COMPANY
Mercator MedSystems, Inc.
FDA-cleared device company Clinical Phase 3
Funding and NIH signals
- NIH award NIH awarded $1M (SBIR Phase II 5R44HL102998-06, continuation, notice May 11, 2026). NIH RePORTER 5R44HL102998-06 (May 11, 2026)
Evidence (1 event)
- May 11, 2026 · NIH RePORTER 5R44HL102998-06
Organization: MERCATOR MEDSYSTEMS, INC.; City/State: San Leandro, CA; Project number: 5R44HL102998-06; Activity code: R44; Fiscal year: 2026; Award notice date: 2026-05-11; FY total cost (award amount): 1000000; Administering IC: National Heart Lung and Blood Institute; Project title: Improved Sirolimus-Analog Adventitial Delivery to Enhance Outcomes in Below-the-Knee Peripheral Artery Disease; Organization type: Domestic For-Profits
- May 11, 2026 · NIH RePORTER 5R44HL102998-06
Timeline
- Grant Government grant — SBIR: $1M (annual award, as published), announced May 11, 2026. Agency: NIH/NHLBI. Source: government award database. source ↗
- Grant Government grant — SBIR: $1.1M (annual award, as published), announced Aug 4, 2025. Agency: NIH/NHLBI. Source: government award database. source ↗
- Trial start Phase 3: Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee source ↗
- Grant Government grant — SBIR: $1M (annual award, as published), announced Mar 7, 2025. Agency: NIH/NHLBI. Source: government award database. source ↗
- Trial start Phase 2: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT source ↗
- Trial start Phase 2: Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT source ↗
- Trial start Phase 2: Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization source ↗
- Trial start Phase 2: Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO) source ↗
- Trial start Phase 2: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization source ↗
- Trial start Phase 2: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization source ↗
- Trial start —: DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes source ↗
- Trial start Not phased (device or behavioral study): Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients source ↗
- Trial start Phase 4: Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease source ↗
Upcoming milestones
- Dec 31, 2026 (ESTIMATED) · Phase 2 · Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT · NCT04862468
- Feb 1, 2028 (ESTIMATED) · Phase 3 · Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee · NCT04433572
Funding
- Government grant — SBIR: $1M (annual award, as published), announced May 11, 2026. Agency: NIH/NHLBI. Source: government award database. source ↗
- Government grant — SBIR: $1.1M (annual award, as published), announced Aug 4, 2025. Agency: NIH/NHLBI. Source: government award database. source ↗
- Government grant — SBIR: $1M (annual award, as published), announced Mar 7, 2025. Agency: NIH/NHLBI. Source: government award database. source ↗
Clinical trials (lead sponsor) 10
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT04862468 | Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Acute Femoropopliteal DVT | Phase 2 | Recruiting | Oct 29, 2021 | Dec 31, 2026 (estimated) |
| NCT04858776 | Perivenous Dexamethasone Therapy: Examining Reduction of Inflammation After Thrombus Removal to Yield Benefit in Subacute and Chronic Iliofemoral DVT | Phase 2 | Active, not recruiting | Aug 8, 2022 | Aug 28, 2025 (actual) |
| NCT04433572 | Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee | Phase 3 | Recruiting | Jul 30, 2025 | Feb 1, 2028 (estimated) |
| NCT03942601 | Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization | Phase 2 | Terminated | Oct 1, 2019 | Apr 30, 2021 (actual) |
| NCT02908035 | Temsirolimus Adventitial Delivery to Improve Angiographic Outcomes Below the Knee (TANGO) | Phase 2 | Unknown status (ClinicalTrials.gov) | Mar 3, 2017 | 2020-09 (estimated) |
| NCT02479555 | Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization | Phase 2 | Unknown status (ClinicalTrials.gov) | 2016-01 | 2020-08 (estimated) |
| NCT02479620 | Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization | Phase 2 | Unknown status (ClinicalTrials.gov) | 2016-06 | 2019-11 (actual) |
| NCT02066103 | Broncho-Adventitial Delivery of Paclitaxel to Extend Airway Patency in Malignant Airway Obstruction Patients | Not phased (device or behavioral study) | Completed | 2014-07 | 2016-06 (actual) |
| NCT02469532 | DANCE Partner: Inflammatory Biomarker Analysis by Femoropopliteal Revascularization Method and Treatment Outcomes | Not listed | Completed | 2015-05 | 2017-10 (actual) |
| NCT01983449 | Effectiveness of Adventitial Dexamethasone in Peripheral Artery Disease | Phase 4 | Completed | 2013-11 | 2016-12 (actual) |