SpinaFX Medical has been granted an FDA Investigational Device Exemption to start a pivotal U.S. trial of Triojection, an intradiscal ozone/oxygen therapy. The randomised, multicentre study will enrol about 300 patients across two arms at up to 30 spine centres to compare Triojection plus nerve root block with nerve root block alone. Primary and secondary endpoints will measure pain, function and the economic impact at 6, 12, 18 and 24 months.
FDA Grants IDE to SpinaFX for U.S. Pivotal Trial of Triojection Intradiscal Therapy
The study will evaluate intradiscal ozone / oxygen injection plus nerve root block compared to nerve root block alone. Credit: sweet_tomato / Shutterstock.com.(sweet_tomato / Shutterstock.com.)
SpinaFX Medical has received an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration to initiate a pivotal clinical trial of its Triojection intradiscal ozone/oxygen therapy.
Trial Authorization and Purpose: The IDE authorises a randomised, multicentre, prospective U.S. trial designed to compare intradiscal ozone/oxygen injection plus nerve root block versus nerve root block alone in patients with symptomatic, contained herniated lumbar discs who have not improved with conservative treatment.
Design and Scale: The study is expected to enrol approximately 300 participants across two treatment arms and may be conducted at up to 30 specialist spine centres across the United States.
Study Objectives and Endpoints
Investigators will evaluate whether adding the Triojection intradiscal ozone/oxygen injection to conventional nerve root block therapy provides superior pain relief and functional improvement compared with nerve root block alone. The trial will also include an economic analysis to assess the cost implications of incorporating Triojection into standard care.
The protocol defines primary and secondary clinical endpoints focused on pain and functional outcomes, measured at 6, 12, 18 and 24 months after treatment. Discussions with clinical sites and laboratory partners are ongoing to support trial conduct, monitoring and data analysis.
"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," said Kieran Murphy, co-founder and Chief Medical Officer of SpinaFX.
Regulatory Support: SpinaFX acknowledged the assistance of Medical Device Regulatory Associates (MCRA) in securing both the IDE and an FDA Breakthrough Device designation for Triojection, the latter of which was received in August 2025.
Current Status: Triojection remains investigational in the United States. Any future regulatory, clinical or commercial decisions will depend on the upcoming trial results and subsequent FDA review.
Source: Medical Device Network (a GlobalData brand). This report is provided for general informational purposes only and should not be taken as medical, regulatory, or legal advice. Professional guidance should be sought before making healthcare or regulatory decisions.
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