- Obstructive Sleep Apnea (“OSA”) impacts up to 1 billion people globally, including 54 million Americans
- Estimates suggest OSA costs the U.S. economy $165 billion annually
- Vivos System offers significant advantages over traditional OSA treatment approaches
- Over 4,300 healthcare professionals registered for Vivos’ education and training Summit in March 2020, with strong and growing interest in this disruptive new technology
Vivos Therapeutics’ Vivos System is the first treatment modality for mild to moderate OSA based on the ability to remodel and enhance the function, size, and shape of the human airway, in most cases avoiding the need for lifelong interventions. The system’s treatment time is a fraction of that of its alternatives, potentially relieving symptoms in a matter of 18-24 months in most cases without the need for surgery (http://ibn.fm/7opjM).
The company’s existing mRNA (Mandibular Repositioning Appliance) is an FDA cleared class II device that treats mild to moderate sleep apnea, snoring, and sleep disordered breathing in adults. This is great news for people suffering from sleep apnea, as the device for most patients can serve as a potential lasting solution to these frustrating and dangerous conditions. It is estimated that OSA affects approximately 1 billion people worldwide, of which 54 million are Americans (http://ibn.fm/jrHQ6).
Vivos created and patented its novel system to combat OSA caused by deficiencies and other tissue anomalies in craniofacial anatomy development, the main cause of 98% of OSA cases. The multidisciplinary treatment protocol is comprised of comfortable and customized oral devices as well as biofunctional therapies, such as training the tongue. Over the course of treatment, the patient’s upper airway is effectively increased and enhanced, reducing tissue obstructions causing OSA. Vivos’ technology represents the first true hope of an effective OSA solution not involving surgery or lifelong interventions (http://ibn.fm/SuE6g).
The company is also developing an mmRNA (Modified Mandibular Repositioning Appliance) device, which is currently undergoing mechanical testing. Once this has been completed, the company plans to submit a 510k to the FDA for class II clearance approval. Once they have the FDA’s 510k clearance and award letter, they will approach Medicare in hopes to have the mmRNA added to the PDAC approved oral devices to treat mild to moderate sleep apnea, snoring, and sleep disordered breathing in adults. If Medicare provides Vivos CMS PDAC approval, they can bill the mmRNA for adults 65 and up with Medicare and/or adults 18 and up with various commercial policies that do follow Medicare guidelines.
Although Vivos devices are currently cleared only for mild to moderate sleep apnea in adults, and not for severe sleep apnea, the company believes its technology represents the most important breakthrough in OSA treatment since CPAP (Continuous Positive Airway Pressure), which involves the continuous use of special face or nasal masks.
Vivos’ proprietary system is designed to promote correct growth and development of the hard and soft tissues surrounding and compromising the oral cavity, nasal cavity, upper and lower jaws, and other tissues which comprise and shape the human airway. The system uses Pneumopedics(R), the natural process induced by Vivos biomimetic technology to widen and expand the patient’s airway, allowing for proper breathing through the nose. This addresses the root cause of OSA effectively.
The Vivos System multidisciplinary treatment protocol involves collaboration between physicians, dentists who have completed advanced training in craniofacial sleep medicine, and other ancillary healthcare providers. Unlike many other approaches, it aims for a lasting resolution by targeting the root cause of sleep apnea. Vivos clinicians can now be found in almost every major city in the U.S. and in many countries.
Vivos sponsored its first online education and training Summit on March of 2020, featuring selected clinicians from the dental and medical arena. The event reached maximum capacity in just three days, with over 500 dentists in attendance. Six additional two-day encore events were quickly scheduled twice a week thereafter to accommodate the surging demand. Over 4,300 healthcare professionals concerned about sleep, breathing, and wellness, are currently registered for the innovative program (http://ibn.fm/dM8CQ).
“By going virtual with sleep/breathing education and training, we have created an opportunity for everyone to come and learn about the latest developments in currently available treatment options,” said Vivos Co-Founder and CEO R. Kirk Huntsman. ” We believe our approach and related services could make a huge difference in the lives of many.”
For more information, visit the company’s website at www.VivosLife.com
NOTE TO INVESTORS: The latest news and updates relating to Vivos Therapeutics are available in the company’s newsroom at http://ibn.fm/VVOS
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