Ognomy Sleep, announced the closing of a $20 million Series A financing round led by Catalyst Investors, with participation from Blue Heron Capital. The round also included new and follow-on investments from Impellent Ventures, LaunchNY, Excell and Upstate Biotech Ventures, University of Buffalo, and strategic partners who have supported the company’s […]
Tag: FDA PREMARKET APPROVAL
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 […]
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 […]






