Vivos Therapeutics Releases Additional Clinical Data Showing Marked Improvement in Pediatric ADHD from Use of Vivos DNA Device
Vivos Therapeutics (NASDAQ:VVOS) has released new clinical data demonstrating significant improvements in children with ADHD and OSA using their FDA-cleared Daytime-Nighttime Appliance (DNA). The study showed remarkable results, including a 50% decrease in pediatric sleep issues and a 58% decrease in ADHD symptoms.
The clinical trial, involving 48 children with an average age of 10.6 years, demonstrated 100% of patients experienced increased transpalatal width (+13.6%) and airway volume (+40%), while OSA severity decreased by 51.4%. The DNA appliance represents the only FDA-cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6-17.
The majority of improvements occurred within the first six months of treatment, offering a promising alternative to traditional adenotonsillectomy surgery and pharmaceutical interventions.Vivos Therapeutics (NASDAQ:VVOS) ha pubblicato nuovi dati clinici che mostrano significativi miglioramenti nei bambini con ADHD e OSA utilizzando il loro Daytime-Nighttime Appliance (DNA), approvato dalla FDA. Lo studio ha evidenziato risultati notevoli, tra cui una riduzione del 50% dei disturbi del sonno pediatrici e una riduzione del 58% dei sintomi dell'ADHD.
La sperimentazione clinica, che ha coinvolto 48 bambini con età media di 10,6 anni, ha dimostrato che il 100% dei pazienti ha sperimentato un aumento della larghezza transpalatale (+13,6%) e del volume delle vie aeree (+40%), mentre la gravità dell'OSA è diminuita del 51,4%. L'apparecchio DNA rappresenta l'unico trattamento non chirurgico, non farmacologico approvato dalla FDA per l'OSA pediatrica da moderata a severa nei bambini di età compresa tra 6 e 17 anni.
La maggior parte dei miglioramenti si è verificata entro i primi sei mesi di trattamento, offrendo una promettente alternativa alla chirurgia adenotonsillectomia tradizionale e agli interventi farmacologici.
Vivos Therapeutics (NASDAQ:VVOS) ha publicado nuevos datos clínicos que muestran mejoras significativas en niños con TDAH y apnea del sueño (OSA) usando su Daytime-Nighttime Appliance (DNA) aprobado por la FDA. El estudio mostró resultados notables, incluyendo una reducción del 50% en los problemas de sueño pediátrico y una reducción del 58% en los síntomas de TDAH.
El ensayo clínico, que involucró a 48 niños con una edad media de 10,6 años, demostró que el 100% de los pacientes experimentó un aumento de la anchura transpalatina (+13,6%) y del volumen de las vías respiratorias (+40%), mientras la gravedad de la OSA disminuyó en un 51,4%. El dispositivo DNA representa el único tratamiento farmacológico y no quirúrgico aprobado por la FDA para la OSA pediátrica de moderada a severa en niños de 6 a 17 años.
La mayoría de las mejoras ocurrieron durante los primeros seis meses de tratamiento, ofreciendo una alternativa prometedora a la cirugía adeno-tonsilar tradicional y a las intervenciones farmacológicas.
Vivos Therapeutics (NASDAQ:VVOS)가 FDA 승인 Daytime-Nighttime Appliance(DNA)를 사용하여 ADHD와 수면무호흡증(OSA)을 가진 어린이들에서 상당한 개선을 보였다는 새로운 임상 데이터를 발표했습니다. 연구는 수면 문제 50% 감소와 ADHD 증상 58% 감소를 포함한 주목할 만한 결과를 보여주었습니다.
평균 연령 10.6세의 48명의 아동을 대상으로 하는 이 임상시험은 모든 환자가 구개전폭(+13.6%) 및 기도용량(+40%)이 증가했으며, OSA 중증도는 51.4% 감소했다는 것을 보여주었습니다. DNA 기구는 6-17세 아동의 중등도에서 심한 pediatric OSA에 대한 비수술적, 비약물적 치료 중 FDA에서 승인된 유일한 치료법을 대표합니다.
대부분의 개선은 치료의 초기 6개월 내에 나타났으며, 전통적인 편도선·아데노이드절제술 및 약물 중재에 대한 유망한 대안을 제시합니다.
Vivos Therapeutics (NASDAQ:VVOS) a publié de nouvelles données cliniques montrant des améliorations significatives chez les enfants atteints de TDAH et d’apnée du sommeil (OSA) grâce à leur Daytime-Nighttime Appliance (DNA) approuvé par la FDA. L’étude a démontré des résultats remarquables, notamment une réduction de 50% des troubles du sommeil chez les enfants et une réduction de 58% des symptômes du TDAH.
L’essai clinique, impliquant 48 enfants d’un âge moyen de 10,6 ans, a démontré que 100% des patients ont connu une augmentation de la largeur transpalatine (+13,6%) et du volume des voies aériennes (+40%), tandis que la gravité de l’OSA a diminué de 51,4%. L’appareil DNA représente le seul traitement non chirurgical et non pharmacologique approuvé par la FDA pour l’OSA pédiatrique modérée à sévère chez les enfants de 6 à 17 ans.
