Organization (Industry)
Vapotherm (United States)
ClinicalTrials.gov lists Vapotherm (United States) as lead sponsor of 10 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: 0 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 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Vapotherm (United States): 10 lead-sponsored trials and 1 legal-entity registration.
Disease areas (14)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Respiratory Insufficiency | 6 |
| Dyspnea | 5 |
| Hypercapnia | 3 |
| Acidosis | 2 |
| Premature Birth | 2 |
Showing 5 of 14 disease areas.
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 |
|---|---|
| 2025 | 1 |
| 2023 | 1 |
| 2022 | 1 |
| 2021 | 2 |
| 2020 | 2 |
| 2018 | 1 |
| 2016 | 1 |
| 2014 | 1 |
| 2013 | 1 |
| 2012 | 1 |
Showing 10 of 11 years.
Recruitment duration, a model prediction: none of the 10 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 |
|---|---|
| 17% hit target (n=6) | 43% on time (n=7) |
Journals published in (7)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Archives of disease in childhood. Fetal and neonatal edition | 2 |
| Pediatrics | 2 |
| Acta paediatrica (Oslo, Norway : 1992) | 1 |
| Annals of emergency medicine | 1 |
| Neonatology | 1 |
Showing 5 of 7 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 |
|---|---|---|
| 63 | 24 | 2025-11-04 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 2 |
FDA recalls (9)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Low Flow Disposable Patient Circuit for the Precision Flow System, Product Code PF-DPC-LOW | Class II | 2022-12-16 |
| Vapotherm Precision Flow, Disposable Patient Circuit PF-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Class II | 2014-08-13 |
| Vapotherm Precision Flow,Disposable Patient Circuit PF-E-DPC-High. For use with the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Class II | 2014-08-13 |
| Vapotherm Precision Flow,Disposable Patient Circuit PFH-DPC-High. For use with the Heliox Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Class II | 2014-08-13 |
| Vapotherm Precision Flow,Disposable Patient Circuit PFNODPC-High. For use with the Precision Flow system and Ikaria INOmax DSIR ¿ System. This DPC allows clinicians to administer nitric oxide non-invasively via high flow nasal cannula. In the Precision Flow High Flow Therapy application, a special disposable patient circuit re-routes the gas to the INOmax injector module then back into the Precision Flow system Precision Flow" is intended for use to add warm moisture to breathing gases from an external source for administration to a neonate/infant, pediatric and adult patients in the hospital, sub-acute institutions, and home settings. It adds heat and moisture to blended medical air/oxygen mixture and assures the integrity of the precise air/oxygen mixture via an integral oxygen analyzer. The flow rates may be from 1 to 40 liters per minute via nasal cannula. | Class II | 2014-08-13 |
Showing 5 of 9 recalls.
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| Vapotherm Inc. | Exeter, US | FDA |
Organization relationships (3)
Shown in this order: most evidence first.
| Related organization | Relationship | Evidence |
|---|---|---|
| Seattle Children's Hospital | Co sponsors trial with | 1 |
| Utah System of Higher Education | Co sponsors trial with | 1 |
| Children's National Research Institute | Co sponsors trial with | 1 |
Latest dated events (87)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2025-11-04 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-11-01 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-07-08 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-04-29 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-04-08 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 87 events.
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, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda import refusals, climate targets, as filed, workforce and board diversity, as filed, clia clinical laboratory certificates, biomarker capability evidence, and biomarkers this organization publishes on.