Organization (Industry)
Inspire Medical Systems, Inc.
ClinicalTrials.gov lists Inspire Medical Systems, Inc. as lead sponsor of 13 trials.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 0 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 1.2 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Inspire Medical Systems, Inc.: 13 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (5)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Sleep Apnea Syndromes | 17 |
| Sleep Apnea, Obstructive | 17 |
| Down Syndrome | 3 |
| Intellectual Disability | 3 |
| Sleep Initiation and Maintenance Disorders | 1 |
Trials by start year as sponsor or collaborator (11)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2025 | 3 |
| 2024 | 1 |
| 2022 | 1 |
| 2021 | 2 |
| 2020 | 2 |
| 2019 | 1 |
| 2016 | 1 |
| 2015 | 3 |
| 2014 | 1 |
Showing 10 of 11 years.
Recruitment duration, a model prediction: none of the 13 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 60% hit target (n=5) | 1 of 4 on time (n=4) |
Journals published in (15)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine | 5 |
| Sleep | 5 |
| American journal of respiratory and critical care medicine | 4 |
| The European respiratory journal | 4 |
| The Laryngoscope | 3 |
Showing 5 of 15 journals.
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 117 | 81 | 2025-12-02 |
SEC-reported annual financials (10)
Shown in this order: newest fiscal year first; SEC EDGAR XBRL companyfacts, USD as reported.
| Fiscal year | Revenue (USD) | Net income (USD) | R&D (USD) |
|---|---|---|---|
| 2025 | 911,981,000 | 145,422,000 | 103,165,000 |
| 2024 | 802,804,000 | 53,509,000 | 114,128,000 |
| 2023 | 624,799,000 | -21,153,000 | 116,536,000 |
| 2022 | 407,856,000 | -44,881,000 | 68,645,000 |
| 2021 | 233,394,000 | -42,042,000 | 37,350,000 |
| 2020 | 115,381,000 | -57,203,000 | 26,092,000 |
| 2019 | 82,050,000 | -33,243,000 | 12,839,000 |
| 2018 | 50,593,000 | -21,828,000 | 7,388,000 |
| 2017 | 28,567,000 | -17,511,000 | 6,194,000 |
| 2016 | not reported | not reported | not reported |
Financing and grant events (13)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2025-08-11 | Other financing | not disclosed | Sec extracted |
| 2024-11-08 | Other financing | not disclosed | Sec extracted |
| 2024-08-06 | Other financing | not disclosed | Sec extracted |
| 2022-08-18 | Debt financing | not disclosed | Sec extracted |
| 2022-08-15 | Other financing | not disclosed | Edgar offerings |
Showing 5 of 13 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| VAI | 6 |
FDA recalls (6)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a pressure sensitive membrane that converts the mechanical energy of respiration into an electrical signal. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A | Class II | 2026-05-11 |
| Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the implantable pulse generator (IPG). Component: N/A | Class II | 2026-05-11 |
| Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | Class II | 2024-07-31 |
| Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system. | Class II | 2024-07-31 |
| Inspire Model 3028, IV Implantable Pulse Generator | Class I | 2024-05-16 |
Showing 5 of 6 recalls.
Manufacturing and distribution sites (2)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Inspire Medical Systems Inc | Golden Valley, US | FDA | |
| INSPIRE MEDICAL SYSTEMS INC | Golden Valley, US | FDA |
Climate targets, as filed (1)
| Reporting year | Net-zero target |
|---|---|
| 2025 | not disclosed |
Workforce and board diversity, as filed (1)
| Reporting year | Workforce % women | Board % women |
|---|---|---|
| 2025 | 52.0% | not disclosed |
Organization relationships (9)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Government of the United States of America | Co sponsors trial with | 2 |
| University of Pittsburgh | Co sponsors trial with | 2 |
| Emory University | Co sponsors trial with | 1 |
| Children's Hospital of The King's Daughters | Co sponsors trial with | 1 |
| Christopher Hartnick, M.D. | Co sponsors trial with | 1 |
Showing 5 of 9 relationships.
Latest dated events (159)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-11-05 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-05-11 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-05-11 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-19 | FDA inspection | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2025-12-02 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 159 events.
Biomarker capability evidence (10)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| FGF4 | Trial sponsor | Named in trial inclusion criteria |
| IDE | Trial sponsor | Primary endpoint in a Phase 3 trial |
| PAPOLA | Trial sponsor | Named in trial inclusion criteria |
| REG3A | Trial sponsor | Named in trial inclusion criteria |
| SULT2A1 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 10 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, active development programs, approved assets, fda warning letters, fda untitled letters, fda import refusals, clia clinical laboratory certificates, and biomarkers this organization publishes on.