| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology | ||
PDUFA 2026 | Phase 3 | -% | FDA review of the new drug application for the treatment of example condition. Read More | Small Molecule | Oncology |
Recent Updates
Recently added Catalysts
Nyxoah SA$1.71
+0.04 (+2.4%)
F 9Pipeline Score MedTech · Clinical
Market Cap
128.27 M
EPS
-2.47
P/E Ratio
-
Value Trade
53.91 K
-4.97 %
Week
-11.42 %
1 Month
-38.54 %
3 Month
-36.92 %
6 Month
-87.6 %
5 Year
-88.04 %
All Time
Cash Data
Cash Position
12.35 K
Monthly Burn
12.35 K
Runway
12,345 mo
Overview
Volume
223.53 K
52 Week Range
2.72 - 8.59
% held by Insiders
20.21 %
% held by Institutions
18.39 %
Enterprise Value
139.99 M
Total Shares
44.69 M
Short %
1.04 %
Float Shares
24.24 M
Company Description
locked
Upcoming Catalyst
Drug Pipeline Intelligence
F9
Pipeline Score -
Pipeline ValueValuation Signal
0
Drugs Scored—
rNPV / MCap Top 6%
Micro Cap (rank 857 of 911)
Percentile RankNyxoah SA has significant pipeline risk (9/100).
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
Genio system Breakthrough | Obstructive Sleep Apnea | — | 2025-12-30 | positive outcomes from the DREAM IDE pivotal study; FDA approval for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65 Read More | Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference Read More | |
Genio system Breakthrough | Obstructive Sleep Apnea | — | 2025-12-30 | positive outcomes from the DREAM IDE pivotal study; FDA approval for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65 Read More | Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference Read More | |
Genio system Breakthrough | Obstructive Sleep Apnea | — | 2025-12-30 | positive outcomes from the DREAM IDE pivotal study; FDA approval for a subset of adult patients with moderate to severe OSA with an AHI of greater than or equal to 15 and less than or equal to 65 Read More | Nyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in NYXH
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
NYXH Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
NYXH▲ +2.4%today
Nyxoah Announces Preliminary Results for the Second Quarter of 2026
Nyxoah SA reported preliminary results for Q2 2026, highlighting a global net revenue of approximately €7.7 million, marking a 21% increase from the previous quarter. The U.S. revenue also showed strong growth at €5.2 million, with 55 new surgeons trained and 89 new accounts activated. Additionally, proposed reimbursement increases from CMS for the Genio procedure are expected to enhance economic value. The company secured $110 million in financing, positioning it for accelerated growth.
Read more →NYXHNyxoah Organisera une Journée Investisseurs à New York le 8 juillet 2026
Nyxoah SA will host an Investor Day on July 8, 2026, in New York, focusing on its business execution in the U.S. and growth strategy. The event will be held at Bank of America and will include discussions on the Genio system's market dynamics and reimbursement environment. A live webcast will be available for remote participants.
Read more →NYXHNyxoah to Host Investor Day in New York on July 8, 2026
Nyxoah SA will host an Investor and Analyst Day on July 8, 2026, in New York. The event will focus on the company's U.S. commercial execution, growth strategy, and key priorities, including the Genio system's market dynamics and reimbursement landscape. Participants will include Nyxoah's leadership and external clinical experts.
Read more →NYXHNyxoah Receives $15 Million from the European Investment Bank
Nyxoah has successfully drawn $15 million from the European Investment Bank, contributing to a total of $110 million raised in June 2026. This funding will primarily support the U.S. launch of their Genio system, a treatment for Obstructive Sleep Apnea. The non-dilutive nature of this financing enhances the company's financial position without affecting existing shareholders.
Read more →NYXHNyxoah Reçoit 15 Millions de Dollars de la Banque Européenne d’Investissement
Nyxoah SA has secured $15 million from the European Investment Bank, completing a total capital raise of $110 million. This funding will primarily support the commercial launch of its Genio system in the U.S. and further investments in R&D. The non-dilutive nature of the financing strengthens the company's balance sheet without affecting existing shareholders.
Read more →NYXHNyxoah’s Genio® Wins Prix Galien UK 2026 Award for Best Medical Technology
Nyxoah's Genio® has been awarded the Prix Galien UK 2026 Award for Best Medical Technology, recognizing its innovative hypoglossal nerve stimulation therapy for Obstructive Sleep Apnea (OSA). This award underscores the technology's impact on patient care and the ongoing efforts of Nyxoah's team and healthcare partners. The company is also expanding its market presence following FDA approval and new financing.
Read more →NYXHLa Thérapie Genio® de Nyxoah Remporte le Prix Galien UK 2026 de la Meilleure Technologie Médicale
Nyxoah SA's Genio® therapy for obstructive sleep apnea has won the Galien UK 2026 award for Best Medical Technology. This award is a significant recognition of the advancements made in treating obstructive sleep apnea, a condition affecting millions. The CEO emphasized the collective effort behind this success, which reflects the commitment to improving patient care. The company is also expanding its market presence following FDA approval.
Read more →NYXHNyxoah Announces Closing of Underwritten Public Offering
Nyxoah SA has successfully closed an underwritten public offering, raising about $95 million through the sale of over 55 million shares at $1.72 each. The company plans to utilize the proceeds to expand its commercialization efforts in the U.S., enhance R&D for its Genio system, and support ongoing clinical research. This move is part of Nyxoah's strategy to strengthen its position in the Obstructive Sleep Apnea market.
Read more →NYXHInformation on the total number of voting rights and shares
Nyxoah SA has disclosed information regarding its total number of voting rights and shares following the issuance of 55,232,558 new shares. This issuance was part of an underwritten public offering in the United States, which included private offerings to institutional investors. The move demonstrates Nyxoah's strategy to enhance its capital base while engaging the investment community.
Read more →NYXHNyxoah Annonce la Clôture de l'Offre
Nyxoah has announced the successful closure of its public offering, which raised approximately $95 million. The offering included the sale of over 55 million ordinary shares at a price of $1.72 per share. The funds will be used for various purposes, including commercialization efforts in the U.S. and ongoing R&D for the Genio system, aimed at treating obstructive sleep apnea.
Read more →NYXH▼ -49.7%on this newsshared move
Nyxoah Announces Pricing of $95 Million Underwritten Public Offering
Nyxoah SA has announced the pricing of a $95 million underwritten public offering, selling 55,232,558 ordinary shares at $1.72 each. The proceeds will be utilized for expanding commercialization efforts in the U.S., advancing R&D for the Genio system, and general corporate purposes. The offering is anticipated to close on June 9, 2026.
Read more →NYXHNyxoah Announces Proposed Offering of Ordinary Shares
Nyxoah SA has announced a proposed underwritten public offering of ordinary shares in the U.S. to fund commercialization and R&D for its Genio system, aimed at treating Obstructive Sleep Apnea. The offering includes a potential 30-day option for underwriters to purchase additional shares. The company has received regulatory approvals for its innovative therapy, but the offering's completion is contingent on market conditions.
Read more →NYXHNyxoah Enters New Chapter of Long Term Value Creation
Nyxoah has announced a leadership transition to appoint a U.S.-based CEO, aiming to enhance its commercial efforts for the Genio system in the U.S. market. Olivier Taelman, the current CEO, will assist during the transition while the company seeks a new leader. This change is expected to support Nyxoah's growth in the expanding Obstructive Sleep Apnea market.
Read more →NYXHNyxoah Entre dans une Nouvelle Phase de Création de Valeur à Long Terme
Nyxoah is initiating a leadership transition to appoint a US-based CEO to accelerate its commercial launch of the Genio system in the US market. Olivier Taelman, the current CEO, will remain involved during the transition period. The company aims to leverage enhanced financial resources and a focused US leadership structure for its growth in the obstructive sleep apnea market.
Read more →NYXHNyxoah Welcomes the Flemish Investors Federation (VFB) at LégiaPark following Q1 2026 Results and U.S. Commercial Momentum
Nyxoah hosted the Flemish Investors Federation at LégiaPark to discuss its Q1 2026 results and U.S. commercial momentum. CEO Olivier Taelman highlighted the successful launch of the Genio system in the U.S. following FDA approval. The event showcased Nyxoah's growth strategy and its investment in a new manufacturing facility to meet increasing demand.
Read more →NYXHNyxoah Reports First Quarter 2026 Financial and Operating Results
Nyxoah reported a strong financial performance for Q1 2026, with a 25% increase in U.S. revenue driven by the successful launch of its Genio system. The company achieved a 100% approval rate for prior authorization submissions, reflecting a favorable reimbursement landscape. However, it still faced a significant operating loss and increased costs associated with its U.S. commercialization efforts.
Read more →NYXHREGULATED INFORMATION
NYXH has announced its upcoming annual and extraordinary shareholders' meetings, scheduled for June 10, 2026. These meetings will include discussions on the financial performance for the year ending December 31, 2025. Shareholders will have the option to attend in person or via video conference, though voting by video will not be permitted. Important decisions, including the approval of annual accounts and director appointments, will be made during these meetings.
Read more →NYXHNyxoah to Participate in the Bank of America 2026 Healthcare Conference
Nyxoah SA has announced its participation in the Bank of America 2026 Healthcare Conference scheduled for May 13, 2026, where it will present its innovative Genio system for treating Obstructive Sleep Apnea. The company aims to showcase its advancements following successful study outcomes and its recent FDA approvals. Nyxoah's focus remains on innovative solutions to improve treatment for OSA patients, emphasizing its commitment to enhancing patient quality of life. The presentation will be accessible through a live audio webcast, and the company will engage with institutional investors during the event.
Read more →NYXHNyxoah to Release First Quarter 2026 Financial Results on May 12, 2026
Nyxoah SA has announced that it will release its financial results for the first quarter of 2026 on May 12, 2026. The company will host a conference call to discuss these results, which will be accessible via their Investor Relations page. Nyxoah focuses on developing treatments for Obstructive Sleep Apnea, with its lead product being the Genio system.
Read more →NYXHNyxoah Reports Fourth Quarter and Full Year 2025 Financial and Operating Results
Nyxoah SA reported strong financial results for Q4 and full year 2025, highlighting successful U.S. commercialization of the Genio system. The company exceeded revenue expectations, achieving €5.6 million in net revenue for Q4 2025, up from €1.3 million in the previous year. Despite increased operating losses due to commercialization investments, positive feedback from the market supports future growth.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Fourth Quarter and Full Year 2025 Financial and Operating Results U.S. Commercialization Off to a Strong Start in First Full Quarter of Sales Foundation Established to Drive Significa
Nyxoah SA announced its financial and operating results for the fourth quarter and full year of 2025, highlighting a successful U.S. commercialization of its Genio system. The first quarter of sales exceeded revenue expectations, supported by positive surgeon and patient feedback. Despite the success, the company reported significant operating losses for the year, driven by increased research and development expenses related to their growth strategy. Looking ahead, Nyxoah aims to drive further growth in 2026 following the positive outcomes of its commercialization efforts.
Read more →NYXHNyxoah to Participate in the Oppenheimer 36th Annual Healthcare MedTech & Services Conference
Nyxoah SA will participate in the Oppenheimer 36th Annual Healthcare MedTech & Services Conference from March 16 to 19, 2026. CEO Olivier Taelman will present on March 16, focusing on the company's innovative Genio system for treating obstructive sleep apnea (OSA). The Genio system received its European CE Mark in 2019 and FDA approval for specific adults in August 2025. Nyxoah aims to improve the quality of life for OSA patients.
Read more →NYXH▼ -5.6%on this news
Nyxoah to Release Fourth Quarter and Full Year 2025 Financial Results on March 19, 2026
Nyxoah announced that it will release its financial results for the fourth quarter and full year of 2025 on March 19, 2026. A conference call will be held to discuss these results, providing an opportunity for stakeholders to engage with company management. The Genio system, a key product from the company, has made significant strides, including FDA approval for certain patients. The company remains focused on the treatment of obstructive sleep apnea through innovative neuromodulation therapies.
