A New U.S. Trial Is Testing Ozone-Oxygen Disc Injections for Stubborn Sciatica

A Toronto medical technology company just cleared a major FDA hurdle to formally test a combination ozone-oxygen and nerve block injection for lumbar disc herniation, aiming squarely at the gap between physical therapy and surgery.

A Familiar Gap in Disc Herniation Care

Anyone who has lived with a herniated disc pressing on a nerve knows the frustrating middle stretch of treatment. Physical therapy, anti-inflammatory medication, activity changes and maybe an epidural steroid injection have all been tried, yet the leg pain, numbness or sciatica-style symptoms linger. Surgery is on the table but usually treated as a later step, reserved for cases that clearly are not improving.

That in-between zone, sometimes called a therapeutic gap by spine researchers, is exactly where a new device is now being formally tested in the United States. A Toronto-based medical technology company announced in June 2026 that it received an FDA Investigational Device Exemption, clearing the way for a large, controlled clinical trial of a combination injection approach for people whose contained disc herniations have not responded to conservative treatment.

What the Combination Injection Actually Involves

The device, marketed as Triojection, pairs two things done during one image-guided outpatient procedure: an injection of a medical ozone-oxygen gas mixture directly into the affected disc, plus a nerve root block delivered near the irritated nerve. The idea behind the disc injection is that the gas mixture can shrink disc volume and ease pressure on a nearby nerve root, while the nerve block adds a separate, more immediate layer of pain relief and reduced inflammation around that nerve.

It is worth being clear that this is still an investigational combination in the U.S. and not a treatment currently offered outside the clinical trial. Nothing about it is guaranteed to work for any individual patient, and it is not a replacement for a full evaluation by a qualified provider who can look at your imaging and history.

Inside the Newly Cleared U.S. Trial

The company's disc injection device earned FDA Breakthrough Device Designation back in August 2025, a status meant to speed development of technologies addressing unmet medical needs, before receiving the Investigational Device Exemption on June 9, 2026 that authorizes the pivotal study itself. The trial is designed as a prospective, randomized, multicenter study enrolling roughly 300 patients across up to 30 specialty spine centers nationwide.

Participants will be split into two groups: one receiving the combined ozone-oxygen disc injection plus nerve root block, and a comparison group receiving the nerve root block alone. Researchers plan to track pain and functional outcomes at 6, 12, 18 and 24 months, along with a separate look at the cost impact of adding the disc injection to standard nerve block care. Prof. Kieran Murphy, the company's co-founder and chief medical officer, described the clearance as "another major milestone for SpinaFX, years in the making."

What International Experience Suggests, and What Remains Unproven

Ozone-oxygen injections for disc problems are not brand new as a concept; variations have been used and studied in clinics abroad for well over a decade, with published case series describing thousands of patients treated across countries including Italy, Spain and Argentina. That accumulated international experience is part of why interest in a rigorous U.S. trial exists at all.

But protocols, injected volumes, gas concentrations and delivery devices have differed considerably from one country and study to the next, which makes it hard to draw firm conclusions that would apply to any single U.S.-cleared device. That variability is precisely why regulators asked for a controlled, randomized comparison rather than relying on outside data alone. For now, this is a research development to watch rather than an option available at your local clinic, and anyone currently dealing with sciatica or disc-related leg pain should keep working with their care team on established options while trials like this play out.

Where This Fits Among Non-Surgical Options for Disc-Related Pain

Ozone-oxygen disc injection is just one entry on a growing list of approaches providers consider before recommending surgery for a herniated disc. Here is a general, informational look at where it sits alongside more familiar options.

1. Physical therapy and targeted exercise: Usually the first step, focused on strengthening supporting muscles and improving movement patterns around the affected area.
2. Epidural steroid injections: An anti-inflammatory injection placed near the spinal nerves, often used to calm a flare before other therapies continue.
3. Nerve root blocks: A more targeted injection near a specific irritated nerve, used both diagnostically and for symptom relief.
4. Non-surgical spinal decompression: A traction-based therapy intended to reduce pressure on discs and nerves over a series of sessions.
5. Regenerative injections such as PRP: Injections using a patient's own blood-derived platelets, an approach still being studied for disc and nerve-related pain.
6. Investigational ozone-oxygen injection (Triojection): The newly trial-cleared combination described above; not yet available outside the study.
7. Minimally invasive discectomy: A smaller surgical procedure to remove the portion of disc pressing on a nerve, considered when conservative care has stalled.
8. Traditional open spine surgery: Reserved for more complex or severe cases where less invasive options have not resolved symptoms.

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