Vivos Therapeutics Receives Groundbreaking FDA 510(k) Clearance to Treat Moderate to Severe Pediatric Sleep Apnea and Snoring
Vivos Therapeutics (NASDAQ: VVOS) has received a groundbreaking FDA 510(k) clearance for its DNA appliance to treat moderate to severe obstructive sleep apnea (OSA) and snoring in children aged 6 to 17. This is believed to be the first such clearance for an oral medical device in pediatric OSA treatment. The approval is based on a multi-site clinical trial that showed significant improvements in OSA symptoms and airway volumes.
Key findings from the study include:
- 50% reduction in sleep-related breathing disorder symptoms
- 58% decrease in snoring
- 62.7% improvement in moderate and severe AHI measurements
- 40% increase in airway volumes
Vivos aims to disrupt the pediatric OSA market, estimated at 10.1 million U.S. children, with its non-invasive, safe, and effective treatment option.
Vivos Therapeutics (NASDAQ: VVOS) ha ricevuto un'importante approvazione 510(k) dalla FDA per il suo dispositivo dentale per trattare l'apnea ostruttiva del sonno (OSA) da moderata a severa e il russare nei bambini di et脿 compresa tra 6 e 17 anni. Si ritiene che sia la prima approvazione di questo tipo per un dispositivo medico orale nel trattamento pediatrico dell'OSA. L'approvazione si basa su uno studio clinico multicentrico che ha mostrato miglioramenti significativi nei sintomi dell'OSA e nei volumi delle vie aeree.
I risultati chiave dello studio includono:
- riduzione del 50% dei sintomi dei disturbi respiratori durante il sonno
- riduzione del 58% del russare
- miglioramento del 62,7% nelle misurazioni della AHI moderata e severa
- aumento del 40% nei volumi delle vie aeree
Vivos punta a rivoluzionare il mercato pediatrico dell'OSA, stimato in 10,1 milioni di bambini statunitensi, con la sua opzione di trattamento non invasiva, sicura ed efficace.
Vivos Therapeutics (NASDAQ: VVOS) ha recibido una innovadora aprobaci贸n 510(k) de la FDA para su dispositivo dental para tratar la apnea obstructiva del sue帽o (OSA) de moderada a severa y el ronquido en ni帽os de 6 a 17 a帽os. Se cree que es la primera aprobaci贸n de este tipo para un dispositivo m茅dico oral en el tratamiento pedi谩trico de la OSA. La aprobaci贸n se basa en un ensayo cl铆nico multic茅ntrico que mostr贸 mejoras significativas en los s铆ntomas de la OSA y en los vol煤menes de las v铆as respiratorias.
Los hallazgos clave del estudio incluyen:
- reducci贸n del 50% en los s铆ntomas de trastornos respiratorios relacionados con el sue帽o
- disminuci贸n del 58% en el ronquido
- mejora del 62.7% en las mediciones del AHI moderado y severo
- aumento del 40% en los vol煤menes de las v铆as respiratorias
Vivos tiene como objetivo revolucionar el mercado pedi谩trico de la OSA, estimado en 10.1 millones de ni帽os en EE.UU., con su opci贸n de tratamiento no invasiva, segura y eficaz.
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鞐瓣惮鞚� 欤检殧 瓴瓣臣電� 雼れ潓瓿� 臧欖姷雼堧嫟:
- 靾橂┐ 甏�霠� 順疙潯 鞛レ暊 歃濎儊 50% 臧愳唽
- 旖旉敞鞚� 58% 臧愳唽
- 欷戨摫霃� 氚� 欷戩 AHI 旄§爼旃� 62.7% 臧滌劆
- 旮半弰 鞖╈爜 40% 歃濌皜
牍勲炒鞀る姅 1觳滊 氇呾潣 氙戈淡 鞎勲彊鞚� 鞛堧姅 鞎勲彊 OSA 鞁滌灔鞚� 牍勳龚鞀奠爜鞚搓碃 鞎堨爠頃橂┌ 須臣鞝侅澑 旃橂 鞓奠厴鞙茧 順茧瀫鞐� 牍犽湪毽� 瓿勴殟鞛呺媹雼�.
