SpinaFX Triojection Device Earns FDA Breakthrough Device Designation for Lumbar Disc Herniation

SpinaFX’s Device Received Approval as a Groundbreaking Device Designation by the US FDA

Announcement

The spinaFX Medical Inc., a known innovator in image-guided interventional spine care, has been positioned as a groundbreaking device designation for its main device, Triojection, by the US Food and Drug Administration (FDA). This company’s milestone applauds triojection’s ability to provide the best effective, safe, and accessible treatment for patients with lumbar disc herniations, a condition addressed as a common cause of disability globally.

The breakthrough devices program is introduced to accelerate the development and evaluation of medical devices. This elaborates the clear advantages, primarily over previous technologies, for extreme or difficult conditions. The designation salutes spinaFX's prioritized reach to the FDA, with a collaborative move towards regulatory processes and leveraging the path towards marketing and clinical accessibility.

A Technological Relief in Spine Care

The triojection is a less invasive, image-oriented process that accelerates an exclusive oxygen-ozone delivery system to minimize pressure within the disc and alleviate nerve compression. Triojection provides a focused, outpatient solution that can be carried out in various healthcare settings, such as ambulatory surgical centers and hospitals. The device meets all FDA-required breakthrough criteria, such as innovative technological approach, safety, accessibility, cost, and recovery time. Further, an effective, unique, and first-class treatment for disc herniation patients is prior to receiving the FDA’s green signal.

‘Triojection’, a New Hope, Proven by Expertise and Science

The lumbar disc herniation is a serious condition affecting millions of people that invites chronic pain, reduces productivity, minimizes quality of life, and loss of mobility. The existing treatments will either fall into two extremes: one is invasive surgery, which is expensive, takes a long recovery time, and carries risk, or conservative care that doesn’t always promise relief. Whereas, triojection fills the comp; lex therapeutic gap. It provides a proven, low-barrier, cost-effective option that can be adopted with less infrastructure, ideal for developing and advanced market health systems.

This regulatory milestone shows spinaFX’s efforts for over two decades of research and development, along with various international studies and partnerships with known clinical experts in Switzerland, Greece, Canada, the United States, and Italy. The company is grateful for the support of its excellent network of investigators and engineers with Prof. Alexis Kelekis (Greece) and Prof. Mario Muto (Italy), the leading experts in the interventional neuroradiology field. The clinical data contribute to triojection’s efficacy, which promises to align with the future publications predicted to spotlight its outcomes throughout its multicenter trials.