TSOI Subsidiary, SandBox Dental Labs, files 510(k) with FDA

June 26, 2017 09:00 ET

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

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