Sam 3.0 Multi-Hour Continuous Ultrasound Device for Home Use

Sustained Acoustic Medicine SAM 3.0 OA325 multi-hour continuous ultrasound device is FDA-cleared for prescription home use to apply high-frequency (3MHz), high-dosimetry (1.3W, 18,720J) ultrasonic energy to generate and sustain deep non-thermal (mechanotransducive) and thermal (vigorous diathermy @ 44C) for the relief of pain associated with limited mobility and function related to soft tissue injuries including knee osteoarthritis, chronic myofascial pain, and shoulder, elbow and ankle tendinopathy. The SAM 3.0 innovation improves battery life and includes faster charging (USB-C) and high fidelity LEDs. This device introduces dual independently operated SAM zone regulation for maximum acoustic streaming and deep tissue stimulation over a sustained 4-hour period, with battery life extended over 8 hours. These are attached to the treatment site with ultrasonic coupling devices to allow for wearability, active daily use, and articulation on the body. The preset frequency, intensity and clinically proven therapeutic parameters cannot be modified by the user. This treatment algorithm provides thermal and mechanical stimulation into deep tissue (5-10 cm), to increase local circulation, stimulate cellular proliferation, improve joint lubricity, reduce inflammation, and relieve pain in the arthritic joint. SAM 3.0 OA325 is certified by the U.S. Arthritis Foundation for Ease-of-Use for arthritis patients with chronic joint pain. The basic science, clinical design efforts, human-factor validations, level I clinical studies and regulatory approvals are supported by the National Institutes of Health program wide initiative of Helping to End Opioid Addiction Long-Term® (NIH HEAL) and the National Institutes on Aging research programs for patients with chronic arthritis pain.