Inspire Medical Systems, Inc. Announces CE Mark Certification under the European Union’s Medical Device Regulation for Inspire Therapy
Inspire Medical Systems, Inc. (NYSE: INSP) has announced CE mark certification under the European Union's Medical Device Regulation (EU MDR 2017/745) for its Inspire therapy, a minimally invasive solution for patients with obstructive sleep apnea (OSA). This certification maintains Inspire's uninterrupted CE mark approval since 2010 and complies with the new, more stringent regulatory framework enacted in 2017.
Two significant changes are now CE marked under the EU MDR: Inspire patients in the EU can undergo full-body MRI scans in the 1.5T MRI environment, subject to specified conditions, and the current version of Inspire therapy's leads with silicone insulation are now CE marked in the EU. This certification is a critical milestone for Inspire, ensuring continued delivery of their product in several European countries.
- Obtained CE mark certification under EU MDR 2017/745 for Inspire therapy
- Maintained uninterrupted CE mark approval since 2010
- EU patients can now undergo full-body MRI scans in 1.5T MRI environment
- Current version of Inspire therapy's leads with silicone insulation now CE marked in EU
- None.
Insights
The attainment of the CE mark certification under the European Union’s Medical Device Regulation (EU MDR 2017/745) represents a significant regulatory achievement for Inspire Medical Systems, Inc. Given the stringent requirements of the new regulatory framework, obtaining this certification implies robust compliance and quality standards adhered to by Inspire. This is a milestone that can enhance the company's reputation and reliability in the European market.
The updated regulation, which came into effect in 2017, demands more detailed documentation and more stringent checks compared to the previous directive. Achieving compliance demonstrates Inspire’s capability to meet higher safety and performance standards, which can lead to increased trust among healthcare providers and patients. Additionally, it suggests that Inspire is well-positioned to continue its operations seamlessly in Europe without facing regulatory interruptions.
For investors, the CE mark under the new MDR can be seen as an advantage as it opens up sustained market access in Europe, potentially leading to stable or increased revenue streams from this region. However, the financial implications should be monitored to ensure the costs associated with meeting these regulatory demands don't outweigh the benefits.
From a market perspective, the CE mark certification under the EU MDR can have several positive implications for Inspire Medical Systems. First, it enables the company to maintain and possibly expand its footprint in the European market, which is critical given the region's significant share in the global medical devices market. The ability to offer full-body MRI scan compatibility and improved lead insulation can enhance the appeal of Inspire therapy among healthcare providers and patients, potentially driving demand.
In the short term, this certification might not result in a major spike in sales immediately, but it solidifies the company’s market position, indicating reliability and long-term commitment to quality. In the long term, as the new capabilities become more widely known and adopted, we might see a gradual increase in revenue from the European market. Investors should watch for any upcoming reports or earnings calls that might provide more insights into market penetration and sales growth linked to this certification.
However, it's important to be cautious about potential increased operational and compliance costs due to the stringent requirements of the new MDR framework. Ensuring that these costs are managed effectively will be important for maintaining profitability.
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 CE mark certification under the European Union’s Medical Device Regulation (EU MDR 2017/745) for Inspire therapy.
“Inspire has a long history of compliance to the European Union’s (EU) quality system and CE mark requirements, with uninterrupted CE mark approval since 2010,” said Tim Herbert, Chairman and President of Inspire. “The Inspire team has worked diligently with our notified body in Europe to complete the review process, which included obtaining temporary approval through derogation authorization to continue to deliver Inspire product in several countries.”
“In 2017 the European Parliament enacted a new regulatory framework (i.e., EU MDR 2017/745) for the certification of medical devices in the EU. As a result, the entire medical device industry must repeat the process for both design and quality system certification to the new, more stringent, requirements. The scale of this transition to a new regulatory framework has proven to be a challenge for medical device manufacturers and the notified bodies who certify them. Given that, Inspire is pleased to reach this critical milestone,” said Andreas Henke, Executive Vice President, Managing Director Europe.
There are two changes to Inspire therapy that are now CE marked under the EU MDR, that were not previously certified under the Active Implantable Medical Device Directive (90/385/EEC). First, Inspire patients in the EU may now undergo full-body MRI scans in the 1.5T MRI environment, provided the conditions specified in the Inspire MRI Guidelines Manual are met. Additionally, the current version of Inspire therapy’s leads with silicone insulation are now CE marked in the EU.
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 Inspire therapy?
What are the two main changes to Inspire therapy now CE marked under EU MDR?
How long has Inspire Medical Systems (INSP) maintained CE mark approval for its therapy?
What is the significance of the EU MDR 2017/745 certification for Inspire Medical Systems (INSP)?