Vivos Therapeutics (NASDAQ: VVOS) a re莽u une approbation r茅volutionnaire 510(k) de la FDA pour son appareil dentaire destin茅 脿 traiter l'apn茅e obstructive du sommeil (OSA) mod茅r茅e 脿 s茅v猫re et le ronflement chez les enfants 芒g茅s de 6 脿 17 ans. Cela est consid茅r茅 comme la premi猫re approbation de ce type pour un dispositif m茅dical oral dans le traitement p茅diatrique de l'OSA. L'approbation repose sur un essai clinique multicentrique ayant d茅montr茅 des am茅liorations significatives des sympt么mes d'OSA et des volumes des voies respiratoires.
Les r茅sultats cl茅s de l'茅tude comprennent :
- r茅duction de 50 % des sympt么mes de troubles respiratoires li茅s au sommeil
- diminution de 58 % du ronflement
- am茅lioration de 62,7 % des mesures AHI mod茅r茅es et s茅v猫res
- augmentation de 40 % des volumes des voies respiratoires
Vivos vise 脿 r茅volutionner le march茅 de l'OSA p茅diatrique, estim茅 脿 10,1 millions d'enfants am茅ricains, avec son option de traitement non invasive, s没re et efficace.
Vivos Therapeutics (NASDAQ: VVOS) hat eine bahnbrechende FDA 510(k) Genehmigung f眉r ihr 顿狈础-骋别谤盲迟 zur Behandlung von moderater bis schwerer obstruktiver Schlafapnoe (OSA) und Schnarchen bei Kindern im Alter von 6 bis 17 Jahren erhalten. Dies wird als die erste Genehmigung dieser Art f眉r ein orales Medizinprodukt in der p盲diatrischen OSA-Behandlung angesehen. Die Genehmigung basiert auf einer multizentrischen klinischen Studie, die signifikante Verbesserungen bei OSA-Symptomen und Luftwegvolumina zeigte.
Wichtige Ergebnisse der Studie umfassen:
- 50% Reduktion der schlafbezogenen Atemst枚rungssymptome
- 58% Abnahme des Schnarchens
- 62,7% Verbesserung der moderaten und schweren AHI-Messwerte
- 40% Erh枚hung der Luftwegvolumina
Vivos zielt darauf ab, den p盲diatrischen OSA-Markt, der auf 10,1 Millionen US-Kinder gesch盲tzt wird, mit seiner nicht-invasiven, sicheren und effektiven Behandlungsoption zu revolutionieren.
- First FDA 510(k) clearance for an oral medical device to treat moderate to severe OSA in children aged 6-17
- Clinical trial showed 62.7% improvement in moderate and severe AHI measurements
- 50% reduction in sleep-related breathing disorder symptoms and 58% decrease in snoring
- 40% increase in airway volumes in study participants
- Potential to capture significant market share in the pediatric OSA sector
- New alliance-based marketing and distribution model expected to widen patient funnel
- None.
Insights
The FDA's groundbreaking 510(k) clearance for Vivos Therapeutics' DNA appliance to treat moderate to severe pediatric obstructive sleep apnea (OSA) represents a significant milestone in pediatric sleep medicine. This approval addresses a critical need, given the estimated
The study's results, showing a
Vivos Therapeutics' new FDA clearance opens up a substantial market opportunity. With an estimated
Investors should note the potential for increased case starts and improved gross profit margins. The ability to treat multiple family members could lead to a compounding effect on sales. However, it's important to monitor the execution of this new business model and its impact on operational costs. The company's ability to scale quickly with minimal investment will be a key factor in translating this regulatory win into financial success.
This FDA clearance for Vivos' DNA appliance is a game-changer in pediatric sleep medicine. Unlike CPAP, which can negatively impact facial growth, or adenotonsillectomy with its high relapse rates, this device offers a non-invasive, growth-friendly alternative. The
Particularly impressive is the
Vivos is poised to disrupt the very significant pediatric obstructive sleep apnea (OSA) market with new FDA clearance and new strategic marketing and distribution model
Vivos鈥� DNA appliance now approved to reduce snoring and treat聽moderate to severe OSA in children aged 6 to 17
LITTLETON, Colo., Sept. 18, 2024 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (鈥淰ivos鈥� or the 鈥淐ompany鈥欌��) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of proprietary treatments for sleep related breathing disorders (SRBDs), including obstructive sleep apnea (OSA), today announced receipt of what is believed to be the first ever U.S. Food and Drug Administration (FDA) 510(k) clearance to treat moderate to severe OSA and snoring in children using Vivos鈥� proprietary flagship oral medical device.
