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Response: Although we acknowledge the applicant's concerns regarding the descriptor for C1739, we do not agree that the device category code should be withdrawn and replaced with a new code effective January 1, 2026, for the following reasons: First, per the applicant's request prior to CY 2026 rulemaking, CMS revised the descriptor for C1739 to read, effective October 1, 2025: Tissue marker, uniquely detectable and identifiable with probe/sensor, any method (implantable), with delivery system

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BPC-157 operates primarily at the vascular and fibroblast level, driving the early angiogenic response and connective tissue rebuilding