Nyxoah Overview
Nyxoah is a medical device company focused on the development and commercialization of hypoglossal nerve stimulation therapy for the treatment of obstructive sleep apnea (OSA). The company has developed a battery-free, leadless, minimally invasive neurostimulator capable of delivering bilateral hypoglossal nerve stimulation for patients with moderate to severe OSA who have failed at conventional positive airway pressure therapy. Nyxoahs therapy consists of a tiny neurostimulator that is implanted in the chin area in a minimally invasive surgery. The system, which is powered by a miniature external battery, is placed under the chin and stimulates the tongue nerve. In March 2019, Nyxoah received CE marking for its novel hypoglossal nerve stimulation therapy for treatment of obstructive sleep apnea. In January 2021, Nyxoah received CE mark magnetic resonance imaging (MRI) conditional labeling for the current Genio neurostimulation-based OSA therapy for treatment of obstructive sleep apnea.
Cumulative Funding Raised Over Time ($)
$3.0MApr 2023
$30.6MFeb 2020
$50.6MJul 2016
$65.6MMar 2023
$76.6MMay 2014
$93.7MNov 2018
$120.7MOct 2024
Latest News
growth-negative
10x Genomics (TXG) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
10x Genomics is expected to report a quarterly loss of $0.27 per share for the quarter ended September 2025, reflecting a year-over-year improvement of 10%. However, revenues are anticipated to decline by 6.1% to $142.39 million compared to the same quarter last year. The consensus EPS estimate has been revised upward by 1.46% over the past 30 days. The companys stock price may be influenced by how actual results compare to these estimates, with potential for movement if the earnings surprise positively or negatively. The Zacks Earnings ESP model suggests that a positive Earnings ESP reading could predict an earnings beat.
growth-positive
Nyxoah to Release Third Quarter 2025 Financial Results on November 13, 2025
Nyxoah, a medical technology company specializing in neuromodulation treatments for Obstructive Sleep Apnea (OSA), announced it will release its third-quarter 2025 financial results on November 13, 2025. The company will host a conference call to discuss these results. Nyxoahs Genio system, a leadless and battery-free hypoglossal neurostimulation therapy for OSA, has received both European CE Mark and U.S. FDA approval. The company completed IPOs on Euronext Brussels and NASDAQ in 2020 and 2021, respectively. The FDA approval in August 2025 marks a significant milestone for Nyxoah, allowing it to expand its market reach.
Public TradingFDA approved/pending approval
growth-negative
Analysts Estimate Nyxoah SA (NYXH) to Report a Decline in Earnings: What to Look Out for
Nyxoah SA is expected to report a year-over-year decline in earnings despite higher revenues for the quarter ending September 2025. The company is anticipated to post a quarterly loss of $0.61 per share, a 10.9% decrease from the previous year, while revenues are projected to increase by 40.3% to $1.95 million. The consensus EPS estimate has been revised downwards by 6.1% over the last 30 days. The Zacks Earnings ESP model suggests that a positive earnings surprise is possible if the actual results exceed these estimates. However, if the results fall short, the stock price may decline.
growth-positive
Nyxoah Shares Rise on First U.S. Commercial Use of Genio System
Nyxoah has initiated the U.S. commercial rollout of its Genio system, a leadless, battery-free neurostimulation therapy for obstructive sleep apnea (OSA), following FDA approval. The first commercial implants have been successfully performed, indicating strong physician demand and growing payor coverage, including CMS. This milestone marks Nyxoahs transition from a pre-commercial innovator to an active player in the U.S. sleep apnea market. The company is poised for sustained commercial momentum with expanding hospital approvals and trained surgeons. Nyxoahs market capitalization is $168.6 million, and it anticipates an earnings growth of 8.8% in 2026. The Genio system offers a minimally invasive approach, enhancing patient comfort and compliance.
Product StageCustomers
growth-positive
Nyxoah Announces First U.S. Commercial Patients Implanted with Genio® System
Nyxoah, a medical technology company, has announced the successful implantation of its Genio® system in the first U.S. commercial patients following FDA approval. This marks a significant milestone for the company, demonstrating strong physician demand and widespread payor coverage. The company has trained surgeons and obtained Value Analysis Committee approvals, with major payors like CMS providing coverage. The early commercial launch indicates a promising foundation for sustained adoption of the Genio system, which offers a new treatment option for Obstructive Sleep Apnea (OSA) patients. The first commercial implants were performed by Dr. Andrew T. Huang at Townsen Memorial Health System in Houston, Texas.
Product StageCustomers
| Sector | Health Tech & Life Sciences |
Funding
| Total funding | $270.7M |
| Last funding | $27M |
| Stage | Public |
| Rounds | 10 |
| Investors | 9 |
Team Members
3
Employees: 51-200
Web & Social Links
| Website | www.nyxoah.com |
| Careers | Careers page |
Locations
Yigal Alon Street 126, Tel Aviv-Yafo, Israel
Rue Edouard Belin 12 1435 Mont-Saint-Guibert, Belgium
Photos & Videos
2 item(s)
Nyxoah Business
Business models
B2B
Product stage
Clinical Trial
Employees
51-200
Sector
Health Tech & Life SciencesMedical DevicesMedical Treatment & TherapeuticsTarget Customer
Healthcare & Life SciencesHealthcareProvidersPatientsCore Technology
Materials & SubstancesImplantsTags (9)
medical-devicesneuro-stimulationsleep-disordersrespiratoryapneachronic-patientsminimally-invasivetreatmentstherapeutic-devicesGeographic Markets
GlobalEuropeNyxoah Financials
$270.7M
Total funding
Undisclosed
Capital raised
$27M
Last funding
Public
Funding stage
10
Total rounds
9
Investors
Cumulative Funding Raised Over Time ($)
$3.0MApr 2023
$30.6MFeb 2020
$50.6MJul 2016
$65.6MMar 2023
$76.6MMay 2014
$93.7MNov 2018
$120.7MOct 2024
Private Equity Funding
PIPE
Oct 2024
$27M
PIPE
Apr 2023
$3M
Undisclosed Investor(s)
PIPE
Mar 2023
$15M
Undisclosed Investor(s)
Undisclosed Round
Feb 2020
$27.6M
Cochlear Limited, ResMed
B Round
Nov 2018
$17.1M
Cochlear Limited
B Round
Jul 2016
$20M
Novallia, Glide Healthcare, Uwe Wascher, Robert Taub
A Round
May 2014
$11M
Viralety Ventures, Jrgen Hambrecht, Uwe Wascher
Public Offering / Exit
POEvent
May 2024
Undisclosed
POEvent
Jul 2021
Undisclosed
POEvent
Sep 2020
Undisclosed
Nyxoah Lifecycle
Cumulative Funding Raised Over Time
$3.0MApr 2023
$30.6MFeb 2020
$50.6MJul 2016
$65.6MMar 2023
$76.6MMay 2014
$93.7MNov 2018
$120.7MOct 2024
All Events
PIPE
Oct 2024
$27M
PIPE
Apr 2023
$3M
Undisclosed Investor(s)
PIPE
Mar 2023
$15M
Undisclosed Investor(s)
Undisclosed Round
Feb 2020
$27.6M
Cochlear Limited, ResMed
B Round
Nov 2018
$17.1M
Cochlear Limited
B Round
Jul 2016
$20M
Novallia, Glide Healthcare, Uwe Wascher, Robert Taub
A Round
May 2014
$11M
Viralety Ventures, Jrgen Hambrecht, Uwe Wascher
POEvent
May 2024
Undisclosed
POEvent
Jul 2021
Undisclosed
POEvent
Sep 2020
Undisclosed
Nyxoah News
174 articles
growth-negative
10x Genomics (TXG) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
10x Genomics is expected to report a quarterly loss of $0.27 per share for the quarter ended September 2025, reflecting a year-over-year improvement of 10%. However, revenues are anticipated to decline by 6.1% to $142.39 million compared to the same quarter last year. The consensus EPS estimate has been revised upward by 1.46% over the past 30 days. The companys stock price may be influenced by how actual results compare to these estimates, with potential for movement if the earnings surprise positively or negatively. The Zacks Earnings ESP model suggests that a positive Earnings ESP reading could predict an earnings beat.
growth-positive
Nyxoah to Release Third Quarter 2025 Financial Results on November 13, 2025
Nyxoah, a medical technology company specializing in neuromodulation treatments for Obstructive Sleep Apnea (OSA), announced it will release its third-quarter 2025 financial results on November 13, 2025. The company will host a conference call to discuss these results. Nyxoahs Genio system, a leadless and battery-free hypoglossal neurostimulation therapy for OSA, has received both European CE Mark and U.S. FDA approval. The company completed IPOs on Euronext Brussels and NASDAQ in 2020 and 2021, respectively. The FDA approval in August 2025 marks a significant milestone for Nyxoah, allowing it to expand its market reach.
Public TradingFDA approved/pending approval
growth-negative
Analysts Estimate Nyxoah SA (NYXH) to Report a Decline in Earnings: What to Look Out for
Nyxoah SA is expected to report a year-over-year decline in earnings despite higher revenues for the quarter ending September 2025. The company is anticipated to post a quarterly loss of $0.61 per share, a 10.9% decrease from the previous year, while revenues are projected to increase by 40.3% to $1.95 million. The consensus EPS estimate has been revised downwards by 6.1% over the last 30 days. The Zacks Earnings ESP model suggests that a positive earnings surprise is possible if the actual results exceed these estimates. However, if the results fall short, the stock price may decline.
growth-positive
Nyxoah Shares Rise on First U.S. Commercial Use of Genio System
Nyxoah has initiated the U.S. commercial rollout of its Genio system, a leadless, battery-free neurostimulation therapy for obstructive sleep apnea (OSA), following FDA approval. The first commercial implants have been successfully performed, indicating strong physician demand and growing payor coverage, including CMS. This milestone marks Nyxoahs transition from a pre-commercial innovator to an active player in the U.S. sleep apnea market. The company is poised for sustained commercial momentum with expanding hospital approvals and trained surgeons. Nyxoahs market capitalization is $168.6 million, and it anticipates an earnings growth of 8.8% in 2026. The Genio system offers a minimally invasive approach, enhancing patient comfort and compliance.
Product StageCustomers
growth-positive
Nyxoah Announces First U.S. Commercial Patients Implanted with Genio® System
Nyxoah, a medical technology company, has announced the successful implantation of its Genio® system in the first U.S. commercial patients following FDA approval. This marks a significant milestone for the company, demonstrating strong physician demand and widespread payor coverage. The company has trained surgeons and obtained Value Analysis Committee approvals, with major payors like CMS providing coverage. The early commercial launch indicates a promising foundation for sustained adoption of the Genio system, which offers a new treatment option for Obstructive Sleep Apnea (OSA) patients. The first commercial implants were performed by Dr. Andrew T. Huang at Townsen Memorial Health System in Houston, Texas.
Product StageCustomers
growth-negative
Publication relating to transparency notifications
Nyxoah SA announced that it received a transparency notification from Vestal Point Capital regarding a change in voting rights. Vestal Point Capital now holds 1,113,575 voting rights, representing 2.97% of the total voting rights as of September 24, 2025. This change signifies a downward crossing of the 3% threshold. Vestal Point Capital, LP, the investment manager, is controlled by Vestal Point Capital, LLC, which is managed by Ryan Wilder. The notification highlights the acquisition or disposal of voting securities or voting rights, indicating a decrease in Vestal Points stake in Nyxoah.
growth-positive
Nyxoah Expands in the Middle East to Provide Wider Access to Genio
Nyxoah SA is expanding its commercial presence in the Middle East following the successful Genio implant in Abu Dhabi. The Genio system, a unique bilateral hypoglossal nerve stimulation system for obstructive sleep apnea (OSA), has received FDA pre-market approval and is now commercially launched in the U.S. Nyxoah aims to partner with healthcare institutions in Dubai, Kuwait, and Abu Dhabi to enhance access to Genio. The global sleep apnea devices market is projected to grow significantly, driven by an aging population and increased prevalence of sleep apnea. This expansion is expected to strengthen Nyxoahs market position. Inspire Medical Systems, a peer in the OSA space, also reported strong results and market penetration.
Product StageCustomersFDA approved/pending approval
growth-positive
Nyxoah Leads The Charge In European Penny Stocks
Nyxoah SA, a medical technology company, is making strides in the penny stock market with its Genio system designed for obstructive sleep apnea. Despite being unprofitable and experiencing increased losses over the past five years, the company has shown growth potential with revenue from its Medical Products segment reaching €4.93 million. A significant milestone was achieved with the recent FDA approval of Genio for specific patient groups, which could drive future revenue growth. However, challenges such as high share price volatility and a limited cash runway remain. Nyxoahs market cap stands at €160.60 million.
FDA approved/pending approval
growth-positive
Nyxoah Provides an Update on Expanded Middle East Presence
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), has expanded its presence in the Middle East by establishing new centers in Dubai, Kuwait, and Abu Dhabi. This expansion follows the first successful Genio® implant in Abu Dhabi in September 2025. Nyxoahs Genio system, a leadless and battery-free hypoglossal neurostimulation therapy, is now more accessible to patients in the region who cannot tolerate CPAP. The company has partnered with leading healthcare institutions to broaden access to its innovative treatment. Nyxoah has received European CE Mark and U.S. FDA approval for its Genio system, marking significant milestones in its growth and commitment to improving patient outcomes.
