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We will be submitting the full data set for journal publication and look forward to discussing more fully once the data are published, hopefully in the first half of 2022. We are extremely encouraged by the data generated by BETTER SLEEP, which were used by our notified body DEKRA to expand our CE Mark indication to include CCC ...
DEKRA attributed the updated Genio® therapeutic indication to the BETTER SLEEP study data presented by the Company, concluding that “the effectiveness results and safety profile for both CCC and non-CCC patients are comparable”. Patients, therefore, do not have to undergo a Drug-Induced Sleep Endoscopy (DISE) procedure to ...
” The Breakthrough Designation is supported by data from the Company’s BETTER SLEEP trial, aimed at addressing the long-term safety and performance of the Genio® system in adult OSA patients with and without CCC. About BETTER SLEEP Trial BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP ...