Company: INSP
Filing Date: 2025-02-10
Form Type: 10-K
Source: 0001609550-25-000011
Chunk: 30

Company: Inspire Medical Systems, Inc.
Filing Date: 2025-02-10
Form: 10-K
Item: Item 1
Chunk 30
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 meta-analysis suggest that hypoglossal nerve stimulation has shown results comparable to those evaluating PAP, and potentially superior to other airway surgeries, in reducing AHI, and that all therapies have demonstrated similar effectiveness in reducing daytime sleepiness. The authors conclude that hypoglossal nerve stimulation could be an effective treatment for moderate to severe obstructive sleep apnea patients who are intolerant of PAP. 

Post market surveillance data support the safety of Inspire therapy

Inspire partnered with implanting surgeons and sleep physicians to publish an analysis of Inspire’s post-market surveillance data in 2024 in the Journal of Clinical Sleep Medicine. Medical device manufacturers are mandated by government regulations to collect and monitor adverse events such as surgical revisions or device explants. Precise estimates of revision and explant rates were calculated by combining the post-market surveillance data with corresponding sales volume. Of 20,881 Inspire therapy devices implanted at least one year prior to the analysis, 151 devices (0.7%) were explanted and 322 devices (1.5%) required a surgical revision procedure within a year of the implant. A subset of 5,820 of these devices were implanted three years prior to the analysis, of which 156 devices (2.7%) were explanted, and 207 devices (3.6%) required a revision procedure between one and three years after implant. 

Sales and Marketing

We have established a methodical approach to market development which centers on active engagement across three key stakeholders in the OSA treatment paradigm: patients, physicians, and sleep centers.

We sell our Inspire system through a direct sales force that primarily targets ENT physicians and sleep centers in the U.S., Europe, and Japan, and through distributors in Singapore and Hong Kong. The implant procedure for our Inspire therapy is typically performed by an ENT physician or in some cases by a neurosurgeon. We also focus on sleep centers because they diagnose and manage large volumes of patients with sleep apnea and are often an important referral base for ENT physicians. In addition, because OSA is sometimes diagnosed during other procedures, we have developed programs to help educate general practitioners and specialists in other fields, such as cardiovascular surgeons, electrophysiologists, and dentists, regarding our Inspire therapy.

We have 335 sales territories in the U.S. and 25 outside of the U.S. We seek to recruit sales representatives with strong sales backgrounds, direct experience developing markets with new technologies, and core knowledge of medical device coding, reimbursement, and the prior