Welcome to our dedicated page for NYXOAH S A news (Ticker: NYXH), a resource for investors and traders seeking the latest updates and insights on NYXOAH S A stock.
Nyxoah SA (NYSE: NYXH) is a pioneering health technology company focused on innovative treatments for sleep disordered breathing, particularly Obstructive Sleep Apnea (OSA). This page serves as the definitive source for official updates about their FDA-cleared Genio neurostimulation system, financial developments, and clinical research progress.
Investors and medical professionals will find curated press releases covering regulatory milestones, partnership announcements, and quarterly earnings reports. All content is sourced directly from company filings and verified channels to ensure accuracy.
Key focus areas include updates about international market expansions, clinical trial outcomes for OSA therapies, and technological enhancements to the Genio platform. Bookmark this page to stay informed about Nyxoah's progress in developing patient-centric solutions for chronic sleep conditions.
Mont-Saint-Guibert, Belgium, April 17, 2023 – Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) announced updates regarding its share capital following the issuance of new shares. The company's total share capital is now EUR 4,923,807.45, with 28,661,985 voting rights available from ordinary shares. Additionally, the report outlines various warrant issuances that allow the holders to subscribe to a total of 2,501,875 securities carrying voting rights. This information is disclosed in accordance with the legal requirement to report large shareholdings.
Nyxoah Raises $3 Million from Equity Offering
On April 13, 2023, Nyxoah announced the successful raising of $3 million through its At-the-Market (ATM) equity offering program, initiated on December 22, 2022. The funds will be utilized for general corporate purposes. This offering was executed under a shelf registration statement effective since January 6, 2023, allowing the company to capitalize on favorable market conditions.
Nyxoah specializes in innovative solutions for treating Obstructive Sleep Apnea (OSA), with its key product, the Genio® system, already CE marked in Europe and under FDA study for U.S. approval. The company aims to enhance patient quality of life by addressing OSA effectively.
Despite the positive fundraising news, Nyxoah continues to face market uncertainties inherent in medical technology development.
Mont-Saint-Guibert, Belgium, March 31, 2023 – Nyxoah SA (Euronext Brussels and Nasdaq: NYXH) announced updated information on its voting rights and share capital. The total share capital now stands at EUR 4,859,382.45, with 28,286,985 ordinary shares carrying voting rights. Following recent share issues, there are also multiple warrants entitling holders to subscribe to additional securities, including 55 from the 2016 ESOP Warrants, 100 from the 2018 ESOP Warrants, 430,500 from the 2020 ESOP Warrants, 1,326,375 from the 2021 ESOP Warrants, and 700,000 from the 2022 ESOP Warrants.
Nyxoah has successfully raised $2.8 million through an at-the-market equity offering as part of a broader $50 million program initiated in December 2022. The funding comes from a historical shareholder, Cochlear Limited, and will be allocated for general corporate purposes. This offering is conducted under a shelf registration statement filed with the SEC. The company is known for its Genio® system, a CE marked technology for treating Obstructive Sleep Apnea (OSA), and is currently seeking FDA approval in the U.S. with its ongoing DREAM IDE pivotal study.
Nyxoah announced a $15 million private placement financing on March 23, 2023, issuing 2,047,544 shares at €6.52 each (approx. $7.10). Gross proceeds of €13.35 million will support corporate purposes, with closing expected around March 30, 2023. Key shareholders, including ResMed and Robert Taub, participated in the offering. Nyxoah specializes in treatments for Obstructive Sleep Apnea (OSA), with its lead product, the Genio® system, having received CE Mark approval. The company is also conducting the DREAM IDE study for FDA approval in the U.S.
Nyxoah reported its fourth quarter and full year 2022 financials, achieving significant milestones in its Obstructive Sleep Apnea treatment development. Key highlights include:
- Completed all 115 implants in the DREAM U.S. pivotal trial.
- Generated €1.3 million in quarterly sales, marking a sequential market share gain in Germany.
- Ended 2022 with a cash position of €94.8 million.
Despite these gains, the company incurred an operating loss of €9.1 million for Q4 and €32.5 million for the full year due to increased R&D and operational expenses. The annual revenue was €3.1 million, up from €0.9 million in 2021.
Nyxoah SA has announced the release of its financial results for the fourth quarter and full year 2022 on March 22, 2023, after market close. The company will host a conference call to discuss the results starting at 10:30pm CET / 4:30pm ET. Nyxoah is focused on developing solutions for Obstructive Sleep Apnea (OSA), with its lead product, the Genio® system, holding a CE Mark since 2019. The product aims to offer innovative treatment for patients with OSA, having received CE approval for expanding its indications.
Nyxoah, a medical technology company specializing in solutions for Obstructive Sleep Apnea (OSA), announced its participation in the Oppenheimer 33rd Annual Healthcare Conference from March 13-15, 2023. CEO Olivier Taelman will present a corporate update on March 14 at 11:20 AM ET, with a webcast available on their Investor Relations website. The company aims to enhance treatment options with its Genio® system, which has received European CE Mark approval and is currently conducting the DREAM IDE pivotal study for FDA approval. This innovative therapy addresses OSA, a condition linked to serious health risks.
Nyxoah has completed the implantation of 115 patients in its DREAM U.S. pivotal study aimed at marketing authorization for the Genio® hypoglossal nerve stimulation system, targeting Obstructive Sleep Apnea (OSA). Additionally, the first PMA module was submitted, and the first patient has been implanted in the ACCCESS U.S. pivotal study, which will evaluate 106 Complete Concentric Collapse (CCC) patients. These studies aim for a 12-month assessment of key efficacy endpoints, providing a pathway to make the Genio solution available to all OSA patients in the U.S.
Nyxoah SA announces its inaugural Investor & Analyst Meeting scheduled for March 23, 2022, in New York City, where senior management will provide a business update followed by presentations from experts in obstructive sleep apnea (OSA). The meeting aims to enhance communication with investors and includes a Q&A session. Nyxoah is known for its innovative Genio® system, aimed at treating OSA. The company holds a European CE Mark for its system since 2019 and is currently pursuing FDA approval through its ongoing DREAM IDE pivotal study. Interested investors can register via the company’s website, with a webcast available post-event.