Zelegent

Zelegent Inc. is a medical technology company that is focused on reducing the severity of snoring, a common cause of both short-term and long-term health issues. Zelegent developed, and now manufactures and sells, the Elevo® Snoring Intervention Set, which allows physicians to perform Elevoplasty® a minimally-invasive, physician’s office-based procedure, to treat patients with mild to moderate snoring. The Elevoplasty procedure shortens, lifts and stiffens the the soft tissue at the top and back of the mouth (the soft palate) to alleviate snoring without the need for general anesthesia.(i) The S.I.LE.N.C.E. Clinical Study that was submitted to the FDA to achieve FDA Clearance (ii) demonstrated that 3 out of 4 patients saw a reduction in snoring at 30 days post-procedure, and experienced significant and prolonged improvement of sleep quality and daytime Approximately 45% of people snore at least sometimes and 25% of people snore regularly at volumes high enough to disturb sleeping partners. Snoring not only impacts the snorer’s health but also impacts the snorer’s partner. Snorers can cause their partner to become frustrated and lose a good night’s sleep. As for the snorer, the immediate negative effects include • excessive daytime sleepiness • increased agitation • decreased productivity • difficulty concentrating Even more concerning is the long-term negative impact that snoring has on an individual’s health by increasing the risk of Obstructive Sleep Apnea, heart attack, high blood pressure, atherosclerosis, stroke and atrial fibrillation.(i) Indications for Use: The Elevo® Kit Snoring Intervention Device is intended for use in stiffening the soft palate tissue; which may reduce the severity of snoring in some individuals.(ii) 510(k) K181107