Summary: Nyxoah reported third-quarter financial results, showcasing a 30% increase in sales and raising €24.6 million to bolster its anticipated US commercialization of the Genio neurostimulation system for obstructive sleep apnea. The company also highlighted progress in its US operations, including the presentation of promising DREAM study data and key leadership hires to drive the anticipated US launch
Key Takeaways:
- Strong Financial Growth Supports US Expansion: Nyxoah achieved 30% sales growth in Q3 and raised €24.6 million to fund its planned US launch of the Genio system, extending its cash runway until mid-2026.
- Strategic Leadership and Operational Moves: The company strengthened its US team with the hiring of a new CFO and commercial leaders to support its transition into the American market.
- Positive Data Drives Market Confidence: Results from the DREAM IDE study presented in September are expected to play a role in securing FDA approval.
Nyxoah, maker of the CE-marked Genio neurostimulation system for the treatment of obstructive sleep apnea (OSA) reported a strong third quarter with 30% sales growth and €24.6 million raised to support its anticipated US launch of Genio.
“Our actions in the third quarter have further positioned us well for a successful US commercial launch. On the back of the robust DREAM data presented in September, we have raised additional capital and are actively focused on building up our US commercial team,” says Olivier Taelman, Nyxoah’s chief executive officer, in a news release. “I am more confident than ever that we have set Genio up for a strong commercial start in the US immediately after FDA approval.”
Recent financial and operating highlights include:
- Presented compelling DREAM data results at International Surgical Sleep Society in September.
- Raised €24.6 million through an ATM program from a single US healthcare-dedicated fund providing incremental flexibility as the company shifts into US commercialization and extending cash runway until mid-2026.
- Strengthened US organization with the hiring of John Landry as chief financial officer and the addition of several commercial leaders in the US.
- Reported third-quarter sales of €1.3 million, representing 30% growth versus third quarter 2023.
- Total cash position of €71 million at the end of the quarter, €95.6 million proforma including the €24.6 million raised.
Following the completion of the BLAST OSA study, the Genio system received its European CE Mark in 2019. 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 patients, currently contraindicated in competitors’ therapy.
Additionally, the company announced positive outcomes from the DREAM IDE pivotal study for FDA and US commercialization approval. Genio currently is an investigational device in the US.
Photo caption: Genio
File photo/Nyxoah
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