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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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In addition, the blood pressure of tails was not significantly different between the control and BPC 157 groups either 5,6

Furthermore, BPC-157 modulates the central dopaminergic and serotonergic systems, which could explain the neuroprotective effects observed in animal models

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