Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device

Rhea-AI Summary

Nyxoah SA (NYXH) celebrated its progress towards U.S. market entry by ringing the Nasdaq Closing Bell on August 29, 2024. The company, focused on innovative solutions for Obstructive Sleep Apnea (OSA), has completed its FDA regulatory submission for the Genio® device. Nyxoah is on track for U.S. approval by the end of 2024 and plans a commercial launch in early 2025.

Key highlights include:

• Positive data from the pivotal DREAM study in spring 2024
• Final module submitted for FDA review
• U.S. commercial team established, led by new CCO Scott Holstine
• Over €85 million raised to fund U.S. launch

CEO Olivier Taelman expressed confidence in Nyxoah's position to enter the U.S. market, citing robust clinical evidence and solid funding.

Positive

• Completed FDA regulatory submission for Genio® device
• On track for U.S. approval by end of 2024
• Planned U.S. commercial launch in early 2025
• Raised over €85 million to fund U.S. launch
• Positive data from pivotal DREAM study in spring 2024
• Established U.S. commercial team with new Chief Commercial Officer

Negative

• None.

Medical Device Analyst

Nyxoah's progress with the Genio® device for OSA treatment is promising. The completion of the FDA regulatory submission and expected approval by end of 2024 are significant milestones. The €85 million capital raise demonstrates strong investor confidence. However, the U.S. sleep apnea market is highly competitive, with established players like Inspire Medical Systems. Nyxoah's success will depend on Genio®'s differentiation, particularly its patient-centric design. The positive data from the DREAM study is encouraging, but real-world performance and physician adoption will be crucial. The planned 2025 U.S. launch aligns with market trends, as demand for minimally invasive OSA treatments grows. Investors should monitor post-launch metrics closely to gauge market penetration and patient outcomes.

Financial Analyst

Nyxoah's financial position appears solid for its U.S. market entry. The €85 million capital raise, combining €48.5 million in equity and a €37.5 million EIB loan, provides a strong runway for the Genio® launch. This funding strategy balances dilution with debt, which is prudent. The U.S. market's size presents a significant revenue opportunity, potentially driving stock appreciation if the launch succeeds. However, investors should consider the burn rate during the pre-launch phase and initial commercialization period. The company's valuation will likely be sensitive to FDA approval timelines and initial sales traction. Long-term profitability will depend on reimbursement strategies and market share gains in a competitive landscape.

Market Research Analyst

The OSA device market is poised for growth, with increasing awareness and diagnosis rates. Nyxoah's timing for U.S. entry seems opportune. The patient-centric approach of Genio® could resonate well, especially if it offers comfort or efficacy advantages over existing solutions. Key success factors will include physician education, patient awareness campaigns and payer relationships. The appointment of Scott Holstine as CCO, along with other key hires, suggests a strategic focus on building a robust commercial infrastructure. Market penetration rate in the first 12-24 months post-launch will be a critical indicator of Genio®'s competitiveness. Investors should watch for partnerships with sleep centers and ENT specialists, as these will be vital for initial adoption and market share growth.

Nyxoah Rings the Closing Bell at Nasdaq while Preparing for U.S. Market Launch of Innovative Sleep Apnea Device

FDA regulatory submission for the Company’s Genio® device is complete, U.S. approval on track for the end of 2024

U.S. commercial launch, expected at the beginning of 2025, fully funded with over €85 million in new capital raised

Nyxoah – NASDAQ Closing Bell Ceremony 29 août 2024

Mont-Saint-Guibert, Belgium – September 2, 2024 10:05pm CET / 4:05PM ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH) (“Nyxoah” or the “Company”), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), rang the Nasdaq Closing Bell on August 29, 2024 to recognize the Company’s recent progress and highlight upcoming milestones on its path to the U.S. market launch of its innovative patient-centric Genio® hypoglossal nerve stimulation technology for OSA, a prevalent and severe sleep-related breathing disorder associated with increased mortality risk and cardiovascular comorbidities.

