The FDA has granted breakthrough device designation to SpinaFX Medical’s Triojection system, a minimally invasive treatment for contained lumbar disc herniations.
Triojection is an image-guided procedure that uses a proprietary oxygen-ozone delivery system to treat the affected spinal disc. During the procedure, clinicians insert a specialized syringe cartridge into the disc under image guidance. The system delivers a controlled mixture of oxygen and ozone, which reduces the pressure inside the disc and alleviates compression on nearby nerves.
SpinaFX designed the approach to precisely target the herniated area without damaging surrounding tissue. It can be performed on an outpatient basis in hospitals, ambulatory surgical centers, or clinics with minimal infrastructure requirements, making it suitable for both advanced and resource-limited healthcare settings.
According to the company, contained lumbar disc herniation is a leading cause of disability worldwide. It is often treated with either conservative care that may not provide relief or invasive surgery with higher costs, risks and longer recovery times. SpinaFX said Triojection offers a targeted alternative that can be deployed quickly across diverse healthcare environments.
“Our mission is to transform spine care and make meaningful minimalist solutions accessible to all,” Founder and Chief Medical Officer Dr. Kieran Murphy said. “This designation by the FDA validates the scientific merit of Triojection and 21 years of work by many people who have helped get us to this point.”
The breakthrough device designation gives device developers prioritized access to the FDA for feedback and review, fostering collaboration with regulators and helping speed the path toward commercialization and clinical availability. The program is intended for devices that could offer more effective treatment or diagnosis for serious or life-threatening conditions.
The Triojection technology builds on more than two decades of research, including international studies and collaborations with clinical experts in Italy, Switzerland, Greece, the U.S. and Canada. SpinaFX stated that clinical data continue to support the device’s efficacy, with upcoming publications anticipated from multicenter trials.
In addition to treating contained disc herniations, the company is exploring other uses of its oxygen-ozone delivery platform for disc-related and musculoskeletal conditions. It is also expanding training programs for physicians in the Triojection procedure.
