Inspire Medical Systems, Inc. Announces FDA Approval and Commercial Launch of New Physician Programmer Platform
Inspire Medical Systems (NYSE: INSP) announced FDA approval for its new physician programmer platform designed for obstructive sleep apnea treatment. Key enhancements include a Bluetooth-enabled telemetry cable, guided workflows for clinicians, improved telemetry range, and integration with Inspire Cloud for patient management. This development further solidifies Inspire's commitment to innovative solutions in sleep apnea therapy. The new platform also lays the groundwork for future products, enhancing its digital ecosystem and potential for remote programming.
- FDA approval of the new physician programmer platform enhances Inspire's product offering.
- Introduces Bluetooth connectivity, improving usability for healthcare providers.
- Guided workflows streamline patient management from activation to follow-up.
- Supports Inspire Cloud integration for better patient data management and analysis.
- None.
MINNEAPOLIS, March 31, 2021 (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, today announced receipt of U.S. Food and Drug Administration (“FDA”) approval for the new Inspire physician programmer platform. The most significant enhancement associated with this approval is the new telemetry cable which enables Bluetooth® connectivity to the programmer tablet.
“In addition to the recently announced approval for the Inspire two-incision procedure, the launch of our new physician programmer platform further demonstrates our long-term commitment to patients through Inspire’s continued investment in our innovative technologies,” said Tim Herbert, President and Chief Executive Officer of Inspire Medical Systems. “The new Inspire physician programmer platform provides multiple key benefits for physicians when managing their patients’ sleep apnea treatment with Inspire therapy.”
The new platform provides four key enhancements over the existing product. First, the new design incorporates guided workflows, which direct clinicians step-by-step through the patient management process from initial Inspire activation, to titration sleep studies, and all the way through long-term patient follow-up visits. Secondly, a new programmer cable has been introduced that provides additional flexibility, comfort and ease of use with a new night-mode that utilizes IR illumination for sleep studies, significantly improved telemetry range, comprehensive user feedback, as well as incorporating new on-cable controls. Third, the new platform interfaces with Inspire Cloud and supports the upload of patient reports for longitudinal patient management and further expands the Inspire digital ecosystem.
Lastly, the new Inspire physician programmer is the foundation for our physician platform of the future. The programmer cable is field-upgradable to support future products, such as the development-stage Inspire V neurostimulator. This new platform also supports further Inspire Cloud integration, providing for potential remote programming, which is also currently under development effort.
Inspire Medical Systems to Participate in Wells Fargo R&D Spotlight Call
Inspire will participate in the Wells Fargo MedTech R&D Spotlight Call Series on Thursday, April 1, 2021 at 11:00 a.m. Eastern Time. To listen to a live webcast, please visit the Investors section of the Inspire website at www.inspiresleep.com. The webcast replay will be available on the Inspire website for two weeks following the completion of the call.
About Inspire Medical Systems
Inspire 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 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, statements regarding the expected benefits of the new physician programmer platform. 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, 2020 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. 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 & Media Contact:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com
FAQ
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