Shots:
- The US FDA has granted an IDE approval to Triojection therapy to initiate US trial in pts with contained herniated lumbar discs who have not responded to conservative therapy
- The trial is expected to enroll 300 pts across ~30 specialty spine centers, comparing intradiscal ozone/oxygen injection plus nerve root block against nerve root block alone to assess pain relief & functional outcomes
- The trial will assess key clinical endpoints related to pain & function over follow-up periods of 6, 12, 18, & 24mos., while also generating safety & health economics data
Ref: PRnewswire | Image: SpinaFX | Press Release
Related News: Xenix Medical Reports the US FDA Clearance for Lux Expandable Lumbar Fusion System
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