PartnersCustomersFDA approved/pending approval
growth-positive
Nyxoah Files Patent Infringement Lawsuit Against Inspire Medical Systems, Inc.
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), has filed a patent infringement lawsuit against Inspire Medical Systems, Inc. The lawsuit, filed in the United States District Court for the District of Delaware, alleges that Inspires devices infringe on three of Nyxoahs patents. Nyxoahs Genio system, a minimally invasive solution for OSA, has received positive feedback following its US commercial launch. The company has also achieved significant milestones, including FDA approval for its Genio system and successful IPOs on Euronext Brussels and NASDAQ. Nyxoah is committed to defending its intellectual property and expanding its market presence.
Public TradingFDA approved/pending approval
growth-negative
Publication relating to transparency notifications
Nyxoah SA announced a transparency notification regarding a passive crossing of a voting rights threshold by Cochlear Investments Pty Ltd. As of August 29, 2025, Cochlear Investments Pty Ltd holds 5,631,319 voting rights, representing 14.999% of the total voting rights in Nyxoah. This marks a slight decrease from their previous holding of 15.04%. The notification was made in accordance with the Act of 2 May 2007 on the disclosure of large shareholdings. Cochlear Investments Pty Ltd is a wholly owned subsidiary of Cochlear Limited. The notification indicates a downward crossing of the 15% threshold, which could imply a growth-negative impact for Nyxoah.
growth-positive
Nyxoah Announces Upcoming Investor Events
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced its participation in several healthcare conferences in September 2025. The company will engage with institutional investors and present its Genio system, a leadless and battery-free hypoglossal neurostimulation therapy for OSA. Following the successful completion of clinical studies, the Genio system received European CE Mark in 2019 and U.S. FDA approval in August 2025. Nyxoah has completed IPOs on Euronext Brussels and NASDAQ, and is now focusing on commercialization and expansion into the U.S. market. The companys participation in these conferences is expected to enhance its visibility and growth prospects.
Public TradingFDA approved/pending approval
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, has issued a press release detailing the issuance of new shares. The companys share capital now stands at EUR 6,449,871.98, with a total of 37,544,782 ordinary shares carrying voting rights. Additionally, there are 2,775,566 rights to subscribe to securities carrying voting rights that have not yet been issued. This development is in accordance with the Belgian Law of 2 May 2007 on the disclosure of large shareholdings. The issuance of new shares is likely to have a growth-positive impact on the company by potentially increasing its capital base.
growth-positive
Nyxoah Reports Second Quarter Financial and Operating Results
Nyxoah, a medical technology company, has received FDA Pre-Market Approval (PMA) for its Genio system, marking a significant milestone. The Genio system is the first bilateral hypoglossal neurostimulation therapy approved in the U.S. for treating Obstructive Sleep Apnea (OSA). The company has commenced the commercial launch of the Genio system in the U.S. Nyxoah reported a 74% year-over-year revenue growth for the second quarter of 2025, with revenue reaching €1.3 million. The FDA approval was supported by data from the DREAM pivotal trial, which demonstrated the systems efficacy across different sleeping positions. This approval is expected to transform Nyxoahs market presence and offer a differentiated solution for OSA patients.
Product StageFDA approved/pending approval
growth-positive
Nyxoah Secures FDA Clearance for Genio System to Treat Sleep Apnea
Nyxoah has received FDA approval for its Genio system, a novel therapy for moderate to severe Obstructive Sleep Apnea (OSA). The Genio system, which features a leadless, battery-free design, offers a unique bilateral nerve stimulation approach. It has shown significant symptom reduction in clinical trials and is now launching in the U.S. market. The systems design allows for non-invasive upgrades and is MRI compatible, enhancing patient convenience. The approval was based on strong results from the DREAM pivotal trial, which demonstrated significant efficacy and safety. This positions Genio as a competitive alternative in the OSA treatment landscape. The global sleep apnea devices market is projected to grow significantly, driven by factors such as an aging population and the development of advanced devices.
Product StageFDA approved/pending approval
growth-positive
Nyxoah Announces Preliminary Results for the Second Quarter of 2025
Nyxoah, a medical technology company, announced preliminary financial results for Q2 2025, showing a 73% revenue increase compared to Q2 2024. The FDA approved its Genio® system for treating moderate to severe Obstructive Sleep Apnea (OSA) in specific adult patients. The company is transitioning its R&D activities from Israel to the U.S. and Belgium. Nyxoah is facing a patent lawsuit from Inspire Medical Systems but plans to defend itself vigorously. The company is also progressing with its ACCCESS clinical trial, which aims to provide significant data on the Genio systems safety and efficacy.
FDA approved/pending approvalProduct StageManagement Changes
growth-positive
FDA approves Nyxoah’s Genio system for obstructive sleep apnoea
Nyxoah has received FDA approval for its Genio system, designed to treat moderate to severe obstructive sleep apnoea (OSA). The system is notable for its bilateral hypoglossal nerve stimulation capability and compatibility with MRI scans, eliminating the need for an implanted battery. The approval was supported by data from the DREAM pivotal trial, which demonstrated significant efficacy in reducing the Apnoea-Hypopnea Index (AHI) and Oxygen Desaturation Index. The Genio system, which had already received the European CE Mark in 2019, is now set to enter the US market, marking a significant milestone for Nyxoah and offering a new treatment option for OSA patients.
Product StageFDA approved/pending approval
growth-negative
Standard BioTools (LAB) Reports Q2 Loss, Tops Revenue Estimates
Standard BioTools reported a quarterly loss of $0.04 per share, aligning with the Zacks Consensus Estimate, and an improvement from the $0.08 loss per share a year ago. The company, which specializes in fluid control equipment, posted revenues of $41.96 million, surpassing the consensus estimate by 5.35%. Despite this, the companys shares have declined by 25.4% since the start of the year, underperforming the S&P 500s gain of 8.6%. The companys earnings outlook remains a critical factor for future stock performance, with a current Zacks Rank of #3 (Hold). The consensus EPS estimate for the next quarter is -$0.04 on $40.7 million in revenues.
growth-positive
Nyxoah Receives Approval from FDA for Genio® System for the Treatment of Obstructive Sleep Apnea
Nyxoah, a medical technology company, has received FDA approval for its Genio system, a treatment for obstructive sleep apnea (OSA). The Genio system, which utilizes a unique bilateral stimulation approach, is now approved for U.S. commercialization. The FDA approval was based on positive results from the DREAM pivotal trial, which demonstrated significant efficacy in reducing the Apnea-Hypopnea Index (AHI) and improving the Oxygen Desaturation Index. The Genio system is notable for its leadless design and compatibility with MRI, offering patients a non-implanted battery solution controlled by a wearable component. This approval marks a significant milestone for Nyxoah, enabling them to expand their market presence in the U.S.
FDA approved/pending approvalProduct StageCustomers
growth-negative
Privia Health (PRVA) Misses Q2 Earnings Estimates
Privia Health reported quarterly earnings of $0.02 per share, missing the Zacks Consensus Estimate of $0.05 per share, marking a -60% earnings surprise. This follows a previous quarters earnings surprise of -50%. Despite this, the company posted revenues of $521.15 million, surpassing the consensus estimate by 11.24%. Over the last four quarters, Privia Health has consistently exceeded revenue estimates but failed to meet earnings expectations. The companys stock has increased by 1.2% since the start of the year, underperforming the S&P 500s 7.9% gain. The stock holds a Zacks Rank #3 (Hold), indicating it is expected to perform in line with the market. Future stock performance will depend on managements commentary and earnings outlook.
growth-positive
Outset Medical, Inc. (OM) Reports Q2 Loss, Beats Revenue Estimates
Outset Medical, Inc. reported a quarterly loss of $0.84 per share, significantly better than the Zacks Consensus Estimate of a $1.76 loss. This represents an earnings surprise of +52.27%. The company also reported revenues of $31.42 million, surpassing the consensus estimate by 5.54%. Despite these positive results, Outset Medical shares have lost about 15.3% since the beginning of the year, underperforming the S&P 500. The companys future stock performance will depend on managements commentary and earnings outlook. The current Zacks Rank for the stock is #3 (Hold), indicating it is expected to perform in line with the market.
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, announced the issuance of new shares, increasing its share capital to EUR 6,432,066.28. The total number of securities carrying voting rights is now 37,441,140, all of which are ordinary shares. Additionally, there are 2,793,941 rights to subscribe to securities carrying voting rights that have not yet been issued. This development is in accordance with the Belgian Law of 2 May 2007 on the disclosure of large shareholdings. The announcement reflects Nyxoahs ongoing efforts to manage its capital structure and enhance shareholder value.
growth-positive
Nyxoah to Release Second Quarter 2025 Financial Results on August 18, 2025
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced it will release its second quarter 2025 financial results on August 18, 2025. The company will host a conference call to discuss these results. Nyxoahs lead product, the Genio® system, is a hypoglossal neurostimulation therapy for OSA, which has received a European CE Mark and is in investigational use in the United States. The company has completed successful IPOs on Euronext Brussels and NASDAQ. Nyxoah has expanded its therapeutic indications following positive study outcomes, further solidifying its position in the market.
growth-positive
Nyxoah’s DREAM Pivotal Study Data Published in the Journal of Clinical Sleep Medicine
Nyxoah, a medical technology company, announced the publication of data from its DREAM pivotal study in the Journal of Clinical Sleep Medicine. The study evaluated the safety and efficacy of the Genio® system for treating Obstructive Sleep Apnea (OSA). Results showed high patient satisfaction and significant improvements in sleep quality, with 90% of patients expressing satisfaction and a notable reduction in snoring scores. The study achieved its co-primary endpoints, with a 63.5% AHI responder rate and a 71.3% ODI responder rate. The findings support Nyxoahs PMA submission to the FDA, indicating a positive impact on the companys growth prospects.
Product Stage
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, announced the issuance of new shares, increasing its share capital to EUR 6,431,121.38. The total number of securities carrying voting rights is now 37,435,640, all of which are ordinary shares. Additionally, there are 2,822,816 rights to subscribe to securities carrying voting rights that have not yet been issued. This development is in accordance with the Belgian Law of 2 May 2007 on the disclosure of large shareholdings. The issuance of new shares is likely to have a growth-positive impact on the company by potentially increasing its market presence and financial resources.
growth-positive
Invitation to attend the extraordinary shareholders’ meeting of the Company to be held on July 2, 2025
Nyxoah has announced an extraordinary shareholders meeting scheduled for July 2, 2025. The meeting will address the introduction of a new right for shareholders who have held at least 5% of the companys shares for three years to nominate directors. This move is seen as a positive step towards enhancing shareholder engagement and influence in the companys governance. The meeting will be accessible via video conference, although voting will need to be done in advance or by proxy. This development is likely to strengthen the companys governance structure and align it more closely with shareholder interests.
growth-negative
Publication relating to transparency notifications
Nyxoah, a company listed on Euronext Brussels and Nasdaq, announced a transparency notification following an acquisition or disposal of voting securities by Vestal Point Capital. As of May 21, 2025, Vestal Point Capital holds 1,809,843 voting rights, representing 4.84% of the total voting rights. The notification was made by Vestal Point Capital, LLC, and its managing member, Ryan Wilder. The notification indicates a crossing of the 5% threshold of voting rights. Vestal Point Capital, LP, an investment management company, can exercise these rights at its discretion. This transparency notification is part of regulatory requirements under the Act of 2 May 2007.
growth-positive
Nyxoah to Present at the Jefferies Global Healthcare Conference
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced its participation in the Jefferies Global Healthcare Conference in New York from June 3-5, 2025. The companys CEO, Olivier Taelman, will present on June 4, 2025. Nyxoahs lead product, the Genio® system, is a hypoglossal neurostimulation therapy for OSA, which has received CE Mark approval in Europe. The company has completed successful IPOs on Euronext Brussels and NASDAQ. Nyxoah is seeking FDA approval for its Genio® system in the U.S. market. The article highlights Nyxoahs growth potential and ongoing efforts to expand its market presence.
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, has issued new shares, increasing its share capital to EUR 6,430,026.16. The total number of securities carrying voting rights now stands at 37,429,265, all of which are ordinary shares. Additionally, there are 2,854,068 rights to subscribe to securities carrying voting rights that have not yet been issued. This update is in accordance with the Belgian law on the disclosure of large shareholdings. The issuance of new shares is likely to have a growth-positive impact on the company by potentially increasing its market presence and financial resources.
growth-negative
Nyxoah SA (NYXH) Q1 2025 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
Nyxoah SA reported a slight decrease in revenue for Q1 2025, attributed to temporary softness in the international AGNS market. The company experienced an increase in operating loss due to investments in its US commercial organization in anticipation of FDA approval for its Genio system. Nyxoah received an approvable letter from the FDA, indicating substantial compliance with US marketing requirements, but the final on-site inspection is pending, introducing uncertainty in the timeline for market entry. The company has built a strong US commercial team and established a CPT code for reimbursement. Nyxoah also marked a milestone by being the first AGNS company to implant in the Middle East.
