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.
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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.
It is structured as a randomised, multi-centre, prospective study and is expected to include 300 participants across two treatment arms.
SpinaFX Medical intends to run the trial at up to 30 specialist spine centres across the US.
Researchers will examine whether adding the Triojection intradiscal ozone/oxygen injection to conventional nerve root block therapy results in improved pain relief and function versus nerve root block alone.
The study will also assess the economic impact of adding the Triojection therapy.
SpinaFX Medical co-founder and chief medical officer Kieran Murphy said: “This IDE is another major milestone for SpinaFX, years in the making. My European colleagues and I have been extensively involved in the clinical development and refinement of intradiscal ozone in Europe and Canada.
“While this approach has been used in certain markets outside the US, the US pivotal trial is intended to evaluate its safety and effectiveness in a rigorous clinical setting and to help determine whether it may become an additional minimally invasive option for appropriately selected patients in the US.”
The study will include primary and secondary clinical endpoints related to pain and functional outcomes at six, 12, 18 and 24 months. Discussions are underway with clinical sites and laboratory partners to support trial execution and data assessment.
SpinaFX Medical also acknowledged the support of Medical Device Regulatory Associates (MCRA) in securing both the IDE approval and the FDA breakthrough device designation for Triojection, which was received in August 2025.
The Triojection therapy remains investigational in the US, with future regulatory, clinical, or commercial outcomes dependent on the upcoming clinical results and subsequent FDA review.
