The rollout of Inspire V for obstructive sleep apnea—Inspire Medical Systems’ new design that streamlines the implant procedure by eliminating the need for a separate sensing lead—has been slower than expected, the company conceded in its second quarter 2025 financial results release and conference call.
Characterizing it as “the largest launch in the history of the company,” Inspire CEO Timothy P. Herbert detailed the challenges Inspire V is facing in the US marketplace.
Inspire V Adoption Challenges
SleepSync Implementation
While not technically complex, the implementation of SleepSync, Inspire’s cloud-based patient management system that accompanies the Inspire V device, has encountered delays at centers as the approval process through customers’ IT departments has proven more time-consuming than anticipated. Many medical centers have delayed implementing SleepSync until their first patients are scheduled to receive the Inspire V device, creating a bottleneck in the rollout process.
“In the second quarter, many centers did not complete the training, contracting, and onboarding criteria required prior to the purchase and implant of Inspire V,” Herbert explained during the company’s second quarter earnings call. “Specifically, implementation of SleepSync has been the most challenging step to accomplish.”
SleepSync is designed to capture information when physicians program the device, providing long-term benefits for patient monitoring and outcomes tracking.
Medicare Billing Complications
Another hurdle has been Medicare billing procedures. Although the new CPT code 64568 for Inspire V was announced in April with a retroactive effective date of January 1, 2025, the software updates necessary for claims submissions and processing didn’t take effect until July 1. This created a three-month gap where Medicare patients could receive the therapy but centers couldn’t bill for the procedures.
This timing issue forced many centers to continue using Inspire IV for Medicare patients rather than risk unpaid procedures. Given that Medicare represents a significant portion of sleep apnea patients, this billing delay substantially impacted adoption rates during the crucial launch period.
“Although traditional Medicare and Medicare Advantage patients could receive Inspire therapy, implanting centers would not be able to bill for those procedures until July 1. Given this dynamic, many centers continued to treat Medicare patients with Inspire IV. With this software update now complete, we anticipate centers will ramp up their efforts to transition to Inspire V,” Herbert said.
Patient Behavior and Market Dynamics
Patient decision-making also influenced the slower-than-expected transition. Some patients chose to delay their procedures after learning that the improved Inspire V system would soon be available, preferring to wait for the newer technology rather than proceed with Inspire IV.
Additionally, the company believes some patients may be postponing Inspire therapy to trial GLP-1 medications for weight loss. While Inspire cannot quantify this impact, they acknowledge it as a potential factor. Interestingly, the company views GLP-1s as a long-term tailwind, as patients often need to lose weight to qualify for Inspire therapy, particularly those who fail the DISE procedure due to high body mass index.
Optimism for Inspire V Adoption
Despite these challenges, Inspire has made progress addressing the bottlenecks.
The company has deployed technical teams to accelerate SleepSync implementation and has completed setup at over 50% of US centers. They expect to complete the vast majority of implementations by the end of the third quarter.
The Medicare billing issue has been resolved with the July 1 software update, allowing centers to properly bill for Inspire V procedures. Centers that have successfully transitioned to Inspire V are already showing promising results, with more than 20% increase in patient implants in the first half of 2025 compared to the same period in 2024.
Clinical Benefits Drive Optimism
Early clinical data support the value proposition of Inspire V. Results from Singapore clinical studies showed a 20% reduction in surgical times, which increases center capacity. From an efficacy standpoint, accelerometer studies demonstrated an 86% inspiratory overlap with patient breathing, representing significantly improved sensing capability compared to previous generations.
The company also received positive news on reimbursement, with CMS proposing increases in Medicare reimbursement rates for 2026. The national average Medicare hospital reimbursement for the new CPT code is proposed to increase to $32,000, up roughly 4% from 2024.
Looking Forward
While the extended rollout timeline has been disappointing, Inspire remains confident in its long-term prospects. The company has addressed the primary implementation challenges and expects accelerated adoption in the latter half of 2025. With strong market demand, positive clinical results, and improving reimbursement rates, Inspire V appears positioned for success once the initial transition hurdles are fully overcome.
The experience highlights the complexity of launching next-generation medical devices, where technical capabilities must align with operational readiness across healthcare systems, regulatory processes, and patient expectations.
