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NYXOAH S A - NYXH STOCK NEWS

Welcome to our dedicated page for NYXOAH S A news (Ticker: NYXH), a resource for investors and traders seeking the latest updates and insights on NYXOAH S A stock.

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 (NYXH) has received an Approvable Letter from the FDA for its Genio® system, a neuromodulation device treating Obstructive Sleep Apnea (OSA). The letter indicates that Nyxoah's Pre-Market Approval (PMA) application substantially meets federal requirements, with final approval pending completion of manufacturing facilities, methods and controls review.

The FDA's review found no additional questions regarding clinical data or biocompatibility supporting the submission. The Genio system maintains its CE Mark and continues commercial operations in Europe, where it's approved for both Complete Concentric Collapse (CCC) and non-CCC patients.

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Nyxoah (NYXH) reported its Q4 and FY 2024 financial results, highlighting key developments in its Obstructive Sleep Apnea (OSA) treatment business. Q4 2024 revenue was €1.3 million (excluding €0.6 million deferred revenue), with a strong gross margin of 73%. Full-year 2024 revenue reached €4.5 million.

The company's cash position strengthened to €85.6 million as of December 31, 2024, up from €57.7 million year-over-year. Operating losses increased to €58.8 million for FY 2024, compared to €45.1 million in 2023, reflecting increased R&D and commercial activities.

Nyxoah completed its PMA submission to the FDA for its Genio system and expects approval by Q1 end. The company has assembled its U.S. commercial team and plans to launch in March 2025.

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Nyxoah (Euronext Brussels/Nasdaq: NYXH), a company developing breakthrough neuromodulation treatments for Obstructive Sleep Apnea (OSA), has scheduled the release of its fourth quarter and financial year 2024 results on March 13, 2025.

The company will host a conference call with management to discuss the financial results on the same day at 1:00pm CET / 8:00am ET. Investors can access the webcast through the company's Investor Relations page or participate in the Q&A session by registering for the earnings call at least 10 minutes before the start time.

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Nyxoah (Euronext Brussels/Nasdaq: NYXH), a pioneer in Obstructive Sleep Apnea (OSA) treatment through neuromodulation, has announced its participation in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference scheduled for March 17-20, 2025.

CEO Olivier Taelman will deliver a corporate presentation on Monday, March 17, 2025, at 8:40am ET. The presentation will be accessible via webcast in the Events section of Nyxoah's Investor Relations website. The company will also be available for one-on-one meetings with institutional investors during the conference.

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Nyxoah (NYXH) has announced the commercial launch of its Genio system in the Middle East, marking a significant expansion of its neurostimulation therapy for Obstructive Sleep Apnea (OSA). The launch was highlighted by the first successful Genio implant at Saudi German Hospital in Dubai, UAE, performed by Dr. Ahmed Yassin Bahgat, Consultant Otolaryngologist.

This milestone represents the first-ever neurostimulation therapy for OSA in the Middle East region. The Genio system is designed as an alternative treatment for OSA patients who cannot tolerate CPAP therapy. The company emphasizes the system's innovative, clinically proven capabilities and its patient-centric approach.

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Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) received a transparency notification from BlackRock, Inc. on January 16, 2025. The notification reveals that BlackRock and its controlled undertakings now hold 1,105,907 voting rights in Nyxoah, comprising 1,065,035 shares and 40,872 equivalent financial instruments. This represents 2.95% of total voting rights (37,427,265) as of January 14, 2025.

The change resulted in BlackRock crossing downward below the 3% threshold. The voting rights are distributed among various BlackRock entities, with BlackRock Advisors, holding the largest portion at 2.76%. The equivalent financial instruments include securities lent and contract differences, accounting for 0.10% of voting rights.

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Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) received a transparency notification from BlackRock, Inc. on December 19, 2024. The notification reveals that BlackRock and its controlled undertakings now hold 1,124,630 voting rights in Nyxoah, comprising 1,122,658 shares and 1,972 equivalent financial instruments. This represents 3.00% of the total voting rights (37,427,265) as of December 17, 2024.

The holdings are distributed across various BlackRock entities, with BlackRock Advisors, holding the largest portion at 2.91% of voting rights. The notification was triggered by BlackRock's total holdings crossing above the 3% threshold.

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Nyxoah has launched its Genio system commercially in England, with the first successful implants performed at University College London Hospitals (UCLH). The system, which treats Obstructive Sleep Apnea (OSA) through neuromodulation, is now covered under the NHS Specialised Services Devices Programme (SSDP). The first two patients received their implants from Mr. Ryan Chin Taw Cheong, Consultant ENT and Sleep Surgeon at UCLH. This launch marks a significant expansion of Nyxoah's innovative OSA treatment in the UK healthcare market.

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Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) has released an update on its voting rights and shares as required by Belgian law. The company reports a share capital of EUR 6,429,682.56 with 37,427,265 ordinary shares, each carrying one voting right. Additionally, there are 2,296,194 subscription rights to securities not yet issued, excluding 346,431 subscription rights that were issued but not yet granted.

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Nyxoah (Euronext Brussels/Nasdaq: NYXH), a medical technology company focused on developing innovative Obstructive Sleep Apnea (OSA) treatments through neuromodulation, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company will deliver a presentation on Wednesday, December 4, 2024, at 2:00pm ET.

Interested parties can access a live audio webcast of the presentation through the investor relations section of Nyxoah's website at investors.nyxoah.com.

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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 $7.65 as of March 28, 2025.

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

The market cap of NYXOAH S A (NYXH) is approximately 317.4M.

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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