Vivos Therapeutics (NASDAQ:VVOS) said its recently acquired Preventive Oral Device, known as POD, has been shown to treat and prevent headaches in a clinical observational study, sending the company's shares skyrocketing.
The US Food and Drug Administration (FDA) 510k-cleared device is worn during sleep to treat Temporomandibular Joint Dysfunction and its symptoms such as headaches and face or neck pain.
According to the company, 92% of study patients reported that their migraine symptoms were resolved following the POD treatment and these results were maintained during follow-up visits ranging from 3 months to 28 months after the treatment began.
Before treatment, patients had an average Migraine Disability Assessment Questionnaire (MIDAS) score of 23.96 +/- 21.34 and following treatment this had reduced by 89.2% to an average MIDAS score of 2.58 +/- 4.87.
“For the tens of millions of patients right here in the US who suffer from migraines, we believe our new POD treatment option has the potential to be a game changer,” Vivos CEO Kirk Huntsman said.
“Not only can this novel oral appliance technology bring relief from migraines, but it is also FDA-cleared to treat patients with TMD, teeth grinding (known as bruxism) and many other conditions related to breathing and sleep disorders.”
He noted that the company believed the novel technology’s potential was just starting to be realized and it was working to obtain additional FDA clearances for other health conditions.
“Importantly, we expect this high margin new product line will start contributing to Vivos’ revenue in the second half of this year as we seek to work our way towards cash flow positive operations,” Huntsman said in a statement.
Following the announcement, Vivos' shares were up 18.2% at US$0.39 in pre-market trading on Monday.
Vivos is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from a variety of health conditions, many of which are associated with breathing-related sleep issues arising from certain dentofacial abnormalities such as mild-to-moderate obstructive sleep apnea (OSA), Temporomandibular Joint Dysfunction (TMD), headaches, and snoring in adults.
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