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BETTER SLEEP Achieves Primary Endpoint Across All Patient Cohorts

BETTER SLEEP Achieves Primary Endpoint Across All Patient Cohorts

  • First clinical data demonstrating effectiveness of HGNS to treat CCC patients
  • As previously disclosed, confirms achievement of primary endpoint of AHI4 reductions for entire population, CCC cohort, and non–CCC cohort at six months, and reports 60%+ responder rates for all three cohorts
  • Exceeds 70% mean reduction in AHI4 among responders in both CCC and non–CCC cohorts

Mont–Saint–Guibert, Belgium "" March 14, 2022, 11:30pm CET / 6:30pm 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 provided additional data from its BETTER SLEEP clinical trial that it showcased in a poster presentation at the 16th World Sleep Congress 2022. World Sleep, a global scientific congress, gathers leaders in sleep medicine and research from around the world for scientific sessions and networking.

Forty–two (42) moderate–to–severe OSA patients in the study received an implant at eight research sites in Australia, 18 of whom presented with Complete Concentric Collapse (CCC) of the soft palate and 24 who were classified as non–CCC. Three patients in each arm did not complete their six–month polysomnography, and as a result, the analysis was calculated based on 36 patients (15 CCC, 21 non–CCC). Of these 36 patients, there were 23 responders (64%), including nine of the 15 CCC patients (60%) and 14 of the 21 non–CCC patients (67%), at six months.

The primary endpoint was achieving at least a 4–point reduction in the apnea–hypopnea index (4% oxygen desaturation, or AHI4) from baseline at six months for the entire 42 patients. The overall reduction was statistically significant with an 11–point reduction (p<0.001), with statistically significant reductions of 10 points (p=0.001) in the CCC cohort and 11 points (p<0.001) in the non–CCC cohort. In addition, mean AHI4 reduction exceeded 70% among responders in both CCC and non–CCC cohorts. These results are subject to final review and validation.

"BETTER SLEEP represents the first clinical study to demonstrate the effectiveness of treating CCC patients with hypoglossal nerve stimulation (HGNS)," said Olivier Taelman, Chief Executive Officer of Nyxoah. "The results give us confidence that we will be able to provide a better treatment option for CCC patients, who comprise approximately 30% of the moderate–to–severe OSA population and are contraindicated for other HGNS options. These data validate our differentiated approach of delivering bilateral stimulation via an implantable device requiring only one incision, and a CCC indication would eliminate the need for patients to undergo an invasive DISE procedure."

"We are also extremely encouraged to have generated such positive clinical results after just six months following implantation, as the growing body of clinical data and real–world experience suggests that patient responses improve meaningfully between months six and twelve," continued Mr. Taelman. "The granting of an expanded CE mark indication to treat CCC patients and Breakthrough Device Designation from the U.S. FDA, both based on BETTER SLEEP, along with the high–level interest among the approximately 50 physicians in attendance at Nyxoah's World Sleep symposium, underscore the strength of the data and excitement for the Genio platform. We continue to work with the FDA on an IDE approval to conduct a clinical trial for CCC patients in the U.S., which we aim to commence later this year."

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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GLOBENEWSWIRE (Distribution ID 1000610787)

Dante Labs unveils Dante Genomics, the Company’s B2B global online marketplace delivering genomic solutions for medical professionals, researchers and pharma

NEW YORK, March 14, 2022 (GLOBE NEWSWIRE) — Dante Labs, a global leader in genomics and precision medicine, today announced the launch of Dante Genomics, an online marketplace portal specifically dedicated to healthcare providers, clinics, researchers and governments which will offer advanced genomic services for research and clinical applications.

This unique marketplace will be the first of its kind in the industry and will provide an intuitive and dynamic experience for customers worldwide. Customers will have the opportunity to choose among several sequencing technologies and options and get a tailored and personalized solution.

"At Dante, we are continually working to provide better genomic solutions to our customers," said Andrea Riposati, CEO of Dante Labs. "With the launch of this new online marketplace, Dante Genomics will make it as easy for clinical professionals and researchers to complete their genomics projects as it is to buy a book or tool on Amazon."

As a Sr. Product Manager in Seattle, Andrea Riposati belonged to the original Amazon team that developed Amazon Business, the Amazon.com ($AMZN) B2B portal that revolutionized industrial and scientific supplies in 2014.

Dante Genomics also provides a transparent pricing model to empower partners to get a personalized quote, while simultaneously purchasing online with a choice of the best deals to suit their specific needs.

The portal hosts a wide range of genomic services, from whole genome sequencing to non invasive prenatal diagnostics. All the services offered are suitable for either research or clinical applications.

Dante Labs recognizes that online B2B buying experiences in the healthcare industry is the need of millions of organizations. Dante Genomics has been designed for a user–friendly experience and has been optimized with easy navigation for desktop and mobile devices. The platform allows for order queries to be addressed online and is supported by secure payment methods and is compliant with the General Data Protection Regulation (GDPR).

Dante Genomics B2B customers have access to premium services including:

  • 1 week turnaround time on most tests
  • Oncology and germline sequencing tests
  • Custom projects
  • Multi–platform sequencing

Clinical and research customers will benefit from B2B features, including:

  • Quote Requests
  • Payment method visibility control (including PO payment option)
  • Quick Order Pad (including CSV upload)
  • Bulk discount
  • Invoicing and payment via wire transfer
  • Multiple currencies
  • Flexible buyer–side user management: several layers of roles and permissions (including Super Admin, Company Admin, Sr. Buyer, Jr. Buyer)

Access the Dante Genomics store at shop.dantegenomics.com to learn more.

