Organization (Industry)
PENUMBRA, INC.
ClinicalTrials.gov lists PENUMBRA, INC. as lead sponsor of 33 trials. It has 4 active development programs and 1 approved asset.
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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 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.0 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers PENUMBRA, INC.: 33 lead-sponsored trials and 3 legal-entity registrations.
Disease areas (11)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Stroke | 18 |
| Ischemic Stroke | 16 |
| Intracranial Aneurysm | 6 |
| Cerebral Hemorrhage | 5 |
| Hemorrhage | 5 |
Showing 5 of 11 disease areas.
Trials by start year as sponsor or collaborator (19)
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 |
| 2023 | 2 |
| 2022 | 3 |
| 2021 | 4 |
| 2020 | 2 |
| 2019 | 4 |
| 2018 | 3 |
| 2017 | 3 |
| 2016 | 2 |
Showing 10 of 19 years.
Recruitment duration, a model prediction: none of the 33 trials evaluated at the 2026-10-09 snapshot is predicted and still running. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (4)
Shown in this order: max phase, then active trials.
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Medical Management | Ischemic Stroke | Not reported | 1 |
| Medical Management | Stroke | Not reported | 1 |
| Mechanical thrombectomy | Ischemic Stroke | Not reported | 2 |
| Mechanical thrombectomy | Stroke | Not reported | 2 |
Approved assets (1)
| Drug | Trials |
|---|---|
| Intravenous (IV) recombinant human tissue plasminogen activator (rtPA) | 1 |
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 |
|---|---|
| 30% hit target (n=20) | 56% on time (n=18) |
Journals published in (17)
Shown in this order: most published in first.
| Journal | Publications |
|---|---|
| Frontiers in neurology | 3 |
| Journal of neurointerventional surgery | 3 |
| Journal of vascular surgery | 3 |
| Stroke | 3 |
| International journal of stroke : official journal of the International Stroke Society | 2 |
Showing 5 of 17 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 |
|---|---|---|
| 75 | 53 | 2025-12-23 |
SEC-reported annual financials (11)
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 | 1,403,665,000 | 177,687,000 | 89,766,000 |
| 2024 | 1,194,615,000 | 14,012,000 | 94,783,000 |
| 2023 | 1,058,522,000 | 90,954,000 | 84,423,000 |
| 2022 | 847,133,000 | -2,002,000 | 79,407,000 |
| 2021 | 747,590,000 | 5,284,000 | 104,552,000 |
| 2020 | 560,412,000 | -15,702,000 | 90,049,000 |
| 2019 | 547,405,000 | 48,458,000 | 51,723,000 |
| 2018 | 444,938,000 | 6,601,000 | 36,165,000 |
| 2017 | 333,764,000 | 4,657,000 | 31,661,000 |
| 2016 | 263,317,000 | 14,814,000 | 23,875,000 |
Showing 10 of 11 fiscal years.
Financing and grant events (11)
Shown in this order: most recent first.
| Date | Round type | Amount (USD) | Source |
|---|---|---|---|
| 2026-05-07 | Other financing | not disclosed | Sec extracted |
| 2026-01-14 | Other financing | not disclosed | Sec extracted |
| 2024-08-13 | Other financing | not disclosed | Sec extracted |
| 2023-02-23 | Other financing | not disclosed | Edgar offerings |
| 2021-10-01 | Other financing | not disclosed | Sec extracted |
Showing 5 of 11 events.
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 10 |
FDA recalls (6)
Shown in this order: most recent first.
| Product | Classification | Initiated |
|---|---|---|
| Penumbra System RED 68 Reperfusion Catheter REF: RED68KIT | Class II | 2026-06-03 |
| Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | Class I | 2020-12-15 |
| Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | Class I | 2020-12-15 |
| Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | Class I | 2020-12-15 |
| Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the efficient removal of thrombus from the neurovasculature. The Penumbra Aspiration Pump is indicated as a vacuum source for Penumbra Aspiration Systems. | Class I | 2020-12-15 |
Showing 5 of 6 recalls.
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 2 | 2023-02-14 |
Manufacturing and distribution sites (4)
Shown in this order: severity rank then name.
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| PENUMBRA, INC. | Alameda, US | FDA | |
| Penumbra Inc. | Roseville, US | FDA | |
| Penumbra Inc. | Livermore, US | FDA | |
| Penumbra Inc. | Salt Lake City, 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 | 45.0% | not disclosed |
Latest dated events (144)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-06-26 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2026-06-03 | FDA recall | FDA enforcement (warning and untitled letters, recalls, inspections, import refusals, debarment) |
| 2026-05-07 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2026-01-14 | Financing | Funding rounds and grants (NIH RePORTER + SEC EDGAR) |
| 2025-12-23 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 144 events.
Biomarker capability evidence (42)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| NPPB | Trial sponsor | Named in trial inclusion criteria |
| TSPAN33 | Trial sponsor | Named in trial inclusion criteria |
| TSPAN33 | Trial sponsor | Named in trial inclusion criteria |
| TSPAN33 | Trial sponsor | Named in trial inclusion criteria |
| TSPAN33 | Trial sponsor | Named in trial inclusion criteria |
Showing 5 of 42 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, fda warning letters, fda untitled letters, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.