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FDA found no human exposure data for the defined substances, major safety-data gaps and insufficient evidence of wound-healing effectiveness

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 felt so good now twice after my infusions