Connecticut-based ZetrOZ Systems has achieved a significant milestone in arthritis care with its sam® 2.0 wearable ultrasound device receiving the Arthritis Foundation's Ease of Use® Certification. This recognition validates the device's accessibility for the nearly 60 million U.S. adults living with arthritis, representing approximately one in four adults who experience pain that limits their daily activities.
The sam® 2.0 device represents a breakthrough in sustained acoustic medicine, delivering long-duration, continuous, multi-hour, high-frequency ultrasound treatment that has been cleared by the U.S. Food and Drug Administration for treating soft-tissue injuries. The device has been documented in multiple clinical studies as an effective treatment for knee osteoarthritis and a spectrum of soft-tissue injuries.
Clinical Validation and Mechanism of Action
The effectiveness of ZetrOZ Systems' technology is supported by extensive clinical evidence, with over 30 clinical studies validating the sam® device's therapeutic benefits. The treatment has been administered to more than 3.7 million patients nationwide, establishing a substantial real-world evidence base for its clinical utility.
The sam® X1 and sam® 2.0 devices employ mechanobiological technology that provides deep warming to affected tissues. This therapeutic approach works by expanding blood vessel diameters and improving blood flow, which increases oxygenated hemoglobin delivery to tissues while facilitating the removal of cytokine enzymes and cellular waste products. These mechanisms collectively accelerate the natural healing process in patients with osteoarthritis and other soft-tissue injuries.
Addressing Unmet Medical Needs
The Arthritis Foundation's Ease of Use® seal specifically certifies products and packaging that have been tested and proven to make life easier for people with arthritis. This certification is particularly significant given that hundreds of children in addition to the 60 million adults have been diagnosed with arthritis and live with pain-related functional limitations.
"We're extremely pleased that the sam® 2.0 device has received the Arthritis Foundation's Ease of Use® certification," said George K. Lewis, founder and CEO of ZetrOZ Systems. "We are proud to support the Foundation's mission to improve the quality of life for people living with arthritis."
Technology and Innovation
ZetrOZ Systems has established itself as the inventor of sustained acoustic medicine, building its technology platform on 48 proprietary patents. The company, which has received research funding from the federal government, serves as the exclusive manufacturer and developer of the sam® product line, specifically designed to treat both acute and chronic musculoskeletal conditions.
The wearable bioelectronic devices represent a significant advancement in sports medicine and rehabilitation, offering patients a non-invasive treatment option that can be integrated into daily activities. The sustained acoustic medicine approach differentiates itself from traditional ultrasound therapy through its ability to deliver continuous treatment over extended periods.
Industry Impact and Future Implications
The certification aligns with the Arthritis Foundation's broader mission to turn arthritis-related obstacles into opportunities by championing life-changing solutions and medical advancements. The Foundation's recognition of the sam® 2.0 device underscores the importance of developing accessible treatment technologies that can improve patient outcomes while reducing barriers to care.
This development represents a convergence of wearable technology and evidence-based medicine, potentially setting new standards for how chronic musculoskeletal conditions are managed in both clinical and home settings. The extensive clinical validation combined with the ease-of-use certification positions the technology as a significant advancement in arthritis care delivery.
