COMPANY

ZetrOZ Systems

HQ: Trumbull, CT source · zetroz.com ↗ · New England

FDA-cleared device company Clinical Phase 2

Location: Trumbull, CT · source · Oct 15, 2026

Profile checked Oct 10, 2026

Keywords: Osteo Arthritis Knee Arthritis Knee Osteoarthritis Osteoarthritis Chronic Pain Tendon Injuries Acute Pain Sport Injury Soft Tissue Injuries Back Pain Muscle Injury Osteo Arthritis of the Knee Measurement of Circulation on Anatomical Locations of the Body Bone Fracture Fresh Fracture Measurement of Diathermy on Anatomical Locations of the Body Musculoskeletal Injury Muscle Spasm Tendinopathy Tendinitis Tendinosis Musculoskeletal Pain Chronic Low Back Pain Intervertebral Disc Displacement Sustained Acoustic Medicine

18Trials (company is sponsor)1FDA records (2 yrs)16NIH grants

Funding and NIH signals

NIH award NIH awarded $2.15M (SBIR Phase II 5R44AG061985-08, continuation, notice Aug 17, 2026). NIH RePORTER 5R44AG061985-08 (Aug 17, 2026)
Evidence (1 event)
- Aug 17, 2026 · NIH RePORTER 5R44AG061985-08
  Organization: ZETROZ SYSTEMS, LLC; City/State: TRUMBULL, CT; Project number: 5R44AG061985-08; Activity code: R44; Fiscal year: 2026; Award notice date: 2026-08-17; FY total cost (award amount): 2154078; Administering IC: National Institute on Aging; Project title: Daily & Localized NSAID Sonophoresis for Symptomatic Treatment of Knee Osteoarthritis; Organization type: Domestic For-Profits

Job counts as of Oct 18, 2026. All funding and NIH signals

Timeline

Aug 17, 2026 Grant Government grant — SBIR: $2.15M (annual award, as published), announced Aug 17, 2026. Agency: NIH/NIA. Source: government award database. source ↗
May 1, 2026 Trial start Phase 2: Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis source ↗
Apr 28, 2026 FDA FDA 510(k) clearance: SAM 3.0 Multi-Hour Continuous Ultrasound Device — K260076, Apr 28, 2026. Applicant at approval: ZetrOZ Systems, LLC. source ↗
Aug 5, 2025 Grant Government grant — SBIR: $2.36M (annual award, as published), announced Aug 5, 2025. Agency: NIH/NIA. Source: government award database. source ↗
Feb 21, 2025 Grant Government grant — SBIR: $1.46M (annual award, as published), announced Feb 21, 2025. Agency: NIH/NIMHD. Source: government award database. source ↗
Oct 1, 2024 Trial start Phase 2: Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis source ↗
Jul 22, 2024 Trial start Phase 1: Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation source ↗
Jun 3, 2023 Trial start Phase 2: Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis source ↗
Jun 1, 2023 Trial start Phase 1: Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture source ↗
Feb 21, 2022 Trial start Phase 1: Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance source ↗
Feb 14, 2022 Trial start Phase 1: Sustained Acoustic Medicine for Osteoarthritis Pain source ↗
Aug 1, 2021 Trial start Phase 1/Phase 2: Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain source ↗
Sep 1, 2020 Trial start —: Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care source ↗
Sep 1, 2019 Trial start Phase 1: Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis source ↗
Jan 1, 2017 Trial start Not phased (device or behavioral study): Long-Duration Ultrasound for Knee Osteoarthritis source ↗
2015-11 Trial start Not phased (device or behavioral study): Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions source ↗
Oct 1, 2015 Trial start —: Real-World Experience of Athletes Treated With SAM source ↗
2014-12 Trial start Not phased (device or behavioral study): Long Duration Therapeutic Ultrasound on Tendon Injuries source ↗
2014-06 Trial start Not phased (device or behavioral study): Low Intensity Ultrasound Therapy for Upper Back Pain Relief source ↗
2014-03 Trial start Not phased (device or behavioral study): Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial source ↗
2014-02 Trial start Not phased (device or behavioral study): Long Duration Therapeutic Ultrasound for Tendon Healing source ↗
2012-10 Trial start Not phased (device or behavioral study): Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis source ↗

Upcoming milestones

May 31, 2027 (ESTIMATED) · Phase 2 · Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis · NCT07515872

Estimated primary completion per ClinicalTrials.gov. Dates move.

Funding

Last 2 years.

Aug 17, 2026 Government grant — SBIR: $2.15M (annual award, as published), announced Aug 17, 2026. Agency: NIH/NIA. Source: government award database. source ↗
Aug 5, 2025 Government grant — SBIR: $2.36M (annual award, as published), announced Aug 5, 2025. Agency: NIH/NIA. Source: government award database. source ↗
Feb 21, 2025 Government grant — SBIR: $1.46M (annual award, as published), announced Feb 21, 2025. Agency: NIH/NIMHD. Source: government award database. source ↗