Read more →NYXH▲ +8.7%on this news
Nyxoah Announces the Signature of a Memorandum of Understanding with Sheikh Shakhbout Medical City Hospital to Improve OSA Therapy Management and Accelerate Access to Genio in the Middle East
Nyxoah has signed a Memorandum of Understanding with Sheikh Shakhbout Medical City Hospital in the UAE to improve Obstructive Sleep Apnea (OSA) therapy management and increase access to its Genio hypoglossal nerve stimulation therapy in the Middle East. The agreement includes initiatives to establish the hospital as a regional center for Genio therapy, focused on patient care and training healthcare professionals. Furthermore, both organizations will explore clinical research opportunities in sleep apnea and related health conditions.
Read more →NYXHNyxoah Invests In Further Expanding Its Belgian Manufacturing Capacity To Support Its Worldwide Growth
Nyxoah SA has announced a significant investment to expand its manufacturing capacity in Belgium, aiming to support its growth in the U.S. and international markets. The company will establish a new facility in Légiapark, which includes a state-of-the-art cleanroom. This expansion is expected to enhance product development and create local jobs, reinforcing Nyxoah's commitment to the life sciences ecosystem.
Read more →NYXHNyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2025 and Provides Revenue Guidance for the First Quarter of 2026
Nyxoah reported preliminary unaudited financial results for Q4 and full year 2025, highlighting strong momentum from its U.S. commercialization efforts post-FDA approval. The company exceeded €10 million in global revenue, driven by the successful launch of its Genio system for treating Obstructive Sleep Apnea. Nyxoah anticipates continued growth and plans to present at the upcoming J.P. Morgan Healthcare Conference.
Read more →NYXHNyxoah to Present at the 44th Annual J.P. Morgan Healthcare Conference
Nyxoah SA will present at the 44th Annual J.P. Morgan Healthcare Conference on January 15, 2026. The presentation will showcase their innovative Genio system for treating Obstructive Sleep Apnea (OSA). The company has achieved significant milestones, including FDA approval and CE mark for expanded indications. A live audio webcast will be available for interested investors.
Read more →NYXHNyxoah Announces Issuance of First Tranche of Convertible Bonds
Nyxoah SA has successfully issued the first tranche of convertible bonds amounting to €22.5 million, part of a larger financing plan of up to €45 million. The funds will be utilized to enhance commercialization efforts and support clinical research for its Obstructive Sleep Apnea treatment. However, conditions for a second tranche remain unmet, which could impact future funding.
Read more →NYXHNyxoah Annonce L’Émission de la Première Tranche des Obligations Convertibles
Nyxoah SA has announced the issuance of the first tranche of convertible bonds amounting to €22.5 million, managed by Heights Capital Management. The bonds carry an annual interest rate of 6.5% and will mature in three years. Proceeds will support the commercialization of their Genio system and ongoing clinical research.
Read more →NYXHNyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Netherlands
Nyxoah has officially launched its Genio® system in the Netherlands, with successful implants performed at OLVG West and Zuyderland hospitals. This innovative therapy for Obstructive Sleep Apnea (OSA) provides a new treatment option for patients who cannot tolerate CPAP. The launch is part of Nyxoah's broader European rollout, reflecting increasing acceptance of their technology.
Read more →NYXHNyxoah Annonce le Lancement Commercial de la Thérapie Innovante Genio® Aux Pays-Bas
Nyxoah has successfully launched its innovative Genio therapy in the Netherlands, with initial implants performed at OLVG West and Zuyderland hospitals. This new system offers an alternative treatment for patients with Obstructive Sleep Apnea who cannot tolerate CPAP. The CEO highlighted the significance of this launch in expanding their European presence and providing effective patient-centered solutions.
Read more →NYXH▼ -5.4%on this news
Publication relating to transparency notifications
Nyxoah SA has disclosed two transparency notifications regarding the shareholdings of Robert Taub and BMI Estate. As of December 1, 2025, Taub holds 4,360,800 voting rights, equating to 10.14% of the company's total voting rights, demonstrating a cautious increase in ownership. This notification aligns with regulatory requirements under Belgian law concerning significant shareholding disclosures.
Read more →NYXHNyxoah to Participate in the Piper Sandler 37th Annual Healthcare Conference
Nyxoah SA will participate in the Piper Sandler 37th Annual Healthcare Conference on December 4, 2025, highlighting its advancements in obstructive sleep apnea treatments. The company's lead product, the Genio system, has received regulatory approvals including CE mark and FDA clearance, expanding its indications. This participation reflects Nyxoah's ongoing commitment to innovation and market presence in the medical technology field. The event will include a live webcast accessible through the company’s investor relations page.
Read more →NYXHLa Thérapie Genio® de Nyxoah Bénéficie d'une Augmentation Significative du Remboursement Medicare en 2026 en Vertu de la Règle Finale du CMS
Nyxoah's Genio therapy has received a significant boost with the Centers for Medicare & Medicaid Services (CMS) finalizing a new reimbursement rate for 2026. The reimbursement for outpatient services under CPT code 64568 will increase by 48% to approximately $45,000, enhancing the therapy's commercial viability. This decision is expected to facilitate broader adoption and expansion of Genio in outpatient surgical centers across the U.S.
Read more →NYXHNyxoah’s Genio® Therapy Receives Significant 2026 Medicare Reimbursement Increases Under Final CMS Rule
Nyxoah announced that its Genio therapy will see substantial Medicare reimbursement increases in 2026, with HOPD reimbursement rising to approximately $45,000 and ASC reimbursement to $42,373. This change is expected to strengthen the economic foundation for the therapy's adoption across U.S. healthcare facilities. The decision by CMS is viewed positively by Nyxoah's CEO, indicating a favorable environment for expanding access to Genio therapy.
Read more →NYXHINTERIM FINANCIAL REPORT third quaRter 2025 TABLE OF CONTENTS Interim financial report 3 1. Business update 3 2. FINANCIAL HIGHLIGHTS 4 3. 2025 OUTLOOK 4 4. RISK FACTORS 5 5. FORWARD-LOOKING STATEMENTS 5 Unaudited conden
Nyxoah reported positive financial results for the nine months ending September 30, 2025, with revenues of 4.4 million, up from 3.3 million in the previous year. The FDA approved the Genio system for moderate to severe obstructive sleep apnea, initiating U.S. commercialization. However, the company experienced a substantial increase in operational expenses and reported a net loss primarily due to currency depreciation. The ongoing ACCCESS study is expected to yield significant safety and efficacy data despite closing patient enrollment early.
Read more →NYXH▼ -5.8%on this newsshared move
Nyxoah Secures Financing Commitments of up to U.S. $77 Million to Drive U.S. Commercialization of Genio
Nyxoah announced that it has secured financing commitments that total up to $77 million, comprised of a private placement and a convertible bond. The funds are earmarked to support the commercialization efforts of its Genio system in the United States, as well as to finance ongoing research and development for Obstructive Sleep Apnea (OSA) treatments. The financing includes significant equity investments from industry partners and management, reflecting confidence in Nyxoah's strategic direction and product efficacy.
Read more →NYXH▼ -9.8%on this news· ran to -22% by day 3shared move
Nyxoah Reports Third Quarter 2025 Financial and Operating Results
Nyxoah SA has reported a robust start to its U.S. commercial launch of the Genio system, achieving first revenue in September and significant reimbursement approvals. In the third quarter of 2025, the company generated €2.0 million in revenue, marking a 56% increase compared to the same period in 2024. Despite this, Nyxoah faced a substantial operating loss of €24.4 million, attributed to increased R&D and administrative expenses as the company scales its commercialization efforts. The overall response from healthcare providers has been positive, indicating strong future prospects.
Read more →NYXHNyxoah to Participate in the Stifel 2025 Healthcare Conference
Nyxoah SA will participate in the Stifel 2025 Healthcare Conference on November 11, 2025, presenting its innovative Genio system for treating Obstructive Sleep Apnea. The presentation will be available via webcast, and the company will hold one-on-one meetings with institutional investors. The Genio system has received CE Mark approval and FDA approval, expanding its therapeutic indications.
Read more →NYXHNyxoah Participera à la Conférence Stifel Healthcare 2025
Nyxoah SA has announced its participation in the Stifel Healthcare Conference 2025, scheduled for November 11, 2025. The company will present its innovative Genio system, a neuromodulation therapy for obstructive sleep apnea, during a live webcast. Investors will also have the opportunity for one-on-one meetings with Nyxoah representatives.
Read more →NYXHNyxoah Publiera ses Résultats Financiers du Troisième Trimestre 2025 le 13 Novembre 2025
Nyxoah SA will publish its financial results for Q3 2025 on November 13, 2025. A conference call will follow the results announcement, allowing management to discuss the financials. The company focuses on innovative solutions for obstructive sleep apnea, with its Genio® system already CE marked and recently approved by the FDA.
Read more →NYXHNyxoah to Release Third Quarter 2025 Financial Results on November 13, 2025
Nyxoah SA will release its financial results for the third quarter of 2025 on November 13, 2025. The company, known for its innovative treatment for Obstructive Sleep Apnea, will host a conference call to discuss these results. The Genio system, Nyxoah's lead product, has recently received FDA approval, further solidifying its market position.
Read more →NYXH▲ +17.2%on this news· ran to +32% by day 1
Nyxoah Annonce les Premiers Patients Commerciaux Aux États-Unis Implantés avec le Système Genio®
Nyxoah has successfully implanted the Genio system in its first commercial patients in the United States following FDA approval. The company reports strong demand from physicians and has secured coverage from major payers, including CMS. This marks a significant milestone in providing innovative therapy for obstructive sleep apnea (OSA) patients in the US.
Read more →NYXH▲ +17.2%on this news· ran to +32% by day 1
Nyxoah Announces First U.S. Commercial Patients Implanted with Genio® System
Nyxoah has successfully implanted the first U.S. commercial patients with its Genio® system for Obstructive Sleep Apnea (OSA) following FDA approval. The company reports strong demand from physicians and successful coverage from major payors. Surgeons have expressed excitement about the system's benefits and ease of use, indicating a positive outlook for future adoption.
Read more →NYXH▲ +17.2%on this news· ran to +32% by day 1shared move
Publication relative à des notifications de transparence
Nyxoah SA announced the receipt of a transparency notification from Vestal Point Capital. This notification, dated October 1, 2025, indicates that Vestal Point Capital now holds 2.97% of Nyxoah's voting rights. The announcement aligns with regulatory requirements for significant shareholding disclosures.
Read more →NYXHNyxoah Présente les Dernières Avancées Concernant son Expansion au Moyen-Orient
Nyxoah has announced its commercial expansion in the Middle East, following the successful implantation of its Genio® system in Abu Dhabi. The company aims to improve access to its innovative treatment for obstructive sleep apnea in Dubai, Kuwait, and Abu Dhabi. CEO Olivier Taelman emphasized the importance of this growing market and the partnerships with local healthcare institutions.
Read more →NYXHNyxoah Provides an Update on Expanded Middle East Presence
Nyxoah SA has announced the expansion of its operations in the Middle East, with new centers in Dubai, Kuwait, and Abu Dhabi following a successful Genio implant in Abu Dhabi. The company aims to enhance access to its leadless hypoglossal nerve stimulation system for patients with Obstructive Sleep Apnea. CEO Olivier Taelman emphasized the importance of this market and the collaboration with regional healthcare leaders.
Read more →NYXHNyxoah Provides Update on Expanded Middle East Presence New Centers in Dubai, Kuwait, and Abu Dhabi Following First Genio Implant in the Region Earlier in 2025 Mont-Saint-Guibert, Belgium
Nyxoah SA has announced the expansion of its operations into the Middle East with new centers established in Dubai, Kuwait, and Abu Dhabi after the successful implantation of the Genio device in Abu Dhabi. This expansion aims to improve access to innovative treatments for Obstructive Sleep Apnea (OSA) as part of Nyxoah's commitment to address the needs of patients unable to tolerate CPAP therapy. The company's CEO highlighted the Middle East as a crucial and growing market, reflecting the successful momentum since its initial launch in the region.
