Author: Asianet Pakistan

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FDA Issues Nyxoah an Approvable Letter for its Genio® System

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FDA Issues Nyxoah an Approvable Letter for its Genio® System

Mont-Saint-Guibert, Belgium – March 26, 2025, 8:00am CET / 3:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA) through neuromodulation, today announced that the U.S. Food and Drug Administration (FDA) has issued an Approvable Letter regarding the Company’s Pre-Market Approval (PMA) application for the Genio® system.

The Approvable Letter means that Nyxoah’s application for marketing the device in the United States substantially meets the requirements of the Federal Food, Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA will approve the application subject to satisfactory completion of a manufacturing facilities, methods and controls review. The Company will work closely with the FDA to address these requests and is committed to bringing this innovative therapy to U.S. patients.

“The FDA has reviewed our submission and determined that it substantially meets the requirements for approval: the FDA’s Approvable Letter included no further questions on the clinical data or biocompatibility that support the submission,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “We are still on the right track to make Genio available to U.S. patients suffering from OSA.”

This decision does not impact Genio’s CE Mark or ongoing commercial activities in Europe, where the device is approved for both Complete Concentric Collapse (CCC) and non-CCC patients.

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 announced positive outcomes from the DREAM IDE pivotal study.

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.

FORWARD-LOOKING STATEMENTS

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current 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; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; the satisfactory completion of a manufacturing facilities, methods and controls review and receipt of FDA approval; entrance to the U.S. market; and the Company’s results of operations, financial condition, liquidity, performance, prospects, growth and strategies. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2025, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
John Landry, CFO
[email protected]

For Media
In United States
FINN Partners – Alyssa Paldo
[email protected]

In International/Germany
MC Services – Anne Hennecke
[email protected]

In Belgium/France
Backstage Communication – Gunther De Backer
[email protected]

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GlobeNewswire Distribution ID 1001076080

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Bitdeer AI Innovative Solutions Recognized with a 2025 Artificial Intelligence Excellence Award

Winning in the outstanding organization of Internet and Technology category, the Award highlights its ongoing contributions to advancing artificial intelligence

SINGAPORE, March 26, 2025 (GLOBE NEWSWIRE) — Bitdeer AI, part of Bitdeer Technologies Group (NASDAQ: BTDR), an emerging AI cloud service provider, is proud to announce that it has been named a winner in the 2025 Artificial Intelligence Excellence Awards, as an outstanding organization of Internet and Technology category, presented by the Business Intelligence Group. This recognition highlights the company’s commitment to innovation and its contributions to advancing artificial intelligence.

The Artificial Intelligence Excellence Awards celebrate the most innovative companies, technologies, and professionals who are leading the way in AI innovation. Winners are selected by a panel of industry experts who evaluate nominees based on their creativity, impact, and measurable success in AI-driven solutions.

“We are incredibly honored to receive this recognition from the Business Intelligence Group,” said Louis Xu, Head of Bitdeer AI.” This award is a testament to the dedication of our team and our mission to push the boundaries of AI to create meaningful solutions that improve business efficiency across different industries.”

“The AI industry is evolving rapidly, and it is through the efforts of companies like Bitdeer AI that we see real-world applications driving change,” said Russ Fordyce, CEO of the Business Intelligence Group. “Their work exemplifies the kind of innovation and leadership that is shaping the future of artificial intelligence.”

Bitdeer AI is committed to leading the way in AI and machine learning innovation, offering a streamlined, scalable AI cloud platform that simplifies AI development workflows and accelerates breakthroughs for AI and HPC. Powered by high-performance, industry-leading GPU infrastructure, Bitdeer AI’s platform provides GPU power and AI Studio, creating an optimized environment to support the entire AI development journey, from model training to deployment. The platform enables seamless integration, fosters cross-team collaboration, and offers flexible pricing options, making advanced AI technologies accessible to businesses of all sizes. Building on its cloud services foundation, Bitdeer AI is advancing to the next stage with GB200 NVL72 deployment and AI Agent technology, driving the evolution of AI applications and empowering enterprises.

About Bitdeer AI
Bitdeer AI is an emerging provider of AI and ML GPU cloud solutions, dedicated to accelerating innovation and empowering businesses with advanced computing resources and an AI training platform. As an NVIDIA Cloud Partner in Singapore, Bitdeer AI delivers high-performance GPU cloud infrastructure, enabling organizations across industries to advance impactful AI initiatives and drive meaningful goals. For more information, please visit https://www.bitdeer.ai.

Forward-Looking Statements
This press release may contain forward-looking statements regarding Bitdeer AI’s anticipated future performance, market opportunities, and business strategies. These statements are based on current beliefs, assumptions, and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Bitdeer.AI disclaims any obligation to update or revise these forward-looking statements to reflect future events or developments, except as required by law.

