COMPANY
Integra LifeSciences
FDA-cleared device company Past trials only
Timeline
- Debt Debt: $600M (not counted as a raise), announced Oct 2, 2026. Source: company release on GlobeNewswire. source ↗
- Trial start —: Urinary Bladder Matrix (UBM) Registry source ↗
- FDA FDA 510(k) clearance: CUSA® Clarity Ultrasonic Surgical Aspirator System — K251162, Oct 8, 2025. Applicant at approval: Integra LifeSciences Corporation. source ↗
- Trial start —: AERA Pediatrics Registry source ↗
- FDA FDA 510(k) clearance: AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) — K250752, Apr 9, 2025. Applicant at approval: Integra LifeSciences Corporation. source ↗
- Trial start —: Tissue Quality of Integra vs. BTM Treated Burns source ↗
- Trial start Not phased (device or behavioral study): MicroMatrix® Flex in Tunneling Wounds source ↗
- Trial start Not phased (device or behavioral study): A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers source ↗
- Trial start —: Bactiseal Catheter Safety Registry Study source ↗
- Trial start —: Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study source ↗
- Trial start —: T-GENVIH-003 LTFU (Long Term Follow Up) Study source ↗
- Trial start —: The CUSA Clarity Bone Tip Study source ↗
- Trial start —: External Ventricular Drainage Post-Market Clinical Follow-up Registry source ↗
- Trial start —: Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve source ↗
- Trial start —: Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair source ↗
- Trial start —: REINVENT Registry (Registry of the Nerve Gap Repair From Integra) source ↗
- Trial start Not phased (device or behavioral study): NeuraGen 3D Pilot Study source ↗
- Trial start —: The SurgiMend PRS Retrospective Study source ↗
- Trial start Not phased (device or behavioral study): The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH) source ↗
- Trial start Not phased (device or behavioral study): AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers source ↗
- Trial start —: Suturable DuraGen™ PMCF Study source ↗
- Trial start —: The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation source ↗
- Trial start —: Bactiseal Catheter Safety Registry in China source ↗
- Trial start —: A Study on the Safety of Hakim Programmable Shunt System source ↗
- Trial start —: The CUSA Clarity Soft Tissue Removal Study source ↗
Upcoming milestones
- Dec 31, 2026 (ESTIMATED) · Not phased · A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers · NCT06453187
- Oct 15, 2028 (ESTIMATED) · · The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation · NCT04494295
- Jan 24, 2029 (ESTIMATED) · · Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve · NCT05397106
- Aug 31, 2029 (ESTIMATED) · · Urinary Bladder Matrix (UBM) Registry · NCT07805798
- 2030-10 (ESTIMATED) · · AERA Pediatrics Registry · NCT07071298
Funding
- Debt: $600M (not counted as a raise), announced Oct 2, 2026. Source: company release on GlobeNewswire. source ↗
Clinical trials (lead sponsor) Showing 50 of 82
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT06760611 | Tissue Quality of Integra vs. BTM Treated Burns | Not listed | Withdrawn | Mar 1, 2025 | Sep 30, 2025 (actual) |
| NCT07805798 | Urinary Bladder Matrix (UBM) Registry | Not listed | Not yet recruiting | Aug 31, 2026 | Aug 31, 2029 (estimated) |
| NCT06453187 | A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers | Not phased (device or behavioral study) | Enrolling by invitation | Nov 18, 2024 | Dec 31, 2026 (estimated) |
| NCT07071298 | AERA Pediatrics Registry | Not listed | Recruiting | Jun 17, 2025 | 2030-10 (estimated) |
| NCT06629506 | MicroMatrix® Flex in Tunneling Wounds | Not phased (device or behavioral study) | Completed | Dec 12, 2024 | Aug 31, 2025 (actual) |
| NCT05397106 | Post Market Clinical Follow-up of CODMAN CERTAS Programmable Valve | Not listed | Active, not recruiting | Jan 24, 2023 | Jan 24, 2029 (estimated) |
