Nyxoah Initiates Search for US-Based CEO to Accelerate Genio Launch
The medical technology company is transitioning leadership to focus on its next phase of growth and commercial traction for its obstructive sleep apnea therapy in the US market.
Tag: Genio
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Nyxoah Raises $27M Through US Healthcare Investor to Support Genio Launch
The investment by a new US-based healthcare investor strengthens the balance sheet and reinforces US focus, the company says.
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FDA Grants Breakthrough Designation for Nyxoah Genio System for Obstructive Sleep Apnea & Complete Concentric Collapse
The FDA will provide the Genio system with priority review and interaction with FDA’s experts throughout the premarket review phase until the product is commercialized in the United States.
Nyxoah Appoints Hypoglossal Nerve Stimulation Pioneer as CMO
The new CMO brings surgical and academic expertise in hypoglossal nerve stimulation.
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Nyxoah Teams Up With AAO-HNSF to Enhance Access to New Sleep Apnea Treatments
The partnership seeks improve patient access to new sleep apnea treatments by streamlining authorization pathways and advocating for broader access to neurostimulator therapies.
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Genio Neurostimulator Reduces Sleep Apnea Severity in Nyxoah’s DREAM US Study
Nyxoah announced 12-month results from its DREAM US pivotal study, designed to support the marketing authorization of the Genio hypoglossal nerve stimulation system for obstructive sleep apnea in the United States.
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Nyxoah to Unveil OSA Neurostimulation Study Results by Early April
Nyxoah SA announced the upcoming release of efficacy and safety data from the DREAM US pivotal study on the Genio neurostimulation system for obstructive sleep apnea.
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Nyxoah Sets Key Milestones for 2024, Aims to Replicate Its European Success Stateside
Nyxoah’s CEO says the company is on the cusp of “the most significant milestone” in its history.
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Nyxoah’s Preliminary Data Shows Revenue Surge Due to Genio Demand for OSA
Nyxoah says the anticipated growth reflects both strong underlying demand for Genio and a focus on streamlining the patient referral pathway.
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Genio Neurostimulator Improves Sleep Apnea in Three Complete Concentric Collapse Patients
In a real-world case series, the Genio neurostimulator effectively reduced sleep apnea symptoms in patients with complete concentric collapse, demonstrating significant improvements in AHI and sleepiness.
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Nyxoah Advances Genio Neurostimulator for OSA in Q3
Nyxoah SA reported a successful third quarter with clinical trial progress for its Genio neurostimulator system for the treatment of obstructive sleep apnea.
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Nyxoah and ResMed Germany Unite for Comprehensive Sleep Apnea Care
Nyxoah SA has partnered with ResMed Germany to increase OSA awareness and therapy penetration in the German market.
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Nyxoah Speeds Pre-Commercialization as Neurostimulator Trial Progresses
Nyxoah announced operating results for the second quarter and first half of 2023, emphasizing advances in its investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for the treatment of OSA.
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Nyxoah Highlights Positive Early Findings from Neurostimulator Trial for Sleep Apnea
The company has completed all 115 implants in the DREAM trial and expects full 12-month data in the first quarter of next year.
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Nyxoah Progresses in Neurostimulator Studies for Sleep Apnea
The clinical and regulatory milestones bring Nyxoah closer to offering its Genio neurostimulator solution to OSA patients in the US, according to the company.
Read MoreFDA Approves Nyxoah Genio 2.1 For Use in DREAM Pivotal Study for Obstructive Sleep Apnea
Genio 2.1’s upgrades are entirely related to the external components of the Genio system, as the implantable stimulator remains unchanged.
Read MoreNyxoah Neurostimulator Trial Reaches Its Primary Endpoints
The trial includes a subgroup of complete concentric collapse patients who are currently contraindicated for unilateral hypoglossal nerve stimulation.
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Patient with Complete Concentric Airway Collapse Achieves Control of Sleep Apnea in Nyxoah Neurostimulator Study
Currently, patients with complete concentric collapse are contraindicated for hypoglossal nerve stimulation OSA therapies.
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