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We noted in the CY 2026 OPPS/ASC proposed rule that based on the description the applicant provided, the Axoguard HA+ Nerve Protector TM is a porcine SIS ECM with hyaluronate-alginate coating used for the management and protection of peripheral nerve injuries where there is no gap or following closure of a gap, and thus, could be encompassed by the descriptors C1763 and C1765

Updated 2 July 2026

elevation suggests contamination or mislabeled product) Clinical Research Findings A comprehensive safety and tolerability analysis evaluated approximately 900 participants across six randomized, double-blind, placebo-controlled trials conducted between 2001-2006

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see also the Spravato REMS document and Spravato labeling available on the FDA website