La majorité des améliorations est apparue au cours des six premiers mois de traitement, offrant une alternative prometteuse à la chirurgie adéno-amygdalienne traditionnelle et aux interventions pharmacologiques.
Vivos Therapeutics (NASDAQ:VVOS) hat neue klinische Daten veröffentlicht, die signifikante Verbesserungen bei Kindern mit ADHS und Schlafapnoe (OSA) zeigen, die mit ihrem Daytime-Nighttime Appliance (DNA), FDA-zugelassen, verwendet werden. Die Studie zeigte bemerkenswerte Ergebnisse, darunter eine 50%ige Reduktion der kindlichen Schlafprobleme und eine 58%ige Reduktion der ADHS-Symptome.
Der klinische Versuch, an dem 48 Kinder mit einem Durchschnittsalter von 10,6 Jahren beteiligt waren, zeigte, dass 100% der Patienten eine Zunahme der transpalatalen Breite (+13,6%) und des Atemwegsvolumens (+40%) erfuhren, während die OSA-Schwere um 51,4% abnahm. Das DNA-Gerät stellt die einzige von der FDA genehmigte nicht-chirurgische, nicht-pharmazeutische Behandlung für mäßige bis schwere pädiatrische OSA bei Kindern im Alter von 6–17 Jahren dar.
Die Mehrheit der Verbesserungen trat in den ersten sechs Behandlungsmonaten auf und bietet eine vielversprechende Alternative zur traditionellen Adenotonsillektomie und zu pharmazeutischen Interventionen.
Vivos Therapeutics (NASDAQ:VVOS) أصدرت بيانات سريرية جديدة تُظهر تحسينات ملحوظة لدى الأطفال المصابين باضطراب فرط الحركة وتشتت الانتباه (ADHD) وانقطاع النفس أثناء النوم (OSA) باستخدام جهاز Daytime-Nighttime Appliance (DNA) المعتمد من FDA. أظهرت الدراسة نتائج بارزة، بما في ذلك انخفاض بنسبة 50% في مشاكل النوم لدى الأطفال وانخفاض بنسبة 58% في أعراض ADHD.
التجربة السريرية، التي شملت 48 طفلاً بمتوسط عمر 10.6 سنوات، أظهرت أن جميع المرضى شهدوا زيادة في العرض القُمي/الاقتحامي للحلق الهوائي (+13.6%)، وارتفاع حجم المجرى الهوائي (+40%)، في حين انخفضت شدة OSA بنسبة 51.4%. الجهاز DNA يمثل العلاج غير الجراحي وغير الدوائي الوحيد المعتمد من FDA لـ OSA pediatrika من مستوى إلى شديد لدى الأطفال من سن 6 إلى 17 عامًا.
الغالبية العظمى من التحسينات ظهرت خلال الأشهر الستة الأولى من العلاج، مما يوفر بديلاً واعداً عن عملية إزالة اللوزتين والتصحيح التقليدي وإجراءات الأدوية.
Vivos Therapeutics (NASDAQ:VVOS) 公布了新的临床数据，显示在使用其经 FDA 批准的 Daytime-Nighttime Appliance (DNA) 时，患有 ADHD 与睡眠呼吸暂停综合征（OSA）的儿童有显著改善。研究显示包括儿童睡眠问题下降 50% 和 ADHD 症状下降 58% 等显著结果。
临床试验涉及 48 名平均年龄 10.6 岁的儿童，结果显示 100% 的患者在颚间宽度增加（+13.6%）和气道容积增加（+40%），同时 OSA 严重程度下降 51.4%。DNA 设备代表了在 6-17 岁儿童中，针对中度至重度儿童期 OSA 的唯一 FDA 批准的非手术、非药物治疗。
治疗的多数改善发生在前六个月内，为传统的腺样体扁桃体切除术及药物干预提供了一个有前景的替代方案。
- FDA-cleared DNA device showed 50% reduction in pediatric sleep issues
- 58% decrease in sleep disordered breathing and ADHD symptoms
- 100% of patients showed increased airway volume (+40%) and transpalatal width (+13.6%)
- 51.4% reduction in OSA severity (AHI scores)
- Only FDA-cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA
- DNA appliance not yet FDA cleared specifically for ADHD treatment
Insights
Vivos' DNA device shows promising clinical results for treating children with both ADHD and OSA, potentially opening a significant untapped market.
This newly released data from Vivos Therapeutics reveals significant clinical benefits of their DNA device in pediatric patients with ADHD and obstructive sleep apnea (OSA). The study showed a 50% decrease in validated Pediatric Sleep Questionnaire scores and a 58% decrease in symptoms of sleep disordered breathing and ADHD-related behaviors like hyperactivity.
The technical results are impressive: 100% of patients experienced increased transpalatal width (+13.6%) and airway volume (+40%), with OSA severity decreasing by 51.4% as measured by AHI scores. These improvements were statistically significant (p<0.00001), with most benefits occurring within the first six months of treatment.
