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Inspire Medical Systems, Inc. Announces Regulatory Approval of Inspire Therapy in Australia

MINNEAPOLIS, Aug. 12, 2020 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) ("Inspirea??), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (a??OSAa??), today announced that the Australian Therapeutic Goods Administration (a??TGAa??) has approved Inspire therapy to treat moderate to severe OSA in patients who are unable to benefit from continuous positive airway pressure (a??CPAPa??).
Recent published data estimates that nearly 5% of Australian men and women are diagnosed with OSA.A  Additional industry estimates indicate that approximately one million Australians have an Apnea Hypopnea Index (a??AHIa??) greater than 15, which qualifies them as moderate or severe OSA patients.A a??This approval for our Inspire therapy is the first step to providing patients and physicians in Australia with a new alternative for the treatment of moderate to severe OSA,a?? said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. a??Inspire therapy is supported by a strong and growing body of clinical evidence demonstrating the safety and efficacy of our therapy. We look forward to completing the reimbursement process in Australia and initiating our commercial activity.a??Concurrent with the regulatory review, Inspire has applied for reimbursement in Australia, and the application is under review by the Medical Services Advisory Committee (a??MSACa??), which is an independent committee established by the Australian Government Minister for Health to evaluate new medical services proposed for public funding. Inspire will continue with the active discussions with the MSAC, including in-person meetings in late 2020. The reimbursement process is anticipated to be completed during 2021 and Inspire expects to launch its therapy in Australia thereafter.About Inspire Medical Systems
Inspire is a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea. Inspirea??s proprietary Inspire therapy is the first and only FDA-approved neurostimulation technology that provides a safe and effective treatment for moderate to severe obstructive sleep apnea.
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