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Dymicron Secures US FDA IDE Approval for Triadyme-C Cervical Disc Study

Shots:

  • Dymicron received the US FDA’s IDE approval to initiate a pivotal trial of Triadyme-C, a cervical artificial disc, to treat symptomatic cervical disc disease (SCDD) across leading US spine centers starting Q4’25
  • The study will compare the safety and effectiveness of Triadyme-C vs. anterior cervical discectomy and fusion (ACDF). The 1EP of the study is defined as NDI score improvement, neurostatus maintenance, and no secondary surgeries
  • Triadyme-C features Adymite, a proprietary polycrystalline diamond material engineered to minimize wear debris and replicate spinal motion via tri-lobed design

Ref: PRNewswire | Image: Dymicron| Press Release

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