What makes this particularly notable is the device's unique position as the only FDA 510k cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children 6-17 years old. This positions Vivos to potentially capture market share from traditional adenotonsillectomy surgery, addressing parental concerns about invasive procedures or medication side effects.
The market opportunity appears substantial given the parallel increases in both ADHD (now affecting ~11% of school-aged children) and pediatric OSA (13-20% of the pediatric population). The study was reasonably sized with 48 completed patients and demonstrated consistent improvements across multiple parameters. Though not yet FDA cleared specifically for ADHD, these results suggest the DNA device could address a significant unmet need in pediatric care by treating the underlying OSA that often manifests as ADHD symptoms.
Previously Unpublished Data Confirms Vivos DNA Devices Offer a Safe and Effective Alternative Treatment for Children with ADHD and Obstructive Sleep Apnea
LITTLETON, Colo., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Vivos Therapeutics, Inc. (“Vivos” or the “Company’’) (NASDAQ: VVOS), a leading medical device and technology company specializing in the development and commercialization of highly effective proprietary treatments for sleep related breathing disorders, including obstructive sleep apnea (OSA), today released previously unpublished clinical data confirming that treatment with Vivos’ FDA-cleared Daytime-Nighttime Appliance (DNA) can provide children with Attention-Deficit/Hyperactivity Disorder (ADHD) and OSA significant relief and improvement in their quality of life.
Vivos’ DNA appliance is the only FDA 510k cleared non-surgical, non-pharmaceutical treatment for moderate to severe pediatric OSA in children ages 6-17, and is increasingly seen as a viable alternative to adenotonsillectomy surgery for OSA. The DNA appliance is part of Vivos’ Complete Airway Repositioning and Expansion (“C.A.R.E.”) line of devices cleared by the FDA to treat OSA in both children and adults.
The diagnosed rates of ADHD in the United States have roughly quadrupled since the 1980s—from an estimated 2–
Multiple studies show a strong link between pediatric OSA and the incidence of ADHD symptoms, with attention deficits reported in up to
“We are seeing a large and untapped market to effectively address ADHD symptoms by treating a child’s OSA using Vivos’ non-surgical and non-pharmaceutical approach. Parents are wary of putting their children through painful surgeries or giving them drugs. Vivos is the first to offer a safe and effective FDA-cleared alternative. And although our Vivos DNA treatment is not yet FDA cleared to treat ADHD per se, we believe this data strongly suggests that by successfully treating a child’s OSA it is possible to reduce or eliminate ADHD symptoms and behaviors,” said Kirk Huntsman, Chairman and CEO of Vivos.
In this current dataset just released by Vivos, children treated with the Vivos DNA appliance reported a
Forty-eight (48) of the original 55 patients completed the clinical trial. There were 28 males and 20 females, with an average age of 10.6 years. As expected from previous studies,
Vivos believes these significant improvements in OSA and ADHD symptoms may allow these children to improve their behavioral performance in school and their academics, making a profound difference in their quality of life. The majority of this improvement was shown to occur in the first six months of treatment.
About Vivos Therapeutics
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. Vivos’ devices have been cleared by the U.S. Food and Drug Administration (FDA) for adult patients diagnosed with all severity levels of OSA and moderate-to-severe OSA in children ages 6 to 17. Vivos’ groundbreaking Complete Airway Repositioning and Expansion (CARE) devices are the only FDA 510(k) cleared technology for treating severe OSA in adults and the first to receive clearance for treating moderate to severe OSA in children.
OSA affects over 1 billion people worldwide, yet
Founded in 2016 and based in Littleton, CO, Vivos is working to change this. Through innovative technology, education, and acquisitions of, or commercial collaborations with, sleep healthcare providers, Vivos is empowering healthcare providers to more thoroughly address the complex needs of OSA patients.
Vivos calls the use of its appliances and protocols to treat OSA The Vivos Method, which offers a proprietary, clinically effective solution that is nonsurgical, noninvasive, and nonpharmaceutical, providing hope to allow patients to Breathe New Life.
For more information, visit www.vivos.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of the Company’s management and other parties made in connection therewith, contain “forward-looking statements” (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. Words such as “may”, “would”, “should”, “expects”, “projects,” “potential,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal”. “aim” and variations of such words and similar expressions are intended to identify forward-looking statements. In this press release, forward-looking statements include, without limitation, those relating to the actual future impact of the clinical data described herein on general patient outcomes and Vivos’ future revenues and results of operations. 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’ control. Vivos’ filings can be obtained free of charge on the SEC’s 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’ expectations with respect thereto or any change in events, conditions, or circumstances on which any statement is based.
Media Inquiries:
Andrew Ballou
(914) 522-0861
Investor Inquiries:
R. Kirk Huntsman
Chief Executive Officer
investors@vivoslife.com
FAQ
What were the key results of Vivos Therapeutics (VVOS) clinical trial for pediatric ADHD and OSA?
How many children participated in the Vivos Therapeutics DNA device clinical trial?
Is the Vivos DNA device FDA-approved for treating ADHD in children?
How long does it take to see improvements with the Vivos DNA device?
What makes Vivos DNA device unique in treating pediatric OSA?
