Vivos Therapeutics Inc, a medical technology company that markets custom oral appliances and protocols for obstructive sleep apnea (OSA), just launched a home sleep apnea test called VivoScore, which is powered by SleepImage.

VivoScore utilizes proprietary cardiopulmonary coupling technology developed by MyCardio LLC (better known as “SleepImage”). VivoScore consists of a single-sensor ring recorder that works with a mobile phone application and proprietary cloud-based algorithms to evaluate sleep quality and clinically diagnose sleep apnea.

“We believe the impact of our exciting new VivoScore product and technology will be significant to the health and wellness of millions who suffer from sleep apnea. Vivos-trained dentists and other healthcare providers will now have access to clinical-grade diagnostic technology at a very low cost that can be seamlessly coupled with our proprietary and highly-effective Vivos System treatment,” says Kirk Huntsman, Vivos chairman and CEO, in a release.

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The SleepImage System, which is the underlining technology for VivoScore, is FDA cleared for the purpose of diagnosing OSA and evaluating sleep disorders in both children and adults.

Vivos recently conducted an informal pilot study with 12 independent Vivos-trained dentists who performed 938 sleep-tests over a three-month period using VivoScore. Fifty-six percent of the patients in the pilot tested positive for OSA, and after receipt of a confirming diagnosis from a physician, 50% of all patients who tested positive entered into treatment for OSA with the company’s core product—the Vivos System.

“VivoScore is simpler, easier to use and more cost-effective than the existing home sleep tests we have been using, especially for pediatric patients,” says Tammarie Heit, DDS, who participated in the VivoScore pilot program, in a release. “To date, we have administered more than 200 VivoScore tests and are continuing to enroll more patients of all ages for treatment. With this new technology, I am able to screen and treat far more patients than ever before, and we’ve already seen an uptick in patients accepting treatment in my practice in a relatively short amount of time.”

The company anticipates increased revenue from VivoScore due to an expected increase in total patients tested and a corresponding increase in patient enrollment in Vivos System treatment. In arriving at that conclusion, the company is relying on the results of its pilot test and other Vivos provider feedback, which may or may not prove reliable on a broader scale.

The company is bringing VivoScore to market under a licensing, distribution, and marketing agreement with MyCardio, LLC d/b/a SleepImage. The agreement is exclusive to the company with respect to white labeling of the VivoScore brand to the dental sleep market in the United States and Canada.

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Key VivoScore features include:

  • Use of a single-sensor ring recorder device that patients wear overnight on their finger with automated Bluetooth connectivity to a mobile application which facilitates a data capture and upload.
  • No consumables are required, which is expected to allow for broad distribution and multi-night sleep evaluations using VivoScore that are often required by insurance carriers.
  • High degree of accuracy comparable to industry standard in-lab polysomnogram (PSG) tests. VivoScore creates comprehensive proprietary sleep quality measures, such as the Sleep Quality Index (SQI), that go beyond clinical diagnosis for sleep apnea to more effectively manage treatment benefit and improve patient outcomes.