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After consideration of the public comments we received and our review of the application, we continue to believe that C1831 appropriately describes the aprevo Cervical ACDF System, because the aprevo Cervical ACDF System is a personalized interbody cage that is implanted using an anterior surgical approach, and C1831 describes any device that is a personalized interbody cage, designed for anterior, lateral, or posterior procedures
The strongest clinical evidence shows 26.5% regrowth over 5 months with microneedling-assisted delivery (Kuceki et al., 2025)
Hydroxylation of 5-methylcytosine by TET1 promotes active DNA demethylation in the adult brain
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