Product StageFDA approved/pending approval
growth-negative
Nyxoah SA (NYXH) Reports Q1 Loss, Lags Revenue Estimates
Nyxoah SA reported a quarterly loss of $0.63 per share, missing the Zacks Consensus Estimate of a $0.49 loss. This represents a negative earnings surprise of 28.57%. The companys revenue for the quarter was $1.12 million, also missing the consensus estimate by 29.71%. Over the last four quarters, Nyxoah has only surpassed consensus EPS estimates once and has consistently missed revenue estimates. The companys shares have declined by about 27.8% since the beginning of the year, underperforming the S&P 500. The future performance of Nyxoahs stock will depend on managements commentary and earnings outlook. The current consensus EPS estimate for the next quarter is -$0.54 with revenues of $2.12 million.
growth-positive
Nyxoah Reports First Quarter Financial and Operating Results
Nyxoah, a medical technology company specializing in neuromodulation treatments for Obstructive Sleep Apnea, reported its first-quarter financial results for 2025. The company is nearing FDA approval for its Genio® system, having received an FDA Approvable Letter and completed necessary validation requirements. The final site inspection is underway, with approval anticipated in the second quarter of 2025. Despite a slight decrease in revenue from €1.2 million in Q1 2024 to €1.1 million in Q1 2025, Nyxoah remains optimistic about its progress. The companys cash and financial assets totaled €63 million as of March 31, 2025. Nyxoahs focus on completing the FDA approval process highlights its commitment to expanding its market presence.
Product StageFDA approved/pending approval
growth-negative
Publication relating to transparency notifications
Nyxoah SA announced that it received a transparency notification from FMR LLC, indicating a change in voting rights. As of April 29, 2025, FMR LLC and its controlled undertakings hold 1,111,240 voting rights, representing 2.97% of the total voting rights, down from a previous threshold of 3%. This change is due to the acquisition or disposal of voting securities or rights. The notification outlines the voting rights linked to securities and equivalent financial instruments held by various entities controlled by FMR LLC. The notification is part of regulatory requirements for transparency in shareholding changes.
neutral
Invitation to attend the annual and the extraordinary shareholders’ meetings of the Company to be held on June 11, 2025
Nyxoah has announced its annual and extraordinary shareholders meetings scheduled for June 11, 2025. The meetings will discuss the statutory annual accounts and consolidated financial statements for the year ended December 31, 2024. The company will provide a video conference option for securities holders to follow the meetings remotely, although it will not serve as an official voting tool. Attendees are encouraged to register early and exercise their voting rights by mail or proxy. The meetings aim to review the financial performance and reports from the board of directors and statutory auditor.
growth-positive
Nyxoah to Release First Quarter 2025 Financial Results on May 14, 2025
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced it will release its first quarter 2025 financial results on May 14, 2025. The company will host a conference call to discuss these results. Nyxoahs Genio® system, a leadless and battery-free hypoglossal neurostimulation therapy for OSA, has received a European CE Mark and is in investigational use in the United States. The company has completed IPOs on Euronext Brussels and NASDAQ, and has expanded its therapeutic indications following successful studies. The announcement is growth-positive, highlighting Nyxoahs progress and upcoming financial disclosures.
Public TradingFDA approved/pending approval
growth-positive
Conditional Issuance of Shares
Nyxoah SA announced a conditional issuance of up to 5 million ordinary shares under its existing at-the-market equity offering programs. This increases the total number of shares that can be sold and issued under the program to 5,662,694. The shares may be sold at prevailing market prices on the Nasdaq Global Market. This move is part of Nyxoahs strategy to raise capital through public trading mechanisms. The announcement does not constitute an offer to sell or a solicitation to buy any securities.
PIPE/PO
growth-positive
Nyxoah Provides Update on FDA Approvable Letter for Genio System
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), has received an Approvable Letter from the FDA for its Genio system. This indicates that the companys Pre-Market Approval (PMA) application substantially meets FDA requirements, with one remaining validation process pending at its U.S. manufacturing site. Nyxoah is confident in completing this final step soon and anticipates full FDA approval in the second quarter of 2025. The company plans to update stakeholders on the progress during its first-quarter earnings call in May. The Genio system is a leadless, battery-free hypoglossal neurostimulation therapy designed to improve the lives of OSA patients.
FDA approved/pending approval
growth-positive
FDA Issues Nyxoah an Approvable Letter for its Genio® System
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), has received an Approvable Letter from the U.S. FDA for its Genio® system. This letter indicates that the companys Pre-Market Approval application substantially meets the necessary requirements, pending a review of manufacturing facilities and methods. The Genio® system, which is already approved in Europe, is a leadless and battery-free hypoglossal neurostimulation therapy. Nyxoah is committed to addressing the FDAs requests to bring this innovative therapy to U.S. patients. The company has previously completed successful IPOs on Euronext Brussels and NASDAQ, and the Genio® system has received CE Mark approval for expanded therapeutic indications.
FDA approved/pending approval
growth-positive
Nyxoah SA (NYXH) Q4 2024 Earnings Call Highlights: Strong Revenue Growth and Strategic US ...
Nyxoah SA is preparing to launch its Genio system in the US market by the end of March 2025, with FDA approval expected soon. The company reported a revenue of EUR1.3 million in Q4 2024 and EUR4.5 million for the full year 2024, marking an 18% increase over 2023. Despite an operating loss of EUR18.3 million in Q4 2024, Nyxoahs cash position improved to EUR85.6 million. The Genio system has shown strong efficacy in clinical trials, and the company has built a robust US-based team to support the launch. Challenges include ensuring sufficient manufacturing capacity and navigating reimbursement pathways. Nyxoah has identified an existing CPT code for reimbursement but acknowledges the need to optimize it for better physician adoption.
Product StageFDA approved/pending approvalExpand
growth-positive
Nyxoah Reports Fourth Quarter and Financial Year 2024 Financial and Operating Results
Nyxoah, a company specializing in neuromodulation treatments for Obstructive Sleep Apnea (OSA), reported its financial and operating results for the fourth quarter and full year 2024. The company achieved a revenue of €1.3 million in Q4 2024 and €4.5 million for the full year, with a gross margin of 73%. Nyxoah is preparing for a U.S. commercial launch of its Genio system in March 2025, pending FDA approval expected by the end of Q1 2025. The company has assembled a U.S. executive leadership team and established a full commercial organization. The increase in revenue is primarily attributed to the commercialization of the Genio system in Germany.
FDA approved/pending approvalManagement ChangesExpand
growth-negative
Nyxoah SA (NYXH) Reports Q4 Loss, Lags Revenue Estimates
Nyxoah SA reported a quarterly loss of $0.49 per share, slightly better than the Zacks Consensus Estimate of a $0.50 loss. However, the companys revenue of $1.35 million missed the consensus estimate by 40.19% and was lower than the $1.96 million reported a year ago. Despite surpassing EPS estimates once in the last four quarters, Nyxoahs revenue performance has been inconsistent. The companys shares have risen by 21.6% since the start of the year, outperforming the S&P 500. The future stock performance will depend on managements commentary and earnings outlook, with current estimates suggesting a mixed trend. Nyxoah holds a Zacks Rank #3 (Hold), indicating expected market-aligned performance.
growth-positive
Nyxoah to Release Fourth Quarter and Financial Year 2024 Financial Results on March 13, 2025
Nyxoah, a medical technology company specializing in neuromodulation treatments for Obstructive Sleep Apnea (OSA), announced it will release its financial results for Q4 and FY 2024 on March 13, 2025. The company will host a conference call to discuss these results. Nyxoahs Genio® system, a battery-free hypoglossal neuromodulation device, has received a CE mark and is awaiting FDA approval for U.S. commercialization. The company has completed two IPOs, one on Euronext Brussels and another on NASDAQ. The Genio® system has shown positive outcomes in clinical studies, including the BLAST OSA and BETTER SLEEP studies, and has expanded its therapeutic indications.
Public TradingFDA approved/pending approval
growth-positive
Nyxoah to Participate in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference
Nyxoah, a medical technology company specializing in neuromodulation treatments for obstructive sleep apnea (OSA), announced its participation in the Oppenheimer 35th Annual Healthcare MedTech & Services Conference. The company will present its innovative Genio® system, a battery-free hypoglossal neuromodulation device, which has shown promising results in reducing OSA burden. Nyxoah has already received a European CE Mark for the Genio® system and is seeking FDA approval for U.S. commercialization. The company completed IPOs on Euronext Brussels in 2020 and NASDAQ in 2021. The conference participation is expected to enhance Nyxoahs visibility among institutional investors and further its growth trajectory.
Public TradingFDA approved/pending approval
growth-positive
Nyxoah Announces Commercial Launch of Genio® Breakthrough Therapy in the Middle East
Nyxoah, a medical technology company specializing in neuromodulation treatments for Obstructive Sleep Apnea (OSA), has announced the commercial launch of its Genio system in the Middle East. The first successful Genio implant was performed at the Saudi German Hospital in Dubai, UAE, with support from Odin Healthcare, marking a significant milestone as the first neurostimulation therapy for OSA in the region. The Genio system, which has received European CE Mark approval, offers an innovative alternative for patients who cannot tolerate CPAP. Nyxoahs CEO, Olivier Taelman, emphasized the companys commitment to expanding access to Genio and transforming OSA treatment worldwide.
CustomersPartners
growth-positive
Hims & Hers Health (HIMS) Surges 27.7%: Is This an Indication of Further Gains?
Hims & Hers Health, Inc. experienced a significant stock rally, closing at $59.18, a 27.7% increase in the last trading session. This surge is attributed to increased trading volume and retail interest following a successful Super Bowl advertisement. The company is expected to report quarterly earnings of $0.12 per share, marking a 1100% year-over-year increase, with revenues projected at $471.42 million, up 91.2% from the previous year. Despite the stocks recent performance, the consensus EPS estimate has remained unchanged over the last 30 days. The stock holds a Zacks Rank #3 (Hold), indicating a neutral outlook. The article highlights the importance of earnings and revenue growth expectations in stock performance.
growth-negative
Publication relating to transparency notifications
Nyxoah SA has announced a transparency notification from BlackRock, Inc. and its related entities, indicating a change in their shareholding. As of January 14, 2025, BlackRock holds 1,105,907 voting rights, representing 2.95% of Nyxoahs total voting rights. This marks a downward crossing of the 3% threshold. The notification includes details of the voting rights held by various BlackRock entities and equivalent financial instruments. The notification is in compliance with the Act of 2 May 2007 on the disclosure of large shareholdings.
growth-positive
Publication relating to transparency notifications
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, announced that it received a transparency notification from BlackRock, Inc. and its related entities. As of December 17, 2024, BlackRock holds 1,124,630 voting rights, representing 3.00% of Nyxoahs total voting rights. This notification was made in accordance with the Act of 2 May 2007 on the disclosure of large shareholdings. The notification indicates an acquisition or disposal of voting securities or rights, and it details the voting rights held by various BlackRock entities. This development suggests a positive growth impact for Nyxoah as it indicates increased interest and investment from a major financial institution.
Investment
growth-positive
Nyxoah introduces neurostimulator device for sleep apnoea in England
Nyxoah has launched its Genio neurostimulator in England, marking a significant milestone for the company. The device is designed to treat obstructive sleep apnoea (OSA) and has been successfully implanted in patients at University College London Hospitals (UCLH). The Genio system, which is battery-free, single-incision, and leadless, offers a new solution for adults with moderate to severe OSA who have not found success with conventional therapies. This product is accessible through the NHS Specialised Services Devices Programme, allowing more patients to benefit from this innovative treatment. Nyxoah aims to expand its collaboration with UCLH and other hospitals in England, furthering its mission to improve sleep for OSA patients.
CustomersExpand
growth-positive
Nyxoah Announces Commercial Launch of Genio® Innovative Therapy in England
Nyxoah, a medical technology company, has announced the commercial launch of its Genio system in England, marking a significant milestone in the treatment of Obstructive Sleep Apnea (OSA). The first successful implants were performed at University College London Hospitals (UCLH), with the Genio system now covered under the NHS Specialised Services Devices Programme. This development allows access to innovative therapies through specialized centers. Nyxoah aims to expand its collaboration with UCLH and other leading hospitals in England. The Genio system, a battery-free hypoglossal neuromodulation device, has shown best-in-class outcomes for reducing OSA burden and has received European CE Mark and positive outcomes from the DREAM IDE pivotal study for FDA approval.
CustomersExpand
growth-positive
Tongue Implant Could Treat Sleep Apnea Without a CPAP
Nyxoah, a medical technology company, has launched its Genio system in England, marking a significant milestone in treating obstructive sleep apnea (OSA). The Genio system is a small implant that offers an alternative to CPAP machines by delivering bilateral stimulation to the hypoglossal nerve, which controls tongue muscles. The commercial launch in England follows successful implants at University College London Hospitals (UCLH), performed by Consultant ENT and Sleep Surgeon Ryan Chin Taw Cheong. Although the Genio has had EU approval since 2019, it remains investigational in the U.S. Nyxoah aims to expand its collaboration with UCLH and other hospitals in England to address the unmet needs of OSA patients.
