The company is now boosting production to 500 units in anticipation of US clinical trials aimed at validating the device’s efficacy for at-home insomnia treatment.
Nyxoah's CEO says the company is on the cusp of "the most significant milestone" in its history.
A $2m funding round will accelerate the company's product development and regulatory and precommercialization efforts as it prepares for a 2024 entry into the North American CPAP market.
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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Proceeds from the financing round will be used in part to finish the pivotal trial for aerSleep II and file for FDA market clearance.
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An interim update highlights the initial treatment benefits for subjects who successfully acclimated to wearing the device and exhibited a response to the single vacuum pressure being tested.
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The Belgium-based company plans to launch its chin patch home sleep test in the US after receiving FDA clearance and closing a €17 million funding round.
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The clinical and regulatory milestones bring Nyxoah closer to offering its Genio neurostimulator solution to OSA patients in the US, according to the company.
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Bioscience Association Manitoba unveiled four winners, including Cerebra, to be honored at its Annual Awards Dinner on March 2. Here’s which award Cerebra is picking up.
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Sommetrics is advancing activities aimed at obtaining US Food and Drug Administration (FDA) market clearance for its flagship product, aerSleep II, which is targeted for the treatment of obstructive sleep apnea in those unable to use CPAP therapy.
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Astronauts find it difficult to maintain a natural circadian rhythm and generally complain about their sleep. A new project will examine the differences between human sleep patterns on earth and in space using an ear EEG.
Read MoreGenio 2.1’s upgrades are entirely related to the external components of the Genio system, as the implantable stimulator remains unchanged.
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X-trodes raised $4.5 million in funding in October 2021, and is now pursuing approval for the technology from the US Food and Drug Administration. If that goes well, the company hopes to start selling the device to sleep clinics in 2023.
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‘The results from the nocturnal adverse event questionnaire illustrate the burden that the second dose places on some patients.’
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The first part of Onera’s post-market study will assess the diagnostic accuracy of Onera STS I in comparison with in-lab polysomnography.
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Sunrise is developing a solution to analyze sleep using a 3-gram sensor coupled with artificial intelligence.
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Sleep Number’s latest upgrades to its 360 smart beds include built-in sensors and mobility accessories to create more accessible smart beds so that people can age in place more comfortably or recover from injuries.
Read MoreMedical device technology company AppYea announced the acquisition of SleepX, a company focused on the development of a wearable sleep apnea monitor.
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