SpinaFX Medical said that its flagship device, Triojection, has been granted Breakthrough Device Designation by the FDA. It's designed for safer treatment for patients suffering from contained lumbar disc herniations.
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.
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. "