Contact
Retainna Lin
[email protected]

 

GlobeNewswire Distribution ID 9410229

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RAA and Duck Creek Technologies announce new SaaS core insurance delivery technology partnership

Duck Creek’s full suite to help RAA deliver more innovative products and value to their 825,000+ members

SYDNEY, March 25, 2025 (GLOBE NEWSWIRE) — Duck Creek Technologies, the global provider defining the future of property and casualty (P&C) and general insurance, has announced a new SaaS core insurance delivery technology partnership with South Australia’s largest personal lines insurer, RAA.

Duck Creek’s solutions, including Policy, Rating, Billing, Claims and Clarity (data and insights), served via their OnDemand cloud-delivery platform, will replace RAA’s incumbent on-premises legacy technology for their personal motor and home insurance products.

Duck Creek’s platform, featuring open and flexible architecture, line-of-business kits, local layers, and simple integrations will help RAA improve speed to market for new products, and provide an increasingly modern and seamless digital user experience for their 825,000+ members.

James Galdes, Chief Technology Officer at RAA said, “We’re excited to welcome Duck Creek as our core insurance technology partner for our personal and motor insurance products. As South Australia’s largest personal lines insurer, our members’ needs and expectations are continually evolving, and we require a more flexible, nimble and sustainable insurance delivery platform. We’ve found this with Duck Creek Technologies. Their future-proof SaaS core insurance delivery technology will help us unlock efficiencies and uplift our staff and members’ experiences now, and into the future.”

In addition to allowing RAA to deliver its members more innovative products, and more value, RAA will also receive significant operational benefits and increased efficiencies from the new solutions.

“Duck Creek’s cloud-native SaaS will help reduce our data center footprint whilst improving scalability and availability. It will simplify regulatory compliance thanks to the platform’s security that’s been built for the Australian context. The fortnightly silent updates through active delivery will eliminate disruptive upgrades and costly downtime. This means we can focus more on delivering coverage, confidence, value and greater member experiences, and focus less on technology,” according to Mr. Galdes.

Christian Erickson, Managing Director APAC, Duck Creek Technologies said the new partnership represents a significant milestone for Duck Creek Technologies.

“As a member-based organisation, RAA required more than just protection for policyholders. They pride themselves on delivering value to members. RAA has a big vision and high expectations and will be pushing the boundaries of innovation and possibilities. We’re looking forward to the challenge of supporting and enabling this,” said Erickson.

RAA’s decision came following a thorough evaluation process. “We leveraged our strategic partners in Gartner and Deloitte to lead a comprehensive market evaluation process. Duck Creek’s evergreen architecture, strong partnership ethos, local product support, and pre-built marketplace connectors were recognised as distinct advantages,” according to Mr. Galdes.

This announcement follows recent news of a new strategic partnership between RAA and Allianz Australia. Under the 20-year partnership, RAA will be responsible for the marketing and distribution of insurance products, while Allianz will be responsible for product, pricing, claims and underwriting.

About Duck Creek Technologies

Duck Creek Technologies is the global intelligent solutions provider defining the future of the property and casualty (P&C) and general insurance industry. We are the platform upon which modern insurance systems are built, enabling the industry to capitalize on the power of the cloud to run agile, intelligent, and evergreen operations. Authenticity, purpose, and transparency are core to Duck Creek, and we believe insurance should be there for individuals and businesses when, where, and how they need it most. Our market-leading solutions are available on a standalone basis or as a full suite, and all are available via Duck Creek OnDemand. Visit www.duckcreek.com to learn more. Follow Duck Creek on our social channels for the latest information – LinkedIn and X.

Media Contacts:
Chris Hamilton
[email protected]

GlobeNewswire Distribution ID 9409701

Posted on

RAA and Duck Creek Technologies announce new SaaS core insurance delivery technology partnership

Duck Creek’s full suite to help RAA deliver more innovative products and value to their 825,000+ members

SYDNEY, March 25, 2025 (GLOBE NEWSWIRE) — Duck Creek Technologies, the global provider defining the future of property and casualty (P&C) and general insurance, has announced a new SaaS core insurance delivery technology partnership with South Australia’s largest personal lines insurer, RAA.

Duck Creek’s solutions, including Policy, Rating, Billing, Claims and Clarity (data and insights), served via their OnDemand cloud-delivery platform, will replace RAA’s incumbent on-premises legacy technology for their personal motor and home insurance products.

Duck Creek’s platform, featuring open and flexible architecture, line-of-business kits, local layers, and simple integrations will help RAA improve speed to market for new products, and provide an increasingly modern and seamless digital user experience for their 825,000+ members.