CustomersPartnersExpand
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, has announced the issuance of new shares, increasing its share capital to EUR 6,429,682.56. The total number of securities carrying voting rights now stands at 37,427,265, all of which are ordinary shares. Additionally, there are 2,296,194 rights to subscribe to securities carrying voting rights that have not yet been issued. This move is in accordance with the Belgian Law of 2 May 2007, which mandates the disclosure of large shareholdings. The issuance of new shares is likely to have a growth-positive impact on the company by potentially increasing its market capitalization and shareholder base.
growth-positive
Nyxoah to Participate in the Piper Sandler 36th Annual Healthcare Conference
Nyxoah, a medical technology company specializing in treatment alternatives for Obstructive Sleep Apnea (OSA), announced its participation in the Piper Sandler 36th Annual Healthcare Conference on December 4, 2024. The company will present its innovative Genio® system, a hypoglossal neuromodulation device, which has shown promising results in clinical studies. Nyxoah has previously completed successful IPOs and received CE mark approval for its device in Europe. The company is currently seeking FDA approval for U.S. commercialization. The article highlights Nyxoahs commitment to innovation and its forward-looking statements regarding the potential advantages and regulatory pathway for the Genio® system. Despite the inherent risks and uncertainties in forward-looking statements, Nyxoah remains optimistic about its future developments.
growth-negative
Invitation to attend the special shareholders’ meeting of the Company to be held on December 19, 2024
Nyxoah has announced a special shareholders meeting scheduled for December 19, 2024, to discuss and approve clauses in agreements with the European Investment Bank (EIB). The company has entered into a loan facility and synthetic warrant agreement with the EIB. A key clause in the loan agreement requires Nyxoah to inform the EIB of any Change-of-Control Event, which could lead to the cancellation of undisbursed credit or demand for prepayment if the EIB is dissatisfied with the events impact. This meeting will allow shareholders to vote on these agreements, with provisions for remote participation via video conference.
Investment
growth-negative
Publication relating to transparency notifications
Nyxoah SA announced that it received a transparency notification from ResMed Inc., indicating a passive crossing of a shareholding threshold. As of October 9, 2024, ResMed Inc. holds 1,727,864 voting rights, representing 4.62% of Nyxoahs total voting rights. This notification was made in accordance with Belgian regulations requiring disclosure of large shareholdings. The crossing of the 5% threshold was noted, with ResMed Inc. not being a controlled entity. The notification was officially dated November 5, 2024, and Nyxoah disclosed this information on November 18, 2024.
growth-positive
Nyxoah SA (NYXH) Q3 2024 Earnings Call Highlights: Strategic Advances Amid Financial Challenges
Nyxoah SA reported a revenue of EUR1.3 million for Q3 2024, with an operating loss of EUR15 million, up from EUR11 million in Q3 2023. The company secured a EUR37.5 million loan from the European Investment Bank and raised EUR24.6 million through an ATM program from a US healthcare fund. This capital extends its cash runway to mid-2026. Nyxoah is preparing for a US commercial launch, hiring key executives, and anticipates FDA approval for its Genio system in Q1 2025. Despite increased cash burn due to commercialization efforts, the company demonstrated strong efficacy in its Dream study, which is crucial for broader acceptance. Challenges include securing reimbursement and publication of the Dream study.
InvestmentExpand
growth-negative
Nyxoah SA (NYXH) Reports Q3 Loss, Tops Revenue Estimates
Nyxoah SA reported a quarterly loss of $0.68 per share, which was worse than the Zacks Consensus Estimate of a $0.46 loss, marking a negative earnings surprise of -47.83%. Despite this, the company posted revenues of $1.73 million, surpassing the consensus estimate by 17.72%. Over the last four quarters, Nyxoah has not exceeded consensus EPS estimates but has topped revenue estimates twice. The companys shares have increased by about 114.4% since the start of the year, outperforming the S&P 500. The future stock movement will depend on managements commentary and earnings outlook. Currently, Nyxoah holds a Zacks Rank #3 (Hold), indicating expected performance in line with the market.
growth-positive
Nyxoah Reports Third Quarter Financial and Operating Results
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea, reported its third-quarter 2024 financial results. The company raised €24.6 million through an ATM program from a U.S. healthcare fund, extending its cash runway until mid-2026. Nyxoah is preparing for a U.S. commercial launch, bolstered by strong DREAM data presented in September. The company reported a 30% increase in sales compared to the previous year and strengthened its U.S. team by hiring John Landry as CFO and other key leaders. Despite reporting a loss for the period, Nyxoahs strategic actions position it for future growth, particularly in the U.S. market.
InvestmentExpandManagement Changes
growth-positive
Nyxoah Appoints John Landry as Chief Financial Officer
Nyxoah, a medical technology company specializing in treatment alternatives for Obstructive Sleep Apnea, announced the appointment of John Landry as Chief Financial Officer, effective November 4, 2024. This strategic move is part of Nyxoahs focus on expanding its presence in the U.S. market. Landry, with over two decades of financial leadership experience, is expected to drive growth and operational efficiency. The current CFO, Loïc Moreau, will transition to the role of President International, focusing on global expansion. These leadership changes reflect Nyxoahs commitment to strengthening its management team to support ambitious growth objectives. Nyxoah has previously completed successful IPOs and received regulatory approvals for its Genio® system, positioning itself for further market expansion.
Management Changes
Privia Health (PRVA) Earnings Expected to Grow: Should You Buy?
growth-negative
Nyxoah SA (NYXH) Expected to Beat Earnings Estimates: What to Know Ahead of Q3 Release
Nyxoah SA is expected to report a year-over-year decline in earnings despite an increase in revenues for the quarter ending September 2024. The earnings report, anticipated on November 6, 2024, could influence the companys stock price depending on whether the actual results meet or exceed expectations. Analysts predict a quarterly loss of $0.46 per share, a 58.6% decline from the previous year, while revenues are expected to rise by 38.7% to $1.47 million. The consensus EPS estimate has been revised 6.7% higher in the past 30 days, indicating a reassessment by analysts. The Zacks Earnings ESP model suggests that a positive Earnings ESP reading, combined with a strong Zacks Rank, could predict an earnings beat.
growth-positive
Publication relating to transparency notifications
Nyxoah SA announced it received a transparency notification from Vestal Point Capital regarding the acquisition or disposal of voting securities or voting rights. Vestal Point Capital now holds 3,000,688 voting rights, representing 8.03% of the total voting rights as of October 9, 2024. This notification was made in accordance with the Act of 2 May 2007 on the disclosure of large shareholdings. The investment management company, Vestal Point Capital, LP, is controlled by Vestal Point Capital, LLC, which in turn is controlled by Ryan Wilder. This development indicates a significant investment in Nyxoah, potentially signaling confidence in the companys future growth.
Investment
growth-positive
Nyxoah to Release Third Quarter 2024 Financial Results on November 6, 2024
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced it will release its third-quarter 2024 financial results on November 6, 2024. The company will host a conference call to discuss these results. Nyxoah is known for its innovative Genio® system, a battery-free hypoglossal neuromodulation device, which has received a European CE Mark and is under investigation for U.S. commercialization. The company has completed successful IPOs on Euronext Brussels and NASDAQ. Nyxoahs recent studies, including the BETTER SLEEP and DREAM IDE pivotal studies, have shown positive outcomes, further supporting its growth and expansion in the OSA treatment market.
growth-negative
Publication relating to transparency notifications
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, announced that it received transparency notifications from Jürgen Hambrecht and BlackRock, Inc. regarding changes in their shareholding. Jürgen Hambrecht, through JH Capital GmbH, now holds 3.91% of Nyxoahs voting rights, crossing the 3% threshold. BlackRock, Inc. reported a passive downward crossing of the 3% threshold, now holding 2.99% of voting rights. These changes indicate a shift in the shareholding structure of Nyxoah, potentially impacting its market perception and investor confidence.
growth-negative
Publication relating to transparency notifications
Nyxoah SA announced it received a transparency notification from BlackRock, Inc. due to a change in BlackRocks group structure. The notification, dated October 3, 2024, indicated that BlackRock now holds 1,116,421 voting rights, representing 3.25% of Nyxoahs total voting rights as of October 1, 2024. This change was due to BlackRocks acquisition of Global Infrastructure Partners, leading to a restructuring within BlackRocks organization. The notification was made in compliance with the Act of 2 May 2007 on the disclosure of large shareholdings. The transaction resulted in BlackRock, Inc. being renamed BlackRock Finance, Inc., and a new publicly listed company named BlackRock, Inc. was established.
Investment
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, a company listed on Euronext Brussels and Nasdaq, announced the issuance of new shares, increasing its share capital to EUR 6,423,111.21. The total number of securities carrying voting rights now stands at 37,389,015, all of which are ordinary shares. Additionally, there are 2,039,481 rights to subscribe to securities carrying voting rights that have not yet been issued. This update is in compliance with the Belgian law on the disclosure of large shareholdings. The issuance of new shares is likely to be seen as a growth-positive move for the company, potentially increasing its market presence and financial flexibility.
growth-positive
Nyxoah SA (NYXH) Q2 2024 Earnings Call Highlights: Strategic Growth and US Market Preparations
Nyxoah SA reported a 29% increase in European sales for the first half of 2024 and raised over EUR85 million in new capital, extending its cash runway into mid-2026. The company is preparing for US market entry, with FDA approval anticipated by late 2024 or early 2025. Nyxoah is building a US commercialization organization, including hiring a new Chief Commercial Officer. Despite a total operating loss of EUR13.3 million for the second quarter, Nyxoah achieved primary endpoints in the DREAM US pivotal study, demonstrating strong efficacy for its Genio system. The company is also partnering with the American Association of Otolaryngology for a US reimbursement strategy. However, the German market remains small and subject to variability.
InvestmentExpandManagement Changes
growth-positive
Nyxoah Secures $27 Million to Boost U.S. Presence
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea, has successfully raised $27 million through an At-the-Market offering. This capital was secured by selling 3 million shares to a U.S. healthcare investor. The funds are intended to bolster Nyxoahs presence in the U.S. market and support the launch of its Genio system in the United States. This strategic financial move comes on the heels of Nyxoahs European CE Mark achievement and favorable study results, which position the company for potential FDA approval and commercialization in the U.S.
Investment
growth-positive
Nyxoah Raises $27 Million through its At-the-Market Offering
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), has raised $27 million through an at-the-market offering. This investment comes from a single U.S.-based healthcare investor and aims to strengthen Nyxoahs financial position and reinforce its focus on the U.S. market. The funds will support the launch of Nyxoahs Genio® system in the United States, following positive outcomes from the DREAM IDE pivotal study. The investment highlights Nyxoahs commitment to innovation and its strategic expansion into the U.S. market, leveraging its successful clinical studies and regulatory approvals. Cantor Fitzgerald & Co. acted as the sales agent for the offering.
Investment
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, listed on Euronext Brussels and Nasdaq under the ticker NYXH, has disclosed information regarding its share capital and voting rights as per the Law of 2 May 2007. The companys share capital stands at EUR 5,907,711.21, with a total of 34,389,015 ordinary shares carrying voting rights. Additionally, there are 2,040,231 rights to subscribe to securities carrying voting rights that have been granted, excluding 643,394 subscription rights that were issued but not yet granted.
growth-positive
DREAM Pivotal Study Data Presented at the International Surgical Sleep Society 2024 Educational Update
Nyxoah, a medical technology company specializing in neuromodulation treatments for Obstructive Sleep Apnea (OSA), presented promising data from its DREAM U.S. pivotal study at the International Surgical Sleep Society 2024 Educational Update. The study demonstrated a 71.0% median reduction in Apnea-Hypopnea Index (AHI) at 12 months, with significant improvements in quality-of-life outcomes. The company is progressing toward FDA approval for its Genio® system, which has already received CE Mark approval in Europe. The data presentation underscores Nyxoahs potential to impact the OSA treatment market positively.
CustomersPublic Trading
growth-negative
Publication relating to transparency notifications
Nyxoah SA announced that it received a transparency notification from BlackRock, Inc. indicating that BlackRock Advisors, LLC went below the 3% threshold of voting rights on September 20, 2024. As of that date, BlackRock, Inc. and its controlled undertakings held 1,116,421 voting rights, representing 3.25% of the total number of voting rights. The notification was made in accordance with article 14 of the Act of 2 May 2007 on the disclosure of large shareholdings. This change in voting rights is due to the disposal of voting securities or voting rights by BlackRock Advisors, LLC.
Investment
growth-positive
Nyxoah to Participate in Upcoming Investor Conferences
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced its participation in three upcoming investor conferences in New York City. CEO Olivier Taelman will deliver corporate updates at the Baird Global Healthcare Conference, H.C. Wainwright 26th Annual Global Investment Conference, and Cantor Global Healthcare Conference. The company will also be available for one-on-one meetings with institutional investors. Nyxoahs lead solution, the Genio® system, is a hypoglossal neurostimulation therapy for OSA. The company aims to use clinical data to obtain FDA approval and enter the U.S. market.
Investment
growth-positive
Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), recently rang the Nasdaq Closing Bell to celebrate its progress and upcoming milestones. The company has completed its FDA regulatory submission for its Genio® device and expects U.S. approval by the end of 2024, with a commercial launch planned for early 2025. Nyxoah has raised over €85 million in new capital, including a €48.5 million equity offering and a €37.5 million loan from the European Investment Bank, to fund this launch. The company is also building a U.S. commercial team, led by new Chief Commercial Officer Scott Holstine.
InvestmentPublic TradingExpandManagement Changes
growth-positive
Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), reported its financial and operating results for the second quarter and first half of 2024. The company completed its FDA regulatory submission and is on track for U.S. approval by the end of 2024. Nyxoah raised over €85 million in new capital, including a €48.5 million equity offering and a €37.5 million loan facility from the European Investment Bank, fully funding its U.S. commercial launch. The company also appointed Scott Holstine as Chief Commercial Officer and other key leaders in sales and marketing. Despite reporting a loss, Nyxoah saw a 29% sales growth in the first half of 2024 compared to the previous year.
