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PTH 134 is one of the earliest artificially synthesized amino acid fragments that was granted approval for the prevention and treatment of osteoporosis

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The applicant stated that it believes that the nominated device meets the substantial clinical improvement threshold, given its novel mechanism addressing unmet need for recurrent nerve compression injuries, and requested that CMS consider the provided clinical data and recognize the Axoguard HA+ Nerve Protector TM as an innovative device offering improved clinical outcomes