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Anil TM, Dandu A, Harsha K, Singh J, Shree N, Kumar VS, et al

Dysbiosis is associated with systemic inflammation and metabolic dysfunction in diabetes, both of which can exacerbate DPN

The applicant stated that it believes that the nominated device meets the substantial clinical improvement threshold, given its novel mechanism addressing unmet need for recurrent nerve compression injuries, and requested that CMS consider the provided clinical data and recognize the Axoguard HA+ Nerve Protector TM as an innovative device offering improved clinical outcomes

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After absorption, vitamin B12 binds in serum to specific B12-binding beta (transcobalamin) and B12-binding alpha1 globulin