InvestmentManagement ChangesExpand
growth-positive
Nyxoah Reports Second Quarter and First Half 2024 Financial and Operating Results
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), reported its financial and operating results for the second quarter and first half of 2024. The company completed its FDA regulatory submission and is on track for U.S. approval by the end of 2024. Nyxoah raised over €85 million in new capital through an equity offering and a loan facility agreement with the European Investment Bank, fully funding its U.S. commercial launch. The company reported a 29% sales growth for the first half of 2024 compared to the same period last year. Key management appointments were made to strengthen the U.S. commercial organization.
InvestmentExpandManagement Changes
growth-negative
Nyxoah SA (NYXH) Reports Q2 Loss, Misses Revenue Estimates
Nyxoah SA reported a quarterly loss of $0.46 per share, slightly missing the Zacks Consensus Estimate of a $0.45 loss. The company posted revenues of $0.83 million for the quarter ended June 2024, which was 56.88% below the consensus estimate and down from $1.21 million a year ago. Despite the earnings miss, Nyxoah shares have risen by about 71% since the beginning of the year. The companys future performance will depend on managements commentary and earnings outlook. The Zacks Rank for Nyxoah is currently #3 (Hold), indicating it is expected to perform in line with the market in the near future.
Customers
growth-positive
Nyxoah to Release Second Quarter and First Half 2024 Financial Results on August 6, 2024
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced it will release its financial results for the second quarter and first half of 2024 on August 6, 2024. The company will host a conference call to discuss these results. Nyxoahs lead product is the Genio® system, a hypoglossal neurostimulation therapy for OSA. The announcement includes forward-looking statements about the companys future performance and regulatory pathway for the Genio® system.
growth-positive
Nyxoah to Release Second Quarter and First Half 2024 Financial Results on August 6, 2024
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced it will release its financial results for the second quarter and first half of 2024 on August 6, 2024. The company will host a conference call to discuss these results. Nyxoahs lead solution, the Genio® system, is a hypoglossal neurostimulation therapy for OSA. The company emphasizes that forward-looking statements in the press release involve risks and uncertainties. The webcast of the call will be available for replay shortly after the close of the call.
growth-positive
Nyxoah Appoints Scott Holstine as Chief Commercial Officer
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), has appointed Scott Holstine as Chief Commercial Officer. With over 26 years of experience in the medical device industry, Scott will lead Nyxoahs commercial operations, focusing on a successful U.S. launch. The appointment is part of Nyxoahs strategy to build a high-performing commercial team in anticipation of FDA approval by the end of 2024. Nyxoahs Genio system, a leadless and battery-free hypoglossal neurostimulation therapy, has shown promising results in studies and is already approved in Europe. The company aims to expand its market presence and improve treatment options for OSA patients.
Management Changes
growth-positive
Nyxoah Secures $40 Million Loan Facility from European Investment Bank
Nyxoah has secured a $40 million loan facility from the European Investment Bank. This financial boost is expected to support the companys growth and development. The loan signifies a strong vote of confidence from the European Investment Bank in Nyxoahs potential and future prospects.
Investment
growth-positive
Nyxoah Has Signed a €37.5 Million Loan Facility Agreement with the European Investment Bank
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea, has signed a €37.5 million loan facility agreement with the European Investment Bank (EIB). The funding, backed by the European Commission’s InvestEU program, will be used for research and development and scaling up manufacturing capacity in Europe and the U.S. The loan is divided into three tranches, with specific conditions for disbursement. Additionally, Nyxoah will enter into a synthetic warrant agreement with the EIB. This funding follows a recent equity offering, providing Nyxoah with over €80 million in growth capital to aid in the commercialization of its Genio system.
Investment
growth-positive
Nyxoah Secures $40 Million Loan Facility from European Investment Bank
Nyxoah has secured a $40 million loan facility from the European Investment Bank. This financial boost is expected to support the companys growth and development initiatives. The loan signifies a positive investment move for Nyxoah, potentially enhancing its market position and operational capabilities.
Investment
growth-positive
Nyxoah Has Signed a €37.5 Million Loan Facility Agreement with the European Investment Bank
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), has secured a €37.5 million loan facility from the European Investment Bank (EIB). The funding, backed by the European Commission’s InvestEU program, will be used for research and development and to scale up manufacturing capacity in Europe and the U.S. The loan is divided into three tranches, each with specific conditions and interest rates. Additionally, Nyxoah will enter into a synthetic warrant agreement with the EIB, granting the bank synthetic warrants that can be exercised under certain conditions. This financial boost follows a recent equity offering, providing Nyxoah with over €80 million in growth capital.
Investment
growth-positive
Nyxoah signs a €37.5m loan with the European Investment Bank
Nyxoah SA, a Belgian medical technology company, announced a €37.5 million loan facility agreement with the European Investment Bank (EIB), backed by the European Commission’s InvestEU program. The funding will be used for research and development and scaling up manufacturing capacity to meet demand in Europe and the U.S. Nyxoah focuses on treating Obstructive Sleep Apnea with its Genio system. The loan is divided into three tranches with specific conditions and interest rates. This follows a recent equity offering where Nyxoah raised €48.5 million, providing over €80 million in growth capital to aid in commercialization and innovation.
Investment
growth-positive
Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), has submitted the fourth and final module of its Premarket Approval (PMA) application for its Genio system to the U.S. FDA. The Genio system is a leadless, battery-free hypoglossal nerve stimulation therapy that is fully-body MRI compatible and controlled by a wearable device. This milestone follows the successful DREAM U.S. pivotal study, which showed significant reductions in key sleep apnea metrics. Nyxoah plans to present the complete DREAM data in September 2024 and aims for a U.S. launch by the end of the year.
Customers
growth-positive
Nyxoah Submits Fourth and Final Module in PMA Application for Genio to the US FDA
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), has submitted the fourth and final module of its Premarket Approval (PMA) application for its Genio system to the U.S. FDA. The Genio system is a leadless, fully-body MRI compatible, non-implanted battery solution controlled by a wearable. This milestone follows the successful DREAM U.S. pivotal study, which showed significant improvements in sleep apnea metrics. Nyxoah aims to launch Genio in the U.S. by the end of 2024. The company has previously received CE Mark approval in Europe and completed IPOs on Euronext Brussels and NASDAQ.
Customers
Growth-Positive
Information on the total number of voting rights and shares
Nyxoah SA has published information regarding the issue of new shares in accordance with the Law of 2 May 2007 on the disclosure of large shareholdings. The share capital stands at EUR 5,904,962.41 with a total of 34,373,015 securities carrying voting rights. The company has also issued several ESOP Warrants between 2018 and 2022, entitling their holders to subscribe to a total number of 2,206,000 securities carrying voting rights.
Investment
growth-positive
Have $5-10? 7 Affordable Stocks That Are About to Breakout.
The article discusses several stocks trading between $5 and $10 that are poised for breakouts, including Payoneer Global, Arcutis Biotherapeutics, Nyxoah, Redwire Corporation, Delcath Systems, Rush Street Interactive, and Acacia Research. Payoneer Global, a fintech company, reported a 19% revenue increase and a 265% net income growth in the first quarter of 2024. Arcutis Biotherapeutics saw significant revenue growth from its dermatological treatments. Nyxoah, a sleep apnea treatment company, is expecting FDA approval by the end of 2024. Redwire Corporation, in the defense sector, showed strong revenue growth. Delcath Systems, an oncology company, reported substantial revenue increases. Rush Street Interactive, in the online casino and sports betting space, revised its EBITDA guidance upward. Acacia Research saw growth in its intellectual property operations.
Customers
growth-positive
Have $5-10? 7 Affordable Stocks That Are About to Breakout.
The article discusses several companies with stocks trading between $5 and $10 that are poised for breakouts. Payoneer Global, a fintech company, reported a 19% revenue increase and a 265% net income growth in the first quarter of 2024. Arcutis Biotherapeutics saw a significant revenue jump due to its dermatological treatments. Nyxoah is making strides in sleep apnea treatment devices and expects FDA approval by the end of 2024. Redwire Corporation, in the defense sector, reported strong revenue growth and became free cash flow positive. Delcath Systems and Rush Street Interactive also showed promising financial results, with the latter revising its EBITDA guidance upward.
Customers
growth-positive
Publication relating to transparency notifications
Nyxoah SA received four transparency notifications from FMR LLC, BlackRock, Inc., Together Partnership, and Gilde Healthcare Holding BV and Gilde Healthcare III Management BV. FMR LLC and BlackRock, Inc. crossed above the 3% threshold of shareholding, while Together Partnership and Gilde Healthcare entities crossed below the 10% threshold. The notifications were in accordance with the Act of 2 May 2007 on the disclosure of large shareholdings.
Investment
growth-positive
Nyxoah to Participate in the Jefferies Global Healthcare Conference
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Jefferies Global Healthcare Conference on June 5-6, 2024, in New York. CEO Olivier Taelman will deliver a corporate presentation on June 5, 2024, at 7:30am ET. The company will also be available for one-on-one meetings with institutional investors. Nyxoahs lead product, the Genio® system, has received European CE Mark approval and is undergoing clinical studies for FDA approval in the U.S. The company aims to expand its market presence and attract investment through this conference.
Investment
Growth-Positive
Information on the total number of voting rights and shares
Argus Research has highlighted dividend growth as a key investment theme for the second half of 2024. The firm believes that companies raising dividends consistently at a double-digit rate are demonstrating strong balance sheets, a focus on shareholder returns, and confidence in the near-term outlook. This is particularly important during periods of potential economic slowdown. Argus notes that average dividend growth in the S&P 500 has been 2.0% per year since 1970, with double-digit growth rare. The firm recommends investors focus on dividend growth rather than yield at this stage of the economic and market cycles.
Investment
growth-positive
Nyxoah Announces Closing of Offering and Partial Exercise of Option to Purchase Additional Shares
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced the closing of its public offering in the U.S., raising approximately $52.5 million. The offering included shares sold to institutional investors in the EU and the U.S. The proceeds will be used for commercialization activities, clinical research, R&D, and general corporate purposes. Cantor Fitzgerald & Co. acted as the sole book-running manager, with Degroof Petercam as a co-manager. The closing of the additional shares is expected on June 3, 2024.
Investment
growth-positive
Nyxoah Announces Pricing of Offering
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced the pricing of an underwritten public offering in the United States. The offering includes 5,374,755 ordinary shares at $9.25 per share, with gross proceeds expected to be approximately $50 million. The funds will be used for pre-commercialization and commercialization activities in the U.S., clinical research, R&D for the next generation of the Genio system, and general corporate purposes. Cantor Fitzgerald & Co. is the sole book-running manager, and Degroof Petercam is acting as a co-manager. The offering is expected to close on May 28, 2024.
Investment
growth-positive
Nyxoah Announces Pricing of Offering
Nyxoah, a medical technology company specializing in treatments for Obstructive Sleep Apnea (OSA), announced the pricing of an underwritten public offering in the United States. The offering includes 5,374,755 ordinary shares at $9.25 per share, with gross proceeds expected to be around $50 million. The funds will be used for commercialization activities in the U.S., clinical research, R&D for the Genio system, and other corporate purposes. Cantor Fitzgerald & Co. is the sole book-running manager, and Degroof Petercam is acting as a co-manager. The offering is expected to close on May 28, 2024.
Investment
growth-positive
Nyxoah Announces Pricing of Offering
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced the pricing of an underwritten public offering in the United States. The offering includes 5,374,755 ordinary shares at $9.25 per share, with gross proceeds expected to be around $50 million. The funds will be used for commercialization activities in the U.S., clinical research, R&D for the Genio system, and general corporate purposes. Cantor Fitzgerald & Co. is acting as the sole book-running manager, with Degroof Petercam as a co-manager. The offering is expected to close on May 28, 2024.
Investment
growth-negative
Nyxoah Announces Reduction of the Maximum Amount Available Under its At the-Market Equity Offering Program
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced a reduction in the maximum amount of shares available under its at-the-market equity offering program. The reduction amounts to 1,569,139 ordinary shares, equating to a share capital decrease of EUR 269,579. This leaves a maximum of 4,430,861 ordinary shares available for issuance, with 3,662,699 shares still available. The reduction increases the authorized capital available to the board by EUR 269,579. The announcement does not constitute an offer to sell or buy any securities. The company emphasizes that forward-looking statements are subject to risks and uncertainties.
Investment
growth-negative
Nyxoah Announces Reduction of the Maximum Amount Available Under its At the-Market Equity Offering Program
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced a reduction in the maximum amount of shares available under its at-the-market equity offering program. Initially set at 6,000,000 shares, the company has reduced this by 1,569,139 shares, resulting in a new maximum of 4,430,861 shares, of which 3,662,699 remain available for issuance. This reduction also increases the authorized capital available to the board by EUR 269,579. The announcement highlights the companys ongoing efforts to manage its financial resources and strategic goals.
