ProSomnus® EVO™ Oral Appliance Therapy Device Receives FDA Clearance for the Treatment of Obstructive Sleep Apnea and Snoring
SAN FRANCISCO, California, December 7, 2020 (Newswire.com) - Sleep Technologies announced that the US Food and Drug Administration (FDA) has cleared the new ProSomnus EVO Sleep and Snore Device for the treatment of Obstructive Sleep Apnea (OSA) and Snoring. EVO is the first Oral Appliance Therapy (OAT) device to utilize MG6™ technology. MG6 technology combines high-performance medical grade materials, manufacturing robotics and artificial intelligence to enable preferred treatment experiences for the treatment of OSA.
“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,” stated Len Liptak, CEO, MBA. “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.”
With the goal of radically improving the performance of OAT devices, ProSomnus engaged dozens of leading sleep clinicians in the development of EVO. This investigation indicated that OAT could play a considerably larger role in the treatment of OSA if OAT devices are improved to be more reliable, comfortable and easy to use.
EVO is engineered to address these insights. Feedback and testing indicate that EVO is flexible and easy to deliver, small and comfortable, precise and effective, hygienic and BPA free, yet durable enough to be the only OAT to pass the US Military Drop Test. Clinical preference investigations indicate that EVO patients strongly prefer EVO to their CPAP and legacy OAT devices.
“If CPAP was the GOLD standard for OSA treatment, ProSomnus EVO is the gold standard for OAT!” stated Edward T. Sall, MD, DDS, MBA. “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.”
“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,” commented B. Kent Smith, DDS, D.ABDSM, D.ASBA. “Marrying a flexible design without sacrificing the impermeability took some magic. Kudos to ProSomnus!”
“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,” stated Mark T. Murphy, DDS, D.ABDSM. “This new material technology changes everything. Nobody manufacturers devices like ProSomnus, period.”
For more information on ProSomnus EVO and access to our interest list for case submission, please contact your ProSomnus representative or email Info@ProSomnus.com.
Source: ProSomnus Sleep Technologies
