Therapeutic Solutions Subsidiary, SandBox Dental Labs, files 510(k) with FDA
June 26 2017 - 9:00AM
InvestorsHub NewsWire
Company Seeks Market
Clearance for Oral Appliance To Treat Moderate Obstructive Sleep
Apnea
OCEANSIDE, CA-(Marketwired – June
26, 2017) - Therapeutics Solutions International, Inc., (OTC
PINK: TSOI) announced today
that their majority-owned subsidiary, SandBox Dental Labs, Inc. has
filed a 510(k) application with the U.S. Food and Drug
Administration (FDA) for market clearance of their custom oral
appliance to treat mild to moderate obstructive sleep apnea
(OSA).
The appliance will be marketed by its tradename “Morpheus™”
which is an intraoral dental device for the treatment of snoring
and obstructive sleep apnea. The Morpheus™, a prescription custom
made titratable mandibular repositioning device, is worn during
sleep with the intention to reduce the incidence of snoring and
obstructive sleep apnea1, 2.
Sleep disorders, including sleep apnea, have become a
significant health issue in the United States. It is estimated that
over 22 million Americans suffer from sleep apnea, with over 80
percent of the cases of obstructive sleep apnea undiagnosed.
“TSOI has a long history of being involved in the dental field
and we are very thrilled to move back into this space and to bring
Morpheus™ to market,” said Timothy Dixon, President and CEO of
Therapeutic Solutions International. “Morpheus™ was
previously tested in a randomized controlled cross over
trial1 against CPAP and a placebo. Morpheus™ is
one of the most technologically advanced and patient friendly sleep
appliances on the market.”
“The oral appliance alternative is now well established in
mainstream medicine, not only for mild to severe OSA and those who
are CPAP non compliant, but also for many as a first line
treatment. While there are many custom appliances available to the
dentist for use in this field, we are excited about the many
advantages the Morpheus™ has, including proven effectiveness,
flexibility of use, and cost effectiveness,” said Dr. Barry
Glassman, Chief Dental Officer of SandBox Dental Labs.
1 Barnes et al. (2004). Efficacy of
Positive Airway Pressure and Oral Appliance in Mild to Moderate
Obstructive Sleep Apnoea.
2 Johal et al. (2016). The Efficacy of
Mandibular Advancement Appliances as a Treatment Alternative to
CPAP in Moderate OSAHS.
About Therapeutic Solutions International,
Inc.
The Company's corporate website is www.therapeuticsolutionsint.com.
Our new products can be viewed on www.projuvenol.com and products
can be ordered at www.youcanordernow.com.
These Supplement products have not been
evaluated by the United States Food and Drug Administration. These
products are not intended to diagnose, treat, cure or prevent any
diseases.
About SandBox Dental Labs, Inc.
The Company's corporate website is http://sandbox.dental
Safe Harbor Statement
This release contains forward-looking statements that are based
upon current expectations or beliefs, as well as a number of
assumptions about future events. Although we believe that the
expectations reflected in the forward-looking statements and the
assumptions upon which they are based are reasonable, we can give
no assurance that such expectations and assumptions will prove to
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are not strictly historical, including statements as to product
launch timing, revenue projections, business strategy, outlook,
objectives, future milestones, plans, intentions, goals, future
collaboration agreements, or otherwise as to future events, such
statements are forward-looking, and are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995. The forward-looking statements contained in this release
are subject to certain risks and uncertainties that could cause
actual results to differ materially from the statements made.
CONTACT INFORMATION
Therapeutic Solutions International, Inc.
ir@tsoimail.com
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