Company: INSP
Filing Date: 2025-05-05
Form Type: 10-Q
Source: 0001609550-25-000020
Chunk: 109

Company: Inspire Medical Systems, Inc.
Filing Date: 2025-05-05
Form: 10-Q
Item: Part I, Item 2
Chunk 109
---
 Inspire systems and support our future regulatory submissions for expanded indications and for new markets such as additional European countries and the Asia Pacific region. For example, in August 2024, we received approval from the FDA for our next generation Inspire system ("Inspire V"), which we expect to fully launch in the U.S. in 2025. 

Beginning late in the first quarter and continuing into the second quarter of 2025, in connection with awareness gained during our ongoing limited market release of the Inspire V system, we began to observe that some patients and physicians are delaying Inspire therapy until Inspire V is available at their location. Additionally, beginning late in the first quarter and continuing into the second quarter of 2025, we began to observe that some of our customers are using their existing inventory of our Inspire IV system ("Inspire IV") prior to purchasing Inspire V systems. While we cannot quantify the impact at this time or predict if these patterns may change, we anticipate that the occurrence of patients and physicians delaying Inspire therapy until Inspire V is available and the destocking by some of our customers of their existing Inspire IV inventory may impact our consolidated revenue until Inspire V is fully launched and our customers have used their existing Inspire IV inventory, which is expected to primarily occur in the second quarter of 2025. We plan to continue to make Inspire IV systems available in the U.S. after the Inspire V launch as inventory levels allow, and outside the U.S., subject to our receiving the appropriate regulatory clearances for Inspire V in foreign markets.

29

Our direct-to-consumer marketing program's goals are therapy awareness, connecting patients with providers, and supporting the patient through their path to Inspire from start to finish. Our investments in advertising are designed to increase patient awareness and encourage them to visit our website. On our website, patients can explore educational materials and videos about sleep apnea, learn about the benefits of Inspire therapy, find physician and clinical site contact information, and stay informed about community awareness events. We also use the Inspire Sleep app as a valuable tool for patient education. Moving forward, we plan to refine and optimize our outreach strategies, with an emphasis on expanding digital advertising efforts to reach more qualified patients. We expect our direct-to-consumer expenditures to increase slightly over 2024 levels during the remainder of 2025.

We have a call center which we refer to as the Inspire Advisor Care Program. The primary purpose of this program is to assist patients