The Memo: SpinaFX Redefining Disc Herniation Treatment with Ozone-Based Therapy

Under the direction of CEO Jeff Cambra, SpinaFX is advancing a minimally invasive therapy for contained lumbar disc herniation that aims to bridge the gap between conservative care and surgery. Leveraging decades of research and an ozone-based delivery platform, the Toronto-based company is building clinical momentum with its Triojection^Ⓡ system. Supported by Breakthrough Device Designation from the FDA, SpinaFX is poised to bring its ozone-based therapy to global markets as an alternative to surgery for millions of patients with debilitating disc herniation.

Origin Story

SpinaFX traces its roots to the work of Dr. Kieran Murphy, a pioneer in interventional neuroradiology and one of the most prolific inventors in spine intervention. “Dr. Murphy has trained in Ireland and the U.S., served as Director of Interventional Neuroradiology at Johns Hopkins, and is now a professor and clinician at the University Health Network in Toronto,” Cambra explained. “He’s a prolific innovator with more than 70 patents, and SpinaFX was born from his two-decade commitment to refining and validating this therapy.

Cambra himself was introduced to the technology in 2013. “It aligned perfectly with a gap I had long identified between conservative care and surgery,” he said. At the time, data were limited, but when Dr. Murphy and an investor acquired the assets in 2021, clinical validation was starting to emerge. “I immediately saw the potential, not just as a business opportunity, but as a passion project that aligned with my domain expertise,” Cambra added.

The Current Landscape

A contained lumbar disc herniation is a common, painful, and often disabling condition, with an estimated two to three million symptomatic cases each year in the U.S. alone. It’s most prevalent in adults aged 30–50, and is more prevalent in men, particularly those engaged in physically demanding roles involving heavy lifting, repetitive motion, or awkward postures. Globally, low back pain, to which disc herniation is a significant contributor, is the leading cause of years lived with disability. According to The Lancet, by 2050, the number of people affected by low back pain is projected to reach 843 million, driven by population growth and aging.

Current treatment options leave many patients in limbo. Conservative care often falls short, steroid injections provide only temporary relief with side effects, and surgery, while effective, is invasive, costly, and recovery-intensive. “Triojection provides an alternative that is non-inferior to surgery, but with fewer complications, no general anesthesia, and a much faster recovery time,” Cambra explained.

Inside the Innovation

At the core of SpinaFX’s approach is Triojection, a single-use, image-guided system designed to precisely deliver ozone in the affected disc.

“Triojection uses a sterile syringe cartridge to deliver a precise dose of medical ozone into the affected disc under fluoroscopic guidance,” Cambra said. “Ozone reduces inflammation, shrinks the disc herniation, and relieves nerve compression. It treats the root cause, not just the symptoms, offering a durable solution without incisions or sedation.”

The system workflow is as follows:

• Air intake and ozone generation: The console system pulls in room air, concentrates oxygen, and ionizes it to create ozone at 35 ± 3 μg/mL using an electric field and internal UV spectroscopy.
• Sterile delivery: This mixture is collected inside a sterile syringe cartridge and injected under image guidance.
• Precision and safety: The real-time concentration display ensures precision, and the entire process is controlled through a computer-guided system that ensures safety, consistency, and traceability for every procedure.

The technology sets itself apart by addressing the biological drivers of disc herniatio

• Not masking pain: “Unlike steroids, we’re not masking pain,” Cambra emphasized.
• Not removing tissue: “And unlike surgery, we’re not cutting or removing disc material.”
• Durability: “Triojection addresses the biological cause of pain by reducing disc volume and inflammation through a safe, precise chemical reaction.”

Clinical studies show that over 70% of patients treated with Triojection avoid surgery, supported by MRI confirmation of disc shrinkage post-procedure. Safety data are also compelling, with a very low rate of minor adverse events (0.6%–1.2%) and no serious complications.

Progress and Milestones

SpinaFX is in the clinical stage of development, with notable milestones achieved:

• Over 70 procedures completed in Canada under the Special Access Program
• Clinical publications showing durable outcomes and measurable disc shrinkage
• FDA Breakthrough Device Designation, validating clinical potential and expediting the regulatory path
• $16M Series B round closed in November 2024, securing runway for FDA IDE trials

Looking ahead, SpinaFX is preparing an FDA IDE submission to initiate U.S. clinical trials and a CE MDR submission for the European market. In parallel, the company is planning a $15 million Series C raise to support U.S. commercialization, build international partnerships, and scale its go-to-market efforts.

Join Us at LSI Europe ‘25

Cambra has been selected to present at LSI Europe ’25 (September 7–11) in front of hundreds of global medical technology companies. Join us in welcoming him to the event in London, where he will share the latest updates on SpinaFX’s technology and development.