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Tag: hgns

LivaNova Shares Positive 12-Month Results From Obstructive Sleep Apnea Study

Recently published study results demonstrate the efficacy of LivaNova Plc’s aura6000 System in treating moderate to severe obstructive sleep apnea (OSA). Published in Annals of Internal Medicine, the full 12-month results from the company’s OSPREY randomized controlled trial (RCT) demonstrate the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), a differentiated neurostimulation modality. Overall, the study authors concluded that pHGNS for OSA yielded clinically significant improvements versus […]

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Industry News

Nyxoah Announces Pricing of $95 Million Underwritten Public Offering

Nyxoah announced the pricing of an underwritten public offering in the United States, which includes shares sold in a private offering to certain qualified or institutional investors outside the United States, including within the European Union, of 55,232,558 of its ordinary shares at an offering price of $1.72 (EUR 1.48) […]

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LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to treat Moderate to Severe Obstructive Sleep Apnea

Industry News Product News Sleep Apnea

LivaNova Receives U.S. FDA Premarket Approval for aura6000 System to Treat Moderate to Severe OSA

LivaNova PLC announced the U.S. Food and Drug Administration (FDA) granted premarket approval (PMA) for the aura6000™ System for the treatment of adult patients with moderate to severe Obstructive Sleep Apnea (OSA). The System utilizes proximal hypoglossal nerve stimulation (p-HGNS), a differentiated neurostimulation modality, to treat OSA in patients with […]

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Industry News

Nyxoah Boosts Manufacturing Investment in Belgium to Fuel International Expansion

Nyxoah SA has announced an important investment in Belgium to further scale its manufacturing capacity to support its continued growth in the United States and international markets. In addition to its existing contract manufacturing operations in the United States, the Company will expand its manufacturing footprint in Wallonia, reflecting Nyxoah’s […]

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Sleep Apnea Patient Health

Hypoglossal Nerve Stimulation Patient Primer

There’s no one-size-fits-all approach for managing sleep apnea. Continuous positive airway pressure (CPAP) has been the go-to treatment for almost 40 years, but doctors have realized that some patients are not able to tolerate a CPAP mask or keep up with CPAP treatment over time. If you have a moderate […]

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nyxoah genio hypoglossal nerve stimulation

Industry News Product News Sleep Apnea

Nyxoah Receives FDA Approval for Genio System for Treatment of OSA

Nyxoah SA announced that the U.S. Food and Drug Administration (FDA) has approved the Genio system (hypoglossal nerve stimulation) for a subset of patients with moderate to severe OSA with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. Genio is […]

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Industry News Product News

Nyxoah Receives FDA Approvable Letter for Genio Hypoglossal Nerve Stimulator

Nyxoah SA, which develops breakthrough treatment alternatives for obstructive sleep apnea (OSA) through neuromodulation, announced an update on the FDA approval process for the Genio system. On March 26, 2025, the Company announced that the U.S. Food and Drug Administration (FDA) issued an Approvable Letter regarding the Company’s Pre-Market Approval […]

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Industry News

Nyxoah Appoints Dr. Maurits S. Boon, MD as Chief Medical Officer

Nyxoah SA today announced the appointment of Dr. Maurits S. Boon, MD as Chief Medical Officer. Dr. Boon joins Nyxoah from Thomas Jefferson University, where he will continue part-time as a professor and Vice Chairman, Education. He is dual board-certified in otolaryngology – head and neck surgery, as well as […]

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Research & Studies Product News Sleep Apnea

Nyxoah DREAM U.S. Pivotal Study Meets Primary Endpoints

Nyxoah SA has announced the DREAM U.S. pivotal study achieved a statistically significant reduction in the co-primary endpoints of 12-month AHI responder rate, per the Sher criteria, and ODI responder rate, both on an ITT basis. The DREAM study is a pivotal trial being conducted under an investigational device exemption […]

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Industry News Partnerships Sleep Apnea

HGNS Maker Nyxoah Partners with ResMed Germany

Nyxoah SA today announced that the Company has entered into a partnership with ResMed Germany to increase OSA awareness and therapy penetration in the German market. Nyxoah and ResMed Germany will establish a continuum of care that will educate and guide OSA patients in the German market from diagnosis through treatment. […]

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