Vivos Therapeutics brings hope to the 90 million Americans affected by obstructive sleep apnea (OSA). Their FDA-cleared Vivos CARE oral devices offer a non-invasive alternative to CPAP therapy, with 97% of patients experiencing symptom relief. This groundbreaking technology empowers patients to rehabilitate their airways through a pain-free, multi-disciplinary approach.
LITTLETON, Colo., Nov. 26, 2024 /PRNewswire-PRWeb/ -- An estimated 90 million adults and children in the U.S. are affected by obstructive sleep apnea (OSA). (1-2) Moreover, the American Sleep Apnea Association reports that OSA-related heart complications contribute to 38,000 deaths annually in the country. (3) "Unfortunately, most patients are not fully informed about the chronic harmful nature of OSA, and they dismiss it as something that doesn't really affect their day-to-day lives—until it does," points out Kirk Huntsman, Chairman and CEO of Vivos Therapeutics, an industry leader in medical technology focused on breathing and sleep health. "This situation is exacerbated by popular myths and misconceptions surrounding this condition, which cause patients to minimize it and lead to a lack of diagnosis or appropriate treatment."
The Biggest Misconception About OSA: It's 'Just Snoring'
Snoring can be loud and annoying, but by itself is mostly harmless. However, intense snoring is a strong indicator of the far more dangerous condition—OSA. OSA is a chronic condition in which breathing stops intermittently, often leading to drops in blood oxygen levels and a multitude of serious health threats. OSA disrupts and weakens respiratory, circulatory, endocrine, excretory, nervous, and even reproductive systems.
Unlike snoring, sleep apnea is linked to severe health risks such as high blood pressure, stroke, glaucoma, diabetes, cancer, fibromyalgia, erectile dysfunction, depression, anxiety, ADD / ADHD, bed wetting, night terrors, snoring, bruxism, malocclusion, allergies, craniofacial asymmetries, fascial distortions, tongue ties, postural asymmetries, pain, temporomandibular joint dysfunction (TMD), migraine headaches, cluster headaches, preeclampsia, premature birth, low birth weight, lower IQ, poor academic performance, and more. (4–7)
Dispelling OSA Myths
Most people, and even medical doctors, hold on to wrong or outdated misconceptions about OSA, which often leads people at risk to believe they are exempt from the damage it can cause, resulting in them not seeking the proper treatment.
Some of the most commons myths surrounding OSA are:
- "I Don't Have Sleep Apnea. If I did, I would know it." An estimated 80% of people with OSA remain undiagnosed and unaware of their condition. (8) What they feel are the downstream effects of OSA such as chronic fatigue, daytime drowsiness, depression, anxiety, high blood pressure, cardiovascular disease or diabetes.
- "Having OSA means I have to wear a CPAP every night": Until recently, CPAP was by far the preferred treatment option, and over 85% of OSA patients were prescribed CPAP. (9) However, that is all changing, as recent FDA clearances have paved the way for a safe and effective new oral medical device option from Vivos Therapeutics.
- "Women don't suffer from OSA": While OSA is more prevalent in men, women can develop it too—especially after menopause or if they have conditions such as polycystic ovary syndrome (PCOS). (10)
- "Healthy people who exercise regularly have nothing to worry about": Factors like obesity and unhealthy habits such as smoking or excessive drinking increase the chances of having OSA. But conditions like hypothyroidism, a family history of OSA, heart or kidney failure, and certain facial, skeletal or neck anatomies can also predispose individuals to the condition, making prevention and treatment complex. (10)
FDA Approval Highlights Non-Invasive Alternative to CPAP for Sleep Apnea Relief
Misconceptions related to OSA can even hinder treatment. "People with OSA are rarely informed of all the options they have. The only thing most patients know of is the continuous positive airway pressure (CPAP) machine, which they often try to avoid," explains Huntsman.
CPAP therapy is wildly unpopular as patients are obliged to sleep connected to a machine every night for an indefinite period; this results in low compliance rates, reducing its ability to help. On the other hand, surgical options are invasive and bring their own set of risks. In this last alternative, success can be unpredictable or temporary.
Vivos Therapeutics is committed to changing this. The company recently received a landmark FDA clearance to treat moderate to severe OSA in both children and adults using its Vivos CARE oral medical devices.
The clinical data presented to the FDA showed that:
- 97% of adult patients saw relief from OSA symptoms.
- 80% of such patients got at least 50% better or improved by one category of severity, and 28% of patients saw their OSA fully resolve (all as measured by Apnea Hypopnea Index (AHI) results).
- Treatment times averaged just 9.7 months, and no further treatment interventions were required.
