Clinical Study Shows 92% of Patients Report Resolution of Migraine Headaches Using Vivos’ POD® Appliance Treatment
May 01 2023 - 7:30AM
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
GannonInvestor Relations
Officer720-442-8113jgannon@vivoslife.com
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