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They further explained that no appropriate clinical APC exists for this procedure and note that it has very low Medicare utilization rates upon which to base a clinical APC assignment

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Dorsam GP, Benton K, Failing J, Batra S

2022;23(8):4429. Published 2022 Apr 17

Preclinical studies have investigated its involvement in: cell migration and fibroblast activity angiogenesis pathways cytoskeletal organization soft-tissue repair models muscle and ligament experimental injury models TB-500 is typically studied for its influence on cellular processes that contribute to tissue remodeling

For your clinic, this impacts: Your service menu Treatment descriptions Consent forms Marketing materials If you say a treatment is "FDA-approved" when it isn't, or hint at benefits the data doesn't back, you risk regulatory trouble