championship.

The partnership forms a main step in creating the championship and speeding up preparations for the debut season scheduled to take place in early 2023, where the Kingdom of Saudi Arabia is among candidate locations to host the first edition of the race.

The partnership was announced during a virtual inauguration ceremony that saw the participation of the E1 Series senior officials, where the ceremony also witnessed announcing the new designs of the electric powerboats RaceBirds.

The PIF is considered a major contributor to the global economy and a main driver for efforts of the digital transformation for the Kingdom of Saudi Arabia, where this investment accords with the PIF’s 2021-2025 strategy that focuses on 13 strategic sectors, including entertainment, tourism and sports, service facilities and renewable energy. The PIF’s investments in future industries are seen in several companies and projects, such as ACWA Power Company, Sudair Project in the renewable energy industry, and Lucid Motors in the electric vehicles industry.

Governor of the Public Investment Fund Yasir Al-Rumayyan said: “We are proud to establish this unique partnership in a sport with a new concept, which comes within the PIF’s strategy to enable innovation globally, open new horizons for future industries, and build up strategic economic partnerships. We believe that our support for new technologies in the sports sector will also contribute to the development of various strategic sectors locally and globally.”

“Our partnership with E1 Series will contribute to the efforts of developing the sustainable technology, which will boost the status of the Kingdom of Saudi Arabia in the future industries and enable it to provide more development opportunities that are important for the national economy.”, he added.

Co-Founder and Chairman of E1 Series Alejandro Agag expressed pride in the partnership with the PIF in this vital project, noting that the support of the fund in this development stage stresses the importance of the upcoming championship and embodies ambition to make a revolution in the industry of marine mobility. He also said that the new design of the RaceBird boat will contribute to accelerate the pace of changing the industry and providing sustainable solutions for entertainment and tourist vessels in the future, expressing hope to work with the PIF to move forwards towards a new era of fast electric powerboats.

Co-Founder and CEO of E1 Series Rodi Basso also expressed happiness for working side by side with the PIF to shape the future of powerboats, noting that establishing a strong partnership with a proper partner like the PIF provides a solid foundation that can open horizons for creating a new sport. He also said that the RaceBird powerboat has formed a unique challenge for the engineering team responsible for its development before they managed to include several practical solutions that can qualify it strongly to participate in upcoming races.

It is worth mentioning that the PIF has contributed to developing and stimulating the entertainment, tourism and sports sector in the Kingdom of Saudi Arabia as part of the Saudi Vision 2030 through supporting high-level sports events, such as supporting the heavyweight world boxing championship and Diriyah E-prix.

Source: Saudi Press Agency

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1,161 New Confirmed COVID-19 Cases, 1,216 Recoveries Reported in Saudi Arabia

Riyadh, The Ministry of Health announced, in a statement here today, that 1,161 new confirmed cases of the novel Coronavirus (COVID-19) have been reported in the Kingdom of Saudi Arabia, bringing the total number to 458,707, including 9,376 active cases.

Of these, there are 1,579 critical cases, while the health condition of the rest is stable.

It added that 15 new deaths have been reported; putting the tally of fatalities, at 7,471.

Meanwhile, as many as 1,216 cases have recovered, raising recoveries’ toll to 441,860.

On the other hand, 86,073 new laboratory tests were conducted, in the last 24-hour, across the Kingdom of Saudi Arabia.

Source: Saudi Press Agency

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KSrelief Performs 154 Surgeries as Part of Medical Campaign to Combat Blindness in Nigeria

Abuja, The Voluntary Medical Team of King Salman Humanitarian Aid and Relief Center (KSrelief) participating in the campaign to combat blindness and related diseases from 6 to 13 June 2021, in the Republic of Nigeria has examined 1,295 cases and performed 154 surgeries, in addition to distributing 231 eyeglasses and dispensing 608 prescriptions, benefiting families and individuals with limited income who are not able to cover the costs of treatment.

The campaign, provided by KSrelief, Saudi Arabia relief arm, aims to treat people with eye diseases and provide them with the necessary medical care in a number of needy countries.

Source: Saudi Press Agency

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Tunisian Prime Minister Meets with Minister of Tourism

Tunis, Tunisian Prime Minister Hichem Mechichi received here today the Minister of Tourism of the Kingdom of Saudi Arabia Ahmed bin Aqeel Al-Khateeb.

During the meeting, relations between the two countries and ways of joint cooperation in the field of tourism were discussed.

Source: Saudi Press Agency