Company: INSP
Filing Date: 2025-02-10
Form Type: 10-K
Source: 0001609550-25-000011
Chunk: 34

Company: Inspire Medical Systems, Inc.
Filing Date: 2025-02-10
Form: 10-K
Item: Item 1
Chunk 34
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 trial was completed and published in the New England Journal of Medicine in 2014 and we received PMA in 2014. Additionally, the device was CE marked for commercialization in the EU in 2010.

We continue to invest in advancing our Inspire system with the goal of providing patients more effective and less invasive therapy for OSA. In 2017, we released the Inspire IV neurostimulator, which is 40% smaller than the previous version while maintaining approximately 11 years of battery life. The Inspire IV device was launched in the U.S. in 2017, and in Europe in 2018.

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Our next generation of the Inspire neurostimulator, Inspire V, was approved by the FDA in 2024, and our updated SleepSync™ programmer was approved by the FDA in 2023. Our Bluetooth®-enabled patient remote control was approved by the FDA in 2021 and the initial commercial launch occurred in 2022. We have launched a cloud-based patient management system called the SleepSync™ platform, which allows physicians to monitor patient compliance and more efficiently coordinate patient care. In 2020, we launched the Inspire Sleep app for patients' smartphones. The app serves as an educational tool and, since 2022, interfaces with the patient remote and SleepSync™ platform, which allows physicians to monitor patient compliance and more efficiently coordinate patient care. We continue to enhance the functionality of this app as part of our overall digital platform development.

The SleepSync™ platform and our app are initial steps in establishing interconnectivity between the patient and their healthcare provider with a long-term plan to improve outcomes by tracking patient activity and adherence, and monitoring for any issues with device use.

Additional Indications

We have sought and continue to seek to expand the approved indications for our Inspire therapy. For instance, in 2023, we received FDA authorization to provide Inspire therapy to the pediatric population with Down syndrome. Also in 2023, the FDA approved an indication expansion to increase the upper limit of AHI to up to 100 events per hour from the original 65 events per hour, and to raise the BMI warning for patients with a BMI of up to 40 from the previous limit of 32. 

Our research and development team focuses on our products currently under development, including our clinical studies involving efforts to improve patient selection, expand indications, and simplify patient management, as well as feasibility studies in which we are evaluating new ways to deliver neurom