Inspire Medical Systems, Inc. Announces CE Mark Certification of Full-Body MRI Compatibility under the European Union’s Medical Device Regulation

Rhea-AI Summary

Inspire Medical Systems, Inc. (NYSE: INSP) has received CE Mark certification for full-body MRI compatibility under the European Union's Medical Device Regulation. This approval expands the use of Inspire therapy, allowing patients with the Inspire IV neurostimulator to undergo full-body MRI scans, in addition to previously approved head, neck, and extremity scans. The certification applies retroactively to all patients with the device implanted since 2018.

This milestone enhances Inspire's ability to serve patients with obstructive sleep apnea (OSA) who struggle with CPAP. The full-body MRI compatibility, already available in the United States for two years, addresses a significant barrier for potential patients concerned about future access to MRI diagnostics. Inspire has conducted extensive testing to ensure safe performance in 1.5T MRI environments.

Positive

• CE Mark certification for full-body MRI compatibility received
• Retroactive approval for all Inspire IV neurostimulator patients since 2018
• Expanded market potential by addressing a barrier for potential patients
• Alignment with U.S. approval, providing consistent benefits across markets

Negative

• None.

MINNEAPOLIS, July 19, 2024 (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), today announced that the European Union Medical Device Regulation (EU MDR) has approved additional magnetic resonance imaging (MRI) scan conditions for use with Inspire therapy. This full-body MRI approval expands the Inspire use labeling that previously allowed only head, neck, and extremity MRI scans. Most importantly, this approval is retroactive, applying to all patients with the Inspire IV neurostimulator device, introduced in 2018, already in place.

“Expanding compatible use to include full-body MRI is a significant milestone in our effort to bring Inspire to more obstructive sleep apnea patients who struggle with CPAP. Providing the full range of scan options enables us to better help all current and future patients with their imaging needs,” said Tim Herbert, Chairman and CEO of Inspire. “This full-body MRI compatibility has been an important benefit for patients in the United States for the past two years, and this new approval will provide the same positive benefit for patients in Europe going forward.”

“Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy,” said Andreas Henke, Executive Vice President, Managing Director Europe. “Compatibility with this important diagnostic tool will provide peace of mind for current and future Inspire patients.”

MRI scanners use powerful magnets and radiofrequency (RF) energy to create detailed images of the inside of the body. Every year, millions of MRIs are performed in Europe to evaluate cancer, neurological, musculoskeletal, and other conditions. Inspire has completed extensive testing to validate performance in the 1.5T MRI environment and demonstrate the conditions that allow scans to be performed safely.

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 in France. 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, 2023 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

FAQ

What new certification did Inspire Medical Systems (INSP) receive for its neurostimulator device?

Inspire Medical Systems received CE Mark certification for full-body MRI compatibility under the European Union's Medical Device Regulation for its Inspire IV neurostimulator device.

How does the new CE Mark certification benefit existing Inspire (INSP) patients in Europe?

The certification applies retroactively to all patients with the Inspire IV neurostimulator implanted since 2018, allowing them to undergo full-body MRI scans in addition to previously approved head, neck, and extremity scans.

What was the previous limitation on MRI scans for Inspire (INSP) therapy patients in Europe?

Previously, Inspire therapy patients in Europe were only allowed to undergo MRI scans of the head, neck, and extremities. The new certification expands this to include full-body MRI scans.

How does the full-body MRI compatibility of Inspire (INSP) therapy compare between Europe and the United States?

The full-body MRI compatibility has been available for Inspire therapy patients in the United States for the past two years. With this new certification, European patients now have the same benefit.