MINNEAPOLIS, July 09, 2018 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (INSP) ("Inspire”), a medical technology company focused on the development and commercialization of innovative and minimally invasive solutions for patients with obstructive sleep apnea (OSA), today announced that Aetna Inc., one of the leading health plans in the United States, will provide coverage for the Company’s Inspire therapy, effective immediately. Aetna’s plan provides coverage for approximately 22 million members.
“We are very pleased to receive this positive coverage decision from Aetna. We believe this coverage decision is a major milestone and has the potential to facilitate patient and physician access to and interest in Inspire therapy,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “There is a strong body of clinical data supporting Inspire therapy, including the 5-year STAR data, the ADHERE 300-patient registry data and other supportive publications. We believe our growing body of clinical and real-world data will be the basis for further coverage decisions by other major health plans.”
Under its policy, Aetna considers Inspire’s U.S. Food and Drug Administration (FDA) approved hypoglossal nerve neurostimulation device to be medically necessary for the treatment of moderate to severe OSA when a number of criteria are met. These include a previous attempt at continuous positive airway pressure (CPAP) treatment and patient selection consistent with FDA approval guidelines.
Inspire therapy is an innovative, closed-loop, minimally invasive solution that provides comfort and convenience, resulting in high compliance for patients with moderate to severe OSA. The safety and efficacy of Inspire therapy is supported by a significant body of clinical data, which includes a publication in the New England Journal of Medicine and more than 50 peer-reviewed publications. Inspire obtained CE Mark for its Inspire therapy in 2010 and FDA approval in 2014. To date, physicians have treated more than 3,000 patients worldwide with Inspire therapy.
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. Inspire Medical Systems’ 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.
For additional information about Inspire, please visit www.inspiresleep.com
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning: our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire therapy or any future products we may seek to commercialize; our ability to facilitate patient and physician access to and interest in Inspire therapy; estimates regarding the annual total addressable market for our Inspire therapy in the United States and our market opportunity outside the United States, future results of operations, financial position, research and development costs, capital requirements and our needs for additional financing; commercial success and market acceptance of our Inspire therapy; competitive companies and technologies in our industry; our ability to expand our indications and develop and commercialize additional products and enhancements to our Inspire system; our business model and strategic plans for our products, technologies and business, including our implementation thereof; our ability to accurately forecast customer demand for our Inspire system and manage our inventory; our ability to expand, manage and maintain our direct sales and marketing organization, and to market and sell our Inspire system in markets outside of the United States; our ability to hire and retain our senior management and other highly qualified personnel; our ability to commercialize or obtain regulatory approvals for our Inspire therapy and system, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims of infringement; and our expectations about market trends.
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