Read more →NYXHREGULATED INFORMATION INSIDE INFORMATION Nyxoah Announces Proposed Offering of Ordinary Shares Mont-Saint-Guibert, Belgium
Nyxoah SA has announced a proposed underwritten public offering of ordinary shares in the United States, potentially including private offerings to qualified investors in the EU. The proceeds are intended for advancing commercialization of the Genio system, clinical data collection, and further research and development initiatives. The offering is subject to market conditions, and there is no guarantee regarding its completion or terms. The Genio system has previously received regulatory approvals, positioning Nyxoah strategically in the Obstructive Sleep Apnea market.
Read more →NYXH▼ -9%on this newsshared move
Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc. Mont-Saint-Guibert, Belgium
Nyxoah has filed a patent infringement lawsuit against Inspire Medical Systems, claiming that Inspire's IV and V devices violate several patents held by Nyxoah. The lawsuit, lodged in the United States District Court for Delaware, seeks injunctive relief and damages. Nyxoah emphasizes its commitment to protecting its intellectual property and highlights the positive reception of its Genio system for treating Obstructive Sleep Apnea. The company is optimistic about its recent FDA approval and the potential to expand its patient base.
Read more →NYXHREGULATED INFORMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium)
Nyxoah SA has announced that it received a transparency notification from Cochlear Limited and Cochlear Investments Pty Ltd regarding a passive crossing of a voting rights threshold. As of August 29, 2025, Cochlear Investments holds 5,631,319 voting rights, which amounts to 14.999% of the total voting rights. This notification is part of regulatory compliance as stipulated by Belgian law concerning large shareholdings.
Read more →NYXH▼ -5.4%on this newsshared move
Nyxoah Announces Upcoming Investor Events
Nyxoah SA, a medical technology company specializing in treatment for Obstructive Sleep Apnea (OSA), announced its participation in several investor conferences scheduled for September 2025. These events include the Wells Fargo Healthcare Conference and the Morgan Stanley Annual Global Healthcare Conference. The company highlighted the success of its Genio system, which is designed to treat OSA and has received regulatory approvals both in Europe and the U.S. Nyxoah's attendance at these conferences demonstrates its commitment to expanding investor interest and discussing the future of its innovative therapies.
Read more →NYXH▲ +5.6%on this news
REGULATED INFORMATION Nyxoah Reports Second Quarter Financial and Operating Results FDA Approves Genio System for U.S. Market; Company Begins Commercial Launch Mont-Saint-Guibert, Belgium
Nyxoah reported its second-quarter financial results alongside FDA approval for its Genio System, marking a significant milestone for the company. The Genio System is the first bilateral hypoglossal neurostimulation therapy approved in the U.S., addressing the needs of obstructive sleep apnea patients. While the company saw a 74% increase in revenue year-over-year, it also reported rising operating losses and increased R&D expenses. The FDA approval is expected to catalyze commercial growth as the company begins executing its strategy in the United States.
Read more →NYXH▲ +5.6%on this news
Nyxoah Reports Second Quarter Financial and Operating Results
Nyxoah SA has announced its second quarter financial results for 2025, during which it received FDA approval for its Genio system, marking it as the first bilateral hypoglossal neurostimulation therapy authorized in the U.S. The company also reported a significant increase in revenue of 74% year-over-year, reaching €1.3 million. However, Nyxoah faced an increased operating loss of €19.9 million, attributed to rising research and development expenses. The Genio system's commercial launch in the U.S. has begun as part of the company's efforts to support OSA treatment.
Read more →NYXH▼ -5.4%on this news
Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Nyxoah SA has announced preliminary financial results for the second quarter of 2025, highlighting a 73% increase in revenue compared to the previous year. The company received FDA approval for its Genio system, which is now authorized for treating a specific subset of patients with moderate to severe obstructive sleep apnea. However, Nyxoah anticipates a rise in operating expenses and is facing a patent infringement lawsuit from Inspire Medical Systems. Additionally, the company plans to transition its R&D functions from Israel to the U.S. and Belgium.
Read more →NYXHNyxoah Receives Approval from FDA for Genio System for the Treatment of Obstructive Sleep Apnea U.S. Commercialization Officially Launched Mont-Saint-Guibert, Belgium
Nyxoah SA has received FDA approval for the Genio system, designed to treat Obstructive Sleep Apnea (OSA) in patients with a specific severity range. The system utilizes a unique approach to hypoglossal nerve stimulation with a leadless, battery-free design that allows for full-body MRI compatibility. The FDA's decision is bolstered by positive data from the DREAM clinical trial, which showed significant efficacy in reducing Apnea-Hypopnea Index scores. Following its commercial launch in the U.S., Nyxoah aims to improve treatment options for OSA patients.
Read more →NYXHNyxoah to Release Second Quarter 2025 Financial Results on August 18, 2025
Nyxoah SA has announced it will release its financial results for the second quarter of 2025 on August 18, 2025, and will host a conference call at that time. The company, which specializes in solutions for Obstructive Sleep Apnea through its Genio® system, is focused on ongoing development and commercialization. Past positive outcomes from clinical studies have bolstered Nyxoah’s position in the market. Interested parties can listen to or participate in the conference call through provided links.
Read more →NYXH▼ -5.4%on this newsshared move
Nyxoah’s DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine
Nyxoah SA has announced the publication of data from its DREAM pivotal study in the Journal of Clinical Sleep Medicine, confirming the efficacy and safety of its Genio® device for the treatment of Obstructive Sleep Apnea (OSA). The 12-month results show a 63.5% AHI responder rate and significant patient satisfaction, with over 90% of users pleased with the therapy. The publication also details a notable reduction in snoring scores and improved quality of life metrics for participants. However, several serious adverse events were recorded during the study, highlighting potential risks associated with the device.
Read more →NYXHNyxoah to Present at the Jefferies Global Healthcare Conference
Nyxoah SA, a company specializing in innovative solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Jefferies Global Healthcare Conference scheduled for June 3-5, 2025. CEO Olivier Taelman is set to deliver a presentation on June 4, highlighting the company's advancements, including its Genio® system, which has received regulatory approvals. The announcement emphasizes Nyxoah's strategic engagement with investors and ongoing efforts to expand its market presence.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports First Quarter Financial and Operating Results Company On Track for Anticipated PMA Approval in the Second Quarter of 2025 Successfully Completed FDA Validation Requirements, Final Sit
Nyxoah has reported its first-quarter financial and operating results for 2025, highlighting progress towards FDA Pre-Market Approval (PMA) for its Genio system, expected in Q2 2025. The company successfully completed validation requirements and is in the final phase of FDA review. Despite financial challenges, including increased operating losses, Nyxoah continues to focus on commercializing its innovative treatment for Obstructive Sleep Apnea. The upcoming on-site inspection is seen as a crucial next step towards obtaining full approval.
Read more →NYXHNyxoah Reports First Quarter Financial and Operating Results
Nyxoah has reported its financial results for the first quarter of 2025, showing a revenue of €1.1 million, a decrease from €1.2 million in the same period last year. The company is progressing towards FDA approval for its Genio® system, having received an Approvable Letter from the FDA. They are in the final stages of regulatory review and expect to receive PMA approval in the second quarter of 2025. However, operating losses and R&D expenses have increased significantly, indicating the challenges the company faces as it prepares for commercialization in the U.S.
Read more →NYXHNYXOAH SA (Euronext Brussels: NYXH) Rue Edouard Belin 12, 1435 Mont-Saint-Guibert, Belgium (hereinafter the " Company ") Invitation to attend the annual and the extraordinary shareholders' meetings of the Company to be h
NYXOAH SA has invited its shareholders to attend both the annual and extraordinary meetings scheduled for June 11, 2025. The meetings will address critical issues, including the approval of annual accounts and proposed changes to the company's remuneration policy. Additionally, shareholders will be able to attend these meetings remotely via video conference, although this does not allow for voting. Key executive agreements regarding severance payments and director appointments are also on the agenda.
Read more →NYXHNyxoah to Release First Quarter 2025 Financial Results on May 14, 2025
Nyxoah SA has announced that it will release its financial results for the first quarter of 2025 on May 14, 2025. The company's management will host a conference call to discuss these results, which will be accessible via webcast. Nyxoah focuses on innovative treatments for Obstructive Sleep Apnea (OSA) and has made strides in the regulatory process with its lead product, the Genio® system. Despite the positive developments, the company has acknowledged potential risks and uncertainties impacting future performance.
Read more →NYXHINSIDE INFORMATION REGULATED INFORMATION Conditional Issuance of Shares Mont-Saint-Guibert, Belgium
Nyxoah SA has announced a conditional issuance of up to 5 million ordinary shares through its at-the-market equity offering programs. This move increases the total available shares under the program to 5,662,694. The shares can be sold at prevailing market prices on the Nasdaq Global Market, aiming to leverage current market conditions for funding. This issuance follows a previous decision made on December 22, 2022, regarding the conditional issuance of shares.
Read more →NYXH▲ +6.1%on this news
Nyxoah Provides Update on FDA Approvable Letter for Genio System Expects to meet final FDA requirements for full PMA approval in the second quarter Mont-Saint-Guibert, Belgium
Nyxoah SA provided an update on its FDA approval process for the Genio system, a treatment for Obstructive Sleep Apnea (OSA). Recently, the FDA issued an Approvable Letter for Nyxoah's Pre-Market Approval (PMA) application, indicating that the application meets the necessary requirements. The company is now focused on completing one remaining validation process at its manufacturing site, anticipating potential approval in the second quarter of 2025. Nyxoah plans to discuss the review process further during its upcoming earnings call in May.
Read more →NYXH▼ -8.8%on this news
Nyxoah S.A. Investors: Company Investigated by the Portnoy Law Firm
Nyxoah S.A. is under investigation by the Portnoy Law Firm for possible securities fraud, prompting investors who incurred losses to consider legal action. The firm has initiated a potential class action lawsuit to help recover losses. Recently, Nyxoah received an Approvable Letter from the FDA for its Genio® system, but this is coupled with warnings of a potential delay in commercial launch, which likely contributed to a significant drop in stock price, closing down 21.36%. Investors are encouraged to seek information on their rights and options.
Read more →NYXH▼ -21.4%on this news· ran to -38% by day 3shared move
INSIDE INFORMATION REGULATED INFORMATION FDA Issues Nyxoah an Approvable Letter for its Genio System Mont-Saint-Guibert, Belgium
Nyxoah SA has announced that the U.S. FDA issued an Approvable Letter for its Genio system in relation to its Pre-Market Approval application. This letter indicates that the application largely fulfills the necessary requirements, paving the way for FDA approval contingent on further reviews of manufacturing practices. CEO Olivier Taelman expressed optimism about making the Genio system available to U.S. patients suffering from Obstructive Sleep Apnea. The device is already approved in Europe and the company will work closely with the FDA to complete the process.
Read more →NYXHNyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
Nyxoah reported its financial results for Q4 and the full year 2024, showcasing a revenue of €1.3 million for the fourth quarter and €4.5 million for the year. The company is nearing the conclusion of the FDA's PMA application review, with plans for a U.S. commercial launch of its Genio system anticipated by March 2025. However, Nyxoah incurred a substantial operating loss of €18.3 million in Q4, driven by elevated research and development costs. Despite these losses, the company ended the year with a healthy cash position of €85.6 million.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results FDA PMA Application Review Nearing Conclusion Positioned for U.S. Commercial Launch in March 2025 Mont-Saint-Gui
Nyxoah SA reported its financial and operational results for Q4 and the full year 2024, highlighting significant growth and a positive outcome from their DREAM pivotal study. The company anticipates near-term FDA approval for their Genio system, positioning them for a commercial launch in the U.S. by March 2025. Revenue for the year increased compared to the previous year, though rising operational costs led to a larger operating loss. Despite higher operational expenses, Nyxoah's strong cash position indicates ongoing viability and investment in future growth.
Read more →NYXHNyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025
Nyxoah SA announced the release date of its fourth quarter and financial results for 2024, set for March 13, 2025. The company will also host a conference call that day to discuss the results and provide updates on its breakthrough treatment for Obstructive Sleep Apnea. Notably, Nyxoah has achieved significant regulatory milestones, including CE Mark approvals and successful clinical study outcomes, which pave the way for future commercialization efforts in the U.S.
