VVOS - Vivos stock rallies after FDA clears oral device treatment for severe sleep apnea

2023-11-29 08:07:37 ET

Vivos Therapeutics ( NASDAQ: VVOS ) shares rallied premarket on Wednesday after the medtech firm gained first ever FDA 510(k) clearance for oral device treatment of severe obstructive sleep apnea (OSA).

The clearance is backed by statistically significant data obtained from 73 severe OSA patients using the Vivos ( VVOS ) removable CARE (Complete Airway Repositioning and/or Expansion) oral appliances.

The data showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index, and 97% of patients improved or stayed the same.

Kirk Huntsman, chairman and CEO of Vivos, stated, "This achievement is a pivotal milestone for Vivos, and elevates our proven treatment options right into the mainstream of sleep medicine."

This latest approval comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA. It also marks the first time that the regulator has granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older.

Vivos CARE appliances include the flagship DNA oral appliance, the mRNA oral appliance and the mmRNA oral appliance.

Shares of Vivos Therapeutics were trading above 100% premarket

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