The U.S. Food and Drug Administration has cleared the way for a major clinical trial testing whether a minimally invasive ozone gas injection can offer lasting relief for patients with herniated lumbar discs who have not improved with standard care. The study, which will enroll 300 patients at up to 30 spine centers across the country, compares a targeted intradiscal ozone and oxygen injection combined with a nerve root block against the nerve root block alone.
The treatment, known as Triojection, delivers a precise mixture of medical-grade ozone and oxygen directly into the damaged disc using image guidance. Researchers hope the injection can shrink the herniated tissue and reduce inflammation, addressing the root cause of pain rather than just masking symptoms. The trial is designed to measure pain levels and physical function at 6, 12, 18 and 24 months, with the goal of determining whether this approach can safely fill what experts call a “therapeutic gap” between failed conservative therapies and surgery.
For the estimated millions of people worldwide who suffer from contained disc herniations, the current options are limited. Many patients try physical therapy, anti-inflammatory drugs, or epidural steroid injections. When those fail, the next step is often invasive surgery such as a microdiscectomy. Dr. Kieran Murphy, an interventional neuroradiologist and co-founder of SpinaFX Medical, noted that the technique has been used in Europe and Canada for years but has not yet been rigorously tested in the United States. “This IDE is another major milestone,” he said, adding that the U.S. trial will evaluate safety and effectiveness in a controlled setting to determine if the therapy could become a standard option for appropriately selected patients.
How the Study Will Work
The trial is randomized and multicenter, meaning patients will be assigned by chance to receive either the combined ozone and nerve root block treatment or the nerve root block alone. Researchers will also examine the health economics of the procedure, assessing whether adding the ozone injection reduces overall healthcare costs by preventing or delaying surgery. The FDA previously granted Triojection a Breakthrough Device Designation in August 2025, which is reserved for technologies that offer a significant advantage over existing treatments for life-threatening or debilitating conditions.
If the trial succeeds, SpinaFX Medical plans to use the clinical data to support a formal application for FDA marketing authorization. The company emphasizes that the therapy remains investigational in the United States and that any regulatory, reimbursement, or commercial outcomes will depend entirely on the trial results and subsequent review. For patients living with chronic back pain from herniated discs, this study represents a promising step toward a needle-based alternative that could spare them the risks and recovery time of surgery.