Read more →NYXHNyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference
Nyxoah SA will participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference from March 17 to 20, 2025. The CEO, Olivier Taelman, is scheduled to present a corporate overview on March 17. Nyxoah focuses on innovative treatment for obstructive sleep apnea (OSA) via its Genio® neuromodulation device. The company has seen success in its clinical trials, contributing to its growth and expansion within the market.
Read more →NYXHNyxoah Announces Commercial Launch of Genio Breakthrough Therapy in the Middle East
Nyxoah has announced the commercial launch of its Genio system for treating Obstructive Sleep Apnea (OSA) in the Middle East, beginning with a successful implantation at Saudi German Hospital in Dubai. This event marks the first-ever neurostimulation therapy for OSA in the region, representing a significant milestone for the company and its commitment to innovative treatment options. The therapy aims to provide an alternative for patients unable to use traditional CPAP devices. With strong clinical evidence supporting its efficacy, Nyxoah looks to expand its reach and improve patient outcomes in OSA management.
Read more →NYXHNyxoah Announces Commercial Launch of Genio Innovative Therapy in England
Nyxoah has officially launched its innovative Genio therapy for Obstructive Sleep Apnea (OSA) in England, with the first successful implants completed at University College London Hospitals (UCLH). The therapy, which is now covered under the NHS Specialised Services Devices Programme, aims to address the needs of OSA patients. Nyxoah's CEO expressed enthusiasm about collaborating further with UCLH to enhance patient access to this groundbreaking treatment. The company has received previous regulatory approvals supporting the safety and efficacy of the Genio system.
Read more →NYXHREGULATED INFORMATION Information on the total number of voting rights and shares Mont-Saint-Guibert (Belgium)
Nyxoah SA has published regulated information regarding the total number of voting rights and shares. This disclosure is in compliance with the Law of 2 May 2007, which concerns the notification of large shareholdings. The announcement was made on November 27, 2024, detailing information following the issuance of new shares. The details pertain specifically to the company's performance on the Euronext Brussels and Nasdaq markets.
Read more →NYXHNyxoah to Participate in the Piper Sandler 36th Annual Healthcare Conference
Nyxoah SA is set to participate in the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024, where they will present via webcast. The company focuses on developing innovative treatments for Obstructive Sleep Apnea (OSA) and has seen success with their Genio® device, which has received EU regulatory approvals. Recent positive clinical study outcomes further support the effectiveness of their product and expansion into new therapeutic indications. This gathering is an opportunity for Nyxoah to showcase their advancements in the field of medical technology.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Third Quarter Financial and Operating Results FDA approval on track for first quarter 2025, U.S. commercial team build out in progress Company fully funded with cash until mid 2026 Mo
Nyxoah SA reported its third quarter financial results, indicating a revenue increase to €1.3 million, up from €1.0 million a year earlier. The company is on track for FDA approval of its Genio system in Q1 2025 and is expanding its U.S. commercial team. However, it faced an operating loss of €15 million, driven by increased R&D and other operational expenses. Despite these challenges, Nyxoah is fully funded through mid-2026, suggesting strong financial support for its ongoing projects.
Read more →NYXHNyxoah Reports Third Quarter Financial and Operating Results
Nyxoah SA has reported its financial and operational results for Q3 2024, highlighting 30% revenue growth year-over-year to €1.3 million. The company has successfully raised €24.6 million to bolster its U.S. commercialization efforts, with FDA approval expected in Q1 2025. However, Nyxoah also reported an increase in operating loss to €15.0 million due to expanded commercial activities and R&D investments. The total cash position at the end of September 2024 was €71.0 million, though the company faced a monthly cash burn of €5.6 million.
Read more →NYXHNyxoah Appoints John Landry as Chief Financial Officer Current CFO, Lo c Moreau, to Transition into Role of President International Mont-Saint-Guibert, Belgium
Nyxoah SA has appointed John Landry as its new Chief Financial Officer, effective November 4, 2024, as part of a strategic move to focus on the U.S. market. Previously the CFO at Vapotherm Inc., Landry brings extensive experience in financial leadership within healthcare. Concurrently, current CFO Loïc Moreau will transition to the new role of President International, aimed at bolstering Nyxoah's global presence. This leadership change aligns with Nyxoah's ambitions to prepare for commercialization of its Genio system in the U.S.
Read more →NYXHNyxoah to Release Third Quarter 2024 Financial Results on November 6, 2024
Nyxoah SA announced it will release its financial results for the third quarter of 2024 on November 6, 2024, following the market's close. The company, which focuses on innovative solutions for treating Obstructive Sleep Apnea, indicated that management would discuss these results in a conference call. Nyxoah has shown progress with its Genio® neuromodulation device, having received multiple regulatory approvals and positive responses from recent clinical studies. The company's commitment to innovation marks its potential for further advancements in the treatment of Obstructive Sleep Apnea.
Read more →NYXHINSIDE INFORMATION REGULATED INFORMATION Nyxoah Raises $27 Million through its At-the-Market Offering Investment by a new U.S.-based healthcare investor, strengthening the balance sheet and reinforcing U.S. focus Mont-Sa
Nyxoah SA has successfully raised $27 million through its at-the-market offering, selling 3 million shares to a new U.S.-based healthcare investor. This investment is expected to enhance the company's balance sheet and bolster its focus on the U.S. market, particularly with the upcoming launch of its innovative Genio device for obstructive sleep apnea. The funding follows encouraging results from pivotal studies, contributing to Nyxoah's strategic development in the neuromodulation field for sleep disorders.
Read more →NYXHNyxoah Raises $27 Million through its At-the-Market Offering
Nyxoah has raised $27 million through an at-the-market offering, selling 3.0 million shares to a single U.S.-based healthcare investor. This financing is seen as a key step in strengthening the company's balance sheet and solidifying its focus on the U.S. market, particularly as it prepares for the launch of its hypoglossal neuromodulation device, Genio®. The CEO emphasized the significance of this investment in building on positive clinical study data and enhancing the financial position of the company.
Read more →NYXHNyxoah to Participate in Upcoming Investor Conferences
Nyxoah SA announced its participation in three upcoming investor conferences in New York City, where CEO Olivier Taelman will deliver corporate updates. The conferences include the Baird Global Healthcare Conference, the H.C. Wainwright 26th Annual Global Investment Conference, and the Cantor Global Healthcare Conference. Nyxoah is focused on innovative solutions for treating Obstructive Sleep Apnea, highlighted by its lead product, the Genio® system, which is a leadless and battery-free therapy. The sessions are expected to facilitate discussions with institutional investors, and webcasts will be available for broader accessibility.
Read more →NYXHNyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device
Nyxoah has officially rung the closing bell at Nasdaq as it gears up for the U.S. launch of its innovative Genio® device, aimed at treating Obstructive Sleep Apnea (OSA). The company completed its FDA regulatory submission and anticipates U.S. approval by the end of 2024, with plans for a commercial launch in early 2025, supported by over €85 million in new funding. Recent positive results from its pivotal DREAM study further bolster its market entry strategy. CEO Olivier Taelman highlighted the importance of the U.S. market for Nyxoah's growth.
Read more →NYXHNyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results
Nyxoah SA has reported its financial and operational results for the second quarter and first half of 2024, highlighting a completed FDA regulatory submission and an expected U.S. approval by the end of the year. The company has successfully raised over €85 million to fund its U.S. commercial launch and reported a 29% increase in sales compared to the previous year. However, it also faced increased operating losses and significant R&D expenses, reflecting ongoing investments and development challenges.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results FDA regulatory submission complete, U.S. approval on track for end of 2024 U.S. commercial launch fully funded with
Nyxoah has reported its financial and operating results for the second quarter and first half of 2024, highlighting the successful completion of its FDA regulatory submission and a U.S. commercial launch fully funded with newly raised capital. The company reported a revenue decrease to 0.8 million for Q2 2024 compared to 1.1 million for the same period in 2023, with a rising operating loss due to increased research and development expenses. However, the significant capital raised and strategic focus on U.S. market readiness indicates positive future prospects.
Read more →NYXHNyxoah to Release Second Quarter and First Half 2024 Financial Results on August 6, 2024
Nyxoah SA announced it will release its financial results for the second quarter and first half of 2024 on August 6, 2024, after market close. A conference call will be held that same day to discuss these results. Nyxoah specializes in developing innovative solutions for Obstructive Sleep Apnea, with its lead product being the Genio® system, aimed at offering a battery-free therapy for patients. The company aims to enhance the lives of those suffering from this common sleep disorder.
Read more →NYXHNyxoah Appoints Scott Holstine as Chief Commercial Officer
Nyxoah SA has appointed Scott Holstine as the new Chief Commercial Officer to lead its commercial operations, particularly to facilitate a successful U.S. launch of its Genio system, a treatment for Obstructive Sleep Apnea. Holstine brings over 26 years of experience in the medical device industry, including expertise in product launches. The company expects FDA approval by year-end 2024, and Holstine's role will be critical in executing their go-to-market strategy. This leadership change comes at a promising time, fueled by positive study results for the Genio system.
Read more →NYXH▲ +5.3%on this news· ran to +25% by day 3
Nyxoah Has Signed a €37.5 Million Loan Facility Agreement with the European Investment Bank
Nyxoah SA has finalized a €37.5 million loan facility agreement with the European Investment Bank, aimed at enhancing research and development and increasing production capacity. The funds will be allocated across three tranches, supported by the European Commission's InvestEU program. Nyxoah plans to utilize this financing to advance its Genio® system, a treatment for Obstructive Sleep Apnea, while preparing for potential commercialization in Europe and the U.S. The agreement includes the issuance of synthetic warrants to the EIB as part of the funding structure.
Read more →NYXH▲ +5.3%on this news· ran to +25% by day 3
REGULATED INFORMATION INSIDE INFORMATION Nyxoah Has Signed a 37.5 Million Loan Facility Agreement with the European Investment Bank Mont-Saint-Guibert, Belgium
Nyxoah has signed a loan facility agreement worth 37.5 million with the European Investment Bank to bolster its research, development, and manufacturing efforts for its Obstructive Sleep Apnea treatment solutions. The funds will be disbursed in three tranches, with the first tranche already planned. This partnership with the EIB illustrates confidence in Nyxoah's innovative approaches and addresses the rising demand for its Genio system. The company anticipates these resources will significantly enhance its capacity to scale operations and support commercialization efforts in Europe and the U.S.
Read more →NYXHNyxoah Submits Fourth and Final Module in PMA Application for Genio to the
Nyxoah has submitted the fourth and final module of its Premarket Approval (PMA) application for the Genio system to the U.S. FDA. The Genio device, which is designed to treat Obstructive Sleep Apnea (OSA), features a leadless and MRI-compatible design that eliminates the need for implant surgeries. The recent DREAM U.S. pivotal study demonstrated significant clinical benefits, raising optimism for its approval and commercialization in the U.S. Nyxoah is set to present these findings in September and aims for a U.S. launch by the end of 2024.
Read more →NYXH▼ -8.6%on this news
Nyxoah to Participate in the Jefferies Global Healthcare Conference
Nyxoah SA announced its participation in the Jefferies Global Healthcare Conference scheduled for June 5-6, 2024, in New York. CEO Olivier Taelman will present the company's innovative sleep apnea solution, the Genio® system, which has already received CE mark approval in Europe. The company is currently conducting pivotal studies for FDA approval in the United States. This event is expected to provide Nyxoah with valuable exposure to institutional investors.
Read more →NYXHNyxoah Announces Closing of Offering and Partial Exercise of Option to Purchase Additional Shares
Nyxoah SA has successfully closed its underwritten public offering, raising approximately $50 million from the sale of 5,374,755 ordinary shares at an offering price of $9.25 per share. Additionally, underwriters exercised their option to purchase 300,000 more shares for a total gross proceed of approximately $52.5 million. The net proceeds will be utilized for pre-commercial and commercialization activities, clinical data collection, and further research and development of their Genio system designed to treat Obstructive Sleep Apnea. The closing of the exercise is expected on June 3, 2024, pending customary conditions.
