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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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Crurated Partners With More than 50 World Renowned European Winemakers to Raise Funds for Ukraine Relief Efforts

Coveted producers including Louis Roederer Cristal, Domaine Meo-Camuzet, and Domaine Dujac offer up lots of wine for auction with the initial pre-auction value at $100,000

Each bottle sold includes access to an exclusive NFT that verifies authenticity, ownership history, vintage, vineyard location, varietal, and more

LONDON, March 12, 2022 (GLOBE NEWSWIRE) — The world’s top wine producers are responding to the humanitarian crisis in Ukraine in an innovative way. Crurated, the London-based membership wine community designed to connect connoisseurs with world-class producers, has announced it is dedicating the week of March 14-20, 2022 for The All Heart Auction, an online event auctioning rare wines from world renowned producers to support humanitarian needs of the Ukrainian people. Selected producers donating wines for the auction include Louis Roederer Cristal, Domaine Meo-Camuzet, and Domaine Dujac among many others. The initial value of the more than 250 bottles of wine pre-auction totals $100,000. A full list of all producers participating is below.

Members and non-members alike are encouraged to participate and bid. Interested bidders are invited to register for an account at www.crurated.com. Non-members can sign-up for a free Explorer membership, allowing anyone to submit bids on the Crurated platform and participate in the fundraising event.

100% of the funds raised from the auction will be distributed to Red Cross, Save The Children, UNHCR, and UNICEF.

The team from Crurated has also developed a unique platform that offers clients an accompanying NFT with each purchase. Recorded forever on the blockchain, the NFT verifies authenticity of the bottle and provides other important details including ownership history, vintage, vineyard location, varietal, and other key details. The NFTs are easily accessible by tapping on an NFC or RFID enabled phone. The bottle history is also updated via a new blockchain recording anytime the wine is resold and the token moves from one client to another. The company uses Polygon technology for NFTs and blockchain.

“It has been amazing watching the world unite to help the people of Ukraine. Our auction initiative represents how I feel about wine and its ability to offer such a generous gift to the world,” said Alfonso de Gaetano, Founder of Crurated. “Our platform is also perfectly suited for this initiative because we automatically assign an NFT for every bottle that is brought into our warehouse and loaded onto the platform. We are anticipating an exciting auction with generous donors pitching in to help lessen the humanitarian crisis.”

“We have had a special link to Ukraine for more than 20 years and have sponsored a charitable event to help young dancers and their families in Lviv. We’ve also raised funds for the Lviv pediatric hospital,” said Jean-Nicolas & Nathalie Méo, of Meo-Camuzet. “Some of the children we had at home for summer vacation are probably old enough to be fighting now, and we dread the thought of their involvement in this war. We hope that the very special wines we have donated for the auction will receive an appropriate welcome and help support the needs of the Ukrainian civilians.”

Other world-class winemakers participating in the auction include: Larmandier-Bernier, Pascal Agrapart, Pierre Péters, Suenen, Bérêche & Fils, Doyard, Moussé Fils, Salon, Vilmart & Cie, Billecart-Salmon, Geoffroy, Pierre-Yves Colin-Morey, Caroline Colin-Morey, Robert Groffier, Père & Fils, Pierre-Yves Colin-Morey, Caroline Colin-Morey, Robert Groffier Père & Fils, Georges Mugneret-Gibourg, Arnaud Baillot, Duroché, Fourrier, Denis Mortet, Dujac, Chateau Pavie, Tenuta Sette Ponti, Ceretto, Massolino, Poderi Aldo Conterno, Grattamacco, Casanova di Neri, Ciacci Piccolomini d’Aragona, Bartolo Mascarello, Biondi Santi, Argiano, Mascarello Giuseppe e Figlio, Il Marroneto, Giacomo Conterno, Montevertine, Tenuta di Trinoro, Elio Altare, Fontanafredda, Borgogno, and Roberto Voerzio.

About Crurated
Launched in 2021 with an emphasis on France and Italy, Crurated is a membership-based wine community designed to connect connoisseurs with world-class producers. A team of specialists provides personalized services and authentic experiences, while Crurated’s seamless logistics service guarantees quality and provenance thanks to secure wine cellar storage and innovative blockchain technology. For more on Crurated, visit crurated.com.

