Nyxoah SA (NASDAQ:NYXH) saw its stock rise 9.4% after the FDA granted approval for its Genio system designed to treat moderate to severe obstructive sleep apnea (OSA).
The Belgium-based medtech firm secured marketing authorization for its cutting-edge hypoglossal nerve stimulation (HGNS) device, intended for patients with an Apnea-Hypopnea Index (AHI) ranging from 15 to 65. The Genio system offers bilateral stimulation through a leadless design and is compatible with full-body MRI scans at both 1.5T and 3T strengths.
This FDA approval was backed by results from Nyxoah’s DREAM pivotal trial, which reported a 63.5% responder rate and a median AHI reduction of 70.8%. Impressively, the device maintained its effectiveness regardless of sleep position, including a 66.6% median reduction in the particularly difficult supine position.
“Today marks a defining moment for Nyxoah and for U.S. patients suffering from OSA,” stated Olivier Taelman, Nyxoah’s Chief Executive Officer. The company has already established its U.S. commercial team and trained 75 physicians in preparation for the product’s launch.
Cantor Fitzgerald analyst Ross Osborn reaffirmed an Overweight rating and set a $14.00 price target on Nyxoah SA. He noted, “Recall, NYXH has built out a full U.S. commercial organization in anticipation of FDA approval, and has 75 physicians already trained on the Genio technology in the U.S. Importantly, the Genio System is not contra-indicated for patients with Complete Concentric Collapse (CCC). Accordingly, with a U.S. launch on the horizon and NYXH having a differentiated hypoglossal nerve stimulation (HGNS) offering in a current one-player market, addressing an annual $10 billion U.S. market opportunity, we reiterate our OW rating.”
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