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NYXOAH S A - NYXH STOCK NEWS

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Overview

Nyxoah SA is a health-technology company that pioneers innovative therapeutic solutions to treat sleep disordered breathing conditions, with an emphasis on Obstructive Sleep Apnea (OSA). Utilizing state‐of‐the‐art neurostimulation technology, Nyxoah has developed the Genio system – a user‐centered, bilateral neurostimulation therapy that has obtained CE‐Mark validation. This advancement establishes the company as a significant contributor in the medical technology and sleep health sectors, addressing conditions that impact patient quality of life and are closely linked with other serious health risks.

Technology and Therapeutic Innovation

At the core of Nyxoah's operations is its Genio system, an innovative neurostimulation platform designed for the treatment of moderate to severe OSA. The system operates by delivering bilateral neurostimulation, which targets key nerve pathways involved in maintaining airway patency during sleep. This approach not only offers a novel alternative to traditional therapies but also emphasizes a user-centered design that considers patient comfort and daily lifestyle compatibility. The device’s technology merges precision engineering with clinical research, ensuring that both safety and therapeutic efficacy are at the forefront of its design.

Clinical Background and Impact

Obstructive Sleep Apnea is a prevalent sleep disorder with significant health implications, including increased risks of cardiovascular diseases, depression, and stroke. Nyxoah’s therapeutic platform fills an important gap in this space by providing an option for patients who have either not responded well to existing treatments or seek a more comfortable, less invasive solution. By addressing not only the primary symptoms of OSA but also the broader physiological impact, Nyxoah contributes to improved patient outcomes, highlighting the critical intersection between innovative technology and clinical care.

Business Model and Market Strategy

Nyxoah SA generates its revenue primarily through the commercialization of its proprietary neurostimulation system. The company’s business model blends direct device sales with strategic partnerships and licensing agreements to reach various healthcare markets around the globe. This multi-channel approach allows the company to distribute its technology widely while continuing to invest in research and development. The application of a rigorous, clinically validated therapeutic device supports both long-term market growth and industry credibility.

Regulatory and Clinical Credibility

A key element of Nyxoah’s operational success lies in its adherence to stringent regulatory standards. With the Genio system having received CE-Mark validation, the company is recognized for its compliance with European medical device regulations, ensuring that its solutions meet high clinical and safety benchmarks. This regulatory approval not only reinforces the reliability of Nyxoah’s technology but also serves as an indicator of its commitment to developing devices that undergo thorough clinical evaluation before reaching the market.

Competitive Landscape

The market for sleep disordered breathing treatments is competitive and complex, populated by companies offering a range of therapeutic solutions. Nyxoah distinguishes itself by focusing on a unique, technology-driven approach that leverages neurostimulation rather than traditional positive airway pressure-based therapies. By addressing OSA with a system designed to optimize patient adherence and comfort, Nyxoah carves out a niche within a specialized segment of the medical technology industry. This differentiation is critical in a landscape that demands not only innovation but also demonstrable clinical benefits.

Operational and Clinical Integration

Operational excellence at Nyxoah is driven by a deep integration of engineering innovation with clinical expertise. The company maintains robust channels for feedback from healthcare professionals, ensuring that each iteration of its therapeutic device aligns with real-world clinical practices. This synergistic approach supports a cycle of continuous improvement, essential for maintaining credibility and demonstrating the long-term viability of Nyxoah’s solutions in diverse healthcare settings. Furthermore, the company's investment in long-term research initiatives underscores its commitment to evolving therapeutic standards within its field.

Research and Development Focus

Significant research and development efforts are fundamental to Nyxoah’s business strategy. The company allocates considerable resources to advancing neurostimulation technology and refining the functionality of its Genio system. This focus on R&D not only propels forward clinical innovation but also underpins the company’s efforts to provide increasingly effective solutions for patients suffering from OSA and related conditions. Through continuous R&D, Nyxoah adheres to high standards of empirical validation, essential for sustained success in the competitive medtech arena.