Contact:
Michael Volpatt
michael@larkingvolpatt.com

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/55b86cad-5691-4932-825d-2db421ba1005

https://www.globenewswire.com/NewsRoom/AttachmentNg/4144ffac-f7ef-4b74-bcd0-cd2e5bb5ef78

PDF available: http://ml.globenewswire.com/Resource/Download/0f1d1375-a96e-4baa-9585-d3c7484b85f3

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Nyxoah to Participate in the Oppenheimer 32nd Annual Healthcare Conference

Nyxoah to Participate in the Oppenheimer 32nd Annual Healthcare Conference

Mont-Saint-Guibert, Belgium – March 10, 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 Company will present at the Oppenheimer 32ndAnnual Healthcare Conference, which will be held virtually from March 15-17, 2022.

Olivier Taelman, Nyxoah’s Chief Executive Officer, is scheduled to present a corporate update on Wednesday, March 16, 2022, at 10:40am EST. Please click here to access the live webcast of the presentation. The webcast will also be available on the Eventspage of Nyxoah’s investor relations website.

Nyxoah’s updated Investor Presentation can be accessed on the Shareholder Information section of the Company’s Investor Relations page.

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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Sophi.io is INMA 2022 Global Media Awards Finalist for Print Automation

TORONTO, March 10, 2022 (GLOBE NEWSWIRE) — Sophi.io, The Globe and Mail’s AI-powered automation and optimization platform, was announced this week as a finalist in the International News Media Association (INMA)’s 2022 Global Media Awards in the category of Best Innovation in Newsroom Transformation. Partnering with Naviga, it automated print laydown for Agderposten, a regional daily newspaper that serves over 25,000 readers across Norway, and increased print efficiencies by 66%.

“Sophi’s automated machine-learning system is the biggest transformation to print media in decades,” said Gordon Edall, Co-Founder at Sophi.io. “We’re grateful that Agderposten chose to work with Naviga and us. Their commitment to improving efficiency and embracing ground-breaking technology like Naviga Publisher powered by Sophi.io should inspire the entire media industry to look forward to a future where AI and automation helps everyone.”

Naviga Publisher powered by Sophi.io is an artificial intelligence-powered system that emulates human decisions to produce newspaper pages that look like they were created with an understanding of the news of the day as well as high journalistic standards. All editors need to do is roughly prioritize articles and hit the “Print My Newspaper” button to generate an automated print laydown, without templates, in minutes. Handing over this labour-intensive task lets newsrooms focus on their real objective of finding and telling the next important story.

“It’s hours saved for journalism,” said Agderposten’s Editor-in-Chief Katrine Lia. And the staff at Agderposten often cannot tell the difference between pages produced by Sophi and those handled by their editors.

Sophi and Naviga, a large software technology provider for the global publishing industry, have been working with Agderposten for more than a year now and successes there have paved the way to bringing dozens of new titles from several major publishing houses on board this year. Sophi provides cutting edge AI and ML technology that, along with Naviga Publisher, fully automates the end-to-end print production workflow.

Agderposten was the first customer to use Publisher. Its print production process is now centralized, its newspaper laydown is up to 80% automated, and most impressively, Agderposten has realized a 66% reduction in time and resources – lowering the cost of producing the printed newspaper and letting journalists work on creating digital content rather than operating InDesign.

Agderposten CEO Øyvind Klausen said he expected cost savings and efficiency would continue to increase as more of Agderposten’s pages were automated and more of its newspapers implemented the print automation solution.

The Global Media Awards received 854 entries from 252 news brands in 46 countries this year. The judges consist of 50 media experts from 24 countries focused across 20 categories, including news brands, media platforms, subscriptions, advertising, data and insights, product, and newsrooms. The first place winners will be announced on June 9.

