As a result of this FDA clearance, Vivos becomes the first company ever to have approved and bring to market a clear alternative treatment to CPAP or surgical neurostimulation implants for patients with severe OSA. This latest clearance comes just eleven months after the FDA granted Vivos 510(k) clearance for the DNA oral appliance to treat mild-to-moderate OSA, and represents the first time the FDA has ever granted an oral appliance a clearance to treat moderate and severe OSA in adults, 18 years of age and older along with positive airway pressure (PAP) and/or myofunctional therapy, as needed.
Nationally renowned medical sleep specialist, author and lecturer, Dr.
“Vivos trained providers can now treat patients with OSA and conditions associated with OSA comprehensively using our suite of FDA cleared devices, without regard to the severity of their OSA condition and across a range of price point options,” continued
The statistically significant data submitted to the FDA from 73 severe OSA patients showed that 80% of patients experienced an improvement of at least 1 classification or at least a 50% improvement in the Apnea Hypopnea Index (AHI), and 97% of patients improved or stayed the same. Average treatment time was just 9.7 months. Treatment results with severe sleep apnea patients were actually better than with mild and moderate patients. All pre- and post-treatment testing was conducted with no device in the mouth. Unlike all other oral appliances on the market, Vivos’ proprietary
In a separate peer reviewed study published in the
No persistent safety issues were found in any patient cohort published or submitted to date, although some patients required aligners following treatment.
Vivos DNA appliance®
Vivos mRNA appliance®
Vivos mmRNA appliance®
About
The Vivos Method includes treatment regimens that employ the proprietary Vivos Complete Airway Repositioning and/or Expansion (CARE) appliance therapy and other modalities that alter the size, shape and position of the soft tissues that comprise a patient’s upper airway and/or palate. The Vivos Method opens airway space and may significantly reduce symptoms and conditions associated with mild-to-severe OSA, such as lowering Apnea Hypopnea Index scores. Vivos also markets and distributes SleepImage diagnostic technology under its VivoScore program for home sleep testing in adults and children. The Vivos Integrated Practice (VIP) program offers dentists training and other value-added services in connection with using The Vivos Method.
For more information, visit www.vivos.com.
Cautionary Note Regarding Forward-Looking Statements
This press release and statements of the Company’s management 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, including the anticipated benefits of the 510(k) approval described herein. Words such as “may”, “should”, “expects”, “projects,” “intends”, “plans”, “believes”, “anticipates”, “hopes”, “estimates”, “goal” 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’ control. Actual results (including the anticipated benefits of the FDA 510(k) approval described herein) 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 as obtained in the clinical trial, (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 and (v) other risk factors described in Vivos’ filings with the
Vivos Investor Relations Contact:
Julie Gannon
Investor Relations Officer
720-442-8113
jgannon@vivoslife.com
Photos accompanying this announcement are available at:
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Vivos DNA appliance®
Vivos DNA appliance®
Vivos mRNA appliance®
Vivos mRNA appliance®
Vivos mmRNA appliance®
Vivos mmRNA appliance®
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