Read more →NYXHInformation on the Total Number of Voting Rights and Shares
Nyxoah SA has published information related to its voting rights and shares, as required by Belgian law. The company reported a total share capital of EUR 5,851,253.43 and a total of 34,060,390 ordinary shares carrying voting rights. This announcement demonstrates Nyxoah's commitment to regulatory compliance and transparency in its corporate governance. The figures indicate a substantial base of voting rights held by shareholders.
Read more →NYXH▼ -17.7%on this newsshared move
Nyxoah Announces Pricing of Offering
Nyxoah SA has announced the pricing of an underwritten public offering in the United States, selling 5,374,755 ordinary shares at $9.25 each. The offering is expected to raise approximately $50 million, which Nyxoah plans to use for commercialization activities, clinical data gathering, and research and development. The offering is set to close on May 28, 2024, pending customary closing conditions. This capital infusion aims to support Nyxoah's mission to innovate treatments for Obstructive Sleep Apnea.
Read more →NYXH▼ -17.7%on this newsshared move
REGULATED INFORMATION INSIDE INFORMATION Nyxoah Announces Pricing of Offering Mont-Saint-Guibert, Belgium
Nyxoah SA has announced the pricing of its public offering of approximately 5.37 million ordinary shares at $9.25 per share, expected to close on May 28, 2024. This offering is poised to raise about $50 million to advance pre-commercialization and commercialization activities in the United States. Additionally, the company aims to gather clinical data and finance research related to its Genio system, a treatment for Obstructive Sleep Apnea (OSA). Nyxoah has granted underwriters a 30-day option to purchase up to 806,213 additional shares.
Read more →NYXHNyxoah Announces Reduction of the Maximum Amount Available Under its At the-Market Equity Offering Program
Nyxoah has announced a reduction in the maximum amount available under its at-the-market equity offering program, decreasing from 6,000,000 to 4,430,861 ordinary shares. This decision also involves a reduction of 1,569,139 shares and reflects an increase of EUR 269,579 in authorized capital for the board. While the company continues to focus on its Genio® system for treating Obstructive Sleep Apnea, the announcement may raise concerns regarding financial strategy and market confidence.
Read more →NYXHReduction of the Maximum Amount Available Under its At-the-Market Equity Offering Program
Nyxoah SA announced a reduction in the maximum number of ordinary shares available under its at-the-market equity offering program by 1,569,139 shares. This adjustment lowers the maximum to 4,430,861 shares, with 3,662,699 shares remaining available for issuance. The decrease in the offering amount reflects a potential strategy to navigate current market conditions. Despite the reduction, Nyxoah continues to develop its flagship Genio system for Obstructive Sleep Apnea treatment.
Read more →NYXH▲ +8.2%on this news
REGULATED INFORMATION Nyxoah Reports First Quarter 2024 Financial and Operating Results Announced DREAM U.S. pivotal study achieved primary endpoints On track for FDA approval as early as end of 2024 Mont-Saint-Guibert,
Nyxoah SA has reported its financial and operating results for the first quarter of 2024, highlighting significant achievements in its DREAM U.S. pivotal study which met primary endpoints. The company anticipates FDA approval for its Genio system as early as the end of 2024. Despite a substantial increase in revenue attributed to its commercialization efforts, Nyxoah continues to face operational losses. The CEO expressed optimism about future growth driven by strong clinical data and the company's innovative sleep apnea solutions.
Read more →NYXH▲ +8.2%on this news
Nyxoah Reports First Quarter 2024 Financial and Operating Results
Nyxoah has released its financial and operational results for the first quarter of 2024, highlighting significant achievements in their DREAM U.S. pivotal study, which met its primary endpoints. The company anticipates FDA approval for their Genio system by the end of 2024. Additionally, Nyxoah reported a substantial revenue increase of 170% year-over-year, totaling €1.2 million. However, the operating loss rose to €12.2 million due to increased R&D expenses, with a monthly cash burn of approximately €4.5 million.
Read more →NYXH▲ +7.5%on this news· ran to +27% by day 3shared move
Nyxoah to Release First Quarter 2024 Financial Results on May 14, 2024
Nyxoah SA is set to announce its financial results for the first quarter of 2024 on May 14, after market close. The company, which specializes in developing treatments for Obstructive Sleep Apnea, plans to hold a conference call to discuss these results. The Genio® system, Nyxoah's main focus, is designed to improve the quality of life for patients suffering from this condition. However, the company acknowledges various risks and uncertainties related to its future performance and regulatory approvals.
Read more →NYXH▼ -10.4%on this news
Nyxoah Appoints Dr. Maurits S. Boon, MD as Chief Medical Officer
Nyxoah SA has appointed Dr. Maurits S. Boon, MD as its new Chief Medical Officer. Dr. Boon, a dual board-certified specialist in otolaryngology and sleep medicine, will continue his role as a professor at Thomas Jefferson University while leading Nyxoah's efforts to commercialize its innovative Genio system for treating obstructive sleep apnea. The appointment comes as Nyxoah prepares to enter the U.S. market, with a focus on enhancing patient outcomes in sleep disordered breathing.
Read more →NYXH▼ -7.9%on this news
Nyxoah Advances Patient Access Strategy through Partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation
Nyxoah has announced a strategic partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation, becoming a Corporate Champion at the ENTerprise Circle level. This partnership marks the first of its kind for a medical device company and aims to enhance patient access to breakthrough treatments for Obstructive Sleep Apnea through focused advocacy and collaboration. Key strategies include navigating prior authorization requirements and expanding care access via the FDA and AMA.
Read more →NYXH▼ -14.2%on this news· ran to -29% by day 1
REGULATED INFORMATION INSIDE INFORMATION Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints Reports an Apnea-Hypopnea Index (AHI) responder rate of 63.5% on an intent to treat (ITT) basis (p=0.002) Reports
Nyxoah announced positive results from the DREAM U.S. pivotal study, demonstrating significant efficacy in treating Obstructive Sleep Apnea (OSA) with a 63.5% Apnea-Hypopnea Index (AHI) responder rate. The study also reported a 71.3% Oxygen Desaturation Index (ODI) responder rate and a substantial median AHI reduction of 70.8% over 12 months. Conducted under an investigational device exemption, the findings are anticipated to support FDA approval for the company’s Genio hypoglossal nerve stimulation system, which offers a novel treatment option for OSA patients. However, the study noted several serious adverse events that warrant attention as the company moves towards market authorization.
Read more →NYXH▼ -14.2%on this news· ran to -29% by day 1
Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints
Nyxoah announced that its DREAM U.S. pivotal study successfully met its primary endpoints, showcasing a significant Apnea-Hypopnea Index (AHI) responder rate of 63.5% and an Oxygen Desaturation Index (ODI) responder rate of 71.3%. This study, involving 115 patients, indicates the potential of the Genio® hypoglossal nerve stimulation system to improve treatment for obstructive sleep apnea (OSA). Despite positive efficacy results, the study recorded several serious adverse events, warranting careful consideration as the company prepares for FDA approval.
Read more →NYXH▼ -5.2%on this news
REGULATED INFORMATION Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results Expect to report DREAM U.S. pivotal study efficacy and safety data by early April Achieved record quarterly sale
Nyxoah SA has reported its financial results for the fourth quarter and full year of 2023, highlighting record quarterly sales of 1.8 million, significantly up from the previous year. The company completed enrollment in its DREAM U.S. pivotal study and presented positive early efficacy and safety data. Additionally, Nyxoah has raised capital from both existing and new investors, signifying confidence in its outlook for 2024. However, the company also experienced a net loss of 10.8 million in the last quarter, amid rising research and development costs.
Read more →NYXH▼ -5.2%on this news
Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
Nyxoah SA announced its financial and operational results for the fourth quarter and full year 2023, reporting €1.8 million in quarterly sales and €4.3 million for the entire year, representing a 42% year-over-year increase. The company expects to release efficacy and safety data from its DREAM U.S. pivotal study by early April 2024. However, Nyxoah also reported increased operating losses and significant R&D expenses, marking a challenging financial period. Despite this, the company ended the year with a strong cash position of €57.7 million, supporting its growth strategy.
Read more →NYXHNyxoah to Participate in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference
Nyxoah SA will participate in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference on March 12-13, 2024. CEO Olivier Taelman is scheduled to present, and the company will hold 1x1 meetings with institutional investors. Nyxoah focuses on developing treatments for Obstructive Sleep Apnea (OSA) and has received CE mark approval for its Genio® system, positioning itself strategically within the market.
Read more →NYXH▲ +7.3%on this news· ran to +30% by day 3
Nyxoah to Release Fourth Quarter and Financial Year 2023 Financial Results on March 5, 2024
Nyxoah SA has announced its plans to release financial results for the fourth quarter and full financial year of 2023 on March 5, 2024. The company, which focuses on innovative treatments for Obstructive Sleep Apnea, will host a conference call following the results announcement. Nyxoah's lead product, the Genio® system, has received regulatory approval for expanded indications, and the company is actively working towards U.S. commercialization.
Read more →NYXH▼ -6%on this news
Nyxoah Announces 2024 Strategic Priorities
Nyxoah SA has outlined its strategic priorities for 2024, focusing on advancing its lead product, the Genio system, for treating Obstructive Sleep Apnea (OSA). Key plans include completing patient follow-up for the DREAM study and filing the last module of the PMA submission, with a launch targeted for late 2024. Recent data presented indicated promising efficacy and safety results, but further validation is needed. The company aims to enhance its market presence in both the U.S. and Europe, supported by a new Chief Regulatory and Quality Officer and a new partnership with ResMed.
Read more →NYXH▼ -6%on this news
Nyxoah Announces 2024 Strategic Priorities Mont-Saint-Guibert, Belgium
Nyxoah has announced its strategic priorities for 2024, focusing on the commercialization and development of its innovative Genio system for treating Obstructive Sleep Apnea (OSA). The company anticipates significant milestones, including the reporting of DREAM study results and subsequent FDA submission for U.S. approval. The Genio system provides patients with greater control over their therapy, enhancing comfort and compliance. Nyxoah is optimistic about replicating its European success in the U.S. market, fueled by strong patient feedback and upcoming clinical outcomes.
Read more →NYXHNyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023 Mont-Saint-Guibert, Belgium
Nyxoah SA announced preliminary results for the fourth quarter and full year of 2023, highlighting strong sales growth nearly double from the previous quarter. The CEO expressed optimism about upcoming milestones in 2024, including the anticipated data from the DREAM US pivotal trial and plans to file for FDA approval. The company aims to leverage its direct-to-consumer campaigns to streamline patient referrals and has strategic partnerships, notably with ResMed in Germany, to enhance its market presence.
Read more →NYXHNyxoah Announces Real World Case Series Demonstrating Positive Results in Treating CCC Patients with Genio
Nyxoah has revealed positive data from a real-world case series on its Genio® hypoglossal nerve stimulation system for treating complete concentric collapse (CCC) patients. The findings were presented by Dr. Christian Plettenberg and demonstrated an impressive average apnea-hypopnea index (AHI) reduction of 73% and a 58% decrease in the Epworth Sleepiness Scale (ESS). Notably, there were no reported adverse events related to the implant, enhancing the treatment's safety profile. With plans for U.S. commercialization pending FDA approval, Nyxoah aims to broaden access to this therapy for CCC patients who are currently underserved in the market.
Read more →NYXHPublication Relating to a Transparency Notification
Nyxoah SA has received a transparency notification from Deerfield Partners, L.P., indicating that they have crossed the 3% threshold of shareholding as of November 30, 2023. Following the threshold crossing, Deerfield Partners, L.P. holds 856,085 shares, representing 2.99% of the total voting rights. This notification complies with regulatory requirements related to significant shareholdings.
Read more →NYXHNyxoah Strengthens its Executive Leadership Team
Nyxoah has announced the appointment of Francis Kim as Chief Regulatory and Quality Officer, aiming to strengthen its leadership team. Kim brings over 25 years of experience in the medical device and life sciences sectors, having held leadership roles at notable companies such as Medtronic and Philips. This strategic addition comes as Nyxoah prepares for critical upcoming milestones, including data from the DREAM U.S. pivotal study and an anticipated FDA approval by the end of the year.