Market Position and Industry Relevance

Nyxoah SA occupies a distinctive position within the broader medical technology industry. By addressing a significant health challenge through innovative, clinically validated technology, the company reinforces its role as a pivotal contributor to sleep health management. Its approach, which marries technological sophistication with clinical precision, allows it to offer alternatives to conventional treatments and to expand the choices available to patients and healthcare providers. This strategic positioning is reinforced by the company’s transparent adherence to regulatory standards and its ongoing commitment to R&D excellence.

Investor and Analyst Considerations

For investors and market analysts, Nyxoah SA represents a case study in how innovation can transform treatment paradigms in the medical technology field. The company’s focused approach towards addressing OSA through a specialized neurostimulation solution speaks to its dedication to bringing forward clinically innovative therapies that are grounded in extensive research and regulatory compliance. While market dynamics in the healthcare technology sector are subject to ongoing evolution, Nyxoah’s rich interplay of engineering, clinical insights, and regulatory rigor provides a detailed example of how modern medical devices are developed and commercialized.

Conclusion

In summary, Nyxoah SA stands as a notable entity within the health-technology space, operating at the crossroads of innovative medical device development and clinical therapeutic strategies. Its Genio system exemplifies a modern approach to tackling Obstructive Sleep Apnea by integrating advanced neurostimulation technology with a design focused on patient usability and regulatory compliance. Through ongoing investment in research, a commitment to clinical integration, and a distinctive market strategy, Nyxoah maintains a role of significance among healthcare technology innovators. The company’s efforts not only illuminate the challenges of modern sleep disorder treatments but also highlight the potential for technology-driven solutions to redefine therapeutic standards in the industry.

Rhea-AI Summary

Nyxoah SA disclosed new share capital information in a regulatory announcement dated September 30, 2022. The company reported a total share capital of EUR 4,440,069.16 and indicated that there are 25,846,279 securities carrying voting rights, consisting entirely of ordinary shares. Furthermore, it outlined the number of subscription rights for various Employee Stock Option Plans (ESOP) dating from 2016 to 2021, which entitle holders to subscribe for a total of 1,916,625 additional securities.

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Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), will participate in the 17th Annual Wells Fargo Securities Healthcare Conference from September 7-9, 2022, in Everett, MA. Management will conduct one-on-one meetings with investors on September 9. The announcement comes as Nyxoah continues to advance its Genio® system, a revolutionary treatment for OSA. With CE Mark approval since 2019 and ongoing studies for FDA approval, Nyxoah aims to improve patient outcomes and expand its market presence.

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Nyxoah reported strong financial results for Q2 and H1 2022, highlighted by revenues of €935,000, a 5x increase from the previous year. The company completed enrollment in the DREAM U.S. pivotal trial and plans to release 12-month clinical data in fall 2023. Furthermore, FDA approved the ACCCESS study and the Genio® 2.1 system. However, Nyxoah experienced an operating loss of €7.4 million in Q2, with R&D and SG&A expenses rising significantly. The cash position stood at €123.3 million, offering sufficient liquidity for upcoming U.S. commercialization efforts in 2024.

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Nyxoah has announced a distribution agreement with Acurable to offer the AcuPebble SA100 home sleep test for Obstructive Sleep Apnea patients in Germany. This advanced wearable device captures acoustic signals for rapid diagnosis, demonstrating high sensitivity and specificity. The AcuPebble is CE marked and FDA cleared. Nyxoah aims to enhance patient access to effective OSA diagnosis and treatment. The launch is expected in Q4 2022, aligning with Nyxoah's mission to improve the quality of life for OSA patients.

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Nyxoah, a medical technology company based in Belgium, has announced its participation in the Canaccord Genuity 42nd Annual Growth Conference in Boston from August 8 to 11, 2022. Olivier Taelman, CEO, will present a corporate update on August 10 at 3:30pm EDT. Investors can access the live webcast on the Company's Investor Relations website. Nyxoah specializes in solutions for Obstructive Sleep Apnea (OSA) and features the Genio® system, an innovative therapy recognized with a CE Mark since 2019.

