SpinaFX Medical Receives CE Mark MDR Certification for its Triojection® System, Expanding Access to Minimally Invasive Lumbar Disc Treatment Across Europe and Key International Markets

TORONTO, July 15, 2026 /CNW/ — SpinaFX Medical Inc. (“SpinaFX”), a Toronto‑based medical device company specializing in image‑guided, minimally invasive spine care, today announced it has received Medical Device Regulation (MDR) CE Mark certification for its Triojection® System (MDR 843778). This certification enables commercial introduction of Triojection across the European Union and other international jurisdictions accepting CE Mark MDR.

Triojection is SpinaFX’s flagship, image‑guided minimally invasive device designed to deliver a controlled ozone‑oxygen gas mixture for several medically valid procedures, including intervertebral disc injections for patients suffering from persistent pain due to contained lumbar disc herniation who have failed conservative therapies. By combining real‑time image guidance with patented in-syringe spectroscopic measurement of ozone concentration, Triojection offers physicians a reproducible intradiscal procedure that can be performed in ambulatory and hospital settings, with evidence demonstrating potential to reduce the need for more invasive surgical interventions. 

The CE Mark MDR certification of the Triojection System adds to SpinaFX’s regulatory foundation, which includes ISO 13485:2016 / MDSAP and EN ISO 13485:2016 quality management certifications and the U.S. Food and Drug Administration’s (FDA’s) award of a Breakthrough Device Designation for Triojection in 2025. Triojection has also received an FDA Investigational Device Exemption (IDE), which permits SpinaFX to proceed with a clinical trial evaluating image‑guided intradiscal ozone‑oxygen injection for contained herniated lumbar discs. These milestones underscore the company’s commitment to generating high‑quality clinical evidence and advancing new treatment options for spine patients globally. 

“Our CE Mark MDR certification for Triojection is another positive step towards expanding ozone‑oxygen injection use across the world,” said Dr. Kieran Murphy, Chief Medical Officer, Co‑Founder and Chairman of SpinaFX. “CE Mark gives us the ability to commercialize in Europe and Asia, while we pursue our FDA IDE trial in the U.S.–the largest market in the world for intradiscal procedures. The potential impact on suffering patients and health systems is enormous.”

“CE Mark MDR is an important valuation inflection point,” said John Soloninka, Chief Executive Officer of SpinaFX Medical Inc. “Not only does this give us access to the 27 EU member states, but also to 13 other international regions–including the UK, Switzerland, parts of the Middle East, South American and Asian markets–where CE Mark MDR is either accepted or facilitates registration. This gives SpinaFX the ability to generate revenue and robust post‑market evidence as we pursue our FDA clinical trial in advance of a future PMA application.” 

With CE Mark MDR in place, SpinaFX is actively engaging with select distribution partners to initiate launch activities and expand clinical use of the Triojection System in priority markets. Initial commercialization efforts will focus on spine centers and interventional pain practices treating the large cohort of patients with unrelenting pain from contained herniated discs who have failed conservative management yet may not be ideal candidates for more invasive surgical procedures. Through these partnerships, SpinaFX intends to support physician training, real‑world data collection, and health‑economic analyses to demonstrate the potential value of intradiscal ozone‑oxygen therapy for patients, providers, and health systems. 

Triojection remains an investigational device in the United States and will be evaluated under an FDA‑approved IDE; it is not currently approved for commercial sale in the U.S. Any future commercialization will be subject to successful completion of clinical trials, subsequent FDA review, and approval. Regulatory approvals and market access in other geographies will be pursued in accordance with applicable national requirements. 

About SpinaFX Medical Inc.

SpinaFX Medical Inc. is a privately held, Toronto‑based medtech company developing and commercializing image‑guided, minimally invasive technologies for spine care, with an initial focus on intradiscal ozone‑oxygen injection therapy for contained herniated lumbar discs. Backed by experienced clinical, regulatory, and commercial leadership, SpinaFX is committed to advancing evidence‑based solutions that reduce the burden of spine‑related pain and disability worldwide. 

View original content to download multimedia:https://www.prnewswire.com/news-releases/spinafx-medical-receives-ce-mark-mdr-certification-for-its-triojection-system-expanding-access-to-minimally-invasive-lumbar-disc-treatment-across-europe-and-key-international-markets-302826707.html

SOURCE Spinafx medical inc