Read more →NYXHNyxoah to Participate in the Piper Sandler 35th Annual Healthcare Conference
Nyxoah SA, a medical technology company focused on solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Piper Sandler 35th Annual Healthcare Conference set for November 28-30, 2023, in New York. CEO Olivier Taelman will be featured in a Fireside Chat on November 29. The company aims to engage with institutional investors and will present their innovative Genio® system, which received CE Mark approval following successful clinical trials. Nyxoah continues to expand its clinical portfolio and work toward FDA approval for the U.S. market.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Third Quarter 2023 Financial and Operating Results Partners with ResMed Germany to increase OSA awareness and therapy penetration Mont-Saint-Guibert, Belgium
Nyxoah SA reported its financial and operating results for Q3 2023, showcasing substantial revenue growth driven by increased commercialization efforts and a new partnership with ResMed Germany to raise awareness of Obstructive Sleep Apnea (OSA) therapies. The company is poised for potential FDA approval in late 2024, following data release from its DREAM U.S. pivotal trial. Despite these optimistic advancements, Nyxoah reported a significant operating loss of €11 million, driven largely by increased R&D expenses.
Read more →NYXHNyxoah Reports Third Quarter 2023 Financial and Operating Results
Nyxoah has reported its financial and operational results for the third quarter of 2023, highlighting significant sales growth and a strategic partnership with ResMed in Germany aimed at improving OSA therapy penetration. The company's sales reached €1.0 million, compared to €182,000 in the same period last year, with a cash position of €72.5 million expected to fund operations into late 2024. However, Nyxoah also reported an increased operating loss and rising research and development expenses. Looking ahead, the company anticipates FDA approval for its device by late 2024.
Read more →NYXHNyxoah to Participate in the Jefferies London Healthcare Conference
Nyxoah SA is set to participate in the Jefferies London Healthcare Conference from November 14-16, 2023, where CEO Olivier Taelman will provide a corporate update. The company specializes in innovative treatments for Obstructive Sleep Apnea (OSA), particularly with its Genio® system, which has garnered favorable study results and regulatory approval. Following its successful CE marking in 2019 and subsequent IPOs, Nyxoah continues to enhance its market presence. The event will also feature opportunities for one-on-one meetings with institutional investors.
Read more →NYXHNyxoah to Release Third Quarter 2023 Financial Results on November 8, 2023
Nyxoah SA has announced that it will release its financial results for the third quarter of 2023 on November 8, 2023. Following these results, management will hold a conference call to discuss the findings. Nyxoah's focus is on developing solutions for Obstructive Sleep Apnea (OSA), with its lead product being the Genio® system, which has gained CE mark approval. The company is also in the process of pursuing FDA approval through its ongoing DREAM IDE study.
Read more →NYXHNyxoah Announces Partnership with ResMed in Germany
Nyxoah has formed a partnership with ResMed Germany aimed at improving the continuum of care for Obstructive Sleep Apnea (OSA) patients in Germany. This collaboration focuses on increasing awareness and therapy penetration, educating patients from diagnosis to treatment. The partnership intends to enhance marketing initiatives and educational programs to better support clinicians and patients in managing OSA effectively. Nyxoah's advanced Genio system complements the goals of the partnership by offering a unique treatment approach to this widespread condition.
Read more →NYXH▼ -5.6%on this news
Nyxoah to Participate in the Cantor Fitzgerald Global Healthcare Conference
Nyxoah SA, a medical technology company, will participate in the Cantor Fitzgerald Global Healthcare Conference from September 26 to 28, 2023. CEO Olivier Taelman will present a corporate update on September 27, 2023. The company focuses on innovative treatments for Obstructive Sleep Apnea and has received CE mark approval for its Genio® system, with ongoing studies for U.S. commercialization. Nyxoah has also successfully completed two IPOs since 2020.
Read more →NYXHNyxoah Reports Second Quarter and First Half 2023 Financial and Operating Results
Nyxoah SA reported its financial and operational results for the second quarter and first half of 2023, with notable highlights including a 65% responder rate in the DREAM study. The company is ramping up U.S. pre-commercialization efforts and has a robust cash position of €84.5 million. However, they reported an increased operating loss of €11.9 million in Q2, driven by higher research and development expenses and ongoing commercial activities. The company remains focused on expanding their footprint in the German market while preparing for an eventual U.S. launch.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2023 Financial and Operating Results Mont-Saint-Guibert, Belgium
Nyxoah SA reported its financial results for the second quarter and first half of 2023, showing an increase in revenue but a rise in operating losses. The company continues to focus on its DREAM study and has made progress on its PMA filing. Although Nyxoah has increased its revenue, it is also experiencing higher research and development expenses, leading to significant operating losses. The company is building its commercial efforts, particularly in Germany, in preparation for market expansion.
Read more →NYXHNyxoah to Participate in the 43rd Canaccord Genuity Growth Conference
Nyxoah SA announced its participation in the upcoming 43rd Canaccord Genuity Growth Conference scheduled for August 7-10, 2023, in Boston. CEO Olivier Taelman will provide a corporate update on August 9, 2023, as well as engage directly with institutional investors through 1x1 meetings. Nyxoah focuses on innovative treatments for Obstructive Sleep Apnea and has successfully completed studies leading to CE mark approvals for its Genio® system. The company aims to advance its U.S. market presence through the DREAM IDE pivotal study.
Read more →NYXHNyxoah to Release Second Quarter 2023 Financial Results on August 8, 2023
Nyxoah SA announced the upcoming release of its financial results for the second quarter of 2023 on August 8, 2023, after market close. This announcement will be followed by a conference call at 10:30pm CET. Nyxoah is known for its development of innovative solutions for the treatment of Obstructive Sleep Apnea, with its lead product, the Genio® system, already having received CE Mark approval. The company is also working towards FDA commercialization approval through the DREAM IDE pivotal study.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports First Quarter 2023 Financial and Operating Results Mont-Saint-Guibert, Belgium
Nyxoah SA has reported its financial and operating results for the first quarter of 2023, highlighting the completion of all implants in its DREAM U.S. pivotal trial. The company raised €19 million from investors and made notable progress toward FDA approval with a modular PMA submission. However, Nyxoah also reported a significant operating loss and a decline in revenue compared to the previous year. The focus for 2023 will be on data collection and expanding market presence, particularly in the U.S. and Europe.
Read more →NYXHNyxoah Reports First Quarter 2023 Financial and Operating Results
Nyxoah reported its first quarter 2023 financial and operational results, highlighting notable developments such as the completion of all 115 implants in the DREAM U.S. pivotal trial. The company raised €19 million from key investors and continued its focus on expanding its market presence in the U.S. and Europe. However, revenues dropped to €441,000 compared to €660,000 for the same quarter last year, while operating losses increased significantly due to rising R&D and administrative expenses. Preliminary data from their studies show promising responder rates for their therapy, suggesting future potential.
Read more →NYXHNyxoah Appoints Christoph Eigenmann as Chief Commercial Officer
Nyxoah SA has appointed Christoph Eigenmann as its Chief Commercial Officer, effective May 10, 2023. Eigenmann, who has over 20 years of experience in medical technologies, will be responsible for overseeing global commercial activities, sales, and marketing. His background includes significant roles at Johnson & Johnson, where he led orthopedic and neuro businesses. The appointment is seen as a strategic move as Nyxoah prepares to expand its operations, particularly in the U.S. market with its Genio system for treating Obstructive Sleep Apnea.
Read more →NYXH▲ +7.8%on this news
Nyxoah to Release First Quarter 2023 Financial Results on May 16, 2023
Nyxoah SA, a medical technology company focused on Obstructive Sleep Apnea solutions, will release its first quarter 2023 financial results on May 16, 2023. Following the announcement, management will host a conference call to discuss the results. The company is known for its leadless, battery-free Genio® system, which has recently received CE Mark approval for expanded indications. Nyxoah aims to enhance patient quality of life through its innovative treatments for sleep apnea.
Read more →NYXHREGULATED INFOMATION Publication relating to transparency notifications Mont-Saint-Guibert (Belgium)
Nyxoah SA has announced the receipt of two transparency notifications in compliance with Belgian regulations. Together Partnership and ResMed Inc have notified the company of their increased shareholdings, with Together Partnership crossing the 10% threshold and ResMed Inc reaching 5.30%. These notifications are part of Nyxoah's adherence to transparency obligations regarding large shareholding disclosures, revealing a growing interest from significant stakeholders.
Read more →NYXH▲ +10.2%on this news· ran to +34% by day 3
INSIDE INFORMATION REGULATED INFORMATION Nyxoah Raises $3 Million from its At-the-Market Equity Offering Mont-Saint-Guibert, Belgium
Nyxoah SA announced it has raised $3 million from its at-the-market equity offering as part of a larger $50 million program. The funds raised will be allocated for general corporate purposes. The company continues to focus on developing its Genio system, an innovative leadless therapy for Obstructive Sleep Apnea (OSA), which received CE Mark approval based on positive clinical study outcomes. Nyxoah is also conducting a pivotal study for FDA approval in the U.S.
Read more →NYXH▲ +10.2%on this news· ran to +34% by day 3
Nyxoah Raises $3 Million from its At-the-Market Equity Offering
Nyxoah SA raised $3 million through its at-the-market equity offering, which will be directed towards general corporate purposes. The funds were obtained under a previously established $50 million ATM program. Nyxoah is focused on developing the Genio® system, a hypoglossal neurostimulation therapy for Obstructive Sleep Apnea, which has seen positive developments, including CE mark approvals for its therapeutic indications. The company is also pursuing FDA approval through the DREAM IDE pivotal study.
Read more →NYXHNyxoah Raises $3 Million from an At-the-Market Equity Offering
Nyxoah SA has announced the successful raising of $3 million through its at-the-market equity offering program. The funds, primarily acquired from Cochlear Limited, will be allocated for general corporate purposes. The company, which focuses on innovative solutions for Obstructive Sleep Apnea (OSA), has achieved significant milestones including CE mark approval for its Genio system and is currently conducting a pivotal study for FDA approval. This financial boost may enhance Nyxoah's operational capabilities and support further advancements in their product offerings.
Read more →NYXHINSIDE INFORMATION REGULATED INFORMATION Nyxoah Announces a $15 Million Private Placement Financing Mont-Saint-Guibert, Belgium
Nyxoah SA announced a private placement financing, raising $15 million through the sale of new ordinary shares. The financing, involving notable shareholders like ResMed and Robert Taub, will be used for general corporate purposes. The closing is expected to occur around March 30, 2023, pending customary conditions. Nyxoah specializes in innovative treatments for Obstructive Sleep Apnea and has recently expanded its therapeutic indications for its Genio system following successful clinical studies.
Read more →NYXHNyxoah Announces a $15 Million Private Placement Financing
Nyxoah SA has announced a private placement financing of €13.35 million, which translates to approximately $15 million. The financing involves the sale of 2,047,544 new ordinary shares at €6.52 per share. Notable investors include historical shareholders such as ResMed and Robert Taub. The funds raised will be utilized for general corporate purposes, and the transaction is expected to close around March 30, 2023, pending customary conditions.
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Fourth Quarter and Full Year 2022 Financial and Operating Results Completed all 115 implants in the DREAM U.S. pivotal study Mont-Saint-Guibert, Belgium
Nyxoah SA reported its financial and operating results for the fourth quarter and full year of 2022, highlighting key milestones achieved, including the completion of 115 implants in the DREAM study. The company also experienced significant revenue growth in Germany, attributed to the commercialization of its Genio system. Despite these positives, Nyxoah faced an operating loss of $32.5 million, with increased R&D expenses and a notable cash burn rate. The company is focused on securing FDA approval and expanding its commercial reach in the U.S.
