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[9] Patients should be advised to contact their healthcare provider if they experience any severe or persistent side effects, such as difficulty breathing, chest tightness, severe rash, or dizziness

In addition, we stated in the CY 2026 OPPS/ASC proposed rule that we are concerned that the provided evidence did not directly support the applicant's 10 claims that the Axoguard HA+ Nerve Protector TM demonstrates substantial clinical improvement over existing technologies

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