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The Core Difference: Preservative vs No Preservative Bacteriostatic water contains 0.9% benzyl alcohol, a preservative that inhibits bacterial growth and allows multi-dose use over 28 days

Comment: The applicant acknowledged that CMS applies a high evidentiary standard for substantial clinical improvement, typically requiring robust clinical data showing improved patient outcomes such as reduced complications, fewer reoperations, faster recovery, or better functional results compared to the current standard of care

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Bacteriostatic Water for Injection is a sterile, preserved water solution containing benzyl alcohol as a bacteriostatic agent

The research literature focuses overwhelmingly on GHK-Cu because it's the form found naturally in human tissue