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MRI or ultrasound-confirmed partial-thickness rotator cuff tears and tendinopathy without complete disruption represent standard inclusion criteria across most investigations, while full-thickness tears with retraction, massive tears, and advanced degeneration are typically excluded due to concerns about biological healing capacity and mechanical limitations that may compromise regenerative potential [68]
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Each batch undergoes comprehensive testing for heavy metals, microbial contamination, and endotoxins through third-party laboratories including SGS, providing documentation that supports regulatory submissions in markets including North America, Europe, Switzerland, South Africa, Southeast Asia, and Australia