About Naviga
Naviga (https://www.navigaglobal.com) is the leading provider of software and services powering media-rich industries. Their Content Engagement Platform helps companies create, enrich, deliver and monetize content to manage engagements from end-to-end. Their solutions are easy to use, scalable and agile. Combining their experience in media with a dedication to digital, they’ve developed software solutions that help any content-driven business meet the demands of the future of information. With headquarters in Bloomington, MN and regional offices throughout the world, Naviga is a trusted partner serving over 1,400 news media, entertainment media, broadcast, magazine, financial services and corporate clients in 45 countries.

About Sophi.io 
Sophi.io (https://www.sophi.io) was developed by The Globe and Mail to help content publishers make important strategic and tactical decisions. It is a suite of AI and ML-powered automation, optimization and prediction solutions that include Sophi Site Automation, Sophi for Paywalls and Sophi for First Party Data. Sophi also powers Naviga Publisher for one-click automated laydown of print and ePaper publishing. Sophi is designed to improve the metrics that matter most to your business, such as subscriber retention and acquisition, engagement, recency, frequency and volume.

Media Contact  
Jamie Rubenovitch 
Head of Marketing, Sophi 
The Globe and Mail         
416-585-3355  
jrubenovitch@globeandmail.com 
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Ms. Opal Lee, The Nobel Peace Prize Nominee, and Grandmother of Juneteenth, Signed with Creative Artists Agency

Fort Worth, TX, March 10, 2022 (GLOBE NEWSWIRE) — Unity Unlimited, Inc.’s very own ‘Grandmother of Juneteenth’  Ms. Opal Lee, has signed with Creative Artists Agency (CAA), the world’s leading entertainment and sports agency, to obtain talent representation as she campaigns for unity and freedom around the globe.

Ms. Opal began her mission in 2016 with a goal set forth to walk 1,400 miles from Fort Worth, Texas, to the steps of Congress in Washington D.C, intending to establish Juneteenth as a nationally recognized holiday. Through a strategic partnership with global brand storytelling agency [INVNT GROUP]™, and support from CAA and the CAA Foundation, Opal’s Walk 2 DC mobilized into a viral movement across the nation. On June 21, 2021, with Ms. Opal at his side, President Joe Biden signed the bill to make Juneteenth a federal holiday in the United States – the first since 1983, when Martin Luther King Day was established.

Ms. Opal is deeply honored to join CAA’s network and roster of world-class entertainers and changemakers, granting her movement the opportunity to connect with generations of people to share the story of Juneteenth for legacies to come.

The signing comes days after releasing a special edition of Ms. Opal’s children’s book:  Juneteenth A Children’s Story Special Edition. The book explains the significance and origin of Juneteenth to promote the open education of young children, their parents, and teachers worldwide.

Dione Sims, Founder of Unity Unlimited, Inc., explained, “Establishing the federal holiday has created a vacuum for accurate information about Juneteenth, and we are honored that CAA is putting their resources to work to provide Ms. Opal the opportunities to educate the world about Juneteenth and the freedoms that were gained.”

For more information, please visit www.therealopallee.com.

ABOUT OPAL LEE

Ms. Opal is the oldest living board member of the National Juneteenth Observance Foundation (NJOF), founded and led by the late Dr. Ronald Myers, Sr., whose initiative is for Juneteenth to become a national holiday. To bring awareness to the cause, she started her Opal’s Walk 2 DC  campaign in 2016, where she walked 2.5 miles to symbolize the 2.5 years that it took for enslaved people in  Texas to know that they were free. Ms. Opal launched a petition to make Juneteenth a national holiday on Change.org. In September 2020, it delivered the 1.5 million signatures it had received to  Congress. Ms. Opal believes freedom should be celebrated from the 19th of June to the 4th of July.  For more information, visit https://adobe.ly/3hs3jg0.

ABOUT CAA

CAA is a leading entertainment, media, and sports enterprise, with global expertise in motion pictures, television, music, sports, theater, digital media, publishing, endorsements, media finance, consumer investing, fashion, podcasting, speaking, games, and philanthropy. Led by a world-class management team and distinguished by its culture of collaboration and exceptional client service, CAA’s diverse workforce identifies and innovates opportunities for the people and organizations that shape culture and inspire the world. For more information, visit https://www.caa.com.

