Canadian medical technology company SpinaFX Medical has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Triojection device.
Triojection leverages the company’s in-house oxygen-ozone delivery system to target and reduce disc pressure, alleviating nerve compression.
The outpatient procedure can be performed in various healthcare settings, including hospitals, ambulatory surgical centres, and clinics in emerging markets.
It offers advantages, such as its novel approach to treating contained disc herniations and significant benefits in safety, recovery time, and cost.
SpinaFX chairman, founder and chief medical officer Kieran Murphy said: “Our mission is to transform spine care and make meaningful minimalist solutions accessible to all.
“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.”
The breakthrough designation confirms Triojection’s potential as a minimally invasive solution for lumbar disc treatment, offering a novel alternative to traditional methods.
It accelerates the device’s path to commercialisation by facilitating a collaborative regulatory process with the FDA.
According to SpinaFX, Triojection fills a critical gap in existing treatments, providing a low-barrier, evidence-based alternative for both advanced and developing healthcare systems.
The regulatory achievement is the result of over two decades of research and collaborations with experts in Canada, Greece, Italy, Switzerland, and the US.
SpinaFX is also exploring additional applications of its oxygen-ozone delivery platform for other disc-related conditions and musculoskeletal disorders.
The company is expanding educational programmes to train physicians in the effective use of Triojection, ensuring its widespread adoption.
SpinaFX CEO Jeff Cambra said: “Our team is honoured to receive this designation, but we view it as just the beginning.
“We’re committed to working hand-in-hand with the FDA to bring Triojection to patients in the US and beyond. Our goal is to create a new standard in spine care that’s efficient, scalable, and deeply patient-centred.”