Clinical trials (lead sponsor) 18

Record	Title	Phase	Status	Start	Primary completion
NCT06257537	Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis	Phase 2	Completed	Oct 1, 2024	Jun 26, 2026 (actual)
NCT07515872	Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis	Phase 2	Not yet recruiting	May 1, 2026	May 31, 2027 (estimated)
NCT05882812	Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis	Phase 2	Completed	Jun 3, 2023	Dec 31, 2023 (actual)
NCT05050448	Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain	Phase 1/Phase 2	Completed	Aug 1, 2021	Dec 1, 2022 (actual)
NCT06510062	Comparative Evaluation of Sustained Acoustic Medicine Device on Circulation	Phase 1	Completed	Jul 22, 2024	Sep 30, 2024 (actual)
NCT05883241	Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture	Phase 1	Recruiting	Jun 1, 2023	Feb 1, 2026 (estimated)
NCT05254574	Sustained Acoustic Medicine for Osteoarthritis Pain	Phase 1	Recruiting	Feb 14, 2022	May 1, 2026 (estimated)
NCT04391842	Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis	Phase 1	Completed	Sep 1, 2019	Dec 31, 2019 (actual)
NCT03800927	Long-Duration Ultrasound for Knee Osteoarthritis	Not phased (device or behavioral study)	Completed	Jan 1, 2017	Jun 1, 2019 (actual)
NCT05259995	Sustained Acoustic Medicine Ultrasound Diathermy Clinical Performance	Phase 1	Completed	Feb 21, 2022	Jun 30, 2022 (actual)
NCT05254470	Real-World Experience of Patients Treated for Musculoskeletal Injuries With SAM in Routine Care	Not listed	Completed	Sep 1, 2020	Feb 1, 2022 (actual)
NCT02135094	Low Intensity Ultrasound Therapy for Upper Back Pain Relief	Not phased (device or behavioral study)	Completed	2014-06	2015-09 (actual)
NCT04177537	Real-World Experience of Athletes Treated With SAM	Not listed	Completed	Oct 1, 2015	Oct 31, 2015 (actual)
NCT02083861	Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial	Not phased (device or behavioral study)	Completed	2014-03	2014-10 (actual)
NCT02466308	Long Duration Therapeutic Ultrasound for Tendon Healing	Not phased (device or behavioral study)	Completed	2014-02	2014-09 (actual)
NCT02340273	Long Duration Therapeutic Ultrasound on Tendon Injuries	Not phased (device or behavioral study)	Terminated	2014-12	2015-09 (actual)
NCT02609854	Sustained Acoustic Medicine for Chronic Low Back Pain Secondary to Herniated Nucleus Pulposus or Other Conditions	Not phased (device or behavioral study)	Completed	2015-11	2016-04 (actual)
NCT01993693	Wearable Therapeutic Ultrasound Study for Knee Osteoarthritis	Not phased (device or behavioral study)	Terminated	2012-10	2014-07 (actual)

FDA records (last 2 years)

Apr 28, 2026 FDA 510(k) clearance: SAM 3.0 Multi-Hour Continuous Ultrasound Device — K260076, Apr 28, 2026. Applicant at approval: ZetrOZ Systems, LLC. source ↗

NIH awards 16

Annual award amounts. Total $12.1M.

Sep 18, 2024 NIH award 2R44AG061985-06 FY2024: $2,196,474 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Daily & Localized NSAID Sonophoresis source ↗
Mar 6, 2024 NIH award 5R44MD015912-04 FY2024: $1,578,495 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Clinical Optimization of Ultrasonic D source ↗
Aug 10, 2023 NIH award 2R44MD015912-03 FY2023: $1,482,405 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Clinical Optimization of Ultrasonic D source ↗
Jun 3, 2022 NIH award 5R44AG061985-05 FY2022: $1,438,616 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Daily & Localized NSAID Sonophoresis source ↗
Jun 9, 2021 NIH award 5R43MD015912-02 FY2021: $233,597 awarded for that fiscal year; activity R43 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Clinical Optimization of Ultrasonic Dru source ↗
May 27, 2021 NIH award 5R44AG061985-04 FY2021: $1,427,916 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Daily & Localized NSAID Sonophoresis source ↗
Sep 15, 2020 NIH award 2R44AG061985-03 FY2020: $1,442,543 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Daily & Localized NSAID Sonophoresis source ↗
Sep 14, 2020 NIH award 1R43MD015912-01 FY2020: $217,772 awarded for that fiscal year; activity R43 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Clinical Optimization of Ultrasonic Dru source ↗
Aug 5, 2019 NIH award 5R43AG061985-02 FY2019: $223,719 awarded for that fiscal year; activity R43 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Daily and localized NSAID sonophoresis source ↗
Sep 18, 2018 NIH award 1R43AG061985-01 FY2018: $224,176 awarded for that fiscal year; activity R43 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Daily and localized NSAID sonophoresis source ↗
Jun 8, 2017 NIH award 5R44MD008597-06 FY2017: $400,000 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Self-Applied Wearable Ultrasound Therap source ↗
Jun 23, 2016 NIH award 5R44MD008597-05 FY2016: $400,000 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Self-Applied Wearable Ultrasound Therap source ↗
Apr 21, 2016 NIH award 6R44MD008597-04 FY2015: $268,958 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ SYSTEMS, LLC, TRUMBULL, CT. Self-Applied Wearable Ultrasound Therap source ↗
Sep 25, 2015 NIH award 2R44MD008597-03 FY2015: $131,042 awarded for that fiscal year; activity R44 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ, INC., TRUMBULL, CT. Self-Applied Wearable Ultrasound Therapy for O source ↗
May 1, 2014 NIH award 5R43MD008597-02 FY2014: $200,000 awarded for that fiscal year; activity R43 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ, INC., TRUMBULL, CT. Self-Applied Wearable Ultrasound Therapy for O source ↗
Sep 24, 2013 NIH award 1R43MD008597-01 FY2013: $196,601 awarded for that fiscal year; activity R43 (SBIR); PI LEWIS, GEORGE KENNETH; recipient as written: ZETROZ, INC., TRUMBULL, CT. Self-Applied Wearable Ultrasound Therapy for O source ↗