The United States Food and Drug Administration (FDA) has authorized marketing of the ProSomnus EVO [PH] Sleep and Snore Device. The device joins the company’s flagship product, the ProSomnus EVO, in its line of FDA-cleared oral appliance therapy devices for the treatment of obstructive sleep apnea.
The ProSomnus EVO [PH] Sleep and Snore Device was engineered to meet Centers for Medicare Services (CMS) coding guidelines (E0486). Per CMS guidelines, the ProSomnus EVO [PH] device uses mechanical hinge components to precisely reposition and stabilize the patient’s jaw during sleep, increasing pharyngeal space and reducing the risk of upper airway collapse. ProSomnus is in the process of obtaining PDAC (Pricing, Data Analysis and Coding) verification and estimates decision within the next few weeks.
ProSomnus EVO [PH] is approximately 13% smaller than the standard ProSomnus EVO and has approximately 70% less volume in the mouth than traditional, dorsal style dental devices with liners. The device features advancement markings and visual indicators.
Every ProSomnus EVO [PH] device is personalized and digitally manufactured based upon the patient’s anatomy and healthcare provider’s treatment plan for each patient. The ProSomnus EVO [PH] is the only Herbst-style device made from engineered, medical grade class VI-rated material.
“Receiving FDA clearance for the ProSomnus EVO [PH] is a significant milestone for the company and for patients suffering from OSA,” says Len Liptak, co-founder and CEO of ProSomnus, in a release. “This expands our industry-leading suite of FDA-cleared precision medical devices to treat OSA, offering patients and their healthcare providers yet another alternative to CPAP, surgery, and legacy oral appliances. Successfully addressing OSA starts with giving patients a treatment that is safe, effective, and easier to adhere to, and the EVO [PH] is one more patient-preferred precision OAT option available to them.”
“This latest FDA milestone is a big step in making precision OAT available to as many patients as possible,” says John E. Remmers, MD, chief scientist of ProSomnus, in a release. “Despite the alarming prevalence of OSA and its dire consequences, legacy OSA treatments have not improved at a rate that patients deserve, especially in light of the current issues with CPAP treatment. This makes our commitment to developing less invasive therapies even more important, and we look forward to the difference it will make for patients and providers.”
“Our manufacturing platform allows us to advance the quality of our materials. We are continuously expanding our material selection far beyond dental applications and researching and developing innovative medical grade polymers for our products,” says Sung Kim, co-founder and chief technology officer of ProSomnus, in a release. “The improved flexibility of the ProSomnus EVO [PH] makes it even easier for patients to use, while its durability protects it from accidental drops. In addition to being incredibly stain-resistant, the EVO [PH] is precision milled in one piece, so it maintains its fit throughout treatment without deformation, staining or harboring bioburden, unlike soft liner and nylon materials.”