Therapeutics Solutions International Inc (TSOI) announced today that its 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 its custom oral appliance to treat mild to moderate obstructive sleep apnea (OSA).
The appliance will be marketed by its tradename “Morpheus.” It will be a prescription custom made titratable mandibular repositioning device worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.
“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,” says Timothy Dixon, president and CEO of Therapeutic Solutions International, in a release. “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.”
Barry Glassman, DMD, chief dental officer of SandBox Dental Labs, says, “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.”