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The Sonogen device is not cleared by FDA and is not available for sale in the United States.
Low-intensity pulsed ultrasound
Mechanisms of Action
Published studies of LIPUS have reported increased blood flow at the fracture site. Increased vascularity plays a crucial role in bone healing by delivering essential oxygen, nutrients, and growth factors to the injury site, facilitating cellular activities necessary for repair.
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Blood vessels deliver osteoprogenitor cells, mesenchymal stem cells, and immune cells that contribute to inflammation resolution, tissue regeneration, and bone remodeling. Angiogenesis, the process of new blood vessel formation, supports the development of the soft callus by ensuring adequate perfusion, which subsequently mineralizes into a hard callus. Additionally, enhanced vascularization removes waste products and prevents ischemia, reducing the risk of nonunion or delayed healing. Conditions that promote robust blood supply, such as adequate mechanical stability and the presence of vascular endothelial growth factor (VEGF), are associated with faster and stronger bone regeneration.
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Mechanisms of Action
According to the research on LIPUS, ultrasonic shear waves have been shown to be effective in stimulating the cellular integrin response during the healing process. Stimulating cellular integrin receptors promote cell adhesion, migration, and signal pathways essential for tissue regeneration.
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Integrins are transmembrane proteins that facilitate interactions between osteoblasts, osteoclasts, and the extracellular matrix (ECM), playing a key role in mechanotransduction and cellular differentiation. When integrins bind to ECM proteins like collagen and fibronectin, they activate intracellular signaling cascades, such as the focal adhesion kinase (FAK) pathway, which enhances osteoblast proliferation and bone matrix deposition. Additionally, integrin-mediated attachment strengthens the structural integrity of the bone healing environment, supporting mesenchymal stem cell recruitment and osteogenic differentiation. By improving cellular anchoring and mechanical responsiveness, integrin stimulation may also accelerate callus formation, bone remodeling, and overall fracture repair.
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Mechanisms of Action
Sonogen's device is designed specifically to focus acoustic energy on the periosteum, which is a fibrous sheath that covers bones, and contains the blood vessels and nerves that provide nourishment and sensation to the bone. It's a highly vascularized and osteogenic layer surrounding bones that plays a key role in bone tissue regeneration.
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The periosteum contains mesenchymal stem cells (MSCs), osteoprogenitor cells, and fibroblasts, which, when stimulated, proliferate and differentiate into osteoblasts and chondrocytes essential for bone repair. The periosteum also contributes to angiogenesis, ensuring a rich blood supply that supports bone mineralization and remodeling. By leveraging its regenerative capacity, periosteal stimulation may support healing, help reduce the risk of delayed union or nonunion, and support overall bone strength post-fracture.
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Sonogen is developing Ultrasonic Fracture Assessment (UFA) to explore how ultrasound data could help clinicians assess fracture healing over time. The approach is designed to analyze ultrasound echoes—the sound signals reflected from the fracture region—using digital signal processing and convolutional neural networks. The goal is to investigate whether patterns and changes in these signals could provide information about the healing process. X-rays and CT scans remain established tools for orthopedic assessment.
Ultrasonic Fracture Assessment (UFA) is a separate product in development. It is not part of the Sonogen bone growth stimulator and has not been cleared or approved by FDA.
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Select a numbered citation to view the full study details.
Rawool NM, Goldberg BB, Forsberg F, Winder AA, Hume E. Power Doppler assessment of vascular changes during fracture treatment with low-intensity ultrasound. Journal of Ultrasound in Medicine. 2003;22(2):145–153.
Naruse K, Miyauchi A, Itoman M, Mikuni-Takagaki Y. Distinct anabolic response of osteoblast to low-intensity pulsed ultrasound. Journal of Bone and Mineral Research. 2003;18(2):360–369.
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