Canadian company SpinaFX Medical’s minimally invasive Triojection device has secured breakthrough device designation from the US Food and Drug Administration (FDA) for individuals affected by contained lumbar disc herniations, a leading cause of disability globally.
The designation offers the company expedited engagement with the agency, enhancing a cooperative approach to the regulatory process and accelerating its journey to market and clinical use.
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The image-guided procedure utilises an oxygen-ozone delivery system to decrease disc pressure and relieve nerve compression.
It is said to provide an outpatient alternative that can be administered in diverse healthcare environments, including clinics, hospitals and ambulatory surgical centres.
The device fulfils the FDA’s breakthrough criteria by showing potential benefits in safety, cost, accessibility and recovery time, and by demonstrating the ability to enhance outcomes in various economic and geographical settings, including areas with limited healthcare resources.
Designed to be a low-barrier and evidence-based option, the device can be implemented with minimal infrastructure, making it suitable for advanced as well as developing healthcare systems in the market, noted the company.
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By GlobalDataThe regulatory designation is the culmination of various years of research and development, incorporating several international trials and partnerships with clinical specialists from the US, Canada, Switzerland, Italy, and Greece.
SpinaFX Medical is not only focusing on this initial application but is also investigating further uses for its oxygen-ozone delivery technology in addressing other disc-related ailments and musculoskeletal conditions.
Additionally, the company is widening its educational initiatives for training physicians in the safe and evidence-based application of this device procedure.
SpinaFX Medical chief medical officer, founder and chairman Professor 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.”
