Triojection® from SpinaFX Granted Breakthrough Device Designation by U.S. FDA for Minimally Invasive Lumbar Disc Treatment

TORONTO, Aug. 15, 2025 /PRNewswire/ - SpinaFX Medical Inc., ("SpinaFX") a leading innovator in image-guided interventional spine care, is proud to announce that its flagship device, Triojection®, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). This milestone acknowledges Triojection's potential to offer a highly effective, more accessible, and safer treatment for patients suffering from contained lumbar disc herniations, a condition recognized as one of the most common causes of disability worldwide.

The Breakthrough Devices Program is designed to expedite the development and review of medical devices that demonstrate clear advantages over existing technologies for serious or life-threatening conditions. This designation grants SpinaFX prioritized access to the FDA, fostering a collaborative approach to regulatory processes and accelerating the path toward commercialization and clinical availability.

A Technological Leap in Spine Care

Triojection is a minimally invasive, image-guided procedure that leverages a proprietary oxygen-ozone delivery system to reduce pressure within the disc and alleviate nerve compression. Unlike more invasive surgical approaches or prolonged conservative treatments that may fail to provide relief, Triojection offers a targeted, outpatient solution that can be performed in a variety of healthcare settings from hospitals and ambulatory surgical centers to clinics in emerging markets.

The device meets the FDA's stringent Breakthrough criteria:

• Providing a unique, novel and more effective treatment for patients with contained disc herniations.
• Representing a true technological innovation in the spinal care landscape.
• Demonstrating significant advantages in terms of safety, recovery time, cost, and accessibility.
• Showing strong potential to improve outcomes across diverse economic and geographic contexts, including under-resourced health systems.

Meeting an Urgent Global Need

Lumbar disc herniation affects millions of people globally and is a leading contributor to chronic pain, loss of mobility, reduced productivity, and diminished quality of life. Existing treatments often fall into two extremes: conservative care, which may not always bring relief, or invasive surgery, which carries risks, high costs, and extended recovery times.

Triojection fills a critical therapeutic gap. It offers an evidence-based, low-barrier, cost-effective alternative that can be deployed rapidly and with minimal infrastructure ideal for both advanced and developing market health systems.

"Our mission is to transform spine care and make meaningful minimalist solutions accessible to all," said Prof. Kieran Murphy MD, Chairman, Founder and Chief Medical Officer at SpinaFX. "This designation by the FDA validates the scientific merit of Triojection and 21 years of work by many people who have helped get us to this point. It's a vote of confidence in the future of inventiveness in spine health. We sincerely thank all our investors for their support and trust."

Backed by Global Expertise and Scientific Rigor

This regulatory milestone is the result of over two decades of research and development, including multiple international studies and collaborations with leading clinical experts in Italy, Switzerland, Greece, the United States and Canada. SpinaFX acknowledges the contributions of its diverse network of engineers and investigators, including Prof. Mario Muto (Italy) and Prof. Alexis Kelekis (Greece), both pioneers in the field of Interventional Neuroradiology.

Clinical data supporting Triojection's efficacy continues to build, with upcoming publications expected to highlight its outcomes across multicenter trials. The company's engineering, regulatory, and clinical affairs teams along with trusted partners across Europe and the United States have played a critical role in advancing the technology toward approval and adoption.

A Platform for Future Innovation

Beyond this first indication, SpinaFX is exploring additional applications of its oxygen-ozone delivery platform in treating other disc-related conditions and musculoskeletal disorders. The company is also expanding its educational programs to train physicians in safe, effective, and evidence-based use of the Triojection procedure.

"Our team is honored to receive this designation, but we view it as just the beginning," said Jeff Cambra, CEO of SpinaFX. "We're committed to working hand-in-hand with the FDA to bring Triojection to patients in the U.S. and beyond. Our goal is to create a new standard in spine care that's efficient, scalable, and deeply patient-centered. "

About SpinaFX

SpinaFX Medical Inc. is a Canadian-based medical technology company specializing in minimally invasive, image-guided therapies for spinal disorders. Its proprietary technology platform offers non-surgical solutions for treating disc-related conditions, using a unique approach to oxygen-ozone therapy. Committed to democratizing access to advanced spine care, SpinaFX collaborates with leading academic institutions, clinicians, and healthcare providers across the globe.

Forward-Looking Statement

This news release contains predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance, referred to herein as "forward-looking statements", which are made as of the date of this news release or as of the effective date of information described in this release, as applicable. The forward-looking statements address anticipated events or occurrences which may include economic factors, industry trends, market demand, and corporate performance and profitability, that may have an impact on SpinaFX's success. Forward-looking statements are often identified through words or expressions including "expects", "anticipates", "plans", "projects", "estimates", "envisages", "assumes", "intends", "strategy", "goals", "objectives" or variations thereof or stating that certain actions, events or results "may", "can", "could", "would", "might" or "will" be taken, occur or be achieved, or the negative of any of these terms and similar expressions.

All forward-looking statements are based on current beliefs as well as various assumptions made by, and information currently available to SpinaFX's management team. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections, and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. We caution any person reviewing this news release not to place undue reliance on these forward-looking statements as several important factors could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. Neither SpinaFX nor its representatives undertake to update any forward-looking statement, whether written or oral, that may be made from time to time by SpinaFX or its representatives or on behalf of either of them, except as may be required by law.

SOURCE Spinafx medical inc