A Silent Epidemic: The Hidden Impact of Pediatric OSA
Recent published studies report up to 10.1 million U.S. children (ages 6-17) are estimated to suffer from pediatric OSA, a condition often classified as an SRBD. This represents more than a doubling of U.S. children with OSA over the past decade. (1)
Children with moderate to severe OSA often experience a myriad of other serious health conditions such as ADD / ADHD, lower IQ, chronic allergies, mouth breathing, swollen tonsils and adenoids, dental malocclusion, bedwetting, restless leg syndrome, aggression, anxiety, depression, night terrors, sleep fragmentation, obesity, asthma, and more. ADHD symptoms have been reported in up to
The current medical standard for first-line intervention in pediatric OSA is the surgical removal of adenoids and / or tonsils (Adenotonsillectomy, or AT surgery). However, after AT surgery, OSA may relapse or persist in
Vivos' Breakthrough Treatment Offers New Hope for Parents and Children with OSA
Vivos鈥� DNA appliance, which is part of its CARE line of advanced OSA treatment appliances, offers significant clinical advantages over existing therapies for moderate to severe pediatric OSA. It is non-invasive, safe, comfortable, affordable, and highly effective. Designed to reduce nighttime snoring and treat moderate to severe obstructive sleep apnea in children aged 6 to 17, this Vivos device is intended for those diagnosed with snoring and/or OSA who also require orthodontic treatment.
Vivos believes this breakthrough regulatory clearance represents a huge opportunity to capture significant market share in a sector that is desperate for innovation and effective alternatives. Vivos continues to experience consistently high levels of case acceptance across a wide range of patient demographics as it executes its recently announced marketing and distribution plan which is driven by alliances with medical sleep care professionals. Further, Vivos believes it can immediately leverage this FDA clearance by quickly integrating pediatric care into its new provider-based marketing and distribution model and scale revenue relatively quickly with minimal investment.
Kirk Huntsman, Chairman and CEO of Vivos, stated, 鈥淭he FDA 510(k) clearance announced today is, to our knowledge, the first time any oral medical device has ever been approved to treat moderate to severe OSA in children. This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States, but globally. It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA.鈥�
Mr. Huntsman continued, 鈥淥ur recently announced alliance-based marketing and distribution model has the potential to widen the funnel of potential OSA patients we see. In our new strategic business model where we work closely with medical and dental providers, we already see significant opportunities opening up to treat multiple family members of all ages. When Vivos teams up with medical professionals who treat OSA, and when parents are fully informed as to the health risks of untreated OSA on their children, we believe they will overwhelmingly choose Vivos technology over other treatment options.鈥�
鈥淎s we continue to expand beyond dentists and move more directly and vertically into affiliations and collaborations with medical specialists, functional medicine doctors, and other sleep-related healthcare practitioners, we expect this to positively impact our new case starts, revenue growth and gross profit,鈥� Mr. Huntsman concluded.
Results from Groundbreaking Clinical Trial in Children with OSA
A multi-site, multi-nation, controlled, prospective study in pediatric patients (6-17 years of age) served as the basis for this FDA approval. This study examined the effect of Vivos鈥� DNA oral medical device on increasing the pharyngeal airway, potentially reducing symptoms of OSA, and encouraging nasal breathing. Diagnosis of SRBD, including snoring, upper airway resistance syndrome and OSA and need for orthodontic treatment was confirmed by clinical evaluation, orthodontic exam, a Pediatric Sleep Questionnaire and a sleep study by the dentist and sleep physician. Each patient served as their own control, with measurements taken before and after treatment with the same devices, scorers and questionnaires under the auspices of the WRG Institutional Review Board. All apnea-hypopnea index (AHI) measurements (a measurement that helps doctors determine the severity of OSA) were taken with no device in the mouth.
Forty-eight patients (with a mean age 10.6 years, and ranging from 4.5-14.8 years) completed the study. Symptoms of SRBD (such as fatigue, lack of attention, and snoring) decreased from 0.28 to 0.14 (a reduction of
About Vivos Therapeutics, Inc.