“We are honored to ring the Closing Bell and to celebrate our recent clinical and regulatory achievements in the U.S. We look forward with excitement to the upcoming U.S. launch of our lead product, Genio,” commented Olivier Taelman, Nyxoah’s Chief Executive Officer. “The U.S. is the largest healthcare market globally and therefore of strategic importance for us. With robust clinical evidence from our pivotal DREAM study, solid funding in place and our strengthened US commercial team, we feel well positioned to enter the US market. We have submitted the final module of our PMA submission to the FDA and are on track for U.S. approval by the end of 2024. If approved, Genio could become available in the U.S. as early as the beginning of 2025.”

Olivier Taelman, CEO of Nyxoah – NASDAQ Closing Bell Ceremony 29 august 2024

Recent Highlights and Upcoming Milestones of Nyxoah’s U.S. Commercialization Strategy

• Announcement of positive data from the pivotal U.S. study, DREAM, regarding Nyxoah’s Genio® system, an innovative hypoglossal neurostimulation therapy for Obstructive Sleep Apnea (OSA) in spring 2024.
• Final module submitted in the modular PMA submission, initiating FDA interactive review.
• Building a U.S. commercial organization, headed by Scott Holstine as the new Chief Commercial Officer along with key sales, marketing and market access leaders.
• The U.S. market launch of Genio® is fully funded following the successful raising of over €85 million in growth capital through a €48.5 million equity offering and a €37.5 million loan facility agreement with the European Investment Bank (EIB).
• FDA approval expected approval by US Food and Drug Administration by the end of 2024.
• U.S. market launch of Genio® planned for the beginning of 2025.

To view the broadcast of the Nasdaq Closing Bell ceremony, please visit: https://www.nasdaq.com/news-and-insights/nasdaq-stock-market-bell-ceremonies

About Nyxoah

Nyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA). Nyxoah’s lead solution is the Genio® system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world’s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest. 

Following the successful completion of the BLAST OSA study, the Genio® system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors’ therapy. Additionally, the Company announced positive outcomes from the DREAM IDE pivotal study for FDA and U.S. commercialization approval.

For more information, please see the Company’s annual report for the financial year 2023 and visit http://www.nyxoah.com/.

Caution – CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.

Forward-looking statements

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ or managements’ current expectations regarding the entry into of the loan facility agreement and the synthetic warrant agreement with the EIB; the use of proceeds from the loan facility agreement; the Genio® system and ongoing clinical studies of the Genio® system; the potential advantages of the Genio® system; Nyxoah’s goals with respect to the development, regulatory pathway and potential use of the Genio® system; the utility of clinical data in potentially obtaining FDA approval of the Genio® system; reporting data from Nyxoah’s DREAM U.S. pivotal trial; filing for FDA approval; and entrance to the U.S. market. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. Additionally, these risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the “Risk Factors” section of the Company’s Annual Report on Form 20-F for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”) on March 20, 2024, and subsequent reports that the Company files with the SEC. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person's officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Contacts:

Nyxoah
Loïc Moreau, Chief Financial Officer
IR@nyxoah.com

For Media
Belgium/France
Backstage Communication – Gunther De Backer
gunther@backstagecom.be

International/Germany
MC Services – Anne Hennecke
nyxoah@mc-services.eu

 

 

 

 

 

 

 

 

Attachment

• ENGLISH_Press Release_NASDAQ Ring the Bell_FINAL

FAQ

When did Nyxoah (NYXH) ring the Nasdaq Closing Bell?

Nyxoah (NYXH) rang the Nasdaq Closing Bell on August 29, 2024.

What is the expected timeline for Nyxoah's (NYXH) Genio® device FDA approval?

Nyxoah (NYXH) expects FDA approval for the Genio® device by the end of 2024.

When does Nyxoah (NYXH) plan to launch Genio® in the U.S. market?

Nyxoah (NYXH) plans to launch Genio® in the U.S. market at the beginning of 2025.

How much capital did Nyxoah (NYXH) raise to fund its U.S. launch?

Nyxoah (NYXH) raised over €85 million to fund its U.S. launch, including a €48.5 million equity offering and a €37.5 million loan from the European Investment Bank.

What is the name of Nyxoah's (NYXH) pivotal U.S. study for the Genio® system?

Nyxoah's (NYXH) pivotal U.S. study for the Genio® system is called DREAM.