U.S. Markets close in 1 hr 49 mins

Inspire Medical Systems, Inc. Announces Publication Demonstrating Effectiveness of Inspire Therapy in Treating Obstructive Sleep Apnea in Medicare-aged Patients

MINNEAPOLIS, May 14, 2019 (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”), announced today the publication of clinical results comparing the effects of Inspire therapy on Medicare-aged patients to younger patients.  The study, led by physicians at the University of Alabama at Birmingham, followed 235 Medicare-aged patients and 365 younger-aged patients and collected information regarding sleep apnea severity, quality of life and any complications with the procedure.  The results of the study demonstrated that while all patients positively responded to Inspire therapy, the Medicare-aged patients had both a slightly higher response, as well as a slightly higher adherence, to therapy.

The publication, entitled “Upper Airway Stimulation Response in Older Adults with Moderate to Severe Obstructive Sleep Apnea,” appears online in the Journal of Otolaryngology – Head and Neck Surgery (DOI: 10.1177/0194599819848709 http://otojournal.org).

“This study corroborates the growing evidence supporting the safety and efficacy of Inspire therapy for the treatment of OSA in properly selected CPAP-intolerant cases,” said Dr. Kirk Withrow, Associate Professor at the University of Alabama Birmingham and lead author of this publication. “In addition, it specifically affirms the benefit of Inspire therapy for older patients, who have been previously shown to have experienced worse outcomes with other types of sleep surgery.”

The study noted that an age equal to or greater than 65 years is an independent factor for success with Inspire therapy as compared with younger cohorts. The paper concluded that Inspire therapy should be strongly considered in the treatment of older patients who are CPAP intolerant and eligible per the established inclusion criteria.

“We received feedback from several of the regional Medicare administrators indicating the need for published literature that specifically evaluated Medicare-aged patients receiving Inspire therapy,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “We believe the results of this study, which compared the response to therapy, adherence and complications experienced by Medicare-aged and younger-aged populations provide important evidence that the administrators may use in their Medicare coverage development.”

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’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.

For additional information about Inspire, please visit www.inspiresleep.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements other than statements of historical facts are forward-looking statements, including, without limitation, statements regarding Medicare coverage development.  In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “future,” “outlook,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential,” “continue,” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words.

These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, estimates regarding the annual total addressable market for our Inspire therapy in the U.S. and our market opportunity outside the U.S.; 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; our ability to achieve and maintain adequate levels of coverage or reimbursement for our Inspire system or any future products we may seek to commercialize; competitive companies and technologies in our industry; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; 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 dependence on third-party suppliers, contract manufacturers and shipping carriers; consolidation in the healthcare industry; 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 U.S.; risks associated with international operations; our ability to manage our growth; our ability to increase the number of active medical centers implanting Inspire therapy; our ability to hire and retain our senior management and other highly qualified personnel; risk of product liability claims; risks related to information technology and cybersecurity; risk of damage to or interruptions at our facilities; 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 U.S. and international markets; the timing or likelihood of regulatory filings and approvals; risks related to our debt and capital structure; our ability to establish and maintain intellectual property protection for our Inspire therapy and system or avoid claims of infringement; tax risks; risks that we may be deemed an investment company under the Investment Company Act of 1940; regulatory risks; the volatility of the trading price of our common stock; and our expectations about market trends. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this presentation can be found under the captions “Risk Factors” and "Management's Discussion and Analysis of Financial Condition and Results of Operations“ in our Annual Report on Form 10-K filed with the SEC on February 26, 2019, as such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this presentation. Any such forward-looking statements represent management’s estimates as of the date of this presentation. While we may elect to update such forward-looking statements at some point in the future, unless required by applicable law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Thus, one should not assume that our silence over time means that actual events are bearing out as expressed or implied in such forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor and Media Contact:
Bob Yedid
LifeSci Advisors
inspire@lifesciadvisors.com 
646-597-6989