Organization (Industry)
ESTABLISHMENT LABS HOLDINGS INC.
ClinicalTrials.gov lists ESTABLISHMENT LABS HOLDINGS INC. as lead sponsor of 10 trials, counting the companies grouped under it.
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Trials started per year with this organization as sponsor or collaborator, 1990 onward. Companies grouped under this one are not included. 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 1.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers ESTABLISHMENT LABS HOLDINGS INC. and 1 company grouped under it: 10 lead-sponsored trials (7 its own, 3 in the grouped companies) and 1 legal-entity registration (1 its own, 0 in the grouped companies).
Companies grouped under this page (1)
| Company | Lead trials | Legal entities |
|---|---|---|
| Motiva USA LLC | 3 | 0 |
Disease areas (2)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Breast Neoplasms | 3 |
| Syndactyly | 1 |
Trials by start year as sponsor or collaborator (4)
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 | 3 |
| 2022 | 1 |
| 2020 | 2 |
Recruitment duration, a model prediction: none of the 7 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 |
|---|---|
| 1 of 2 hit target (n=2) | 1 of 2 on time (n=2) |
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 |
|---|---|---|
| 29 | 19 | 2025-09-02 |
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 | 211,076,000 | -51,064,000 | 20,247,000 |
| 2024 | 166,025,000 | -84,596,000 | 19,706,000 |
| 2023 | 165,151,000 | -78,502,000 | 26,428,000 |
| 2022 | 161,700,000 | -75,209,000 | 20,269,000 |
| 2021 | 126,682,000 | -41,139,000 | 18,315,000 |
| 2020 | 84,676,000 | -38,121,000 | 13,793,000 |
| 2019 | 89,565,000 | -38,150,000 | 14,991,000 |
| 2018 | 61,208,000 | -21,098,000 | 12,687,000 |
| 2017 | 34,681,000 | -34,897,000 | 6,864,000 |
| 2016 | not reported | not reported | not reported |
Financing and grant events (23)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-04-30 | Debt financing | 265,000,000 | Sec extracted |
| 2025-09-29 | Debt financing | 25,000,000 | Sec extracted |
| 2024-11-08 | Follow-on offering | 49,999,883 | Edgar offerings |
| 2024-11-07 | Registered direct | not disclosed | Sec extracted |
| 2024-11-07 | Debt financing | not disclosed | Sec extracted |
Showing 5 of 23 events.
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| ESTABLISHMENT LABS S.A. | Coyol Alajuela, CR | 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 | not disclosed | not disclosed |
Organization relationships (1)
| Related organization | Relationship | Evidence |
|---|---|---|
| NAMSA (France) | Co sponsors trial with | 1 |
Latest dated events (64)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-04-30 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2025 Q4 | PDUFA decision date | Regulatory decision dates extracted from SEC filings |
| 2025-09-29 | Debt facility | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2025-09-02 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-08-26 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 64 events.
Not on this page
Checked, with nothing recorded for this organization: related companies not grouped here, active development programs, approved assets, journals published in, fda warning letters, fda untitled letters, fda inspection record, fda recalls, fda import refusals, clia clinical laboratory certificates, biomarker capability evidence, and biomarkers this organization publishes on.