SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection®, its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treatment.

The prospective, randomized, multicenter trial will compare intradiscal ozone/oxygen injection plus nerve root block to nerve root block alone in 300 patients in up to 30 US sites

TORONTO, June 9, 2026 /PRNewswire/ - SpinaFX Medical, a clinical-stage medical device company specializing in minimally invasive, image-guided therapies for intravertebral disc disorders, today announced that the U.S. Food and Drug Administration has granted Triojection® an Investigational Device Exemption (IDE), permitting the initiation of a pivotal U.S. clinical trial to evaluate intradiscal ozone/oxygen injection plus nerve root block compared with nerve root block alone in patients with contained herniated lumbar discs that have failed conservative therapy.

The planned study is a prospective, randomized, multicenter trial expected to enroll 300 patients in two treatment arms at up to 30 specialty spine treatment sites . The trial is designed to evaluate whether adding intradiscal ozone/oxygen injection treatment to conventional nerve root block can improve pain and functional outcomes versus nerve root block treatment alone

This IDE approval marks an important regulatory and clinical development for SpinaFX and supports further evaluation of a minimally invasive treatment approach intended to address the therapeutic gap between failed conservative care and surgery for patients with symptomatic contained disc herniation. The study will also evaluate the economics of adding Triojection to conventional treatments.

"This IDE is another major milestone for SpinaFX, years in the making. My European colleagues and I have been extensively involved in the clinical development and refinement of intradiscal ozone in Europe and Canada. While this approach has been used in certain markets outside the United States, the U.S. pivotal trial is intended to evaluate its safety and effectiveness in a rigorous clinical setting and to help determine whether it may become an additional minimally invasive option for appropriately selected patients in the USA," said Prof. Kieran Murphy, Interventional Neuroradiologist, at Toronto Western Hospital, and Co-Founder and Chief Medical Officer of SpinaFX Medical.

Treatment of contained disc herniation remains an area of significant unmet clinical need. According to SpinaFX's clinical background article, there is a recognized "therapeutic gap" for herniated disc treatment, between failed conservative care and surgery. Leaders in interventional spine care have argued for more consistent, minimally invasive, image-guided treatment options for these patients.¹

Published literature cited by SpinaFX reports encouraging clinical findings outside the United States for intradiscal ozone therapy. These studies provide background support for further investigation.²

To address safety, effectiveness, and health economics evidence requirements, primary and secondary endpoints are expected to include clinically meaningful measures of pain and function at 6, 12, 18 and 24 months. Site and core laboratory partnerships are currently under discussion to support study execution and data quality.

SpinaFX also acknowledges MCRA for its expert assistance in obtaining both this IDE approval and Triojection's FDA Breakthrough Device Designation in August 2025.

For shareholders, the IDE represents an important step in the company's clinical and regulatory development plans as it advances evaluation of ozone-based intradiscal therapy in the United States. The IDE permits a pivotal U.S. study designed to generate the clinical evidence needed to support a future application for FDA marketing authorization, for a condition affecting millions of global patients annually, representing a large addressable market with significant unmet need and high associated healthcare costs. Prior international studies performed by Dr. Murphy and Colleagues, and meta-analysis of other investigators' work summarized by SpinaFX provide background context for the investigational rationale, but the therapy remains investigational in the United States, and any regulatory, clinical, reimbursement, or commercial outcomes will depend on the conduct and results of the trial and subsequent review processes.²

About SpinaFX Medical Inc.

SpinaFX Medical Inc is a Canadian-based medical technology company focused on developing minimally invasive, image-guided therapies for patients with disc-related pain and disability. With representation in 9 offices around the world, the company's mission is to address the gap between conservative care and surgery with evidence-based therapies designed for broad clinical accessibility.

Forward-Looking Statements

This press release contains forward-looking statements regarding, among other things, the anticipated initiation, design, enrollment, timing, conduct, endpoints, availability of sites and partners, potential safety or effectiveness outcomes, regulatory interactions, reimbursement prospects, commercialization plans, and market opportunity for the company's investigational technology . These statements are based on current expectations and assumptions and are subject to substantial risks and uncertainties. Actual results may differ materially from those expressed or implied due to a variety of factors, including risks relating to trial initiation and execution, investigational review board and site approvals, site activations, patient enrollment and retention, protocol changes, data variability, safety events, trial results, regulatory feedback and decisions, manufacturing and supply, intellectual property, financing needs, market conditions, and other factors beyond the company's control. Readers should not place undue reliance on these forward-looking statements, which speak only as of the date of this release.

SOURCE Spinafx medical inc