Summary: Nyxoah SA, developer of the CE-marked Genio neurostimulator for obstructive sleep apnea, raised $27 million by selling 3 million shares as part of its $50 million at-the-market offering. The shares were sold to a single US-based healthcare investor, with Cantor Fitzgerald & Co acting as the sales agent. The funds will support the company’s US focus, including the anticipated launch of the Genio system in the US, following the successful DREAM pivotal study and previous European approvals.
Key Takeaways:
- $27M Raised for US Expansion: Nyxoah secured $27 million from a US-based healthcare investor, bolstering its financial position for the US launch of its Genio system.
- Support for Genio’s US Launch: The funding will help Nyxoah prepare for the commercial launch of its Genio neurostimulator for obstructive sleep apnea in the US.
- Regulatory and Clinical Success: Nyxoah’s Genio system has already received CE mark approval in Europe and is on track for FDA approval in the US following positive outcomes from the DREAM pivotal study.
Nyxoah SA, maker of the CE-marked Genio neurostimulator for the treatment of obstructive sleep apnea, announced that the company has sold 3 million shares, raising $27 million in gross proceeds pursuant to the company’s $50 million at-the-market offering at a price per share equal to the market price on the Nasdaq Global Market at the time of sale.Â
The shares were sold, based on interest received, to a single US-based healthcare investor. Cantor Fitzgerald & Co is acting as the sales agent for the at-the-market offering.
The shares were sold by the company pursuant to the company’s shelf registration statement on Form F-3, filed with the Securities and Exchange Commission on Dec 22, 2022, which became effective on Jan 6, 2023, and which included a prospectus supplement and accompanying prospectus related to the at-the-market offering.
“After relocating to the United States with my family this past summer, this investment reinforces our United States focus, builds on our compelling DREAM pivotal study data presented at the International Surgical Sleep Society congress, and strengthens our financial position, providing additional opportunities as we are preparing for the launch of Genio in the United States,” says Olivier Taelman, chief executive officer of Nyxoah, in a release.
Genio for OSA
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.Â
Additionally, the company announced positive outcomes from the DREAM IDE pivotal study for US Food and Drug Administration and US commercialization approval.
Photo caption: Genio
Photo credit: Nyxoah/file photo
