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According to the applicant, the alternative to establishing a new category codeforcing the device into a category like C1763 or C1765would continue the current disincentive for adoption, contradicting CMS's goal of enabling access to worthwhile new therapies, whereas creating a new category code would signal to hospitals that the Axoguard HA+ Nerve Protector TM is recognized as an innovation and encourage appropriate use in patients who need it

I feel it's to protect the supplier regarding law suits

Indeed, plasma cyclin-dependent kinase levels strongly correlated with homocysteine in homocystinuric patients (Fritzer-Szekeres et al, 1998)

Every batch is confirmed for: Purity 99% by HPLC Structural identity via mass spectrometry Third-party Certificate of Analysis (COA) available per lot For Research Use Only