Clinical Study Shows that 92% of patients report resolution of migraine headaches using Vivos’ POD(r), Appliance Treatment.
Study Data Highlights Vivos Treatment Option as Highly Effective in Treating Migraine, One of World’s Most Common Conditions
The results of a clinical observational study conducted by Vivos on the use of the Preventive Oral Device (r), also known as the POD (r), in the treatment and prevention migraine headaches.
Ninety-two (92%) percent of the study patients reported that their migraine symptoms had been completely resolved after treatment. The results were also maintained in follow-up visits from 3 to 28 month after treatment. The validated Migraine Disability Assessment Questionnaire was used to measure the severity of migraines. Prior to treatment, patients had a mean MIDAS of 23.96 +/-21.34. Following treatment, they had a MIDAS of 2.58 +/-4.87. This is a reduction of almost 89.2%.
According to the American Migraine Foundation, migraine headaches affect 39 million Americans alone. Many people choose to live in pain for decades after a treatment that was ineffective. Vivos offers a new treatment that is non-pharmaceutical and highly effective.
“For the tens and millions of migraine sufferers in the United States, we believe that our new POD (r) option could be a game changer. About 9 out of 10 migraine patients have reported relief from their migraines after using this technology. Kirk Huntsman, Chairman and CEO of Vivos, said that this novel oral device technology can not only relieve migraines but also treat TMD, teeth-grinding (also known as bruxism), and many other conditions relating to breathing and sleeping disorders. “We believe that the potential of this novel technology is just beginning to be realized. We are working to obtain FDA clearances for additional chronic and debilitating conditions. We expect that this high-margin new product line will begin contributing to Vivos revenue in the second quarter of this year, as we strive to achieve cash flow positive operations.”
Vivos Therapeutics has acquired the patents for The POD (r) a FDA 510k cleared medical device. The custom device is worn while sleeping to treat Temporomandibular Joint Dysfunction. It helps with symptoms such as headaches and neck or facial pain, pain around the ear or in the ear canal, pain when you chew, clicking or popping sounds when opening or closing your jaw, or difficulty opening widely. TMD is more common in people who experience headaches, aching muscles in the jaw, disturbed sleep, fatigue during the day, or dizziness. Anxiety and depression are also associated with TMD.
About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. is a medical device company that focuses on developing and marketing innovative diagnostic and therapeutic methods for patients with a variety health conditions. Many of these are associated breathing-related sleep issues, arising from certain dental abnormalities, such as mild to moderate obstructive snoring (OSA), Temporomandibular joint dysfunction (TMD), headaches, or snoring among adults. The Vivos Method is the first nonsurgical, noninvasive and nonpharmaceutical solution that is clinically effective for treating mild-to-moderate OSA. It has been proven effective by over 33,000 patients worldwide treated by more than 1,750 dentists.
The Vivos Method is comprised of the Vivos Complete Airway Expansion (CARE), appliance therapy, and associated protocols. These alter the size and shape of the soft tissue that makes up the upper airway or palate. The Vivos Method increases airway space, which may reduce symptoms and conditions related to mild-to moderate OSA. Results may vary. Vivos also distributes SleepImage diagnostic technologies under its VivoScore Program for home sleep testing for adults and children. It also distributes the Preventive Dental Device (r) – known as the POD (r) – for the treatment TMD or bruxism. The Vivos Integrated Practice program (VIP) offers dentists training, as well as other value-added service in connection with The Vivos Method.
Visit www.vivos.com for more information.
Cautionary note regarding forward-looking statements
This press release, and the statements made by the Company’s Management in connection with it, contain “forward-looking” statements (as defined under Section 27A of Securities Act of 1933 as amended and Section 21E of Securities Exchange Act of 1974 as amended) about future events, in particular, the public offering described in this document. Forward-looking statements are identified by words such as “may”,’should’, “expects”, ‘projects”, intends, plans, â€believesâ€, â€anticipates†and similar expressions. These statements are subject to known and unknown risks, and are based on assumptions and estimates that are inherently subjected to significant uncertainties and contingencies. Many of these are outside the control of Vivos. Actual results (including without limitation, the dentist and patient demand of the POD (r) and the impact of POD (r) upon the Company’s revenues and results of operation) may differ materially to those expressed or implied in such forward-looking statement. Vivos’ filings to the Securities and Exchange Commission (SEC) contain a number of risk factors that could lead to a material difference in actual results. Vivos’ filings are available on the SEC website, www.sec.gov, for free. Vivos disclaims all obligations and undertakings, except to the extent required under law, to update or revise any forward-looking statement contained herein in order to reflect any changes in Vivos’ expectations or any changes in events, conditions or circumstances that may have occurred.
Vivos Contact for Investor Relations:
Julie Gannon
Investor Relations Officer
720-442-8113
[email protected]
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