About Dante Labs

Dante Labs is a global genomic data company building and commercializing a new class of transformative health and longevity applications based on whole genome sequencing and AI. Our assets include one of the largest private genome databases with research consent, a proprietary software platform designed to unleash the power of genomic data at scale and proprietary processes which enable an industrial approach to genomic sequencing.

Contact:

Laura D'Angelo
VP of Investor Relations
ir@dantelabs.com
+39 0862 191 0671
www.dantelabs.com


GLOBENEWSWIRE (Distribution ID 8502435)

CS Global Partners: St Kitts and Nevis Formalises Diplomatic Relations with Republic of Sudan, Continues to Strengthen Relations with African Countries

LONDON, March 14, 2022 (GLOBE NEWSWIRE) — The Federation of St Kitts and Nevis is continuing to strengthen its ties with the African continent.

The Permanent Representative of Saint Kitts and Nevis to the United Nations recently met with his Sudanese counterpart, Mr. Ammar M.M. Mohammed, to formalise diplomatic relations, agreeing on a mutual visa waiver to facilitate easier travel.

The Caribbean nation also established diplomatic relations and signed visa waiver agreements with Egypt late last year and with Ghana as recently as last week.

The signing with Egypt occurred on the sidelines of the 76th period of sessions of the United Nations General Assembly in New York, with St Kitts and Nevis' Foreign Minister Mark Brantley.

Minister Brantley has been instrumental to St Kitts and Nevis expanding its bilateral relations across the world, propelling and creating visibility of the islands globally and enabling the nation to have one of the strongest travel prospects in the region. The last few years have seen a deepening of ties with the African continent with relations established with countries like Mozambique, Djibouti, Rwanda, Burkina Faso, and Gabon.

Caribbean and African ties run deep "" the territories have shared history and culture and a lot is being done to strengthen and foster Caribbean–African relations and increase their bargaining power with the world. Last September, for example, leaders from the African Union and the Caribbean Community (CARICOM) convened the first Africa CARICOM Summit.

“We have talked about a closer connection with Africa. We are of Africa, and many, I believe, have agreed that there ought to be a closer nexus between the Caribbean and Africa and that we ought in every sense to be a part of the so–called sixth region of Africa,” Brantley previously noted on the matter.

At the signing event with Sudan, the economic and cultural links between the two nations were promoted, as well as the visa–free access of up to 90 days both ways, for holders of diplomatic, official, and ordinary passports. In addition to the signings, the two diplomats discussed areas of cooperation, natural resources, Citizenship by Investment, transport, and a stronger Africa–CARICOM partnership.

St Kitts and Nevis has for a number of years welcomed a growing number of African investors and businesspeople to settle on the islands through its popular Citizenship by Investment (CBI) Programme. An increasing number of African entrepreneurs are beginning to acknowledge the value of having a second citizenship especially when looking to keep business competitive, access greater global mobility and higher quality education and healthcare services or simply keeping loved ones safe.

The country scored a respectable score of 48 points in the overall rankings in the World Citizenship Report, the highest of all the Caribbean CBI nations. It reached top marks in the Safety and Security, Quality of Life, and Global Mobility motivators.

The report was developed by CS Global Partners, the world's leading government advisory and marketing firm, and measures 187 countries against five motivators that are relevant amongst High Net–Worth Individuals (HNWIs). These motivators include Safety and Security, Economic Opportunity, Quality of Life, Global Mobility and Quality of Life.

As pioneers of the CBI industry, St Kitts and Nevis remains a top destination for those seeking second citizenship from a trusted and reputable country. The islands launched the Programme in 1984 and have since been recognised as the market's 'Platinum Standard' brand and have been consistently ranked as the world's best programme by the CBI Index, published annually by the Professional Wealth Management magazine.

Those who choose St Kitts and Nevis gain a wide range of benefits including:

  • The right to live, work and study in St Kitts and Nevis
  • Alternative business prospects
  • The ability to pass down citizenship
  • A fair tax regime, with no worldwide income, inheritance, and gift tax for tax residents

Investors can call St Kitts and Nevis home by simply investing in the country's Sustainable Growth Fund, which utilises revenue generated to support different sectors of society, including tourism, health, education and construction.

The Sustainable Growth Fund is the most direct investment path to St Kitts and Nevis citizenship and requires an investment of just US$150 000.00.

The Sustainable Growth Fund allows future citizens of St Kitts and Nevis to be part of the success story as this investment channel enables both applicants and the nation to thrive.

Monies from the Fund have offered a much–needed injection of foreign direct investment for St Kitts and Nevis, often in a way that can make a significant developmental difference and a sizable impact on economic activity.

St Kitts and Nevis' CBI Programme contributed more than 30 per cent of GDP in the country in 2020.

According to the CBI Unit Head Les Khan, the Programme's revenue was a “main driver” during lockdown when tourism was at an all–time low.

In December 2021, Minister Brantley stated that St Kitts and Nevis' bilateral agreements totalled an all–time high. The historic announcement revealed that citizens of the small eastern Caribbean nation could access over 161 jurisdictions worldwide, including major business hubs in Asia, Europe, Africa, and the Americas.

During his Budget 2022 presentation in December, Minister Brantley said that the Ministry of Foreign Affairs and Aviation “shall continue to seek means of convergence with all of our partners, that we advance our discussions and actions around our mutual interests.”

He also added that the government would continue to build on key affiliations with strategic partners to further strengthen bilateral relations and forecasted that face–to–face engagements at ministerial and ambassadorial levels would increase as quarantine and travel restrictions ease.

St Kitts and Nevis' increasing international diplomacy and travel partnerships are a major pull factor for time–poor high net worth investors looking to obtain a second citizenship.

Contact:
pr@csglobalpartners.com
www.csglobalpartners.com
+447824029952

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ab2b792e–13ff–485b–b1e1–2e4ab86a53ce


GLOBENEWSWIRE (Distribution ID 8502474)