Surgical Robotics Technology
SpinaFX Medical Inc. announces 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. “
Source: SpinaFX