James Galdes, Chief Technology Officer at RAA said, “We’re excited to welcome Duck Creek as our core insurance technology partner for our personal and motor insurance products. As South Australia’s largest personal lines insurer, our members’ needs and expectations are continually evolving, and we require a more flexible, nimble and sustainable insurance delivery platform. We’ve found this with Duck Creek Technologies. Their future-proof SaaS core insurance delivery technology will help us unlock efficiencies and uplift our staff and members’ experiences now, and into the future.”

In addition to allowing RAA to deliver its members more innovative products, and more value, RAA will also receive significant operational benefits and increased efficiencies from the new solutions.

“Duck Creek’s cloud-native SaaS will help reduce our data center footprint whilst improving scalability and availability. It will simplify regulatory compliance thanks to the platform’s security that’s been built for the Australian context. The fortnightly silent updates through active delivery will eliminate disruptive upgrades and costly downtime. This means we can focus more on delivering coverage, confidence, value and greater member experiences, and focus less on technology,” according to Mr. Galdes.

Christian Erickson, Managing Director APAC, Duck Creek Technologies said the new partnership represents a significant milestone for Duck Creek Technologies.

“As a member-based organisation, RAA required more than just protection for policyholders. They pride themselves on delivering value to members. RAA has a big vision and high expectations and will be pushing the boundaries of innovation and possibilities. We’re looking forward to the challenge of supporting and enabling this,” said Erickson.

RAA’s decision came following a thorough evaluation process. “We leveraged our strategic partners in Gartner and Deloitte to lead a comprehensive market evaluation process. Duck Creek’s evergreen architecture, strong partnership ethos, local product support, and pre-built marketplace connectors were recognised as distinct advantages,” according to Mr. Galdes.

This announcement follows recent news of a new strategic partnership between RAA and Allianz Australia. Under the 20-year partnership, RAA will be responsible for the marketing and distribution of insurance products, while Allianz will be responsible for product, pricing, claims and underwriting.

About Duck Creek Technologies

Duck Creek Technologies is the global intelligent solutions provider defining the future of the property and casualty (P&C) and general insurance industry. We are the platform upon which modern insurance systems are built, enabling the industry to capitalize on the power of the cloud to run agile, intelligent, and evergreen operations. Authenticity, purpose, and transparency are core to Duck Creek, and we believe insurance should be there for individuals and businesses when, where, and how they need it most. Our market-leading solutions are available on a standalone basis or as a full suite, and all are available via Duck Creek OnDemand. Visit www.duckcreek.com to learn more. Follow Duck Creek on our social channels for the latest information – LinkedIn and X.

Media Contacts:
Chris Hamilton
[email protected]

GlobeNewswire Distribution ID 9409701

Posted on

RAA and Duck Creek Technologies announce new SaaS core insurance delivery technology partnership

Duck Creek’s full suite to help RAA deliver more innovative products and value to their 825,000+ members

SYDNEY, March 25, 2025 (GLOBE NEWSWIRE) — Duck Creek Technologies, the global provider defining the future of property and casualty (P&C) and general insurance, has announced a new SaaS core insurance delivery technology partnership with South Australia’s largest personal lines insurer, RAA.

Duck Creek’s solutions, including Policy, Rating, Billing, Claims and Clarity (data and insights), served via their OnDemand cloud-delivery platform, will replace RAA’s incumbent on-premises legacy technology for their personal motor and home insurance products.

Duck Creek’s platform, featuring open and flexible architecture, line-of-business kits, local layers, and simple integrations will help RAA improve speed to market for new products, and provide an increasingly modern and seamless digital user experience for their 825,000+ members.

James Galdes, Chief Technology Officer at RAA said, “We’re excited to welcome Duck Creek as our core insurance technology partner for our personal and motor insurance products. As South Australia’s largest personal lines insurer, our members’ needs and expectations are continually evolving, and we require a more flexible, nimble and sustainable insurance delivery platform. We’ve found this with Duck Creek Technologies. Their future-proof SaaS core insurance delivery technology will help us unlock efficiencies and uplift our staff and members’ experiences now, and into the future.”

In addition to allowing RAA to deliver its members more innovative products, and more value, RAA will also receive significant operational benefits and increased efficiencies from the new solutions.

“Duck Creek’s cloud-native SaaS will help reduce our data center footprint whilst improving scalability and availability. It will simplify regulatory compliance thanks to the platform’s security that’s been built for the Australian context. The fortnightly silent updates through active delivery will eliminate disruptive upgrades and costly downtime. This means we can focus more on delivering coverage, confidence, value and greater member experiences, and focus less on technology,” according to Mr. Galdes.

Christian Erickson, Managing Director APAC, Duck Creek Technologies said the new partnership represents a significant milestone for Duck Creek Technologies.

“As a member-based organisation, RAA required more than just protection for policyholders. They pride themselves on delivering value to members. RAA has a big vision and high expectations and will be pushing the boundaries of innovation and possibilities. We’re looking forward to the challenge of supporting and enabling this,” said Erickson.

