Inspire Medical Systems, Inc. Announces FDA Approval of Expanded, Full-Body MRI Compatibility with Inspire Therapy
Inspire Medical Systems (NYSE: INSP) announced FDA approval for additional MRI scan conditions for its Inspire therapy, expanding from head, neck, and extremity scans to full-body MRIs. This retroactive approval applies to all patients using the Inspire IV neurostimulator since its 2018 launch. CEO Tim Herbert emphasized that this milestone will alleviate concerns for patients regarding future MRI access, thereby enhancing treatment options for those suffering from obstructive sleep apnea. The therapy is recognized as the only FDA-approved neurostimulation technology for this condition.
- FDA approval for full-body MRI use increases market potential for Inspire therapy.
- Retroactive approval applies to all existing Inspire IV neurostimulator patients.
- Expansion of compatible MRI usage improves patient confidence in treatment options.
- None.
MINNEAPOLIS, July 06, 2022 (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, today announced that the United States Food and Drug Administration (FDA) 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, President and CEO of Inspire. “Until now, concern over future access to MRI had been a barrier for some patients considering Inspire therapy. 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 the United States 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.
For detailed information about Inspire MRI conditional labeling, access Inspire MRI Guidelines at manuals.inspiresleep.com.
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. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ “future,” “outlook,” “guidance,” ‘‘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. 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 fiscal year ended December 31, 2021, as updated in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, 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. 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. 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
bob@lifesciadvisors.com
646-597-6989
FAQ
What did Inspire Medical Systems announce on July 6, 2022?
How does the FDA's approval impact Inspire therapy patients?
What technology is used in Inspire therapy?
How does the new MRI approval benefit Inspire Medical Systems' market position?
