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Yes pilot batches or samples can be arranged for R&D, stability studies, or formulation trials

While animal studies consistently demonstrate beneficial effects across diverse injury models and tissue types, the absence of adequately powered, controlled human clinical trials prevents definitive conclusions about efficacy in human disease

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Every batch undergoes quality testing before release

(See Table 3 on page 10.) Because they are now inclusive of all imaging, the existing ultrasound documentation guidelines are reiterated in conjunction with the new codes