RAA’s decision came following a thorough evaluation process. “We leveraged our strategic partners in Gartner and Deloitte to lead a comprehensive market evaluation process. Duck Creek’s evergreen architecture, strong partnership ethos, local product support, and pre-built marketplace connectors were recognised as distinct advantages,” according to Mr. Galdes.

This announcement follows recent news of a new strategic partnership between RAA and Allianz Australia. Under the 20-year partnership, RAA will be responsible for the marketing and distribution of insurance products, while Allianz will be responsible for product, pricing, claims and underwriting.

About Duck Creek Technologies

Duck Creek Technologies is the global intelligent solutions provider defining the future of the property and casualty (P&C) and general insurance industry. We are the platform upon which modern insurance systems are built, enabling the industry to capitalize on the power of the cloud to run agile, intelligent, and evergreen operations. Authenticity, purpose, and transparency are core to Duck Creek, and we believe insurance should be there for individuals and businesses when, where, and how they need it most. Our market-leading solutions are available on a standalone basis or as a full suite, and all are available via Duck Creek OnDemand. Visit www.duckcreek.com to learn more. Follow Duck Creek on our social channels for the latest information – LinkedIn and X.

Media Contacts:
Chris Hamilton
[email protected]

GlobeNewswire Distribution ID 9409701

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Reese Witherspoon to keynote Meltwater Summit 2025 with dynamic speaker lineup

The annual two-day event will feature industry leaders from top brands including Microsoft, Yahoo, Heineken, Paramount, and more

SAN FRANCISCO, March 25, 2025 (GLOBE NEWSWIRE) — Meltwater, a global leader in media, social and consumer intelligence, today announced a lineup of industry-leading speakers for Meltwater Summit 2025. Set against the backdrop of Times Square in New York City, the event returns for its third year on May 6-7 and will be headlined by Reese Witherspoon as the celebrity keynote speaker.

Award-winning actress, producer, entrepreneur, and bestselling author, Witherspoon has mastered the art of storytelling across film, media, and business—turning her passion for authentic narratives into globally recognized brands like Hello Sunshine, Draper James, and Reese’s Book Club. At Meltwater Summit, she’ll share insights on driving impact through storytelling, building meaningful connections through social platforms, developing cohesive multi-channel brand strategies, and scaling women-centric businesses. Her experience embodies this year’s Summit theme, Insights to Impact, offering attendees a unique perspective on transforming data into stories that foster lasting consumer relationships.

Meltwater Summit is a premier two-day event for PR and marketing professionals eager to transform data and insights into impactful strategies. Building on past success with keynote speakers like Ryan Reynolds, Bethenny Frankel and Trevor Noah, Witherspoon will headline this year’s conference that features a diverse lineup of industry leaders from the world’s top brands. Sessions will explore topics such as building brand resilience in a disinformation-driven world, breaking through in today’s crowded media landscape, tapping into social listening for trend forecasting, and mastering AI for PR and Marketing.

Featured speakers at Meltwater Summit 2025 include:

  • Barbara Peng, CEO, Business Insider
  • Sona Iliffe-Moon, Chief Communications Officer, Yahoo
  • Sawyer Hemsley, Co-Founder & Chief Brand Officer, Crumbl
  • Melissa Layton, Vice President, Global Communications, Crocs, Inc.
  • Stephanie Cohen Glass, Director of Corporate Communications, Microsoft
  • Vanessa Mbonu, Vice President of Marketing, NAACP
  • Narek Garit, Global Measurement & Analysis Lead, Heineken
  • Temeka Easter Rice, Head of Social Media, Vanguard
  • John Box, CEO, Meltwater

“Our vision for Meltwater Summit is to build a vibrant community of PR, Comms and Marketing professionals where they can engage in meaningful conversations and share innovative strategies that address the challenges they face every day,” said Jenny Force, Global VP of Demand Generation, Meltwater. “By bringing together the brightest minds in our industry, we’re creating a space for experts to share their knowledge and drive real impact. We are thrilled to have Reese Witherspoon join us, as she exemplifies the transformative power of storytelling and brand authenticity in today’s market.”

Learn more about Meltwater Summit 2025, the agenda, featured speakers, and registration information here: https://www.meltwater.com/en/summit/2025#register

For more information, please contact:
Kelly Costello
Corporate Communications Director
[email protected]

About Meltwater
Meltwater empowers companies with solutions that span media, social and consumer intelligence. By analyzing ~1 billion pieces of content daily and transforming them into vital insights, Meltwater unlocks the competitive edge to drive results. With 27,000 global customers, 50 offices across six continents, and 2,300 employees, Meltwater is the industry partner for global brands making an impact. Learn more at meltwater.com.

GlobeNewswire Distribution ID 9410126