| NCT04494295 | The MIRROR Registry: Minimally Invasive IntRaceRebral HemORrhage Evacuation | Not listed | Recruiting | Oct 23, 2020 | Oct 15, 2028 (estimated) |
| NCT05652296 | External Ventricular Drainage Post-Market Clinical Follow-up Registry | Not listed | Completed | Mar 3, 2023 | Dec 16, 2024 (actual) |
| NCT05113381 | The Purpose of This Study is to Determine Whether CerebroFlo™ EVD Catheter is Effective During the Treatment of Intraventricular Hemorrhage (IVH) | Not phased (device or behavioral study) | Completed | Sep 15, 2021 | Jul 31, 2025 (actual) |
| NCT06034652 | T-GENVIH-003 LTFU (Long Term Follow Up) Study | Not listed | Completed | Sep 12, 2023 | Jan 19, 2024 (actual) |
| NCT04923867 | Suturable DuraGen™ PMCF Study | Not listed | Completed | Apr 28, 2021 | Jul 31, 2024 (actual) |
| NCT05182177 | The SurgiMend PRS Retrospective Study | Not listed | Completed | Jan 31, 2022 | Dec 31, 2024 (actual) |
| NCT06276543 | Bactiseal Catheter Safety Registry Study | Not listed | Recruiting | Sep 29, 2024 | Jul 31, 2026 (estimated) |
| NCT06297187 | Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study | Not listed | Completed | Feb 23, 2024 | Jul 31, 2024 (actual) |
| NCT01324271 | inVENT-In-Office Study | Not phased (device or behavioral study) | Completed | 2011-01 | 2012-05 (actual) |
| NCT01496287 | Tympanostomy Tube Placement in Children in the Office (Inova Study) | Not phased (device or behavioral study) | Completed | 2011-12 | 2012-04 (actual) |
| NCT01202578 | Evaluation of the Tympanostomy Tube Delivery System | Phase 2/Phase 3 | Completed | 2010-09 | 2010-11 (actual) |
| NCT01054703 | Clinical Evaluation of the Ethmoid Sinus Spacer | Not phased (device or behavioral study) | Terminated | Apr 1, 2007 | Nov 1, 2007 (actual) |
| NCT00939796 | Clinical Study of the Tympanostomy Tube Delivery System | Not phased (device or behavioral study) | Completed | 2009-03 | 2009-06 (actual) |
| NCT00791934 | Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide | Not phased (device or behavioral study) | Completed | 2008-08 | 2011-11 (actual) |
| NCT01046877 | Singapore Tympanostomy Tube Delivery System Study | Not phased (device or behavioral study) | Completed | 2008-12 | 2010-08 (actual) |
| NCT01107379 | Optimization and Refinement of Technique in In-Office Sinus Dilation 2 | Not listed | Completed | 2010-04 | 2012-01 (actual) |
| NCT00231062 | Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) | Phase 3 | Completed | 2005-04 | 2006-06 (actual) |
| NCT01714687 | Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET) | Not phased (device or behavioral study) | Completed | Oct 1, 2012 | Oct 1, 2015 (actual) |
| NCT01685229 | Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis | Not listed | Completed | Sep 1, 2012 | Apr 1, 2015 (actual) |
| NCT02150044 | Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion | Not phased (device or behavioral study) | Completed | 2010-02 | 2010-10 (actual) |
| NCT00941993 | Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus | Not phased (device or behavioral study) | Completed | 2008-04 | 2011-01 (actual) |
| NCT00939393 | Balloon Sinus Dilation In Office or OR | Not phased (device or behavioral study) | Completed | Apr 1, 2008 | Jun 1, 2009 (actual) |
| NCT02087150 | Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter | Not phased (device or behavioral study) | Completed | Feb 1, 2014 | Dec 1, 2016 (actual) |
| NCT00939471 | Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis | Not phased (device or behavioral study) | Completed | Apr 1, 2007 | Jul 1, 2009 (actual) |
| NCT02347943 | Global Sinus Surgery Registry | Not listed | Terminated | Jan 1, 2015 | Nov 1, 2015 (actual) |
| NCT01444391 | inVENT-visIOn Study | Not phased (device or behavioral study) | Completed | 2011-10 | 2012-05 (actual) |
