MINNEAPOLIS, April 21, 2020 (GLOBE NEWSWIRE) — Inspire Medical Systems, Inc. (NYSE: 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 that the U.S. Food and Drug Administration (“FDA”) has approved an expanded age range for Inspire therapy to include 18-21 year old patients, as compared to the previous minimum age requirement for patients to be 22 years old. Following a detailed review of the clinical evidence and iterative discussions with the FDA, Inspire believes that this is the initial step in the pediatric approval process, with further expansion to lower age groups possible.
“This expanded approval represents meaningful progress in making Inspire therapy available to the pediatric population. The FDA and Inspire worked collaboratively to include the 18-21 year old population within the existing indication, and in the process, identified the key measures that could lead to making Inspire available to the teenage population,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “We will conduct additional research on the specific characteristics of OSA in the pediatric population, including continuing the ongoing clinical study for adolescents with Down Syndrome.”Inspire therapy will immediately be available in the U.S. for patients 18 years of age and older with moderate to severe OSA who are not able to benefit from CPAP. The primary procedure for this population today is a tonsillectomy, and the FDA’s indication provides guidance for attending physicians regarding patient selection.About Inspire Medical SystemsInspire 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, please visit www.inspiresleep.com.Forward Looking StatementsThis 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 the pediatric approval of our Inspire therapy, our clinical study for adolescents with Downs Syndrome and our additional research on the specific characteristics of OSA in the pediatric population. 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; the impact of the ongoing and global COVID-19 pandemic; general and international economic, political, and other risks, including currency and stock market fluctuations and the uncertain economic environment; our ability to enhance our Inspire system, expand our indications and develop and commercialize additional products; and 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. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release 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 for the year ended December 31, 2019, as updated by our Current Report on Form 8-K filed on April 13, 2020, as such factors may be updated from time to time in our other filings with the SEC. Our Annual Report on Form 10-K for the year ended December 31, 2019, our Current Report on Form 8-K filed on April 13, 2020 and the other documents we file with the SEC from time to time are each 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 press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. 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. 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
646-597-6989
[email protected]
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