In September, the US Food and Drug Administration (FDA) cleared Oventus Medical’s O2Vent Optima, a customized 3D-printed nylon oral appliance, for the treatment of obstructive sleep apnea (OSA). Oventus Medical Ltd now shares the news that it has been notified by the Pricing, Analysis and Coding (PDAC) contractors, which support The Centers for Medicare & Medicaid Services (CMS) in the United States, that O2Vent Optima has been approved for Medicare reimbursement.
Oventus CEO, Chris Hart, M.Phil, BSc, BDSc, says in a release, “This is a very significant development for Oventus. It means that patients accessing government-funded healthcare in the US can now access our treatment which has been proven to have exceptional efficacy, both in our clinical trials and when used by patients for the treatment of their obstructive sleep apnoea. It opens up a whole market that may not have previously been able to afford our treatment and we expect further increased demand for our ‘lab in lab’ model as a result.
“Given we were only granted FDA clearance for the Optima last September, the board considers this an outstanding outcome and thanks go to the Oventus team for the substantial effort which went into achieving it.”