| NCT01047904 | Anesthetizing the Tympanic Membrane in Healthy Volunteers | Not phased (device or behavioral study) | Completed | 2009-08 | 2009-11 (actual) |
| NCT01346332 | Healthy Volunteer Study | Not listed | Completed | Apr 1, 2011 | Feb 1, 2012 (actual) |
| NCT01455948 | Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis | Not phased (device or behavioral study) | Terminated | 2012-02 | 2012-11 (actual) |
| NCT05339594 | REINVENT Registry (Registry of the Nerve Gap Repair From Integra) | Not listed | Terminated | May 30, 2022 | Jun 3, 2024 (actual) |
| NCT01611246 | Earset Healthy Volunteer Study | Not listed | Completed | May 1, 2012 | Aug 1, 2012 (actual) |
| NCT05610267 | Gentrix® Surgical Matrix for Soft Tissue Reinforcement in Ventral Hernia Repair | Not listed | Completed | Nov 22, 2022 | Dec 28, 2022 (actual) |
| NCT05343143 | NeuraGen 3D Pilot Study | Not phased (device or behavioral study) | Terminated | May 15, 2022 | Jul 11, 2023 (actual) |
| NCT01612806 | A Multi-center, Prospective, Randomized Study With PriMatrix and PriMatrix Ag for the Treatment of Venous Leg Ulcers | Not phased (device or behavioral study) | Terminated | 2011-06 | 2017-02 (actual) |
| NCT04300075 | The CUSA Clarity Bone Tip Study | Not listed | Withdrawn | 2023-06 | 2024-08 (estimated) |
| NCT04496414 | Bactiseal Catheter Safety Registry in China | Not listed | Completed | Sep 1, 2020 | Nov 30, 2020 (actual) |
| NCT03010319 | PriMatrix for the Management of Diabetic Foot Ulcers | Not phased (device or behavioral study) | Completed | 2017-01 | 2020-08 (actual) |
| NCT02021279 | ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study | Not phased (device or behavioral study) | Completed | Jun 11, 2014 | Apr 28, 2021 (actual) |
| NCT04298268 | The CUSA Clarity Soft Tissue Removal Study | Not listed | Completed | Mar 30, 2020 | Nov 24, 2021 (actual) |
| NCT04207229 | CERTAS Programmable Valve Registry | Not listed | Completed | Nov 21, 2019 | Nov 18, 2021 (actual) |
| NCT03816202 | Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF) | Not listed | Completed | Apr 25, 2019 | Aug 27, 2019 (actual) |
| NCT04285489 | A Study on the Safety of Hakim Programmable Shunt System | Not listed | Completed | May 2, 2020 | Jul 28, 2020 (actual) |
| NCT05024656 | AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers | Not phased (device or behavioral study) | Withdrawn | 2021-09 | 2024-02 (estimated) |
| NCT03626623 | Diabetic Foot Ulcer Study Comparing Cytal Wound Matrix 1-Layer to Standard of Care | Not phased (device or behavioral study) | Terminated | May 21, 2019 | Feb 18, 2020 (actual) |
FDA records (last 2 years)
- FDA 510(k) clearance: CUSA® Clarity Ultrasonic Surgical Aspirator System — K251162, Oct 8, 2025. Applicant at approval: Integra LifeSciences Corporation. source ↗
- FDA 510(k) clearance: AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80) — K250752, Apr 9, 2025. Applicant at approval: Integra LifeSciences Corporation. source ↗
NIH awards 4
- NIH award 1R44GM059531-01 FY1999: $251,148 awarded for that fiscal year; activity R44 (SBIR); PI CAHN, FREDERICK; recipient as written: INTEGRA LIFESCIENCES CORPORATION, PLAINSBORO, NJ. PEPTIDE ENHANCED ARTIFICIAL SK source ↗
- NIH award 1R43GM060084-01 FY1999: $122,809 awarded for that fiscal year; activity R43 (SBIR); PI KEMNITZER, JOHN E; recipient as written: INTEGRA LIFESCIENCES CORPORATION, PLAINSBORO, NJ. GAS BLOWN RESORBABLE BIOMATE source ↗
- NIH award 1R41NS036091-01 FY1997: $99,998 awarded for that fiscal year; activity R41 (STTR); PI BATRA, SURENDRA; recipient as written: INTEGRA LIFESCIENCES CORPORATION, PLAINSBORO, NJ. NERVE REGENERATION USING MAGNET source ↗
- NIH award 1R43NS034224-01 FY1995: $99,990 awarded for that fiscal year; activity R43 (SBIR); PI BATRA, SURENDRA; recipient as written: INTEGRA LIFESCIENCES CORPORATION, PLAINSBORO, NJ. CAVERNOSAL NERVE REPAIR FOLLOWI source ↗
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