l carnitine sub q L-Carnitine – Compounded Carnitine (L) Injection |

10.1186/s12958-022-00892-8 142 HuangY.ZhuL.LiH.YeJ.LinN.ChenM.et al (2022b)

Subject to the applicant adequately addressing these concerns, we would agree that the technology meets the cost criterion and are proposing to approve the Total Ankle Talar Replacement for new technology add-on payments for FY 2024 subject to the technology receiving Breakthrough Device designation and FDA marketing authorization as a Breakthrough Device for the same indication by July 1, 2023

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This reflects findings made in PD patients, thereby demonstrating a higher immune-related face validity of the AAV1/2-A53T-SYN mouse model compared to the toxin-induced MPTP and 6-OHDA models