Vivos Therapeutics, Inc. (NASDAQ: VVOS) is a medical technology company focused on developing and commercializing innovative diagnostic and treatment methods for patients suffering from breathing and sleep issues arising from certain dentofacial abnormalities such as obstructive sleep apnea (OSA) and snoring in adults and children. The Vivos Method (comprised of Vivos鈥� Complete Airway Repositioning and/or Expansion (CARE) and other oral appliance therapy combined with adjunctive therapies) represents the first clinically effective nonsurgical, removable, nonpharmaceutical, and cost-effective solution for treating mild to severe OSA in adults and moderate to severe OSA in children. It has proven effective in over 45,000 patients treated worldwide by more than 2,000 trained dentists.
The Vivos Method includes treatment regimens that employ the proprietary CARE appliance therapy and other appliances that alter the size, shape, and position of the soft tissues that comprise a patient鈥檚 upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA in adults, such as lowering Apnea Hypopnea Index scores. Vivos also employs a marketing and distribution model where it collaborates with sleep-treatment providers to offer patients OSA treatment options and help promote sales of its appliances. For more information, visit聽.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company鈥檚 management made in connection therewith contain 鈥渇orward-looking statements鈥� (as defined in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended) concerning future events, including the anticipated benefits to the Company of the new 510(k) clearance described herein. Words such as 鈥渕ay鈥�, 鈥渟hould鈥�, 鈥渆xpects鈥�, 鈥減rojects,鈥� 鈥渋ntends鈥�, 鈥減lans鈥�, 鈥渂elieves鈥�, 鈥渁nticipates鈥�, 鈥渉opes鈥�, 鈥渆stimates鈥�, 鈥済oal鈥� and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve significant known and unknown risks and are based upon several assumptions and estimates, which are inherently subject to significant uncertainties and contingencies, many of which are beyond Vivos鈥� control. Actual results (including the whether the anticipated benefits of the FDA 510(k) clearance described herein are actually achieved by the Company, including with respect to the Company鈥檚 revenue and gross profit) may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially include, but are not limited to: (i) the risk that Vivos may be unable to implement revenue, sales and marketing strategies that increase revenues, (ii) the risk that some patients may not achieve the desired results from using Vivos products, (iii) risks associated with regulatory scrutiny of and adverse publicity in the sleep apnea treatment sector; (iv) the risk that Vivos may be unable to secure additional financings on reasonable terms when needed, if at all, or maintain its Nasdaq listing and (v) other risk factors described in Vivos鈥� filings with the Securities and Exchange Commission (鈥淪EC鈥�). Vivos鈥� filings can be obtained free of charge on the SEC鈥檚 website at www.sec.gov. Except to the extent required by law, Vivos expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Vivos鈥� expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.
References
- Magnusdottir, Solveig, and Elizabeth A. Hill. 鈥淧revalence of Obstructive Sleep Apnea (OSA) among Preschool Aged Children in the General Population: A Systematic Review.鈥� Sleep Medicine Reviews, vol. 73, 1 Feb. 2024, p. 101871, www.sciencedirect.com/science/article/abs/pii/S1087079223001272#:~:text=Studies%20published%20before%
202014% 20reported, https://doi.org/10.1016/j.smrv.2023.101871. Accessed 9 Feb. 2024. - Urbano, Gino Luis, et al. 鈥淭he Link between Pediatric Obstructive Sleep Apnea (OSA) and Attention Deficit Hyperactivity Disorder (ADHD).鈥� Children, vol. 8, no. 9, 19 Sept. 2021, p. 824, https://doi.org/10.3390/children8090824.
- P谋nar Ergenekon, et al. 鈥淢edical Treatment of Obstructive Sleep Apnea in Children.鈥� Journal of Clinical Medicine, vol. 12, no. 15, 30 July 2023, pp. 5022鈥�5022, https://doi.org/10.3390/jcm12155022. Accessed 30 Sept. 2023.
Vivos Investor Relations Contact:
Bradford Amman, CFO
FAQ
What is the new FDA clearance Vivos Therapeutics (VVOS) received for pediatric OSA treatment?
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