Investment
growth-positive
Nyxoah Announces Proposed Offering of Ordinary Shares
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced a proposed underwritten public offering of ordinary shares in the United States. The offering may also include shares sold in a private offering to qualified or institutional investors outside the U.S. Nyxoah plans to use the proceeds for pre-commercialization and commercialization activities in the U.S., clinical research, R&D for the next generation of the Genio system, and other general corporate purposes. Cantor Fitzgerald & Co. is the sole book-running manager, with Degroof Petercam as a co-manager. The offering is subject to market conditions and other factors.
InvestmentPublic Trading
growth-positive
Nyxoah Reports First Quarter 2024 Financial and Operating Results
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), reported its financial and operating results for the first quarter of 2024. The company achieved significant milestones, including the successful completion of the DREAM U.S. pivotal study, which met its primary endpoints and demonstrated strong efficacy. Nyxoah is preparing for FDA approval by the end of 2024 and has appointed Dr. Maurits S. Boon as Chief Medical Officer. The company also advanced its patient access strategy through a partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation (AAO-HNSF). Nyxoah reported quarterly sales of €1.2 million, a 170% increase from Q1 2023, and a total cash position of €44.3 million.
CustomersPartnersManagement Changes
growth-positive
Nyxoah to Release First Quarter 2024 Financial Results on May 14, 2024
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced it will release its first quarter 2024 financial results on May 14, 2024. The company will host a conference call to discuss these results. Nyxoahs lead solution is the Genio® system, a hypoglossal neurostimulation therapy for OSA. The company also provided cautionary notes about forward-looking statements and the risks associated with them.
growth-positive
Nyxoah to Release First Quarter 2024 Financial Results on May 14, 2024
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced it will release its first quarter 2024 financial results on May 14, 2024. The company will host a conference call to discuss the results. Nyxoahs lead solution, the Genio® system, is a hypoglossal neurostimulation therapy for OSA. The company emphasizes the forward-looking nature of its statements, highlighting potential risks and uncertainties. The webcast of the call will be available for replay shortly after the call ends.
growth-positive
Invitation to attend the annual and the extraordinary shareholders’ meetings of the Company to be held on June 12, 2024
Nyxoah SA has announced its annual and extraordinary shareholders meetings to be held on June 12, 2024. The agenda includes the approval of the annual accounts, discharge of directors and auditors, and amendments to the remuneration policy to include restricted share units (RSUs) for non-executive directors. Several directors are up for reappointment, including independent directors and representatives of entities. The extraordinary meeting will address the renewal of the authorization for the board to increase share capital. Shareholders can attend in person or via video conference, though remote voting is not permitted.
Management Changes
growth-positive
Nyxoah Appoints Dr. Maurits S. Boon, MD as Chief Medical Officer
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), has announced the appointment of Dr. Maurits S. Boon as Chief Medical Officer. Dr. Boon, a pioneer in hypoglossal nerve stimulation therapy, will continue to serve part-time as a professor and Vice Chairman, Education at Thomas Jefferson University. His appointment comes as Nyxoah prepares to enter the U.S. market with its Genio system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA.
Management Changes
growth-positive
Information on the total number of voting rights and shares
Nyxoah SA, listed on Euronext Brussels and Nasdaq, has announced the issuance of new shares, increasing its share capital to EUR 4,927,355.12. The total number of securities carrying voting rights is now 28,682,635, all of which are ordinary shares. Additionally, the company has issued several ESOP warrants from 2018 to 2022, entitling holders to subscribe to a total of 2,236,000 securities carrying voting rights. This disclosure is in accordance with the Law of 2 May 2007 on the disclosure of large shareholdings.
growth-positive
Nyxoah Advances Patient Access Strategy through Partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), has announced a strategic partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation (AAO-HNSF). This partnership makes Nyxoah the first medical device company to become a Corporate Champion at the ENTerprise Circle level. The collaboration aims to improve patient access to new treatments for OSA by navigating CMS and private payer authorization requirements, preparing for interactions with the FDA and AMA CPT, and advocating for reduced hurdles to bilateral hypoglossal nerve stimulation (HGNS) therapy. The partnership is expected to enhance Nyxoahs market presence and patient reach in the U.S.
Partners
growth-positive
Nyxoah Announces DREAM U.S. Pivotal Study Meets Primary Endpoints
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced that its DREAM U.S. pivotal study met its primary endpoints. The study reported a 63.5% AHI responder rate and a 71.3% ODI responder rate on an intent-to-treat basis. The results pave the way for the Genio® hypoglossal nerve stimulation system to gain FDA approval for U.S. commercialization. The study enrolled 115 patients and showed significant improvements in AHI and ODI metrics over 12 months. The company is finalizing its PMA application and anticipates launching Genio in the U.S. pending FDA approval.
Customers
growth-positive
Nyxoah S.A. (NASDAQ:NYXH) Q4 2023 Earnings Call Transcript
Nyxoah S.A. reported its Q4 2023 earnings, meeting expectations with an EPS of $-0.41. The company highlighted significant achievements in 2023, including a 43% increase in sales, completion of key clinical trials, and a new partnership with ResMed Germany. Nyxoah is preparing for a potential FDA approval and U.S. market launch by late 2024 or early 2025. The company is also expanding its U.S. commercial team and continuing to grow its presence in Europe. Financially, Nyxoah reported Q4 revenue of €1.8 million, a 42% year-over-year increase, and has a cash runway into late 2024.
CustomersPartnersExpand
growth-positive
Nyxoah Reports Fourth Quarter and Financial Year 2023 Financial and Operating Results
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), reported its financial and operating results for Q4 and the full year 2023. The company achieved record quarterly sales of €1.8 million, representing a significant growth of 87% sequentially and 42% year-over-year. Full-year sales reached €4.3 million, a 41% increase from the previous year. Nyxoah ended the year with 48 active German accounts and a total cash position of €57.7 million. The company plans to accelerate investments in the U.S. for a late 2024 launch and increase market penetration in Europe. Nyxoah also highlighted its partnership with ResMed in Germany.
CustomersInvestmentPartners
Growth-Negative
Nyxoah SA (NYXH) Reports Q4 Loss, Misses Revenue Estimates
Nyxoah SA reported a quarterly loss of $0.41 per share, in line with the Zacks Consensus Estimate, compared to a loss of $0.52 per share a year ago. The company, which belongs to the Zacks Medical Info Systems industry, posted revenues of $1.96 million for the quarter ended December 2023, missing the Zacks Consensus Estimate by 2.39%. This compares to year-ago revenues of $1.34 million. Nyxoah SA shares have added about 241.2% since the beginning of the year. The companys earnings outlook and the industry outlook could have a material impact on the performance of the stock.
growth-positive
Nyxoah to Participate in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Oppenheimer 34th Annual Healthcare MedTech & Services Conference scheduled for March 12-13, 2024. CEO Olivier Taelman will deliver a corporate presentation on March 12, 2024. The company will also be available for one-on-one meetings with institutional investors. Nyxoahs lead product, the Genio® system, has received European CE Mark approval and is currently undergoing a pivotal study for FDA approval in the U.S.
CustomersInvestment
growth-positive
Nyxoah to Release Fourth Quarter and Financial Year 2023 Financial Results on March 5, 2024
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced that it will release its financial results for the fourth quarter and financial year 2023 on March 5, 2024. The company will host a conference call to discuss these results. Nyxoahs lead solution, the Genio® system, has received European CE Mark approval and is currently undergoing a pivotal study for FDA approval in the U.S. The company aims to provide innovative solutions for OSA patients to improve their quality of life.
growth-positive
Nyxoah Announces 2024 Strategic Priorities
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced its strategic priorities for 2024. These include completing patient follow-up in the DREAM U.S. pivotal study, filing the final module for PMA submission, accelerating U.S. commercial investments, and increasing market penetration in Europe. The company recently hired Francis Kim as Chief Regulatory and Quality Officer and expanded its market access. Nyxoah aims to replicate its European success in the U.S. with the Genio system, which has shown promising preliminary results. The company also highlighted its partnership with ResMed in Germany and ongoing efforts to secure reimbursement at launch.
CustomersPartnersInvestmentManagement Changes
growth-positive
Nyxoah Announces Preliminary Results for the Fourth Quarter and Full Year 2023
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced preliminary unaudited results for Q4 and full year 2023. The company reported a 40% increase in Q4 revenue to approximately €1.8 million and a 41% increase in full-year revenue to approximately €4.3 million. Nyxoah ended the year with 48 active German accounts. The company anticipates significant growth in 2024, driven by strong demand for its Genio system, upcoming FDA approval filings, and contributions from its partnership with ResMed in Germany.
CustomersPartners
growth-positive
Nyxoah Announces Real World Case Series Demonstrating Positive Results in Treating CCC Patients with Genio®
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced positive results from a real-world case series using its Genio® hypoglossal nerve stimulation system to treat Complete Concentric Collapse (CCC) patients. The data, presented by Dr. Christian Plettenberg at the DGSM Conference in Berlin on December 8, 2023, showed a 73% average reduction in the apnea-hypopnea index (AHI) and a 58% reduction in the Epworth Sleepiness Scale (ESS). These results further validate Genio’s effectiveness, particularly for CCC patients who are contraindicated to other commercially available therapies in the U.S. Nyxoah aims to expand its market presence in Europe and is awaiting FDA approval for U.S. commercialization.
Customers
growth-negative
Publication Relating to a Transparency Notification
Nyxoah SA announced that it received a transparency notification from Deerfield Partners, L.P. indicating that Deerfield Partners crossed the 3% threshold on November 30, 2023, and now holds 2.99% of the total voting rights. This downward crossing of the threshold was due to a sale of shares by Deerfield Partners. The notification includes details about the controlled undertakings and the individuals involved.
Investment
growth-positive
Nyxoah Strengthens its Executive Leadership Team
Nyxoah, a medical technology company specializing in innovative solutions for Obstructive Sleep Apnea (OSA), has appointed Francis Kim as its new Chief Regulatory and Quality Officer. With over 25 years of experience in the medical device and life sciences sectors, Kim will lead Nyxoah’s Global Regulatory and Quality departments. This leadership change comes at a crucial time as the company prepares for the U.S. market entrance, with data from the DREAM U.S. pivotal study expected in early 2024 and FDA approval anticipated by the end of the year. Nyxoahs lead solution, the Genio® system, has already received European CE Mark approval.
Management Changes
growth-positive
Nyxoah to Participate in the Piper Sandler 35th Annual Healthcare Conference
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Piper Sandler 35th Annual Healthcare Conference, scheduled for November 28-30, 2023, in New York. CEO Olivier Taelman will participate in a Fireside Chat on November 29, 2023, and the company will be available for one-on-one meetings with institutional investors. Nyxoahs lead product, the Genio® system, has received European CE Mark approval and is undergoing further studies for U.S. FDA approval. The companys participation in the conference is expected to enhance its visibility and attract potential investors.
Partners
growth-positive
Nyxoah S.A. (NASDAQ:NYXH) Q3 2023 Earnings Call Transcript
Nyxoah S.A. held its Q3 2023 earnings call on November 11, 2023, discussing its financial performance and strategic initiatives. The company reported €1 million in revenue for the quarter and highlighted its ongoing clinical trials, including the DREAM U.S. pivotal study, which is expected to yield data by March 2024. Nyxoah is preparing for a U.S. market launch and FDA approval by late 2024. The company also announced a partnership with ResMed Germany to enhance patient care for obstructive sleep apnea (OSA) and increase market penetration. Nyxoah continues to expand its U.S. commercial infrastructure and aims to drive revenue growth in Europe, particularly in Germany.
PartnersExpand
growth-positive
Nyxoah Reports Third Quarter 2023 Financial and Operating Results
Nyxoah, a medical technology company, has reported its financial and operating results for Q3 2023. The company has partnered with ResMed Germany to increase Obstructive Sleep Apnea (OSA) awareness and therapy penetration. The company reported sales of €1.0 million and ended the quarter with 46 active German accounts. The company also ended the quarter with a cash position of €72.5 million. The companys CEO, Olivier Taelman, commented that the company is entering one of the most exciting times in its history and expects FDA approval in late 2024.
PartnersInvestment
growth-positive
Nyxoah to Participate in the Jefferies London Healthcare Conference
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Jefferies London Healthcare Conference from November 14-16, 2023. CEO Olivier Taelman will deliver a corporate update on November 15, 2023. The company will also hold 1x1 meetings with institutional investors. Nyxoahs lead product, the Genio® system, has received European CE Mark approval and is undergoing a pivotal study for FDA approval in the U.S. The companys investor presentation is available on its website.
Investment
growth-positive
Nyxoah to Release Third Quarter 2023 Financial Results on November 8, 2023
Nyxoah, a medical technology company specializing in innovative solutions for Obstructive Sleep Apnea (OSA), announced it will release its third-quarter 2023 financial results on November 8, 2023. The company will host a conference call to discuss the results on the same day. Nyxoahs lead product, the Genio® system, is a hypoglossal neurostimulation therapy for OSA. The system received its European CE Mark in 2019 and is currently undergoing a pivotal study for FDA approval in the U.S. The announcement is expected to have a growth-positive impact on the company.
Public Trading
growth-positive
Nyxoah Announces Partnership with ResMed in Germany
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), has announced a partnership with ResMed Germany. The partnership aims to increase OSA awareness and therapy penetration in the German market. The companies will establish a continuum of care to guide OSA patients from diagnosis through treatment, accelerate patient identification, and better support patient set-up on the appropriate therapy. The partnership will also involve OSA helplines, direct-to-consumer marketing initiatives, sales and marketing efforts targeting ENTs and sleep physicians, and patient and clinician educational programs and symposiums.
