The US Food and Drug Administration (FDA) has cleared a new oral appliance from ProSomnus Sleep Technologies. Prosomnus’ EVO Sleep and Snore Device has been cleared for the treatment of obstructive sleep apnea (OSA) and snoring.

EVO is the first oral appliance to use ProSomnus’ MG6 (Medical Grade 6) technology. MG6 technology combines high-performance medical-grade materials, manufacturing robotics, and artificial intelligence. The material is so durable that the appliance passed a US military drop test.

“Advanced materials, robotics, and artificial intelligence are transforming medicine, from orthopedics devices to surgical interventions. These technologies enable precision medicine and are improving treatment outcomes, minimizing side effects, and speeding up recovery times,” says Len Liptak, MBA, CEO of ProSomnus, in a release. “EVO utilizes these important technologies to offer sleep medicine clinicians and providers with a new, frontline treatment option that they can trust, and patients prefer.”

ProSomnus conducted research to help understand how to radically improve the performance of oral appliance therapy devices. The company engaged dozens of leading sleep clinicians (determined by FSI, 2020 and ProSomnus company market research) in the development of EVO. They found that oral appliance therapy could play a considerably larger role in the treatment of obstructive sleep apnea if devices are improved to be more reliable, comfortable, and easy to use.

[RELATED: ProSomnus Is a 2020 Red Herring Top 100 North America Finalist]

ProSomnus engineered EVO to address these insights. Its feedback and testing for the BPA-free device indicate that EVO is flexible and easy to deliver, small and comfortable, precise and effective, and hygienic. The ProSomnus EVO Institutional Review Board Preference Test, 2020, indicates that EVO patients strongly prefer EVO to their CPAP and legacy oral appliances.

“If CPAP was the GOLD standard for OSA treatment, ProSomnus EVO is the gold standard for OAT!” says Edward T. Sall, MD, DDS, MBA, medical director at ProSomnus, in a release. “There simply are no tradeoffs with this material and design. Monolithic, precise, incredibly comfortable and designed to prevent side effects that commonly arise. As an ENT sleep physician, I must say, this is the kind of solution that the medical community has been waiting for.”

B. Kent Smith, DDS, DABDSM, DASBA, says in a release, “ProSomnus EVO reminds me of the comfortable cotton socks I put on every morning. They always fit, they conform, and after it is in place, you forget about it. Marrying a flexible design without sacrificing the impermeability took some magic. Kudos to ProSomnus!”

Mark T. Murphy, DDS, DABDSM, says in a release, “ProSomnus EVO is much easier to deliver than other hard acrylic device designs…it had more of the forgiveness and flex that we see with printed nylon or soft-liner appliances. It still has all of the precision you expect and will still be super easy to keep clean. This new material technology changes everything. Nobody manufacturers devices like ProSomnus, period.”

For more information or to access to the on ProSomnus EVO interest list for case submission, contact a ProSomnus representative.