Read more →NYXHNyxoah Reports Fourth Quarter and Full Year 2022 Financial and Operating Results
Nyxoah SA reported its financial and operating results for the fourth quarter and full year 2022, highlighting significant advancements in its clinical studies and commercial efforts. The company completed all implants in the DREAM U.S. pivotal study and achieved a revenue increase to €3.1 million for the year, primarily driven by its Genio® system in Germany. However, it also reported an increased operating loss of €32.5 million due to heightened research and development expenses. Despite these challenges, Nyxoah remains focused on expanding its market presence and enhancing its supply chain capabilities.
Read more →NYXHNyxoah to Release Fourth Quarter and Full Year 2022 Financial Results on March 22, 2023
Nyxoah SA, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), will announce its fourth quarter and full year 2022 financial results on March 22, 2023, after market close. The release will be accompanied by a conference call with management, intended to provide insights into the company's performance. Nyxoah's Genio® system, a leadless and battery-free hypoglossal neurostimulation therapy, has garnered positive attention due to its recent CE mark approvals and ongoing pivotal studies for U.S. commercialization.
Read more →NYXHNyxoah to Participate in the Oppenheimer 33rd Annual Healthcare Conference
Nyxoah SA announced its participation in the Oppenheimer 33rd Annual Healthcare Conference, set for March 13-15, 2023, where CEO Olivier Taelman will deliver a corporate update on March 14. The company specializes in innovative treatments for Obstructive Sleep Apnea (OSA), with its lead product, the Genio system, having received the European CE Mark. Following successful clinical trials, Nyxoah is also pursuing FDA approval through the DREAM IDE study for U.S. commercialization.
Read more →NYXHNyxoah Announces Achievement of Key Clinical and Regulatory Milestones
Nyxoah has announced significant progress in its clinical and regulatory efforts concerning the Genio hypoglossal nerve stimulation system, designed to treat Obstructive Sleep Apnea. The company has achieved full enrollment in its DREAM U.S. pivotal study, with all 115 patients implanted. Additionally, Nyxoah submitted its first module for the PMA submission and commenced the ACCCESS U.S. pivotal study. These milestones mark an important step towards gaining marketing authorization in the United States and expanding treatment options for OSA patients.
Read more →NYXH▲ +10.8%on this news
Nyxoah Announces Inaugural Investor & Analyst Meeting
Nyxoah SA announced its inaugural Investor & Analyst Meeting scheduled for March 23, 2023, in New York City. The event will feature a business update from senior management and presentations from key opinion leaders in the field of obstructive sleep apnea. It aims to engage investors and provide insights into Nyxoah's innovative solutions, particularly the Genio® system for treating Obstructive Sleep Apnea. The meeting will also include a Q&A session and a reception for attendees.
Read more →NYXHNyxoah Appoints Mr. Daniel Wildman to its Board of Directors Mont-Saint-Guibert, Belgium
Nyxoah SA has appointed Daniel Wildman as an Independent Director to its Board of Directors. Wildman, a seasoned veteran in the medical device field, will leverage his extensive experience to assist the company as it expands its research and development and commercial strategies. He expressed his enthusiasm for Nyxoah's Genio system, which addresses Obstructive Sleep Apnea. This strategic addition to the board is also timely as the company seeks FDA approval for its innovative therapy.
Read more →NYXHNyxoah Files Shelf Registration Statement and Announces At-the-Market Equity Offering Program
REGULATED INFORMATION Nyxoah Files Shelf Registration Statement and Announces At-the-Market Equity Offering Program Mont-Saint-Guibert, Belgium – December 22, 2022, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical techn
Read more →NYXHINSIDE INFORMATION REGULATED INFORMATION Nyxoah Files Shelf Registration Statement and Announces At-the-Market Equity Offering Program Mont-Saint-Guibert, Belgium
REGULATED INFORMATION Nyxoah Files Shelf Registration Statement and Announces At-the-Market Equity Offering Program Belgium - December 22, 2022, 10:10pm CET / 4:10pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical technology company focu
Read more →NYXHNyxoah to Participate in the Piper Sandler 34th Annual Healthcare Conference
Nyxoah to Participate in the Piper Sandler 34th Annual Healthcare Conference Mont-Saint-Guibert, Belgium – November 17, 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
Read more →NYXHNyxoah Reports Third Quarter 2022 Financial and Operating Results
REGULATED INFORMATION Nyxoah Reports Third Quarter 2022 Financial and Operating Results DREAM US pivotal 12-month clinical data expected in fall of 2023 Mont-Saint-Guibert, Belgium – November 8, 2022, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoa
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Third Quarter 2022 Financial and Operating Results DREAM US pivotal 12-month clinical data expected in fall of 2023 Mont-Saint-Guibert, Belgium
REGULATED INFORMATION Nyxoah Reports Third Quarter 2022 Financial and Operating Results DREAM US pivotal 12-month clinical data expected in fall of 2023 Mont-Saint-Guibert, Belgium - November 8, 2022, 10:05pm CET / 4:05pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoa
Read more →NYXHNyxoah Announces Change to Board of Directors
Nyxoah Announces Change to Board of Directors Mont-Saint-Guibert, Belgium – October 24, 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 innova
Read more →NYXHNyxoah announces Change to Board of Directors Mont-Saint-Guibert, Belgium
Nyxoah announces Change to Board of Directors Belgium - October 24, 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
Read more →NYXHNyxoah to Release Third Quarter Financial Results on
Nyxoah to Release Third Quarter Financial Results on November Nyxoah to Release Third Quarter Financial Results on November Mont-Saint-Guibert, Belgium - October 18, 2022, 10:30pm CET / 4:30pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medi
Read more →NYXHNyxoah to Participate in the 17th Annual Wells Fargo Securities Healthcare Conference
Nyxoah to Participate in the 17th Annual Wells Fargo Securities Healthcare Conference Mont-Saint-Guibert, Belgium – August 18, 2022, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the devel
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2022 Financial and Operating Results DREAM enrollment complete, 12-month clinical data expected in fall of 2023 Mont-Saint-Guibert, Belgium
REGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2022 Financial and Operating Results DREAM enrollment complete, 12-month clinical data expected in fall of 2023 Mont-Saint-Guibert, Belgium - August 8, 2022, 10:05pm CET / 4:05pm ET - Nyxoah SA (Euronext Bru
Read more →NYXHNyxoah Reports Second Quarter and First Half 2022 Financial and Operating Results
REGULATED INFORMATION Nyxoah Reports Second Quarter and First Half 2022 Financial and Operating Results DREAM enrollment complete, 12-month clinical data expected in fall of 2023 Mont-Saint-Guibert, Belgium – August 8, 2022, 10:05pm CET / 4:05pm ET – Nyxoah SA (Euronext Brusse
Read more →NYXHNyxoah and Acurable Enter into Distribution Agreement in Germany for the AcuPebble SA100 Home Sleep Test
Nyxoah and Acurable Enter into Distribution Agreement in Germany for the AcuPebble SA100 Home Sleep Test Nyxoah and Acurable Enter into Distribution Agreement in Germany for the AcuPebble SA100 Home Sleep Test Belgium - August 2, 2022, 8:00am CET / 2:00am ET - Nyxoah SA (Euro
Read more →NYXHNyxoah to Present at the Canaccord Genuity 42nd Annual Growth Conference
Nyxoah to Present at the Canaccord Genuity 42nd Annual Growth Conference Mont-Saint-Guibert, Belgium – July 27, 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 comm
Read more →NYXHNyxoah to Release Second Quarter and First Half 2022 Financial Results on
Nyxoah to Release Second Quarter and First Half 2022 Financial Results on August 8, 2022 Nyxoah to Release Second Quarter and First Half 2022 Financial Results on August 8, 2022 Mont-Saint-Guibert, Belgium - July 19, 2022, 10:30pm CET / 4:30pm ET - Nyxoah SA (Euronext Brusse
Read more →NYXHNyxoah Announces CE Mark Approval for Genio 2.1
Nyxoah Announces CE Mark Approval for Genio 2.1 Nyxoah Announces CE Mark Approval for Genio 2.1 The next generation external activation chip leverages Nyxoah's scalable platform to continuously enhance patient comfort and therapy efficacy Mont-Saint-Guibert, Belgium - July 18
Read more →NYXH▲ +13.2%on this news
Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio in Complete Concentric Collapse Patients
Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio in Complete Concentric Collapse Patients REGULATED INFORMATION Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio in Complete Concentric Collapse Patients First ACCCESS patient expec
Read more →NYXHNyxoah Joins the Euronext Tech Leaders Initiative, Included in the Euronext Tech Leaders Index
Nyxoah Joins the Euronext Tech Leaders Initiative, Included in the Euronext Tech Leaders Index Mont-Saint-Guibert, Belgium – June 7, 2022 4:30pm ET / 10:30pm CET– Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the d
Read more →NYXH▼ -6.5%on this news
FDA Approves Genio 2.1 For Use in DREAM U.S. IDE Pivotal Study New smartphone application, upgraded activation chip, improved user interface, and stimulation amplitude trimming enhance patient experience and comfort Mont
FDA Approves Genio 2.1 For Use in DREAM U.S. IDE Pivotal Study New smartphone application, upgraded activation chip, improved user interface, and stimulation amplitude trimming enhance patient experience and comfort Belgium - June 1, 2022, 10:30pm CET / 4:30pm ET - Nyxoah SA
Read more →NYXHNyxoah Reports First Quarter 2022 Financial and Operating Results
REGULATED INFORMATION Nyxoah Reports First Quarter 2022 Financial and Operating Results Mont-Saint-Guibert, Belgium – May 10, 2022, 08:50pm CET / 2:50pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the devel
Read more →NYXHREGULATED INFORMATION Nyxoah Reports First Quarter 2022 Financial and Operating Results Mont-Saint-Guibert, Belgium
First Quarter 2022 Financial and Operating Results Belgium - May 10, 2022, 08:50pm CET / 2:50pm 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
Read more →NYXH▲ +7.9%on this newsshared move
Nyxoah Nominates Raymond Cohen and Virginia Kirby for Appointment to Its Board of Directors
Nyxoah Nominates Raymond Cohen and Virginia Kirby for Appointment to Its Board of Directors Mont-Saint-Guibert, Belgium – May 6, 2022, 7:00am CET / 1:00am ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the dev
Read more →NYXHNyxoah to Release First Quarter 2022 Financial Results on May 9 and Host Conference Call on May 10, 2022
Nyxoah to Release First Quarter 2022 Financial Results on May 9 and Host Conference Call on May 10, 2022 Mont-Saint-Guibert, Belgium – April 28, 2022, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company fo
Read more →NYXHNyxoah Reports Full Year 2021 Operating and Financial Results
REGULATED INFORMATION Nyxoah Reports Full Year 2021 Operating and Financial Results Mont-Saint-Guibert, Belgium – March 24, 2022, 9:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the develop
Read more →NYXHREGULATED INFORMATION Nyxoah Reports Full Year 2021 Operating and Financial Results Mont-Saint-Guibert, Belgium
REGULATED INFORMATION Full Year 2021 Operating and Financial Results Belgium - March 24, 2022, 9:30pm 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 inno
Read more →NYXH▲ +6.2%on this news
BETTER SLEEP Achieves Primary Endpoint Across All Patient Cohorts
BETTER SLEEP Achieves Primary Endpoint Across All Patient Cohorts BETTER SLEEP Achieves Primary Endpoint Across All Patient First clinical data demonstrating effectiveness of HGNS to treat CCC patients As previously disclosed, confirms achievement of primary endpoint of AHI
Read more →NYXHNyxoah 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 c
Read more →NYXHNyxoah to Present BETTER SLEEP Data, Host Physician Events at World Sleep Congress 2022
Nyxoah to Present BETTER SLEEP Data, Host Physician Events at World Sleep Congress 2022 Mont-Saint-Guibert, Belgium – March 7, 2022, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the devel
Read more →NYXHNyxoah to Release Full Year 2021 Financial Results on March 24 and Host Conference Call on March 25, 2022
Nyxoah to Release Full Year 2021 Financial Results on March 24 and Host Conference Call on March 25, 2022 Mont-Saint-Guibert, Belgium – March 3, 2022, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company fo
Read more →NYXHNyxoah to Present at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference
Nyxoah to Present at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference Mont-Saint-Guibert, Belgium – February 4, 2022, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on
