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

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

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

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