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Nyxoah SA Ordinary Shares (symbol: NYXH) is at the forefront of medical technology, focusing on innovative solutions to address Obstructive Sleep Apnea (OSA). The company is committed to enhancing the lives of individuals suffering from sleep-disordered breathing conditions through its state-of-the-art products and services.
Nyxoah's flagship product, the Genio system, is a CE-Mark validated, bilateral neurostimulation therapy designed to treat moderate to severe OSA. This user-centered system provides an effective and non-invasive treatment option for a condition that has been linked to increased mortality risks and various comorbidities, including cardiovascular diseases, depression, and stroke.
The Genio system stands out in the market due to its unique approach, focusing on bilateral stimulation to open the airway during sleep, thereby improving the quality of life for patients. The development and commercialization of this innovative platform underscore Nyxoah's commitment to addressing critical health issues with cutting-edge technology.
Recent achievements of Nyxoah include advancements in clinical trials, expansion into new markets, and strategic partnerships that underscore the company's growth potential and dedication to innovation. Financially, Nyxoah has shown resilience and strategic foresight, ensuring robust investment in research and development to maintain its competitive edge.
Nyxoah continually updates its stakeholders with the latest company news, ensuring transparency and fostering investor confidence. With its headquarters in Belgium, Nyxoah is well-positioned to expand its global presence and continue its mission of providing effective solutions for OSA and related conditions.
Stay informed with the latest updates and developments from Nyxoah to keep track of their performance, events, and strategic initiatives.
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.
Nyxoah announced the appointment of Mr. Daniel Wildman as an Independent Director to its Board of Directors on January 9, 2023. Mr. Wildman brings over 40 years of experience in the medical device industry, holding significant positions at major companies like Johnson & Johnson and Boston Scientific. His expertise is expected to bolster Nyxoah's R&D and commercial strategies, particularly for the Genio® hypoglossal nerve stimulation system aimed at treating Obstructive Sleep Apnea (OSA). The appointment is effective immediately, pending shareholder confirmation.
Nyxoah SA has disclosed significant information regarding its share capital and voting rights, as mandated by Belgian law. As of December 29, 2022, the company's share capital stands at EUR 4,440,069.16, with a total of 25,846,279 securities carrying voting rights, comprising all ordinary shares. Additionally, Nyxoah has issued various employee stock option plan (ESOP) warrants, including 700,000 warrants in 2022, allowing subscribers to acquire 4,270,750 total shares. This announcement follows the issuance of new warrants and is essential for transparency with investors.
Nyxoah has filed a $200 million shelf registration statement with the SEC, allowing for the potential sale of various securities. This provides strategic flexibility for future capital access. Additionally, the company has initiated an at-the-market equity offering program, enabling the sale of up to $50 million worth of common shares, with no more than 6 million shares to be issued. The shares will be sold at current market prices on the Nasdaq. This initiative follows Nyxoah's recent progress and approvals in Obstructive Sleep Apnea treatments.
Nyxoah announced its participation in the Piper Sandler 34th Annual Healthcare Conference from November 29 to December 1, 2022, at the Lotte New York Palace hotel. Olivier Taelman, the CEO, will present a corporate update during a fireside chat on December 1 at 12:00 PM ET. A webcast will be available via the Investor Relations website. Nyxoah's lead product, the Genio® system, treats Obstructive Sleep Apnea (OSA) and attained the CE mark in 2019.
Nyxoah reported its financial results for Q3 2022, revealing €182,000 in revenue, a slight decline from €203,000 in the previous year. This drop was largely attributed to a supply disruption affecting €700,000 in orders in Germany. The company completed 110 out of 115 implants for the DREAM U.S. pivotal trial, with 12-month data expected in fall 2023. Operating loss increased to €8.8 million. Nyxoah's cash position stands at €115.4 million, with a monthly cash burn of approximately €3 million.
Nyxoah announced the resignation of Raymond Cohen from its board of directors, effective October 18, 2022. This change occurs in a company focused on innovative solutions for treating Obstructive Sleep Apnea (OSA), highlighting the need for strong leadership amid ongoing product developments. The company’s Genio® system received CE Mark approval in 2019 and is currently undergoing the DREAM IDE pivotal study for FDA approval. This management shift may impact Nyxoah’s strategic direction as it continues to expand its market presence.
Nyxoah will participate in the Jefferies London Healthcare Conference from November 15-17, 2022. The event will be held at The Waldorf Hilton, London. CEO Olivier Taelman will provide a corporate update during a fireside chat on November 17 at 10:25am GMT. A webcast will be available on the Company's Investor Relations page. Nyxoah specializes in treating Obstructive Sleep Apnea with its lead product, the Genio® system, which received European CE Mark approval in 2019.
Nyxoah has announced the release date for its third quarter financial results, scheduled for November 8, 2022, after market close. The medical technology company specializes in innovative solutions for Obstructive Sleep Apnea (OSA). The company’s management will host a conference call at 10:30 PM CET / 4:30 PM ET to discuss the results. Interested investors can register for the call online. Nyxoah is known for its Genio® system, which has received CE mark approval for treating OSA and is currently conducting studies for FDA approval.
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