{"id":67568,"date":"2022-06-02T05:21:51","date_gmt":"2022-06-02T05:21:51","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=92717"},"modified":"2022-06-02T05:21:51","modified_gmt":"2022-06-02T05:21:51","slug":"fda-approves-genio-2-1-for-use-in-dream-u-s-ide-pivotal-study","status":"publish","type":"post","link":"https:\/\/kuwaitnewsgazette.com\/fda-approves-genio-2-1-for-use-in-dream-u-s-ide-pivotal-study\/","title":{"rendered":"FDA Approves Genio\u00ae 2.1 For Use in DREAM U.S. IDE Pivotal Study"},"content":{"rendered":"
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FDA Approves Genio\u00ae 2.1 For Use in DREAM U.S. IDE Pivotal Study\u00a0<\/b><\/p>\n

New smartphone application, upgraded activation chip, improved user interface, and stimulation amplitude trimming enhance patient experience and comfort<\/i><\/p>\n

Mont-Saint-Guibert, Belgium \u2013 June 1, 2022, 10:30pm CET \/ 4:30pm ET \u2013 Nyxoah SA (Euronext Brussels\/Nasdaq: NYXH)<\/b>(\u201cNyxoah\u201d or the \u201cCompany\u201d), a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA), today announced that the U.S. Food and Drug Administration (FDA) has approved the use of Nyxoah’s next generation Genio\u00ae 2.1 system for use in the Company\u2019s DREAM U.S. IDE pivotal study. Genio\u00ae 2.1\u2019s upgrades are entirely related to the external components of the Genio\u00ae system, as the implantable stimulator remains unchanged.<\/p>\n

Genio\u00ae 2.1 further demonstrates Nyxoah\u2019s patient-centric approach to addressing the needs of those suffering from moderate-to-severe OSA. The system\u00a0features updates to the Genio\u00ae activation chip and a new smartphone application to enable daily reporting of therapy usage, which will support therapy acclimation and long-term compliance. Additional features of Genio\u00ae 2.1 include an improved user interface and the ability for clinicians to make more incremental stimulation adjustments. This is particularly meaningful for patients who are more sensitive to neurostimulation, as with Genio\u00ae 2.1 physicians can fine-tune stimulation amplitude to determine the optimal level of comfort for patients without compromising therapy efficacy.<\/p>\n

\u201cGenio\u00ae 2.1\u2019s features, along with existing full-body 3.0T MRI compatibility, illustrate Nyxoah\u2019s patient-first mission in OSA product development,\u201d commented Olivier Taelman, Nyxoah\u2019s Chief Executive Officer. \u201cThe updated activation chip and new smartphone app, combined with our upgraded user interface and increased stimulation resolution, represent key next steps in optimizing patient outcomes. We are excited to make these important new features available to patients in our DREAM trial.\u201d<\/p>\n

About Nyxoah<\/b>
\nNyxoah is a medical technology company focused on the development and commercialization of innovative solutions to treat Obstructive Sleep Apnea (OSA).\u00a0Nyxoah\u2019s lead solution is the Genio\u00ae system, a patient-centered, leadless and battery-free hypoglossal neurostimulation therapy for OSA, the world\u2019s most common sleep disordered breathing condition that is associated with increased mortality risk and cardiovascular comorbidities. Nyxoah is driven by the vision that OSA patients should enjoy restful nights and feel enabled to live their life to its fullest.<\/p>\n

Following the successful completion of the BLAST OSA study, the Genio\u00ae system received its European CE Mark in 2019. Nyxoah completed two successful IPOs: on Euronext Brussels in September 2020 and NASDAQ in July 2021. Following the positive outcomes of the BETTER SLEEP study, Nyxoah received CE mark approval for the expansion of its therapeutic indications to Complete Concentric Collapse (CCC) patients, currently contraindicated in competitors\u2019 therapy. Additionally, the Company is currently conducting the DREAM IDE pivotal study for FDA and US commercialization approval.<\/p>\n

For more information, please visit\u00a0http:\/\/www.nyxoah.com\/<\/u><\/a>.<\/p>\n

Caution\u00a0<\/b>\u2013 CE marked since 2019. Investigational device in the United States. Limited by U.S. federal law to investigational use in the United States.<\/p>\n

Contacts:<\/b>
\nNyxoah<\/b>
\nLoic Moreau, Chief Financial Officer
\ncorporate@nyxoah.com<\/u><\/a>
\n+32 473 33 19 80<\/p>\n

Jeremy Feffer, VP IR and Corporate Communications
\njeremy.feffer@nyxoah.com<\/u><\/a>
\n+1 917 749 1494<\/p>\n

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