Summary: Nyxoah SA, the maker of the CE-marked Genio neurostimulator system for obstructive sleep apnea, reported its financial and operational results for the second quarter and first half of 2024. The company has completed its FDA regulatory submission for Genio and expects a decision by the end of 2024. Key financial and operational milestones include strengthened US commercial organization, significant capital raised, and sales growth.
Key Takeaways:
- FDA Submission Completed: Nyxoah SA has completed its regulatory submission for the Genio neurostimulator system, with an FDA decision expected by the end of 2024.
- Financial Growth: The company reported raising over €85 million in growth capital and showed a 29% sales growth in the first half of 2024 compared to the same period last year.
- US Market Preparation: Nyxoah has strengthened its US commercial team with key leadership appointments and is preparing for a potential market launch pending FDA approval.
Nyxoah SA, maker of the CE-marked Genio neurostimulator system for the treatment of obstructive sleep apnea, reported financial and operating results for the second quarter and first half of 2024, as it aims for US approval for Genio.
The company’s US Food and Drug Administration (FDA) regulatory submission for Genio is complete, and it expects approval by the end of 2024.
Financial and operating highlights include:
- Submitted final module in the modular Premarket Approval submission, initiating US Food and Drug Administration (FDA) interactive review.
- Strengthened US commercial organization, highlighted by the appointments of Scott Holstine as chief commercial officer and key sales, marketing, and market access leaders.
- Raised 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.
- Reported second quarter 2024 sales of €0.8 million and first half 2024 sales growth of 29% over the same period last year.
“With the FDA interactive review well advancing, our focus is fully shifted to US commercial readiness. Key commercial leadership is in place, and we are kicking off the recruitment of top sales and marketing talents. We will present the full DREAM US pivotal study data at the ISSS (International Surgical Sleep Society) meeting in September, which will further differentiate Genio’s unique, patient-centric hypoglossal nerve stimulation solution,” says Olivier Taelman, Nyxoah chief executive officer, in a release.
Taelman adds that the company’s recent €85 million in capital raise provides Nyxoah “with a cash runway into mid-2026, fully funding the US launch.”
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