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Homocysteine has been linked to heart disease and other chronic conditions
The new code, though valid, has the subtlety of being an off-label use of the only two valid devices, so its not likely to be payable under coverage policies until the manufacturers can change their approved FDA labeling
The company clarified that: While the delay may affect near-term business plans, it also demonstrates that the company is following strict manufacturing and regulatory standards before introducing the product to the market
Storage duration critically impacts effectiveness - reconstituted GHK-Cu lasts only 21-28 days refrigerated due to copper oxidation concerns (shorter than most peptides), requiring strategic reconstitution of amounts usable within this window rather than preparing entire vials at once
However, large meta-analyses and regulatory reviews have not established a definitive causal relationship