SpinaFX Secures CE Mark for Triojection System to Treat Herniated Discs

The Triojection device uses image-guided technology to deliver a precise ozone-oxygen mixture to patients suffering from persistent pain caused by contained lumbar disc herniation. Designed for use in both hospitals and ambulatory clinics, the system incorporates in-syringe spectroscopic measurement to ensure ozone concentration remains consistent during procedures. For patients who have exhausted conservative therapies but are not yet candidates for major surgery, the device offers a reproducible alternative intended to lower the necessity for invasive interventions.

This regulatory milestone complements the company's existing quality management certifications and its 2025 FDA Breakthrough Device Designation. While the system remains under investigation in the United States—where SpinaFX is currently running clinical trials under an FDA Investigational Device Exemption—the company is now shifting its focus to distribution partnerships in international markets. Chief Executive Officer John Soloninka noted that the certification provides a platform to generate revenue and gather post-market evidence while the firm prepares for future U.S. regulatory applications. Launch efforts will prioritize spine centers and specialized pain practices to facilitate physician training and real-world data collection.