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Since both MPTP and 6-OHDA primarily mimic acute PD models, a lack of chronic models persists

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however, we maintain some of our concerns listed in the CY 2026 OPPS/ASC proposed rule (90 FR 33588 through 35589), including the lack of comparative data between the Axoguard HA+ Nerve Protector TM and the predicate device and other currently available treatments for the indicated condition