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 who are not interested in wearing an oral appliance at night and who do not wish to undergo invasive, often hospital based, surgery.
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. *
The S.I.Le.N.C.E. Clinical Study that was submitted to the FDA to achieve FDA Clearance** 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 alertness. ***
- 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.
- 56% of partners sleeping with a snorer claim that snoring has an adverse effect on their wellbeing.12
- Partners of a frequent and heavy snorer lose at least one hour of sleep per night due to secondhand snoring. A study found that the partners’ sleep quality improved when snoring was alleviated or reduced.
- Approximately 25 percent of American couples slept separately to get a good night’s sleep. 68% of those older than 58 years report snoring was their deciding factor to sleep separately.1, 13
As for the snorer, the immediate negative effects include 2.3
- 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 (OSA) 2,3
- Heart attack 2,3
- High blood pressure 2,3,4
- Carotid Artery thickening and atherosclerosis caused by snoring-associated vibration 6,2,8
- Stroke, often caused by carotid artery thickening
- Atrial fibrillation’
- Type 2 diabetes 2,3,4
- Thinning of retinal thickness that causes reduction of visual acuity’
When one considers the numerous negative effects resulting from snoring and the current treatment options, it is apparent why Zelegent was driven to provide an alternative for those patients seeking relief from snoring who are not interested in wearing an oral appliance at night and do not wish to undergo invasive, often hospital based, surgery.
*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.
Headquartered in Newport Beach, California, Zelegent, Inc. has developed 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 stiffens and shortens the soft palate to alleviate snoring without the need for general anesthesia
Zelegent was incorporated in January 2015 and was the result of a brainstorm of two snoring pathology and treatment specialists: Dr. David Volpi, a New York City snoring specialist and founder of eos sleep, and Dr. Yosef Krespi, the Director of the Center for Sleep Disorders, and the NYHNI Professor of Clinical Otolaryngology at Columbia University. They had imagined a novel tool: one that would allow sleep specialist otolaryngologists to perform a simple, elegant, office-based interventional procedure that alleviates the airway obstructive symptoms of snoring. It would do this by acting on the soft palate, the anatomic cause of most Snoring, rather than the base of the tongue.
In April 2015, the company was accepted into the elite EvoNexus technology company incubator in Irvine, California which further accelerated Zelegent’s efforts to prove the clinical benefits of the Elevoplasty procedure, obtain FDA clearance and launch the product.
Dr. Yosef Krespi presented Zelegent’s single-center pilot clinical trial results at the 3rd Congress of European Otorhinolaryngology and Head and Neck Surgery (ORL-HNS) in Prague, Czech Republic in June 2015. The presentation, included post-op and 4-6-month follow up results for the first 20 of the 45 subjects treated for snoring with the prototype version of the device. The endpoints included improvements in quality of life, sleep quality, and the elimination of snoring.
In 2016, based on experience gained during the successful completion of the single-center pilot clinical trial and physician advisors, Zelegent redesigned and finalized the final version of the Elevo Snoring Intervention Kit .
In early 2017, Zelegent began the clinical trial necessary to submit for FDA clearance of the Elevoplasty® procedure and Elevo® Snoring Intervention Kit. The Snoring Intervention via Elevoplasty® in a Non-Surgical Clinical Environment (S.I.Le.N.C.E.) Study, sponsored by Zelegent, Inc. was an 8-center, 52-patient U.S. clinical study that demonstrated the Elevoplasty procedure could safely and effectively reduce snoring in some patients without sleep apnea.* More information regarding this study can be found at S.I.Le.N.C.E. Clinical Study S.I.Le.N.C.E. Clinical Study. The investigators in the S.I.Le.N.C.E. Clinical Study included both academic institutions and private practitioners, among them some of the foremost thought leaders in sleep disorder treatments and international lecturers on sleep surgery in the field of otolaryngology.
After the final Elevoplasty enrollment in the SILENCE trial in September 2017 1-month, 3-month, and 6-month patient outcomes data began to be collected for the anticipated FDA submission. In April 2018, the final 6-month patient follow-up data collection was completed and Zelegent submitted its 510(k) application to the FDA.
In December 2018, the FDA granted Zelegent 510(k) clearance for its Elevo Snoring Intervention Kit used in the Elevoplasty procedure. Also in FDA, Zelegent engaged in a distribution partnership with Cook Medical’s ENT division to market and sell the the Elevo Set Snoring Intervention Kit.
In early 2019, the Cook U.S. ENT sales team underwent Elevoplasty training and in April 2019 Cook began a series of U.S. Elevoplasty physician training sessions.
To date, over 130 Otolaryngologists and Oral and Maxillofacial Surgeons have been trained and over 500 patients have undergone the Elevoplasty procedure without any adverse events.
Early in 2022, Zelegent was granted its second FDA 510(k) clearance allowing the use of a new polymer material which is designed to extend the shelf life and in vivo duration of the Elevo® implant.