Oventus Launches FDA-Cleared Sleep Apnea Device

Oventus, a Brisbane-based medical device company seeking to change the way sleep disorders are treated, has announced the U.S. launch of O₂Vent T, the first and only FDA cleared sleep disorder device that provides relief for snoring and obstructive sleep apnea (OSA) via a unique, separate airway that avoids multiple sites of obstruction, including the nose, the soft palate and the tongue. There are an estimated 50-70 million American adults that suffer from sleep disorders and 12-18 million adults that have sleep apnea.
 
The O₂Vent T uses 3D-printing technologies and is customized for each patient from medical-grade titanium, making it lighter and easier to wear than other devices intended to treat sleep disorders. The launch of O₂Vent T is taking place in San Francisco during the G’Day Australia events being held Jan 21. San Francisco will be the first market in the U.S. to offer this new technology to consumers.
 
A collaboration with Australia’s peak scientific body, the CSIRO (Commonwealth Scientific and Industrial Research Organization), has seen Oventus take its revolutionary technology global, offering real hope to millions of U.S. sufferers of OSA.
 
“O₂Vent T is unique because the patented airway design allows patients to breathe through a separate airway, which has never been done before,” said Dr. Chris Hart, founder and clinical director for Oventus. “This differentiated design essentially acts as a second ‘nose’ for patients and may be a more comfortable solution than other technologies on the market for the millions of patients who suffer from untreated OSA.”
 
The O₂Vent T works by stabilizing the jaw position, bringing the tongue forward to reduce airway collapse. It is 3D printed in titanium and individually made to suit each individual user. The O₂Vent T was born out of Dr. Hart’s own personal experience and desperation for a good night’s sleep. A self proclaimed “chainsaw snorer” and sleep apneic who also suffered nasal congestion, he fashioned the original prototype of what would become the O₂Vent Mono. This novel invention is expanding into multiple global markets as the incidence of OSA and its associated myriad of health problems continues to grow.
 
OSA occurs when the air passage in the throat becomes obstructed during sleep and causes people to stop breathing. It is estimated that OSA affects approximately 12-18 million people in the U.S. This condition can have serious medical implications, including high blood pressure, stroke, irregular heartbeats, and diabetes. Similarly, individuals who suffer from OSA often have other serious side effects which can impact personal relationships, work performance and overall quality of life, including: chronic fatigue or excessive daytime sleepiness, poor concentration, irritability and mood changes, impotence, or sex drive changes. The majority of individuals who have OSA are overweight or obese. Other contributing factors include: alcohol consumption (particularly in the evening, before bed), certain thyroid illnesses, sedatives, nasal congestion and/or obstruction, or facial bone shape and size of the muscles in the face or neck.
 
“The rising epidemic of OSA and its consequences are under-diagnosed and marginally managed at best,” said Dr. Michael Sodeifi, an oral and maxillofacial surgeon and one of the first clinicians in San Francisco to treat patients with O₂Vent T. “It has huge impacts on society by adversely affecting our physical and mental health, personal relationships and job performance. As both a surgeon trained to treat this condition and a sufferer, I am very excited to be working with Oventus to introduce this device to other patients in the United States.”
 
A 2016 clinical study showed Oventus’ first generation product, the O₂Vent Mono, either eliminated or significantly reduced snoring in 100 per cent of patients. A second clinical trial is currently under way to add to the growing body of evidence as the device is rolled out worldwide.
 
The O₂Vent launch will initially roll out in in several markets in the U.S., including: San Francisco, Los Angeles, Boston, Leawood, KS, and Delaware.