SpinaFX Medical a leading innovator in image-guided interventional spine care, announced 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 recognised 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 prioritised access to the FDA, fostering a collaborative approach to regulatory processes and accelerating the path toward commercialisation and clinical availability.

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 centres 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.