Triojection is SpinaFX’s flagship, image‑guided minimally invasive device designed to deliver a controlled ozone‑oxygen gas mixture for several medically valid procedures, including intervertebral disc injections for patients suffering from persistent pain due to contained lumbar disc herniation who have failed conservative therapies. By combining real‑time image guidance with patented in-syringe spectroscopic measurement of ozone concentration, Triojection offers physicians a reproducible intradiscal procedure that can be performed in ambulatory and hospital settings, with evidence demonstrating potential to reduce the need for more invasive surgical interventions. 

The CE Mark MDR certification of the Triojection System adds to SpinaFX’s regulatory foundation, which includes ISO 13485:2016 / MDSAP and EN ISO 13485:2016 quality management certifications and the U.S. Food and Drug Administration’s (FDA’s) award of a Breakthrough Device Designation for Triojection in 2025. Triojection has also received an FDA Investigational Device Exemption (IDE), which permits SpinaFX to proceed with a clinical trial evaluating image‑guided intradiscal ozone‑oxygen injection for contained herniated lumbar discs. These milestones underscore the company’s commitment to generating high‑quality clinical evidence and advancing new treatment options for spine patients globally.