SpinaFX Wins FDA IDE Nod for Triojection Pivotal Trial

SpinaFX Medical, a clinical-stage company developing minimally invasive, image-guided therapies for intravertebral disc disorders, has been granted U.S. Food and Drug Administration (FDA) investigational device exemption (IDE) for a pivotal U.S. clinical trial to evaluate Triojection intradiscal ozone/oxygen injection plus nerve root block compared with nerve root block alone in patients with contained herniated lumbar discs that have failed conservative therapy.

The prospective, randomized, multicenter trial aims to enroll 300 patients in two treatment arms at up to 30 specialty spine treatment sites. The trial is designed to assess if adding intradiscal ozone/oxygen injection treatment to conventional nerve root block can improve pain and functional outcomes versus nerve root block treatment alone.

SpinaFX said the IDE approval supports further evaluation of a minimally invasive treatment approach to address the therapeutic gap between failed conservative care and surgery for patients with symptomatic contained disc herniation. The study will also evaluate the economics of adding Triojection to conventional treatments.

Primary and secondary endpoints are expected to include clinically meaningful measures of pain and function at six, 12, 18, and 24 months. Site and core laboratory partnerships are currently under discussion.

“This IDE is another major milestone for SpinaFX, years in the making. My European colleagues and I have been extensively involved in the clinical development and refinement of intradiscal ozone in Europe and Canada,” said Prof. Kieran Murphy, interventional neuroradiologist at Toronto Western Hospital and co-founder and chief medical officer of SpinaFX. “While this approach has been used in certain markets outside the United States, the U.S. pivotal trial is intended to evaluate its safety and effectiveness in a rigorous clinical setting and to help determine whether it may become an additional minimally invasive option for appropriately selected patients in the USA.”