Colorado, August 17, 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 a more detailed summary of the national study results announced by the Company on July 13, 2021, is now available on the Company’s website at: https://vivoslife.com/investor-relations/.
As previously announced, one in four patients in the study treated with Vivos’ 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. The more detailed study data now available reports that prior to treatment, 20 patients had severe OSA, which, from an AHI perspective, improved (post-treatment) or is improving (mid-treatment) by 53%. Of these 20 patients, none have reported worsening of their OSA symptoms, while 3 patients still have severe OSA, 12 have moderate OSA, 4 have mild OSA and 1 has no OSA.
The study data also reports that for the 18 patients who began the study with moderate OSA, the average percent improvement in AHI score is 64%. One patient’s AHI score worsened by 1 category (an increase of 10.4 in AHI), while another slightly increased by 2.1. The balance of the patients had improved AHI scores by an average of 64%. After treatment or mid-treatment, 2 patients remained moderate, 10 have mild symptoms and 5 have resolved their OSA symptoms.
In addition, 36 patients in the study had mild symptoms pre-treatment. Of these, 1 now has severe symptoms, 4 have moderate symptoms, 16 have mild symptoms and 15 have no symptoms of OSA.
Commenting on the additional study data, Kirk Huntsman, Vivos’ Chairman and CEO, stated, “By addressing maxillary palatal deficiencies, we believe Vivos’ treatment protocols represent an improvement over CPAP and mandibular advancement devices (known as MAD) with 27% of the study participants reporting a complete resolution of their OSA symptoms. These measurements are taken without a Vivos appliance in the mouth, whereas MAD measurements are taken with the appliance in place. The more detailed data now available from this study confirms that the Vivos device works well for many patients, with the study showing very strong and statistically significant evidence for an increase in airway volume and transpalatal width (p<0.00001). We know the investment community and other interested parties have been looking for more real world data about our devices, so we are pleased to share this more detailed study summary and its positive results.”
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.