Research to be presented at SLEEP 2024 indicates ProSomnus’ oral appliances improve OSA treatment outcomes and patient satisfaction.


Summary: ProSomnus Inc will showcase two scientific abstracts at SLEEP 2024 in Houston, demonstrating the clinical performance and patient satisfaction of their oral appliance therapy (OAT) devices for the treatment of obstructive sleep apnea (OSA). One study revealed that 98% of patients with mild to moderate OSA were successfully treated with ProSomnus OAT devices, while the other highlighted high levels of satisfaction among patients and providers.

Key Takeaways:

  • ProSomnus devices, made from medical-grade material, treated 98% of patients with mild to moderate OSA to an AHI of less than 10 events per hour.
  • Post-market surveillance showed 98% of patients and providers reported a “first time fit” with a ProSomnus OAT device, with 99% of patients and 98% of providers expressing satisfaction with the appliance.
  • The studies highlight the growing recognition of non-CPAP therapies for OSA.

ProSomnus Inc will showcase two scientific abstracts at SLEEP 2024 in Houston on the clinical performance and patient satisfaction of their precision oral appliance therapy devices for the treatment of obstructive sleep apnea (OSA).

“A growing number of physicians are realizing the need for non-CPAP OSA therapy, due to recent research documenting patient preferences, FDA recalls, treatment compliance, and treatment effectiveness rates,” says Len Liptak, chief executive officer of ProSomnus, in a release. “ProSomnus is proud to be associated with these scientific abstracts which further investigate and establish the clinical safety and performance of precision oral appliance therapy for patients with Obstructive Sleep Apnea.”

The Abstracts

  • Abstract ID 1262: “Evaluating the clinical performance of a novel, precision oral appliance therapy medical device made wholly from a medical grade class VI material for the treatment of obstructive sleep apnea”
    • This study evaluated the clinical performance of a novel, precision oral appliance therapy (ProSomnus OAT) medical device made entirely from a US Pharmacopeia (USP) medical grade class VI qualified material for the treatment of OSA. Data from 91 patients with OSA found that 98% of patients with mild and moderate OSA were successfully treated to an AHI <10 events per hour. No patients discontinued treatment due to material-related side effects. The results of the study show that a precision ProSomnus OAT device made from USP Class VI qualified material is safe and efficacious for the treatment of OSA.
  • Abstract ID 0606: “Post market surveillance from precision OAT cases indicates high levels of patient and provider satisfaction”
    • Review of post-market surveillance surveys collected from 10,880 patients and 646 providers over a 60-month period showed that 98% of patients and providers reported a “first time fit,” indicating a high-quality device made precisely to specification. 99% of patients reported being satisfied with their appliance, and 98% of providers reported being satisfied with the device upon delivery to the patient.

File photo / ProSomnus EVO