Clinical Study Shows 92% of Patients Report Resolution of Migraine Headaches Using Vivos’ POD® Appliance Treatment
Study Data Highlights New Vivos Treatment Option is Highly Effective in Treating Migraine Headaches, One of the World’s Most Common Illnesses
LITTLETON, Colo., May 01, 2023 (GLOBE NEWSWIRE) — Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from a variety of health conditions, many of which are associated with breathing related sleep issues arising from certain dentofacial abnormalities, today announced the results of a recent clinical observational study on the application of Vivos’ recently acquired Preventive Oral Device® (known as The POD®) in the treatment and prevention of migraine headaches.
The study demonstrated statistically significant results, with ninety-two percent (92%) of study patients reporting their migraine symptoms were completely resolved following completion of treatment. Moreover, the results were maintained during follow-up visits extending from 3 to 28 months after treatment began. Migraine severity was measured by the validated Migraine Disability Assessment Questionnaire (MIDAS). Prior to treatment patients had an average MIDAS score of 23.96 +/- 21.34 and following treatment had a MIDAS score of 2.58 +/- 4.87, a reduction of 89.2%.
Migraine headaches affect over 39 million people in the United States alone according to the American Migraine Foundation. This common debilitating pain condition can impact people for decades, with many choosing to accept living in pain after seeking treatment which proved ineffective. With this new treatment available from Vivos, patients can now find highly effective non-pharmaceutical relief from their local dentist.
“For the tens of millions of patients right here in the U.S. who suffer from migraines, we believe our new POD® treatment option has the potential to be game changer. Dentists who are using this technology report migraine resolution in about 9 out of 10 migraine sufferers. Not only can this novel oral appliance technology bring relief from migraines, but it is also FDA cleared to treat patients with TMD, teeth grinding (known as bruxism) and many other conditions related to breathing and sleep disorders,” said Vivos Chairman and CEO Kirk Huntsman. “We believe this novel technology’s potential is just starting to be realized, and are working to obtain additional FDA clearances for other chronic and debilitating health conditions. Importantly, we expect this high margin new product line will start contributing to Vivos’ revenue in the second half of this year as we seek to work our way towards cash flow positive operations.”
Vivos Therapeutics recently acquired the patents and rights for The POD®, an FDA 510k cleared device. The custom device is worn during sleep to treat Temporomandibular Joint Dysfunction (TMD) and aid in symptoms of TMD such as headaches, facial or neck pain, pain in or around the ear, pain when chewing, painful clicking or popping when opening or closing the jaw, or difficulty opening wide. People who develop TMD are more likely to report headaches, aching jaw muscles, disturbed sleep, daytime fatigue or dizziness, anxiety and depression have also been associated with TMD.
About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from a variety of health conditions, many of which are associated with breathing related sleep issues arising from certain dentofacial abnormalities such as mild-to-moderate obstructive sleep apnea (OSA), Temporomandibular Joint Dysfunction (TMD), headaches, and snoring in adults. The Vivos Method represents the first clinically effective nonsurgical, noninvasive, nonpharmaceutical and cost-effective solution for treating mild to moderate OSA. It has proven effective in over 33,000 patients treated worldwide by more than 1,750 trained dentists.
The Vivos Method includes the Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and associated protocols that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-moderate OSA, such as lowering Apnea Hypopnea Index scores. Patient results will vary. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children, as well as the Preventive Oral Device®, known as the POD®, for the treatment of TMD and/or bruxism (unconsciously teeth grinding) and the Vivos Sleep POD™, which is a mandibular advancement device for the treatment snoring and mild to moderate obstructive sleep apnea in adults. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
For more information, visit www.vivos.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management made in connection therewith contain “forward-looking statements” (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, particularly with respect to the public offering described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos’ control. Actual results (including, without limitation, dentist and patient demand for the POD® for the indications of use described herein and the impact of the POD® on the Company’s revenue and results of operations) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to, the risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.
Vivos Investor Relations Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com
