The FDA has awarded breakthrough device status to SpinaFX Medical’s Triojection system for treating contained lumbar disc herniations. Triojection is a minimally invasive, image-guided procedure delivering a controlled oxygen-ozone mix into the affected disc. The treatment aims to reduce disc pressure and relieve nerve compression without harming surrounding tissue. It can be performed on an outpatient basis in hospitals, surgical centres, or clinics with minimal infrastructure. Contained lumbar disc herniation is a major global cause of disability, often addressed with conservative care or invasive surgery. SpinaFX says Triojection offers a targeted, lower-risk alternative suitable for diverse healthcare settings. Founder and CMO Dr. Kieran Murphy said the FDA recognition validates over 21 years of research and development. Breakthrough designation provides priority FDA review and enhanced collaboration to accelerate market availability. The technology builds on international research with clinical experts from Italy, Switzerland, Greece, the US, and Canada. Clinical data have shown positive results, with further publications expected from multicenter trials. SpinaFX is also exploring wider applications of its oxygen-ozone platform for spinal and musculoskeletal conditions. Training programs are being expanded to equip physicians with Triojection procedure skills.