Nyxoah Submits Final Module for FDA Approval of Innovative Sleep Apnea Treatment
Portfolio Pulse from Benzinga Newsdesk
Nyxoah has submitted the final module of its Premarket Approval (PMA) application for its innovative sleep apnea treatment, Genio, to the FDA. Genio is a unique hypoglossal nerve stimulation (HGNS) solution that is leadless, fully-body MRI compatible, and powered by a wearable device. The DREAM U.S. pivotal study data showed significant improvements in sleep apnea metrics.
July 01, 2024 | 6:52 am
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Nyxoah has submitted the final module of its PMA application for Genio to the FDA. This marks a significant milestone in bringing their innovative sleep apnea treatment to the U.S. market.
Submitting the final PMA module is a critical step towards FDA approval, which could significantly impact Nyxoah's market presence and revenue potential in the U.S. The positive results from the DREAM study further bolster the product's prospects.
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