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
mechanism unexplained Relative contributions of direct peptide effects versus downstream IGF-1 actions inadequately characterized Long-term receptor sensitivity and potential for desensitization inadequately studied Individual patient variability in response not well-characterized Potential for differential effects based on endogenous growth hormone status unclear Long-Term Safety Considerations Critical safety questions remain unanswered regarding chronic peptide administration: Cardiovascular safety concerns FDA warnings cite risks of increased heart rate, systemic vasodilation, flushing, and transient hypotension Immunogenicity risks FDA identifies both peptides as potentially immunogenic with risk of serious immune reactions including anaphylaxis Cancer risk theoretical concern that chronic growth hormone/IGF-1 elevation could promote cellular proliferation
Early data showed potentially better body composition outcomes, though more research is needed
ADME prediction with KNIME: In silico aqueous solubility consensus model based on supervised recursive random forest approaches
Cgnz1 allele confers kidney resistance to damage preventing progression of immune complex-mediated acute lupus glomerulonephritis
[DOI] [PubMed] [Google Scholar] 7.Wang H, Yao Q, Zhu W, et al
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