FDA Greenlights New Back Pain Therapy Trial

SpinaFX Medical has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA), enabling the initiation of a pivotal clinical trial for its Triojection therapy. This study, set to commence in the United States, will rigorously evaluate the safety and effectiveness of intradiscal ozone/oxygen injection combined with a nerve root block.

The randomized, multi-center, prospective study aims to enroll 300 participants across two treatment arms. Researchers will compare the efficacy of adding Triojection therapy to conventional nerve root block versus the latter alone in patients suffering from symptomatic contained herniated lumbar discs who have not responded to conservative treatments. The trial will also examine the economic implications of this novel treatment approach.

Scheduled to run at up to 30 specialist spine centers nationwide, the trial will assess primary and secondary clinical endpoints related to pain and functional outcomes over 24 months. This milestone follows SpinaFX's receipt of the FDA breakthrough device designation in August 2025. The Triojection therapy is currently investigational in the US, with future regulatory and commercial decisions pending the outcomes of this clinical evaluation.