LITTLETON, Colo. - Vivos Therapeutics, Inc. (NASDAQ:VVOS), a medical technology company, has announced FDA clearance for its oral appliance to treat pediatric obstructive sleep apnea (OSA). The approval marks the first for a device of its kind to address moderate to severe OSA and snoring in children aged 6 to 17.
The condition, affecting an estimated 10.1 million U.S. children, can lead to serious health issues such as ADD/ADHD, lower IQ, and depression. Traditional treatments like adenotonsillectomy have shown a relapse in 21% to 73% of cases, while CPAP machines are seldom prescribed for children due to potential impacts on cranial and facial growth.
Vivos' DNA appliance, part of its CARE line, is designed to be non-invasive, comfortable, and affordable. It aims to reduce snoring and treat OSA in children who also require orthodontic treatment. The company believes this FDA clearance will allow it to quickly capture significant market share and scale revenue with minimal investment through its new provider-based marketing and distribution model.
The clearance was based on a controlled, prospective study that demonstrated a 50% reduction in symptoms of SRBD and a 58% decrease in snoring among participants. The study also reported a 62.7% improvement in moderate and severe AHI measurements, with airway volumes increasing by 40% on average.
Kirk Huntsman (NYSE:HUN), CEO of Vivos, expressed optimism about the clearance, stating it opens a new market for millions of children with sleep-related disorders. The company plans to expand its reach by partnering with medical professionals, offering a non-surgical solution that has already been effective in over 45,000 patients worldwide.
Vivos' method, which includes proprietary CARE appliance therapy, is part of a comprehensive approach to treating OSA and related conditions. The company also collaborates with sleep-treatment providers to promote its appliances and treatment options.
The information in this article is based on a press release statement from Vivos Therapeutics, Inc.
In other recent news, Vivos Therapeutics has disclosed several significant developments. The company's Board of Directors has approved the 2024 Omnibus Equity Incentive Plan, designed to offer stock-based awards to motivate and retain employees. Stockholder approval is still pending for this plan, which is set to replace the existing 2019 Stock Option and Stock Issuance Plan.
In tandem, the Board has authorized contingent stock option grants to certain executives and employees, including CEO R. Kirk Huntsman and CFO Bradford Amman, contingent upon stockholder approval of the new plan. The company has also amended and restated employment agreements for Huntsman and Amman, effective from January 1, 2025.
On the financial front, Vivos Therapeutics reported a 19% increase in total revenue for the second quarter of 2024, with Ascendiant Capital maintaining a Buy rating on the company's stock. Ascendiant also increased the shares target to $6.60 from $6.40, suggesting a potential 180% upside.
Lastly, the company closed a $7.5 million equity growth investment to strengthen its cash position and announced a strategic marketing and distribution alliance in Colorado, aimed at enhancing product accessibility. These recent developments highlight Vivos Therapeutics' strategic efforts towards sustained growth and profitability.
InvestingPro Insights
The recent FDA clearance for Vivos Therapeutics, Inc.'s (NASDAQ:VVOS) pediatric OSA treatment device is a significant milestone for the company, which is poised to tap into a market with a substantial number of affected U.S. children. As Vivos aims to revolutionize the treatment of pediatric obstructive sleep apnea with its non-invasive DNA appliance, investors may be keen to understand the financial health and market performance of the company.
InvestingPro data shows Vivos Therapeutics with a market cap of roughly $9.52 million, reflecting the size of the company in the competitive medical technology landscape. Despite the company's promising technology, it has been experiencing a quick cash burn, as evidenced by a revenue decline of 9.24% over the last twelve months as of Q2 2024. However, the quarterly revenue growth paints a more optimistic picture, with a 19.41% increase in Q2 2024, which may signal an uptick in business activity following the FDA clearance.
The stock's volatility is apparent, with significant price movements in both directions recently: a 20.17% increase over the last month, and yet a 37.36% decrease over the last six months as of the same date, highlighting the speculative nature of investing in Vivos at this time. Moreover, the company holds more cash than debt on its balance sheet, an InvestingPro Tip that suggests a degree of financial flexibility despite the current cash burn rate.
Investors looking for dividends will need to look elsewhere, as Vivos does not pay a dividend to shareholders. This is not uncommon for growth-focused medical technology companies that reinvest earnings back into the business. For those interested in further insights, there are additional InvestingPro Tips available at https://www.investing.com/pro/VVOS, which delve into the company's valuation multiples, profitability expectations, and stock price volatility.
As Vivos Therapeutics continues to navigate the post-clearance market, these InvestingPro insights provide a snapshot of the company's financial standing and market performance, which are crucial for investors considering the potential risks and rewards associated with this innovative medical technology player.
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