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Nyxoah SA announced the release of its Q2 and H1 2022 financial results on August 8, 2022, after market close. The healthcare company specializes in solutions for Obstructive Sleep Apnea (OSA), with its lead product, the Genio® system, already CE marked. Following positive study outcomes, Nyxoah expanded its therapeutic indications, enhancing its market position. Investors can join a conference call on the same day at 10:30pm CET / 4:30pm ET to discuss the results. For further details, visit the investor relations page.

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Nyxoah has announced the CE Mark Approval for its next-generation Genio® 2.1 system, enhancing the treatment of Obstructive Sleep Apnea (OSA)

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Nyxoah has received FDA Investigational Device Exemption (IDE) approval to begin the ACCCESS study for its Genio® system, aimed at treating adult patients with moderate-to-severe Obstructive Sleep Apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate. This clinical trial will involve up to 106 patients, with key endpoints assessed at 12 months post-implant. The first patient implant is expected in Q4 2022. This marks a significant advancement in the treatment options for CCC patients who have not benefitted from CPAP therapy.

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Mont-Saint-Guibert, Belgium, June 30, 2022 – Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) has disclosed information per article 15 of the Law of 2 May 2007 regarding its capital structure. The updated share capital stands at EUR 4,438,351.16, with the total number of voting rights amounting to 25,836,279 (all ordinary shares). The press release also details the unissued rights to subscribe to various securities, totaling 1,932,125 from different ESOP warrants, enhancing future voting rights potential.

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Nyxoah, a medical technology company focused on Obstructive Sleep Apnea, has joined the Euronext Tech Leaders Initiative as of June 7, 2022. This initiative includes over 100 high-growth technology companies with a collective market capitalization exceeding 1 trillion Euros. Nyxoah's inclusion in the Euronext Tech Leaders Index provides benefits such as improved trading conditions for retail investors and enhanced international visibility. The company is known for its Genio® system, a hypoglossal neurostimulation therapy that received CE Mark approval in 2019 and is currently undergoing FDA pivotal study.

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FAQ

What is the current stock price of NYXOAH S A (NYXH)?

The current stock price of NYXOAH S A (NYXH) is $6.06 as of April 8, 2025.

What is the market cap of NYXOAH S A (NYXH)?

The market cap of NYXOAH S A (NYXH) is approximately 243.7M.

What is the primary focus of Nyxoah SA?

Nyxoah SA specializes in developing and commercializing innovative neurostimulation therapies to treat sleep disordered breathing, with a primary focus on Obstructive Sleep Apnea (OSA).

How does the Genio system work?

The Genio system is a bilateral neurostimulation device that targets specific nerve pathways to help maintain airway patency during sleep, offering a non-invasive treatment option for moderate to severe OSA.

What benefits does neurostimulation therapy offer over traditional treatments?

Neurostimulation therapy can be less invasive than traditional continuous positive airway pressure methods and is designed for enhanced patient comfort and adherence, addressing the root causes of airway obstruction.

How does Nyxoah ensure the safety and efficacy of its device?

Nyxoah’s Genio system has achieved CE-Mark validation after rigorous clinical testing and regulatory review, ensuring that the device meets high standards for safety and effectiveness in treating OSA.

What distinguishes Nyxoah from other companies in the sleep health sector?

Nyxoah differentiates itself through its focus on a unique neurostimulation approach, combining engineering excellence with clinical research, which positions its technology as a viable alternative in addressing sleep disordered breathing.

What role does research and development play at Nyxoah?

Research and development are at the core of Nyxoah’s operations, driving continuous innovation in neurostimulation technology and ensuring that its products meet evolving clinical and regulatory standards.
NYXOAH S A

Nasdaq:NYXH

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Medical Instruments & Supplies
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Belgium
Mont-Saint-Guibert