SAM 2.0 / 1% diclofenac patch / ZetrOZ - LARVOL DELTA

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: ZetrOZ, Inc. | Trial completion date: Dec 2024 ➔ Feb 2026 | Trial primary completion date: Jun 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics • Pain

Sustained Acoustic Medicine for Osteoarthritis Pain (clinicaltrials.gov) - P1 | N=200 | Recruiting | Sponsor: ZetrOZ, Inc. | Completed ➔ Recruiting | N=30 ➔ 200 | Trial completion date: Feb 2023 ➔ May 2026 | Trial primary completion date: Jan 2023 ➔ May 2026

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: ZetrOZ, Inc. | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Dec 2024 ➔ Feb 2026

Enrollment open • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (clinicaltrials.gov) - P2 | N=200 | Completed | Sponsor: ZetrOZ, Inc. | Recruiting ➔ Completed | N=120 ➔ 200 | Trial completion date: Dec 2024 ➔ Feb 2024 | Trial primary completion date: Dec 2024 ➔ Dec 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: ZetrOZ, Inc.

New P2 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine for Knee Osteoarthritis Pain (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: ZetrOZ, Inc. | Recruiting ➔ Completed | N=90 ➔ 30

Enrollment change • Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: ZetrOZ, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Musculoskeletal Diseases • Orthopedics • Pain

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: ZetrOZ, Inc. | Trial completion date: Dec 2023 ➔ Dec 2024 | Initiation date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain (clinicaltrials.gov) - P1/2 | N=60 | Completed | Sponsor: ZetrOZ, Inc. | Recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ Dec 2022 | Trial primary completion date: Sep 2022 ➔ Dec 2022

Trial completion • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: ZetrOZ, Inc.

New P2 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture (clinicaltrials.gov) - P1 | N=90 | Not yet recruiting | Sponsor: ZetrOZ, Inc.

New P1 trial • Musculoskeletal Diseases • Orthopedics • Pain

Sustained Acoustic Medicine for Knee Osteoarthritis Pain (clinicaltrials.gov) - P1 | N=90 | Recruiting | Sponsor: ZetrOZ, Inc.

New P1 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: ZetrOZ, Inc.

New P1/2 trial • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Sustained Acoustic Medicine Combined with A Diclofenac Ultrasound Coupling Patch for the Rapid Symptomatic Relief of Knee Osteoarthritis: Multi-Site Clinical Efficacy Study. (PubMed, Open Orthop J) - P1 | "Sustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain. The clinical findings suggest that this treatment approach may be used as a conservative, non-invasive treatment option for patients with knee osteoarthritis. Additional research is warranted on non-weight bearing joints of the musculoskeletal system as well as different topical drugs that could benefit from improved localized delivery.Clinical Trial Registry Number: (NCT04391842)."

Clinical • Journal • Immunology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoarthritis • Pain • Rheumatology

SAM 2.0 Treatment Provides Non-Surgical Pain Relief for Federal Employees and Veterans Suffering From Knee Arthritis (PRNewswire) - "A recent research study published in The Open Orthopaedics Journal highlights the efficacy of SAM ultrasound when combined with a 1% diclofenac ultrasound gel patch in the treatment of pain and complications due to knee osteoarthritis...'Sustained Acoustic Medicine combined with 1% topical diclofenac rapidly reduced pain and improved function in patients with moderate to severe osteoarthritis-related knee pain.'"

Clinical • Osteoarthritis • Pain