Partners
Growth-Positive
Nyxoah to Participate in the Cantor Fitzgerald Global Healthcare Conference
Nyxoah SA, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), has announced its participation in the Cantor Fitzgerald Global Healthcare Conference, taking place from September 26 to 28, 2023. Nyxoahs CEO, Olivier Taelman, will provide a corporate update at the event. The company will also be available for one-on-one meetings with institutional investors. Nyxoahs lead solution is the Genio system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA.
Partners
growth-positive
Nyxoah to Participate in Upcoming Investor Conferences
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced its participation in two upcoming investor conferences in New York City. CEO Olivier Taelman will deliver corporate updates at the H.C. Wainwright 25th Annual Global Investment Conference on September 12, 2023, and the Baird Global Healthcare Conference on September 13, 2023. The company will also be available for one-on-one meetings with institutional investors. Nyxoahs lead solution, the Genio® system, has received European CE Mark approval and is currently undergoing a pivotal study for FDA approval in the U.S.
Investment
growth-positive
Information on the Total Number of Voting Rights and Shares
Nyxoah SA, listed on Euronext Brussels and Nasdaq, has issued new shares, increasing its share capital to EUR 4,925,869.05. The total number of securities carrying voting rights is now 28,673,985. Additionally, there are several ESOP warrants issued in 2018, 2020, 2021, and 2022, entitling holders to subscribe to a total of 2,426,000 securities carrying voting rights. This information is disclosed in accordance with Belgian law on the disclosure of large shareholdings.
Investment
growth-negative
Nyxoah Reports Second Quarter and First Half 2023 Financial and Operating Results
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), reported its financial and operating results for the second quarter and first half of 2023. The company presented promising preliminary data from its DREAM study but faced increased losses due to higher R&D and commercial expenses. Nyxoah reported second-quarter sales of €1.1 million and ended the quarter with €84.5 million in cash. The company is accelerating its U.S. pre-commercialization efforts and expanding its market presence in Germany. Despite the financial losses, Nyxoah remains optimistic about its future market entry and ongoing clinical trials.
CustomersExpand
Growth-Negative
Nyxoah SA (NYXH) Reports Q2 Loss, Tops Revenue Estimates
Nyxoah SA reported a quarterly loss of $0.49 per share, which is more than the expected loss of $0.45 per share. This is also higher than the loss of $0.21 per share reported a year ago. Despite this, the companys revenues increased to $1.21 million for the quarter ended June 2023, surpassing the Zacks Consensus Estimate by 15.64%. This is also higher than the revenues of $1 million reported a year ago. The companys shares have increased by about 54.7% since the beginning of the year. The future performance of the stock will depend on the companys earnings outlook and the performance of the Medical Info Systems industry.
Investment
Growth-Positive
Information on the Total Number of Voting Rights and Shares
Nyxoah SA has announced the issuance of new shares, in accordance with article 15 of the Law of 2 May 2007 on the disclosure of large shareholdings. The companys share capital now stands at EUR 4,924,151.05, with a total of 28,663,985 securities carrying voting rights. Additionally, the company has issued several ESOP Warrants between 2016 and 2022, entitling their holders to subscribe to a total number of 2,437,500 securities carrying voting rights.
Investment
Growth-Positive
Publication Relating to a Transparency Notification
Nyxoah SA has announced that it received a rectification of an earlier transparency notification from ResMed Inc. The correction relates to the number of shares and the percentage of voting rights held by ResMed Inc. on March 30, 2023. ResMed Inc. held 1,619,756 shares, representing 5.73% of the total number of voting rights, not 1,499,756 shares or 5.30% of the voting rights as stated in the April 2023 notification.
Investment
growth-positive
Nyxoah to Participate in the 43rd Canaccord Genuity Growth Conference
Nyxoah SA, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the 43rd Canaccord Genuity Growth Conference in Boston, Massachusetts. The companys CEO, Olivier Taelman, will deliver a corporate update on August 9, 2023. Nyxoahs lead solution is the Genio system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA. The company received its European CE Mark in 2019 and completed two successful IPOs in September 2020 and July 2021.
Public Trading
growth-positive
Nyxoah to Release Second Quarter 2023 Financial Results on August 8, 2023
Nyxoah, a medical technology company specializing in innovative solutions for Obstructive Sleep Apnea (OSA), announced it will release its second quarter 2023 financial results on August 8, 2023. The company will host a conference call to discuss these results. Nyxoahs lead product, the Genio® system, is a hypoglossal neurostimulation therapy for OSA. The company has received European CE Mark approval and is conducting a pivotal study for FDA approval in the U.S.
growth-positive
Nyxoah S.A. (NASDAQ:NYXH) Q1 2023 Earnings Call Transcript
Nyxoah S.A. reported better-than-expected earnings for Q1 2023. The company discussed their operating activities and financial results during an earnings call. They highlighted the progress of their DREAM study and the submission of PMA modules. Nyxoah also announced the appointment of Christoph Eigenmann as Chief Commercial Officer to prepare for the U.S. market entry. They reported European sales below expectations due to transitory factors but anticipate growth in the second quarter. Nyxoah aims to focus on patient follow-up, enter the U.S. market, and drive revenue growth in Germany and other European markets. They raised €15.9 million in private investments and have sufficient cash runway until late 2024.
InvestmentManagement ChangesExpand
growth-negative
Nyxoah Reports First Quarter 2023 Financial and Operating Results
Nyxoah, a medical technology company, has reported its financial and operating results for Q1 2023. The company completed all 115 implants in the DREAM U.S. pivotal trial, with 12-month data expected in Q1 2024. The company also raised €19 million from new and historical shareholders including ResMed, Cochlear and Robert Taub, Nyxoah’s Chairman and Founder. The company ended the quarter with 40 active German accounts and quarterly sales of €441 thousand. However, the company reported a loss of €11,911 for the period.
InvestmentManagement ChangesExpand
growth-negative
Nyxoah SA (NYXH) Reports Q1 Loss, Lags Revenue Estimates
Nyxoah SA reported a quarterly loss that was worse than expected, with a negative earnings surprise. The companys revenues also missed estimates. The stock has outperformed the market so far this year, but the future outlook is uncertain. The companys earnings outlook and estimate revisions have been mixed. The stock is currently ranked as a Hold. The industry outlook for Medical Info Systems is positive, which could impact the stocks performance. Another company in the medical sector, Cresco Labs Inc., is set to report its results soon.
CustomersInvestment
Neutral
Invitation to Attend the Annual Shareholders’ Meeting of the Company to be Held on June 14, 2023
Nyxoah SA has invited its shareholders to attend the annual shareholders meeting to be held on June 14, 2023. The meeting will discuss the annual accounts for the financial year ended on December 31, 2022, the annual report of the board of directors, the statutory auditors report, and the remuneration report among other things. The meeting will also confirm the appointment of Wildman Ventures LLC, represented by Mr. Daniel Wildman, as an independent director of the company.
Management Changes
Nyxoah Appoints Christoph Eigenmann as Chief Commercial Officer
Nyxoah to Release First Quarter 2023 Financial Results on May 16, 2023
growth-positive
Publication Relating to Transparency Notifications
Nyxoah received transparency notifications from Together Partnership and ResMed Inc. regarding the acquisition of voting securities or voting rights. Together Partnership now holds 10.42% of the total voting rights, while ResMed Inc. holds 5.30%. The notifications were received on April 18, 2023.
Partners
growth-neutral
Information on the Total Number of Voting Rights and Shares
Nyxoah has published information on the total number of voting rights and shares in accordance with the disclosure of large shareholdings. The companys share capital is EUR 4,923,807.45, and it has a total of 28,661,985 securities carrying voting rights, all of which are ordinary shares. In addition, there are several rights to subscribe to securities carrying voting rights that have not yet been issued. These include ESOP Warrants issued in 2016, 2018, 2020, 2021, and 2022, with varying numbers of securities. The article does not mention any specific impact on the company or any partners, customers, or investors involved. The event described in the article occurred on April 17, 2023.
Public Trading
Strength Seen in Nyxoah SA (NYXH): Can Its 10.2% Jump Turn into More Strength?
growth-positive
Nyxoah Raises $3 Million from its At-the-Market Equity Offering
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), has raised $3 million in gross proceeds through its at-the-market equity offering. The funds will be used for general corporate purposes. Nyxoahs lead solution is the Genio® system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA. The company has received European CE Mark approval and is conducting a pivotal study for FDA and U.S. commercialization approval. The announcement emphasizes the companys commitment to developing innovative solutions for OSA patients and improving their quality of life. The press release also includes cautionary statements regarding forward-looking statements and the risks associated with the companys plans and events.
Investment
growth-positive
Nyxoah Raises $3 Million from its At-the-Market Equity Offering
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea, has raised $3 million in gross proceeds through its at-the-market equity offering. The funds will be used for general corporate purposes. Nyxoahs lead solution is the Genio® system, a patient-centered, leadless, and battery-free hypoglossal neurostimulation therapy for OSA. The company has received CE Mark approval in Europe and is conducting the DREAM IDE pivotal study for FDA approval in the US. Nyxoah aims to provide innovative solutions for OSA patients to enjoy restful nights and live their lives to the fullest.
Investment
growth-positive
Nyxoah S.A. (NASDAQ:NYXH) Q4 2022 Earnings Call Transcript
Nyxoah S.A. held its Q4 2022 earnings call, announcing the successful implantation of all 115 patients in its U.S. pivotal study DREAM and the filing of the first module in its PMA submission. Preliminary data from the study showed positive results, with a high responder rate and safety in line with expectations. The company also reported strong sales in Europe and expansion into new markets. Nyxoah aims to focus on patient follow-up, prepare for entry into the U.S. market, and drive further revenue growth in Germany and other European markets in 2023. Financially, the companys revenue tripled in Q4 2022 compared to the same period in 2021. Nyxoah had a cash and financial assets balance of €94.9 million as of December 31, 2022, providing a runway into the second half of 2024.
CustomersInvestment
Nyxoah Raises $3 Million from an At-the-Market Equity Offering
Nyxoah Announces a $15 Million Private Placement Financing
Nyxoah Announces a $15 Million Private Placement Financing
growth-positive
Nyxoah Reports Fourth Quarter and Full Year 2022 Financial and Operating Results
Nyxoah, a medical technology company, has reported its financial and operating results for the fourth quarter and full year 2022. The company completed all 115 implants in the DREAM U.S. pivotal study and achieved quarterly sales of €1.3 million. The company ended the year with 38 active German accounts, up from 12 at the start of the year. The company also strengthened its supply chain with a Belgium manufacturing facility receiving clearance from the EU notified body. Nyxoahs total cash position was €94.8 million at the end of 2022.
InvestmentExpand
growth-positive
Nyxoah to Release Fourth Quarter and Full Year 2022 Financial Results on March 22, 2023
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea, will release its fourth quarter and full year 2022 financial results on March 22, 2023. The company will host a conference call to discuss the results. Nyxoahs lead solution is the Genio system, a patient-centered therapy for OSA. The Genio system has received CE Mark approval in Europe and is currently undergoing clinical trials for FDA approval in the United States.
Public Trading
growth-positive
Nyxoah to Participate in the Oppenheimer 33rd Annual Healthcare Conference
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), will participate in the Oppenheimer 33rd Annual Healthcare Conference. The companys CEO will deliver a corporate update and the presentation will be available on Nyxoahs Investor Relations website. Nyxoahs lead solution, the Genio® system, received its European CE Mark in 2019 and the company completed successful IPOs on Euronext Brussels and NASDAQ. They are currently conducting a pivotal study for FDA and U.S. commercialization approval. The conference participation is expected to have a positive impact on the companys growth.
PartnersInvestment
growth-positive
Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones
Nyxoah has announced the achievement of key clinical and regulatory milestones. The company has completed all 115 implants in its DREAM U.S. pivotal study, submitted the first module in the modular PMA submission, and implanted the first patient in the ACCCESS U.S. pivotal study. These milestones bring Nyxoah closer to offering its Genio solution to all Obstructive Sleep Apnea (OSA) patients in the U.S. The DREAM study is designed to support the marketing authorization of the Genio system, while the ACCCESS trial focuses on complete concentric collapse (CCC) patients. Nyxoah is a medical technology company focused on developing and commercializing innovative solutions to treat OSA.
CustomersInvestment
growth-positive
Nyxoah Announces Achievement of Key Clinical and Regulatory Milestones
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), has achieved key clinical and regulatory milestones. The company has completed all 115 implants in its DREAM U.S. pivotal study, submitted the first module in the modular PMA submission, and implanted the first patient in the ACCCESS U.S. pivotal study. These achievements bring Nyxoah closer to offering its Genio solution to OSA patients in the U.S. The DREAM study aims to support the marketing authorization of the Genio hypoglossal nerve stimulation system, while the ACCCESS trial focuses on complete concentric collapse (CCC) patients. Nyxoahs CEO, Olivier Taelman, emphasized the companys mission to provide Genio to patients regardless of CCC status and without the requirement for a CCC diagnosis.
