TORONTO, July 16, 2026
SpinaFX Medical Inc. has achieved a significant regulatory milestone with the Medical Device Regulation (MDR) CE Mark certification for its Triojection® System, enabling commercialization across the European Union and multiple international markets that recognize CE Mark MDR certification. The approval represents a major advancement for the company’s mission to expand access to image-guided, minimally invasive spine treatments for patients suffering from persistent pain caused by contained lumbar disc herniation. Designed to deliver a precisely controlled ozone-oxygen gas mixture during intradiscal procedures, the Triojection System combines real-time imaging with patented spectroscopic technology to improve treatment precision while offering physicians a reproducible minimally invasive alternative to conventional surgical interventions. The latest certification strengthens SpinaFX’s growing regulatory portfolio and supports the company’s global commercialization strategy as it continues clinical development in the United States under an FDA Investigational Device Exemption (IDE).
CE Mark MDR Opens European and Global Market Access
The newly awarded CE Mark MDR certification authorizes the commercial introduction of the Triojection System throughout the 27 European Union member states while also facilitating market entry into several additional international regions where CE Mark certification is accepted or accelerates regulatory approval. According to the company, the certification significantly expands commercial opportunities across the United Kingdom, Switzerland, selected Middle Eastern countries, South America, and Asia, providing access to a broad international market for minimally invasive spine care. The approval complements SpinaFX’s existing ISO 13485:2016, MDSAP, and EN ISO 13485:2016 quality management certifications, further validating the company’s commitment to regulatory excellence and medical device quality. Company executives believe the expanded regulatory footprint will allow the organization to generate commercial revenue, strengthen physician adoption, and collect valuable post-market clinical evidence while preparing for future regulatory milestones in the United States.
Innovative Image-Guided Technology Targets Lumbar Disc Pain
The Triojection® System is designed to support image-guided intradiscal ozone-oxygen injection therapy for patients experiencing chronic pain resulting from contained lumbar disc herniation who have not responded adequately to conservative treatments. Unlike more invasive spinal procedures, Triojection integrates real-time imaging guidance with a patented in-syringe spectroscopic ozone concentration measurement system, enabling physicians to accurately deliver therapeutic ozone-oxygen mixtures during minimally invasive interventions. Clinical evidence suggests that this approach may help reduce pain, improve patient outcomes, and potentially decrease the need for more extensive spinal surgery. The technology is intended for use in both hospital and ambulatory care settings, providing physicians with a standardized treatment platform that emphasizes procedural consistency, precision, and patient safety while addressing one of the most common causes of chronic lower back pain worldwide.
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Regulatory Progress Supports Global Commercial Expansion
The CE Mark certification follows several important regulatory achievements for SpinaFX Medical, including the FDA Breakthrough Device Designation granted to the Triojection System in 2025 and the subsequent FDA Investigational Device Exemption (IDE) authorizing a U.S. clinical trial evaluating image-guided intradiscal ozone-oxygen therapy. While the device remains investigational in the United States pending completion of clinical studies and future Premarket Approval (PMA) review, the company has already begun engaging distribution partners across Europe and other approved regions to support commercialization. Initial launch activities will prioritize spine centers and interventional pain clinics, accompanied by physician training initiatives, real-world evidence collection, and health-economic analyses aimed at demonstrating the long-term value of minimally invasive ozone-oxygen therapy. By combining robust regulatory achievements with ongoing clinical research and international commercialization efforts, SpinaFX is positioning itself as an emerging innovator in the rapidly evolving field of minimally invasive spine technologies, offering new therapeutic options for patients with chronic lumbar disc disease.
Source: SpinaFX Medical press release
