SpinaFX Medical has received the US Food and Drug Administration (FDA) investigational device exemption (IDE) to study its Triojection therapy.

The IDE enables SpinaFX to begin a pivotal clinical trial in the US.

The study will evaluate the use of intradiscal ozone/oxygen injection plus nerve root block compared with nerve root block alone in patients with symptomatic contained herniated lumbar discs who have not seen benefits from conservative treatments.