Sleep Data Articles & Analysis
2 news found
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 ...