Colorado, July 13, 2021
Vivos Therapeutics, Inc. (the “Company” or “Vivos”) (NASDAQ:VVOS), a medical technology company focused on developing and commercializing innovative diagnostic and treatment modalities for patients suffering from sleep-disordered breathing, including mild-to-moderate obstructive sleep apnea (OSA), today announced results from a national study commissioned by the Company to assess patients’ airway function and OSA symptoms after undergoing the Vivos treatment.
In the study, 28 percent of the 74 adult patients treated with the Company’s FDA Class 1 DNA appliance for certain orofacial anomalies reported no remaining OSA symptoms, which is defined as patients having an Apnea Hypopnea Index (AHI) score of less than five post-treatment.
This real world patient data was gathered from multiple sites and has been submitted to the U.S. Food and Drug Administration to be used as part of the Company’s process for obtaining 510k clearance for the DNA appliance to treat mild-to-moderate OSA. Patients who experienced little to no OSA symptoms may no longer require CPAP, neuro-stimulation, or other lifetime interventions. Other company case studies suggest potential long-term stability in the outcomes, although a clinical trial will be required to confirm whether or not these changes remain stable.
Most importantly, these AHI findings were recorded with no oral appliance in place during sleep tests. Typically, when sleep tests are performed to evaluate the impact of OSA treatment, they are conducted with the treatment modality in place—whether it is CPAP, oral appliances, or neuro-stimulation implants. Since treatment with the DNA appliance is typically complete after just 12-24 months, patients’ post-treatment sleep tests are performed and evaluated in the patient’s natural state, unaided by any device.
Eighty-two (82) percent of the patients in the study showed some improvement in AHI scores, with 64 percent improving by at least one full category, such as moderate to mild OSA. In 15 percent of patients, AHI scores worsened, and in 4 percent of patients there was no change. Average treatment time with the Company’s Class 1 DNA appliance for certain orofacial anomalies was just 14 months. Not all of the patients in the study had completed treatment at the time this data was collected and a small percentage of patients required additional cosmetic orthodontia.
Commenting on the study results, Kirk Huntsman, Vivos Chairman and CEO, stated, “We are not aware of any treatment for OSA where 28 percent of patients are restored post-treatment to AHI scores that are within normal limits and with the potential for no ongoing intervention. In a previous outside analysis of real world data, which is pending publication, the number of patients who finished Vivos treatment with fully resolved OSA was 1 out of 3. In that instance, patients were treated directly for their OSA by the Company’s FDA cleared mRNA appliance, which is very similar to the DNA appliance, showing our latest data is consistent. Simply put, we believe this clinical data shows that our core technology is a game-changer for OSA sufferers who undergo the Vivos treatment. As we recently reported, 97 percent of patients reported they fully achieved their treatment goals. The dentists who treated these patients know this is a huge breakthrough, and pretty soon the rest of the world will too.”
This analysis of 74 adult patients treated by 30 independent Vivos-trained dentists over an average treatment time of 14 months, with inclusion criteria review and statistical analysis performed by The EyeDeas Company, an independent research company. A number of patients in the study remain in treatment, some of whom are also receiving CPAP therapy (except during sleep testing). The study was not conducted under the auspices or supervision of an Institutional Review Board but gathered as Real World Data. Analysis and review was conducted in June 2021.
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, particularly with respect to the public offering described herein. Words such as “aim,” “may,” “could,” “expects,” “projects,” “intends,” “plans,” “believes,” “predicts,” “anticipates,” “hopes,” “estimates” and variations of such words and similar expressions are intended to identify forward-looking statements. These statements involve 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, without limitation, the anticipated benefits of Australian regulatory approval described here on the Company’s sales and ability to obtain regulatory approvals in other countries) 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, the risk factors described in Vivos’ filings with the Securities and Exchange Commission (“SEC”). Vivos’ filings can be obtained free of charge on the SEC’s website at 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.