CustomersInvestment
growth-positive
Nyxoah Announces Inaugural Investor & Analyst Meeting
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea (OSA), announced its inaugural Investor & Analyst Meeting on March 23, 2023. The meeting will provide a business update from the companys senior management and presentations from key opinion leaders in the field of obstructive sleep apnea. Nyxoahs lead solution, the Genio® system, received its European CE Mark in 2019 and the company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval. The meeting is expected to have a positive impact on the companys growth.
InvestmentManagement Changes
Nyxoah Appoints Mr. Daniel Wildman to its Board of Directors
growth-positive
Nyxoah Files Shelf Registration Statement and Announces At-the-Market Equity Offering Program
Nyxoah SA, a medical technology company, has filed a $200 million shelf registration statement with the U.S. Securities and Exchange Commission. The company also entered into a sales agreement with Cantor Fitzgerald & Co., allowing it to sell new ordinary shares with an aggregate offering price of up to $50 million. The number of offered shares will not exceed 6 million. The shares will be sold at the current USD market price of the Nyxoah ordinary share on the Nasdaq Global Market at the time of sale.
InvestmentPublic Trading
growth-positive
Nyxoah and Acurable Enter into Distribution Agreement in Germany for the AcuPebble SA100 Home Sleep Test
Nyxoah has entered into a distribution agreement with Acurable to provide the AcuPebble SA100 home sleep test to OSA patients in Germany. The AcuPebble SA100 is a next-generation wearable home sleep test that uses acoustic signals to diagnose OSA. The partnership allows Nyxoah to offer cutting-edge OSA home sleep diagnosis and treatment solutions. AcuPebble is designed to be more patient- and practitioner-friendly than traditional tests, enabling ease of diagnosis and routine monitoring of the condition. The distribution of AcuPebble in Germany is expected to launch in the fourth quarter of 2022.
Partners
growth-positive
Nyxoah Announces CE Mark Approval for Genio® 2.1
Nyxoah has received CE Mark approval for its next generation Genio 2.1 system, which is designed to treat Obstructive Sleep Apnea (OSA). The approval pertains to the external components of the system and will be available to all patients who have received Genio implants. Genio 2.1 offers improved patient comfort and compliance with a new smartphone application and upgraded external activation chip. It provides daily feedback on therapy usage and allows patients to adjust stimulation amplitude within pre-defined boundaries. The system also includes additional sensors for physicians to tailor therapy stimulation parameters based on patient position and throughout the night. Nyxoah aims to address the needs of OSA patients and accelerate market share gains.
CustomersPartners
growth-positive
Nyxoah Receives FDA IDE Approval to Initiate the ACCCESS Study of Genio® in Complete Concentric Collapse Patients
Nyxoah has received FDA approval to initiate a clinical trial called ACCCESS to evaluate the use of its Genio® system for the treatment of adult patients with moderate-to-severe Obstructive Sleep Apnea (OSA) and Complete Concentric Collapse (CCC) of the soft palate. The trial will implant up to 106 patients, with the first patient expected to be implanted in Q4 2022. Nyxoah is the only hypoglossal nerve stimulation (HGNS) company with a positive CCC clinical trial and CCC approval in Europe, and the ACCCESS study further strengthens its leadership position in addressing the needs of these patients. The company aims to provide a minimally invasive solution for CCC patients who are refractory to CPAP and currently have no other treatment options. Nyxoah has already secured a CCC label expansion in Europe and FDA Breakthrough Device Designation for its Genio® system.
Investment
growth-positive
Nyxoah Reports Full Year 2021 Operating and Financial Results
Nyxoah SA, a medical technology company, has reported its financial and operating results for the full year ending December 31, 2021. The company generated revenue of €852,000 from the commercialization of Genio® in Europe, mainly in Germany. It also reported positive data from the BETTER SLEEP clinical trial and received expanded CE mark indication to treat CCC patients. The company raised $97.8 million in a Nasdaq initial public offering in July. It also entered an exclusive licensing agreement with Vanderbilt University to develop next-generation neurostimulation technologies.
InvestmentExpand
growth-positive
Nyxoah Announces Closing of Nasdaq Initial Public Offering and Underwriters' Full Exercise of Option to Purchase Additional Shares
Nyxoah, a medical technology company focused on treating Obstructive Sleep Apnea, has announced the closing of its initial public offering (IPO) on the Nasdaq. The IPO consisted of 2,835,000 ordinary shares priced at $30 per share, resulting in total gross proceeds of $85.1 million. The underwriters of the offering have also exercised their option to purchase additional shares in full, bringing the total gross proceeds to $97.8 million. The closing of the exercise of the option is expected to occur on July 9, 2021. Piper Sandler, Stifel, and Cantor acted as joint book-running managers for the offering.
Public Trading
growth-positive
Nyxoah announces full-body 1.5T and 3T MRI compatibility for the Genio® system to treat Obstructive Sleep Apnea (OSA)
Nyxoah has received CE Mark Magnetic Resonance Imaging (MRI) conditional labeling for its Genio system, allowing patients to undergo full-body 1.5T and 3T MRI scans. This expands the benefits of the Genio systems bilateral stimulation therapy for the treatment of Obstructive Sleep Apnea (OSA). The company aims to minimize disruption to patients daily lives and improve their quality of life. The MRI compatibility is unique to Nyxoah in the field of neurostimulation-based OSA therapies. The Genio system has already received European CE Mark approval and is currently undergoing additional studies for therapy indication expansion and FDA approval.
Customers
growth-positive
First US patient implanted in the DREAM pivotal IDE study, with the Genio® system for the treatment of Obstructive Sleep Apnea (OSA)
Nyxoah S.A., a health-technology company, has announced the successful implantation of the first US patient in the DREAM pivotal IDE study. The study is designed to support the marketing authorization of the Genio system in the United States. The Genio system is a patient-centered, next-generation hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA). The implantation took place at the Nose and Sinus Institute Boca Raton, Florida. The DREAM study will enroll 134 patients, who will undergo the implantation procedure in up to 26 centers worldwide.
CustomersPartnersExpand
growth-positive
Sleep disorder co Nyxoah raises €85m in Euronext IPO
Nyxoah, a medical device company focused on the development and commercialization of hypoglossal nerve stimulation therapy for Obstructive Sleep Apnea, raised €85 million ($100 million) in an IPO on the Euronext stock exchange. The companys valuation increased from €362 million ($423 million) to €413 million ($485 million) after the IPO. The company was founded in Israel in 2009 and has received FDA and EU CE marketing approval for its device. With the new funds, Nyxoah plans to increase its workforce in Israel from 38 to 50 out of a total workforce of 85.
InvestmentExpand
growth-positive
Nyxoah launches its Initial Public Offering on Euronext Brussels
Nyxoah S.A., a health-technology company focused on the development and commercialization of innovative solutions and services to treat sleep disordered breathing conditions, has announced the terms of its initial public offering of new shares, with admission to trading of all of its shares on the regulated market of Euronext Brussels. The company is looking to raise between €60 million and €79 million. The funds raised will be used to conduct clinical trials in the United States, Europe and Australia, fund product development and research and development activities, fund the marketing strategy and commercialization efforts, and for general corporate purposes.
InvestmentPublic Trading
growth-positive
Nyxoah Announces Intention to Launch an Initial Public Offering on Euronext Brussels
Nyxoah S.A., a health-technology company focused on the development and commercialization of innovative solutions and services to treat sleep disordered breathing conditions, has announced its intention to raise new funds through an Initial Public Offering (IPO) on Euronext Brussels. The company is developing the Genio system, a CE-Mark validated, user-centered, bilateral neurostimulation therapy to treat moderate to severe Obstructive Sleep Apnea (OSA). Current shareholders have already expressed their commitment to subscribe for an aggregate amount of no less than €15 million in the Offering to the Nyxoah IPO.
InvestmentPublic Trading
growth-positive
Nyxoah Gets FDA OK to Begin Study on Its Implanted Neurostimulator for Sleep Apnea
The US Food and Drug Administration (FDA) has approved Nyxoah SAs Investigational Device Exemption (IDE) application, allowing the company to commence its pivotal DREAM study of its Genio system for the treatment of obstructive sleep apnea (OSA). The DREAM study will enroll 134 patients in the US and internationally to confirm the safety and effectiveness of the Genio system. Nyxoah is excited to partner with selected study centers and expand its global footprint. The Genio system is a battery-free, leadless, and minimally invasive implanted neurostimulator that stimulates the hypoglossal nerve to keep the upper airway open during sleep.
Customers
growth-positive
Nyxoah raises €25 million in private funding round
Nyxoah, a healthtech company developing neuromodulation-based therapeutic solutions for sleep disordered breathing conditions, has raised €25 million in a private financing round. ResMed Inc., a world-leading digital health company, joined as a new shareholder. The funding will be used to advance the development of the Genio® system, conduct clinical trials, and accelerate market access and commercialization activities. Nyxoah aims to treat obstructive sleep apnea (OSA), a common sleep disorder affecting almost one billion people globally. The Genio® system is a battery-free, leadless, and minimally invasive implanted neurostimulator designed to keep the upper airway open during sleep. Nyxoah has received its European CE Mark and is preparing for market entrance in the United States.
Investment
Cochlear ups investment in sleep device - Australian Manufacturing Forum
growth-positive
Nyxoah publishes positive Obstructive Sleep Apnea data from BLAST OSA study in the European Respiratory Journal
Nyxoah, a healthtech company, has published positive data from the BLAST OSA study in the European Respiratory Journal. The data demonstrate the safety and efficacy of the Genio® system, a next-generation neurostimulation therapy for Obstructive Sleep Apnea (OSA). The results validate the Genio® system as a novel, safe, and effective treatment for OSA. The study showed a significant reduction in OSA severity, improvement in patients quality of life, and high device usage. Nyxoah aims to bring this innovative technology to OSA patients in Europe, Australia, New Zealand, and the United States. OSA is a common sleep disorder affecting almost 1 billion people globally. The Genio® system is a battery-free, leadless, and minimally invasive neurostimulator that offers an alternative to Positive Airway Pressure (PAP) therapy.
Customers
growth-positive
Nyxoah sleep apnea nerve-stim therapy gains CE Mark - Medical Design and Outsourcing
Nyxoah has received CE Mark approval for its hypoglossal nerve stimulation therapy for obstructive sleep apnea. The Genio system is a battery-free, leadless neurostimulator designed for patients who have failed conventional CPAP therapy. The approval was based on data from a clinical study conducted in France and Australia. Nyxoah plans to publish the study results in a medical journal. Cochlear led a funding round of $17.1 million for Nyxoah in November, with funds being used for post-CE Mark European market studies and FDA approval.
CustomersInvestment
growth-positive
Sleep disorder device co Nyxoah raises $17m
Nyxoah S.A., a medical device company focused on hypoglossal nerve stimulation therapy for Obstructive Sleep Apnea, has raised €15 million ($17.1 million) in a financing round led by Cochlear Ltd. Cochlear invested €13 million and a representative of Cochlear has joined the Nyxoah board. The funding will be used for post-CE Mark European market development activities and to work toward Investigational Device Exemption with the US FDA.
InvestmentPartnersPublic Trading
growth-positive
This Tiny Implant Uses Electrical Impulses To Stop You Snoring
Nyxoah, a company specializing in sleep apnoea treatment, has developed an implant that aims to combat the condition. The implant is positioned under the skin next to the nerve controlling the tongue muscle and sends electrical impulses to ensure the airway remains open during sleep. Nyxoah plans to conduct a clinical trial with 25 patients next month. The device is seen as a more comfortable alternative to existing treatments such as Continuous Positive Airway Pressure (CPAP), which are often poorly tolerated by patients. If successful, the implant could provide an attractive alternative to CPAP therapy.
CustomersPartners
growth-positive
Sleep apnea prevention co Nyxoah raises $20m
Nyxoah, a medical technology company that has developed a solution for obstructive sleep apnea, has raised $20 million in funding. The companys CEO, Robert Taub, is also an investor and co-founder. The new investors in this round include Glide Healthcare and SWIR, while Novallia provided a loan of unknown value. Nyxoahs prior investors, including Taub himself and other private investors, also participated. The funds raised will be used for clinical trials and the development of a second generation product. Nyxoah is headquartered in Belgium with its R&D center in Israel.
InvestmentPartners
growth-positive
Sleep Apnea co Nyxoah raises €8 million
Belgium-Israeli medical device company Nyxoah has raised �8 million in its Series A round. The funds will be used to finance a multi-center clinical trial in Europe. Nyxoah has developed a tiny chip that is implanted in the chin and uses electrical stimulation to ensure that airways remain unblocked for people who suffer from sleep apnea. The current investment round is to finance the clinical trial. Nyxoahs co-founder and largest investor is Robert Taub.
Investment
Nyxoah Team
Employee Info
| Employees (range) | 51-200 |
| Exact count | 197 |
| Team members | 3 |
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Nyxoah Internal
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Admin Info
| Confidence | 92/100 |
| Missing | markets, not claimed |
| BI Verification | Yanina Wainscheinker |
| Registrar ID | 514082726 |
| Crunchbase | nyxoah |
| Creator | Sharon Shapira |
| Creator email | shapira.sharon2@gmail.com |
| Last updater | Yanina Wainscheinker |
| Updater email | yanina.wainscheinker@sncentral.org |
| Last update | 2024-08-27T00:00:00.000Z |
| Created | 2014-12-16T00:00:00.000Z |
| Status detail | Public on Euronext on Sep, 2020<br>Public on NASDAQ on Jul, 2021<br> |