Empowering Patients with a Multi-Disciplinary Alternative to Traditional OSA Therapies
Vivos CARE devices are worn just 10 hours per day overnight, and typically there is no pain or other material side effects. "Our biggest challenge is to get patients and their doctors to understand that a lifetime sentence of nightly CPAP use is not the only way," highlights Huntsman. "We are the only company in the world that can offer patients the full spectrum of choice when it comes to treating their OSA. For those who wish to rehabilitate their airways, the only real non-surgical option is the FDA-cleared Vivos CARE devices as part of a multi-disciplinary treatment protocol."
About VIVOS THERAPEUTICS
Obstructive sleep apnea (OSA) affects over 936 million people worldwide, yet 85% remain undiagnosed and unaware of their condition. This chronic disorder is not just a sleep issue—it's closely linked to nearly every modern chronic health condition. While the medical community has made strides in treating sleep disorders, breathing and sleep health remain areas that are still not fully understood. As a result, solutions are often mechanistic and fail to address the root causes of OSA.
Vivos Therapeutics, founded in 2016 and based in Littleton, CO, is changing this. Through innovative technology, education, and partnerships with dentists, functional medicine doctors, and sleep specialists, Vivos is empowering healthcare providers to more thoroughly address the complex needs of patients. Their groundbreaking device is the only FDA 510(k) cleared technology for treating severe OSA and the first to receive clearance for treating moderate to severe OSA in children.
The Vivos Method offers a unique, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope for patients with mild to severe OSA. Vivos: Breathe New Life. For more information, visit http://www.vivos.com.
References
1. Benjafield, Adam V, et al. "Estimation of the Global Prevalence and Burden of Obstructive Sleep Apnoea: A Literature-Based Analysis." The Lancet Respiratory Medicine, vol. 7, no. 8, Aug. 2019, pp. 687–698, http://www.thelancet.com/journals/lanres/article/PIIS2213-2600(19)30198-5/fulltext, https://doi.org/10.1016/s2213-2600(19)30198-5.
2. Magnusdottir, Solveig, and Elizabeth A. Hill. "Prevalence of Obstructive Sleep Apnea (OSA) among Preschool Aged Children in the General Population: A Systematic Review." Sleep Medicine Reviews, vol. 73, 1 Feb. 2024, p. 101871, http://www.sciencedirect.com/science/article/abs/pii/S1087079223001272#:~:text=Studies%20published%20before%202014%20reported, https://doi.org/10.1016/j.smrv.2023.101871.
3. Girardin Jean-Louis, et al. "Obstructive Sleep Apnea and Cardiovascular Disease: Role of the Metabolic Syndrome and Its Components." Journal of Clinical Sleep Medicine : JCSM : Official Publication of the American Academy of Sleep Medicine, vol. 4, no. 3, 15 June 2008, p. 261, pmc.ncbi.nlm.nih.gov/articles/PMC2546461/.
4. Drager, Luciano F., et al. "Sleep Apnea and Cardiovascular Disease." Circulation, vol. 136, no. 19, 7 Nov. 2017, pp. 1840–1850, doi.org/10.1161/circulationaha.117.029400.
5. G JEAN-LOUIS, et al. "Obstructive Sleep Apnea and Cardiovascular Disease: Evidence and Underlying Mechanisms." Minerva Pneumologica, vol. 48, no. 4, Dec. 2009, p. 277, pmc.ncbi.nlm.nih.gov/articles/PMC3106988/.
6. Kazuki Shiina. "Obstructive Sleep Apnea -Related Hypertension: A Review of the Literature and Clinical Management Strategy." Hypertension Research, 29 Aug. 2024, http://www.nature.com/articles/s41440-024-01852-y, doi.org/10.1038/s41440-024-01852-y.
7. Romina Abelleira, et al. "Relationship between Obstructive Sleep Apnea and Type 2 Diabetes Mellitus." Medicina Clínica, 1 Apr. 2024, https://doi.org/10.1016/j.medcle.2023.11.014. Accessed 28 May 2024.
8. Laher, Ismail, et al. "The Public Health Burden of Obstructive Sleep Apnea REVIEWS." Sleep Sci, vol. 14, no. 3, 2021, pp. 257–265, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8848533/pdf/ssci-14-03-0257.pdf, https://doi.org/10.5935/1984-0063.20200111.
9. "Hidden Health Crisis Costing America Billions Underdiagnosing and Undertreating Obstructive Sleep Apnea Draining Healthcare System." American Academy of Sleep Medicine, 2016.
10. Mayo Clinic. "Sleep Apnea - Symptoms and Causes." Mayo Clinic, 28 July 2020, http://www.mayoclinic.org/diseases-conditions/sleep-apnea/symptoms-causes/syc-20377631. Accessed 8 Nov. 2024.
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