After two years, Owensboro resident Cathryn Bonar and her team at Vivos have obtained a patent for an innovative oral appliance to treat mild to moderate sleep apnea.
Bonar is the Senior Vice President for Compliance at Vivos, a Colorado-based specification development company. She and her team created the device, which is a Modified Mandibular Repositioning Nighttime Appliance (mmRNA).
“This is a slam dunk for the medical community,” Bonar said. “Medicare approved the product during the pending process. It will be huge for medicare billing, and now, commercial insurance will recognize the device and provide coverage, too.”
The device resembles a retainer and similarly fits in a user’s mouth. Bonar and her crew joined forces with Todd Huntsman and the innovation team at Vivos to create the device, which recently gained FDA approval. She said the device is much less invasive than a CPAP.
“A lot of people don’t want to use CPAPs, and some people are medically intolerant,” she said. “They are excited about the mmRNA because it’s less invasive and offers a practical alternative.”
With the patent and Medicare approval, the dentists who prescribe the device can now bill medical insurance for their services.
“Our clients are independent dentists from all over the country,” Bonar said. “We rely on them to work in conjunction with medical doctors. The doctors diagnose through a sleep test, and the dentists provide the appliance. I called (Huntsman) a couple of years ago and told him we had to get a device so that patients could begin billing Medicare.”
Over two years ago, Bonar led the effort to get the device recognized by the FDA, which would ease the intensive process of obtaining Medicare compliance. From design to FDA approval, the entire process took 2 years, and then another 2 years from then for the patent and Medicare approval.
In addition to Huntsman, Bonar also worked with Braden Bennett and Justin Harris on the project, referring to it as the ultimate team effort. Dr. Dave Singh also played a pivotal role as the physician behind the advancement.
Bonar said the implementation is non-evasive, non-surgical, non-pharmaceutical, and pain-free. Vivos claims that in most cases, people are only in treatment for 18-24 months.
“It took all of us working together,” she said. “This is a great holistic approach to clinically treating varying cases of obstructive sleep apnea and enhancing patient’s pallets.”
Read more about the device and Bonar’s efforts here.
