ProSomnus adds a new device to its US Food and Drug Administration (FDA)-cleared EVO line of oral appliances for obstructive sleep apnea. Launched in the United States at the American Academy of Dental Sleep Medicine 2025 annual meeting, the EVO Guided oral appliance is bioengineered to dilate the oropharynx and the velopharynx for optimal therapeutic success.
EVO Guided is engineered to encourage the oral mechanics linked with elevated levels of treatment success, while minimizing, if not avoiding, counterproductive mechanics such as inaccurate mandibular repositioning and stabilization, posterior tongue posture, and forcing larger than necessary separation of the upper and lower teeth.
EVO Guided has a 95-degree guided prescription post-titration mechanism that guides the mouth closed and stabilizes the mandible within microns of the target therapeutic position. It features lingual-less maxillary and mandibular dental overlays that encourage an anterior tongue posture to minimize deformation and collapse of the ventral wall of the velopharynx.
“We designed EVO Guided with enhanced efficacy in mind, prioritizing 3-dimensional precision mandibular positioning and maximizing tongue space,” says Sung Kim, ProSomnus chief technology officer, in a release.
According to ProSomnus, EVO Guided is 100% personalized based on records from each patient’s oral structures without prefabricated components or modifications. In clinical studies, ProSomnus devices have shown evidence for non-inferiority to CPAP, superior symptom alleviation, patient preference in people with OSA and sleep bruxism, and mitigation of specific dental side effects linked with other oral appliances.
“The ProSomnus EVO Guided device has a true custom, anatomical design that maximizes efficacy by guiding mandibular repositioning and guiding the tongue anteriorly while maintaining mouth closure,” says Edward T. Sall, MD, DDS, MBA, medical director at ProSomnus, in a release. “As both a physician and dentist treating patients, I believe it should be considered as the new ‘gold standard’ for oral appliance therapy in the treatment of OSA.”
Early Clinical Feedback on EVO Guided
During a soft launch earlier this year, ProSomnus gathered feedback on the new device. ProSomnus shares a selection of the encouraging feedback in a press release:
- “ProSomnus continues to innovate. What’s their motivation to improve a device that is already ‘best of class’? Ah yes…better compliance, better results. We will never get 100%, but the EVO Guided device moves the needle in the right direction and provides a comfortable lingual-less design.”—Kent Smith, D-ABDSM, ASBA
- “The new ProSomnus EVO Guided device is super easy for insertion, offers a perfect fit every time, and patients have reported it to be extremely comfortable. Given the very low profile and lingual-less design, it’s becoming a preferred device option for our GoTo Sleep Centers.”—Stacey C. Layman DDS, DABDSM
- “The lingual-less design, refined post structure, and precision engineering of EVO Guided provide greater tongue space and comfort—key factors in enhancing efficacy and patient outcomes.”—Michael Gelb, DDS, MS
- “ProSomnus EVO devices fit seamlessly with zero adjustments. The new EVO Guided device, featuring an additional 5 degrees of post taper, eliminates the need for elastics to manage jaw drop—its enhanced post angulation provides ideal support. Existing EVO users who have upgraded to EVO Guided appreciate the increased tongue space due to reduced appliance bulk, allowing for greater comfort. With less material interference, less protrusion may be necessary, enabling the tongue to achieve its natural, unobstructed position more efficiently.”—David E. Federici, DMD
- “EVO Guided is now my go-to oral device. Having made over 1,500 devices, I see the impact of its lingual-less design, 95-degree lower guided post, and improved lip closure—offering patients more tongue space, reduced protrusion, and greater comfort. The seamless chairside delivery makes treatment effortless, and patient feedback has been overwhelmingly positive, with more predictable results.”—John A. Carollo, DMD, FAASM, DABDSM
- “The recently introduced ProSomnus EVO Guided device addresses several patient concerns prevalent in previous models. This device provides enhanced tongue space, increased resistance to mouth opening, and a compact design that minimizes bulk within the buccal vestibules. My patients have expressed their satisfaction with the comfort of their new device. It is my new favorite appliance.”—Dana Blalock, DDS
- “I just had my first night with my new ProSomnus EVO Guided device, and it was the best sleep I’ve had in years. After 8 years of CPAP, followed by 10 years of using every type of device, this is by far the most comfortable device I’ve ever used. There was absolutely no interference with my tongue—just the natural feel of my teeth and palate. It was as if I had nothing in my mouth at all. Everyone needs an EVO Guided device!”—Alan Blanton, DDS, MS, DABDSM
- “ProSomnus EVO Guided represents a major step forward in the evolution of oral appliance therapy—intelligently simplifying the treatment of OSA without compromising efficacy or precision. Designed with the clinician and patient in mind, the device leverages years of scientific research, bioengineering expertise, and countless anatomical data points from intra-oral precision scans to create what I would call ‘intelligent simplicity.’ EVO Guided is more than a device; it’s a solution. It empowers more dentists to treat with confidence, streamlines device selection, and brings us closer to true personalization in the era of precision medicine. It’s a breakthrough that reflects the deep understanding of OSA pathophysiology and the practical realities of clinical care. I believe EVO Guided will have a major impact on expanding access to better health for more patients.”—Shouresh Charkhandeh, DDS, BMedSc
- “ProSomnus has pushed the bar higher with its new EVO Guided device. Reduced thickness and minimal encroachment of the tongue space, the ability to be a velopharynx dilator, and the elimination of needing elastics all lead me to now choose the EVO Guided as my number one choice for my patients.”—Ben Utterback, DDS, DABDSM
