Vivos Therapeutics to Begin Clinical Trial at Stanford Medicine
11 Ottobre 2023 - 1:30PM
Vivos Therapeutics, Inc. (“Vivos” or the “Company") (NASDAQ: VVOS),
a medical technology company focused on developing innovative
treatments for patients suffering from mild-to-moderate obstructive
sleep apnea (OSA) and snoring in adults, announced that its
flagship daytime-nighttime appliance (DNA) will be tested in a
clinical trial at Stanford Medicine.
The protocol has been finalized and participant
enrollment will begin in early 2024. Study participants with
moderate to severe OSA will be randomly assigned to either
treatment with Vivos’ DNA appliance or CPAP (continuous positive
airway pressure), the current industry standard for OSA treatment.
Sleep studies will be performed prior to and following a course of
treatment using in-lab polysomnography to assess changes in the
patients’ apnea-hypopnea index (AHI).
The DNA appliance recently received 510(k)
clearance by the FDA for the treatment of mild-to-moderate OSA in
adults and represents an entirely novel modality of treatment for a
disease that is estimated to afflict 1 in 4 adults in the United
States.
“In a retrospective review of 220 patients1, we
have seen that Vivos’ oral appliance therapy decreases the
apnea-hypopnea index (AHI) while increasing airway volume. The
median reduction in AHI was 49% in this cohort and a quarter of
patients resolved their OSA completely. These end results were
measured after a 12-18 month course of therapy without the
appliance in the mouth - meaning the effects persisted while not
using treatment - something not seen with CPAP,” says Cecilia Wu
MD, Co-Chair of the Clinical Advisory Board at Vivos Therapeutics.
“While Vivos believes in these results, it is important to apply
the highest standards in medical research in the form of a
prospective randomized controlled trial. This will truly test
Vivos’ treatment to the same standard as all other modalities.”
“We are extremely excited to be starting this
trial at Stanford Medicine, which has been in the works for some
time” added R. Kirk Huntsman, Chairman and CEO of Vivos. “I am
confident that our technology will bear the scrutiny of a
well-designed, prospective clinical trial. There is no better place
to for our technology to undergo rigorous scientific testing than
at a respected institution like Stanford. Our treatment is
comfortable, safe and non-invasive, and we believe that at the end
of this study, the conclusion will be that Vivos should become an
essential part of every OSA care plan.”
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 breathing and sleep issues arising from
certain dentofacial abnormalities such as mild-to-moderate
obstructive sleep apnea (OSA) 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 in adults. It has proven effective in
approximately 40,000 patients treated worldwide by more than 1,800
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. Vivos also markets and
distributes SleepImage diagnostic technology under its VivoScore
program for home sleep testing in adults and children. 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, the conference call referred
to herein, 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 “aim,” “expect,” “may,”
“could," “should”, “expect,” “project,” “intend,” “plan,”
“believe,” “predict,” “anticipates,” “hopeful,” “estimate” 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 the
Company’s control. Actual results (including, without limitation,
(1) the ability to enroll an adequate number of individuals meeting
required criteria to provide statistically significant results from
the clinical trial, (ii) lack of adequate positive outcomes from
following the protocols outlined in the clinical trial to prove
efficacy, and (iii) if positive outcomes do occur, the ability to
receive additional FDA clearances from the clinical outcomes or
otherwise capitalize on such outcomes on a timely or cost effective
basis) may differ materially and adversely 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, uncertainties relating to the design and execution of
the study referred to herein as well as impact the Company’s
ability to generate additional revenue if the clinical trial fails
to demonstrate that the DNA is effective and the other risk factors
relating to the Company and its business described in the Company’s
filings with the Securities and Exchange Commission (“SEC”). The
Company’s filings can be obtained free of charge on the SEC’s
website at www.sec.gov. Except to the extent required by law, the
Company 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 the Company’s
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
1Katz D, Demaria S, Heckman S, Lin F, Kushida C. Use of the
Complete Airway Repositioning and Expansion (CARE) approach in 220
patients with Obstructive Sleep Apnea (OSA): A retrospective cohort
study. Sleep Med. 2022 Nov;99:18-22.
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