Press Release Details

Inspire Medical Systems, Inc. Announces FDA Approval for Apnea Hypopnea Index Indication Expansion and Increased Body Mass Index Labeling

June 9, 2023

MINNEAPOLIS, June 09, 2023 (GLOBE NEWSWIRE) -- Inspire Medical Systems, Inc. (NYSE: INSP) (Inspire), a medical technology company focused on the development and commercialization of innovative, minimally invasive solutions for patients with obstructive sleep apnea (OSA), announced today that it has received approval from the Food and Drug Administration (FDA) on an expanded indication. The update includes an increase on the upper limit of the Apnea Hypopnea Index (AHI) to 100 events per hour from 65, and raises the Body Mass Index (BMI) warning in the labeling to 40 from 32.

“We are excited that the FDA has approved Inspire’s application to expand our indication to include patients with AHI up to 100 events per hour,” said Tim Herbert, President and Chief Executive Officer of Inspire. “These patients experience severe OSA and have historically had limited treatment options available. Data from our ADHERE registry demonstrated that Inspire is a safe and effective treatment for this patient population and we are grateful to our surgeon and sleep physician partners who participated in this registry. Furthermore, we are very pleased that the FDA raised the BMI warning in the labeling to 40 from 32,” concluded Mr. Herbert.

About Inspire Medical Systems

Inspire is a medical technology company focused on the development and commercialization of innovative, 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, those regarding our expectations to commercialize Inspire therapy. Forward-looking statements involve inherent risks and uncertainties, and important factors could cause actual results to differ materially from those anticipated, including the factors identified 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 fiscal year ended December 31, 2022 filed with the SEC, and 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 and the Investors page of our website at www.inspiresleep.com. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them in light of new information or future events.

Investor and Media Contact
Ezgi Yagci
Vice President, Investor Relations
ezgiyagci@inspiresleep.com
617-549-2443


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Source: Inspire Medical Systems