Read more →NYXHNyxoah Provides General Corporate Update
Nyxoah Provides General Corporate Nyxoah Provides General Corporate Update Transformational 2021 positions Nyxoah for further clinical, regulatory, and commercial milestones in 2022 Belgium - January 10, 2022, 7:00am CET / 1:00am ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH
Read more →NYXHNyxoah Announces Participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference
Nyxoah Announces Participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference Mont-Saint-Guibert, Belgium. – November 12, 2021, 10:30 pm CET / 4:30 pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focuse
Read more →NYXHNyxoah appoints new CFO
Nyxoah appoints new CFO Nyxoah appoints new CFO Mont-Saint-Guibert, Belgium - November 8, 2021, 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 in
Read more →NYXHNyxoah Announces Participation in the Stifel 2021 Virtual Healthcare Conference
Nyxoah Announces Participation in the Stifel 2021 Virtual Healthcare Conference Mont-Saint-Guibert, Belgium. – November 3, 2021, 10:30 pm CET / 4:30 pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the develop
Read more →NYXHNyxoah Announces CE-Mark Indication Approval to Treat Complete Concentric Collapse (CCC) Patients
REGULATED INFORMATION Nyxoah Announces CE-Mark Indication Approval to Treat Complete Concentric Collapse (CCC) Patients Notified Body DEKRA approves IFU changes to remove warning regarding CCC patients Mont-Saint-Guibert, Belgium – October 4, 2021, 10:30pm CET / 4:30pm ET – Ny
Read more →NYXHNyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio System for Obstructive Sleep Apnea and Complete Concentric Collapse
REGULATED INFORMATION Nyxoah Announces U.S. FDA Breakthrough Device Designation Granted for the Genio® System for Obstructive Sleep Apnea and Complete Concentric Collapse Mont-Saint-Guibert (Belgium), September 14, 2021, 8:00 am CET / 2:00 am ET – Nyxoah SA (Euronext Brussels/N
Read more →NYXHNyxoah Announces Participation in the Cantor 2021 Virtual Global Healthcare Conference
Nyxoah Announces Participation in the Cantor 2021 Virtual Global Healthcare Conference Mont-Saint-Guibert (Belgium), September 13, 2021, 10:30 pm CET / 4:30 pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on th
Read more →NYXHNyxoah Announces Participation in the Baird 2021 Global Healthcare Conference
Nyxoah Announces Participation in the Baird 2021 Global Healthcare Conference Mont-Saint-Guibert, Belgium – September 2, 2021, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH)(“Nyxoah” or the “Company”), a medical technology company focused on the development
Read more →NYXH▲ +10.9%on this newsshared move
REGULATED INFORMATION Nyxoah Issues First Half 2021 Financial Results Mont-Saint-Guibert, Belgium
First Half 2021 Financial Results Mont-Saint-Guibert, Belgium - August 31, 2021, 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 soluti
Read more →NYXH▲ +10.9%on this newsshared move
Nyxoah Issues First Half 2021 Financial Results
REGULATED INFORMATION Nyxoah Issues First Half 2021 Financial Results Mont-Saint-Guibert, Belgium – August 31, 2021, 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 comm
Read more →NYXHNyxoah to Release First Half 2021 Financial Results on August 31 and Host Earnings Conference Call on
Nyxoah to Release First Half 2021 Financial Results on August 31 and Host Earnings Conference Call on September 1, Mont-Saint-Guibert, Belgium. - August 11, 2021, 10:30 pm CET / 4:30 pm ET - Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) ("Nyxoah" or the "Company"), a medical te
Read more →NYXHNyxoah Appoints Rita Johnson-Mills to its Board of Directors
Nyxoah Appoints Rita Johnson-Mills to its Board of Directors Mont-Saint-Guibert, Belgium – August 27, 2021, 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 commercializa
Read more →NYXHNyxoah to Release First Half 2021 Financial Results on August 31 and Host Earnings Conference Call on September 1, 2021
Mont-Saint-Guibert, Belgium. - August 11, 2021, 10:30 pm CET / 4:30 pm 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 Apn
Read more →NYXHREGULATED INFOMATION Publication relating to a transparency notification Mont-Saint-Guibert (Belgium)
REGULATED INFOMATION Publication relating to a transparency notification (Belgium), July 14, 2021, 10:30pm CET / 4:30pm ET - In accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings, Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) announces t
Read more →NYXHNyxoah Announces Closing of Nasdaq Initial Public Offering and Underwriters’ Full Exercise of Option to Purchase Additional Shares
REGULATED INFORMATION Nyxoah Announces Closing of Nasdaq Initial Public Offering and Underwriters’ Full Exercise of Option to Purchase Additional Shares Mont-Saint-Guibert, Belgium – July 8, 2021, 10:30pm CET / 4:30pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or
Read more →NYXHNyxoah Announces Pricing of Nasdaq Public Offering
Mont-Saint-Guibert, Belgium – July 2, 2021, 2:40pm CET / 8:40am 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
Read more →NYXHNyxoah Announces Launch of Proposed Public Offering in the United States
REGULATED INFORMATION Nyxoah Announces Launch of Proposed Public Offering in the United States Mont-Saint-Guibert, Belgium – June 25, 2021, 12:30 pm CET / 6:30 am ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the d
Read more →NYXHNyxoah Issues First Quarter 2021 Results
Nyxoah Issues First Quarter 2021 Results Mont-Saint-Guibert, Belgium – June 10, 2021, 11:45pm CET / 5:45pm ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions
Read more →NYXHNyxoah files Registration Statement for Proposed Initial Public Offering in the United States
Nyxoah files Registration Statement for Proposed Initial Public Offering in the United States Mont-Saint-Guibert, Belgium – June 10, 2021, 11:30pm CET / 5:30pm ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the devel
Read more →NYXHNyxoah BETTER SLEEP Trial Reaches its Primary Endpoints
REGULATED INFORMATION Nyxoah BETTER SLEEP Trial Reaches its Primary Endpoints Mont-Saint-Guibert, Belgium – 7 June 2021, 7:00 am CET / 1:00 am ET – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and comme
Read more →NYXHNyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States
REGULATED INFORMATION Nyxoah Announces Submission of Draft Registration Statement For Proposed Public Listing in the United States Mont-Saint-Guibert, Belgium – 19 April 2021 – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused
Read more →NYXHNyxoah Reports Full Year 2020 Results
Nyxoah Reports Full Year 2020 Results Conference call and webcast today at 3pm CET / 9am ET Mont-Saint-Guibert, Belgium – 9 April 2021 – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercializatio
Read more →NYXHNyxoah to Delay Full Year 2020 Earnings Release Until April 9, 2021
Nyxoah to Delay Full Year 2020 Earnings Release Until April 9, 2021 Mont-Saint-Guibert, Belgium – 2 April 2021 – Nyxoah SA (Euronext Brussels: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions
Read more →NYXHNyxoah announces the publication of first positive clinical data in an OSA patient suffering from Complete Concentric Collapse (CCC)
Nyxoah announces the publication of first positive clinical data in an OSA patient suffering from Complete Concentric Collapse (CCC) Mont-Saint-Guibert, Belgium – 3rd March 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the
Read more →NYXHNyxoah to present at the Oppenheimer 31st Annual Healthcare Conference
Nyxoah to present at the Oppenheimer 31st Annual Healthcare Conference Mont-Saint-Guibert, Belgium – 24th February 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions
Read more →NYXHNyxoah receives FDA approval for full-body 1.5T and 3T MRI compatibility for the Genio system to treat Obstructive Sleep Apnea (OSA)
Nyxoah receives FDA approval for full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA) Mont-Saint-Guibert, Belgium – 9th February 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on
Read more →NYXHNyxoah and Vanderbilt University enter exclusive licensing agreement regarding next generation neurostimulation technologies to treat Obstructive Sleep Apnea (OSA)
Nyxoah and Vanderbilt University enter exclusive licensing agreement regarding next generation neurostimulation technologies to treat Obstructive Sleep Apnea (OSA) Mont-Saint-Guibert, Belgium – 2nd February, 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health
Read more →NYXHNyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio system to treat Obstructive Sleep Apnea (OSA)
Nyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA) Mont-Saint-Guibert, Belgium – 26th January, 2021 – Nyxoah SA (Euronext: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development
Read more →NYXHNyxoah to Participate in Annual Piper Sandler Healthcare Conference
Nyxoah to Participate in Annual Piper Sandler Healthcare Conference Mont-Saint-Guibert, Belgium – 20th November 2020 – Nyxoah S.A. (EBR: NYXH) (“Nyxoah” or the “Company”), a health-technology company focused on the development and commercialization of innovative solutions and se
Read more →NYXHNyxoah announces the end of the Stabilisation Period and the Full Exercise of the Over-allotment Option
This announcement does not constitute an offer to sell, or an invitation to offer or buy or subscribe for, securities. An investment in the Offered Shares involves substantial risks and uncertainties. Prospective investors should read the entire prospectus, and, in particular, s
Read more →NYXHNyxoah Announces Commencement of Trading of Shares on Euronext Brussels
An investment in the Offered Shares involves substantial risks and uncertainties. Prospective investors should read the entire prospectus, and, in particular, should see "Risk Factors" for a discussion of certain factors that should be considered in connection with an investment
Read more →NYXHNyxoah Raises up to €85 million (US$100m) in Successful Initial Public Offering
An investment in the Offered Shares involves substantial risks and uncertainties. Prospective investors should read the entire prospectus, and, in particular, should see "Risk Factors" for a discussion of certain factors that should be considered in connection with an investment
Read more →NYXHNyxoah Initial Public Offering Multiple Times Over Subscribed and Early Closing Announced
An investment in the Offered Shares involves substantial risks and uncertainties. Prospective investors should read the entire prospectus, and, in particular, should see "Risk Factors" for a discussion of certain factors that should be considered in connection with an investment
Read more →NYXHNyxoah launches its Initial Public Offering on Euronext Brussels
An investment in the Offered Shares involves substantial risks and uncertainties. Prospective investors should read the entire prospectus, and, in particular, should see "Risk Factors" for a discussion of certain factors that should be considered in connection with an investment
Read more →NYXHNyxoah Announces Intention to Launch an Initial Public Offering on Euronext Brussels
An investment in the Offered Shares involves substantial risks and uncertainties. Prospective investors should read the entire prospectus, and, in particular, should see "Risk Factors" for a discussion of certain factors that should be considered in connection with an investment
Read more →NYXHNyxoah receives IDE approval from the U.S. Food and Drug Administration (FDA) for its DREAM study
Nyxoah receives IDE approval from the U.S. Food and Drug Administration (FDA) for its DREAM study Study supporting the approval of Nyxoah’s Genio® system in the U.S. to be initiated in the coming months Mont-Saint-Guibert, Belgium – 25 June 2020, Nyxoah S.A., a healthtech compa
Read more →NYXHNyxoah raises €25 million in private funding round
Nyxoah raises €25 million in private funding round Mont-Saint-Guibert, Belgium – 12 February 2020, Nyxoah S.A., a healthtech company developing neuromodulation-based therapeutic solutions for sleep disordered breathing conditions, today announced that it has raised €25 million i
Read more →NYXHNyxoah announces data demonstrating the benefits and safety of its Genio system implantation technique for the treatment of Obstructive Sleep Apnea published in Laryngoscope Investigative Otolaryngology
Nyxoah announces data demonstrating the benefits and safety of its Genio® system implantation technique for the treatment of Obstructive Sleep Apnea published in Laryngoscope Investigative Otolaryngology Data show that the implantation procedure of the Genio® system is relativel
Read more →NYXHNyxoah publishes positive Obstructive Sleep Apnea data from BLAST OSA study in the European Respiratory Journal
Nyxoah publishes positive Obstructive Sleep Apnea data from BLAST OSA study in the European Respiratory Journal Compelling data published in prestigious journal show safety and efficacy of the Genio® system, a next-generation neurostimulation therapy for Obstructive Sleep Apnea
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