ABOUT UNITY UNLIMITED

Unity Unlimited, Inc. is a non-profit organization whose main mission is to provide educational activities and resources to the young and old, fostering unity and harmony within the community, the city,  the state, the nation, and the world regardless of race and culture, or denomination. For more information, visit: www.unityunlimited.org/

ABOUT [INVNT GROUP] 

[INVNT GROUP] was established in 2020, as an evolution of the founding global live brand storytelling agency INVNT in 2008, with a vision to provide consistent, meaningful, well-articulated BrandStory across all platforms. With offices in New York, Sydney, London, Singapore, San Francisco, Stockholm, Detroit, and Washington D.C.; headed by President and CEO, Scott Cullather, [INVNT GROUP], THE GLOBAL BRANDSTORY PROJECT™ represents a growing portfolio of complementary disciplines designed to help forward-thinking organizations everywhere, impact the audiences that matter, anywhere. The GROUP consists of modern brand strategy firm Folk Hero; creative-led culture consultancy, Meaning; production studio & creative agency, HEVĒ; events for colleges and universities, INVNT Higher Ed, and the original live brand storytelling agency, INVNT. For more information, visit www.invntgroup.com.

Daria Hookfin
Hooked On Ent
16825009347
daria@hookenterprises.com

Dione Sims
Unity Unlimited
18173176262
dione.sims@unityunlimited.org

 

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EMGA advises on US$200M debt raise for BTG Pactual with JICA

LONDON, March 10, 2022 (GLOBE NEWSWIRE) — Emerging Markets Global Advisory Limited (EMGA), the niche investment bank focused on emerging markets, announces today another landmark Senior Debt capital raise transaction that will allow BTG Pactual to continue the expansion of its small and medium-sized enterprise (SME) lending activities in Brazil.

The US$200 million debt facility was provided by JICA and the transaction follows on from two previous DFI financed facilities of US$140 million and US$300 million respectively that EMGA has had also advised on.

A JICA spokesman said, “Thanks to EMGA’s support, we will partner Banco BTG Pactual S.A. addressing the funding gap for MSMEs in Brazil. BTG Pactual is among the first to introduce digital platforms offering financial solutions to businesses throughout the whole nation. With its digital platforms readily available to support the lending operation, Banco BTG Pactual S.A. can efficiently extend credits to the Northeast and Northern Regions, where only a limited number of financial institutions are actively operating to serve businesses at this time.”

Sajeev Chakkalakal, Managing Director and Head of Investment Banking at EMGA, said: “It was a real pleasure to help BTG’s team again by advising on this additional facility aimed at funding BTG’s small and medium enterprise loan portfolio across Brazil. JICA is an important partner of EMGA and its position as a pre-eminent development finance institution also offers another new strategic long term funding source for BTG.”

Jeremy Dobson, Managing Director, and Head of Business Development at EMGA, added: “Our team is delighted to have acted as advisor again to BTG and look forward to their continued success.”

BTG Pactual: BTG is the largest investment bank in Latin America, the 6th largest bank in Brazil by shareholders equity and a key player in providing loans and guarantees to a broad set of clients, from SMEs to large corporations. BTG is a pioneer in promoting climate finance in Brazil and plays a pivotal role in channeling resources towards projects with a positive impact in the community.

JICA: The Japan International Cooperation Agency is a governmental agency that delivers the bulk of Official Development Assistance for the government of Japan. It is chartered with assisting economic and social growth in developing countries, and the promotion of international cooperation.

Emerging Markets Global Advisory Limited (EMGA), with offices in London and New York, helps financial institutions and corporates seeking new debt or equity capital. EMGA’s multi-national team combine the decades of experience necessary to complete transactions on behalf of their clients within the world’s emerging markets and frontier economies, including Brazil which remains a key market. With a proven track record in capital formation and strategic advisory throughout diverse economic cycles, EMGA continues expanding its geographic reach and service offering, solidifying its place in the market as one of the industries pre-eminent emerging markets focused niche investment banks.

Contact info@emergingmarketsglobaladvisory.com