SpinaFX
SpinaFX is a medical device company dedicated to transforming the future of back pain treatment through innovative, minimally invasive, image-guided therapies. They focus on filling the therapeutic gap for contained lumbar herniated discs by providing early alternatives to surgery, using patented technology backed by clinical data to address and eliminate low back and leg pain caused by herniated discs.
Industries
Nr. of Employees
small (1-50)
SpinaFX
1920 Yonge Street, Suite 300, Toronto, Ontario, M4S 3E2, Canada
Patents
Products
Investigational image-guided intradiscal gas injection system
A minimally invasive device-based therapy to deliver a controlled oxygen–ozone gas mixture into a contained lumbar intervertebral disc via percutaneous needle under imaging guidance to reduce herniation volume and relieve nerve-root compression (investigational; regulatory approvals pending in many jurisdictions).
Investigational image-guided intradiscal gas injection system
A minimally invasive device-based therapy to deliver a controlled oxygen–ozone gas mixture into a contained lumbar intervertebral disc via percutaneous needle under imaging guidance to reduce herniation volume and relieve nerve-root compression (investigational; regulatory approvals pending in many jurisdictions).
Services
Operational management of domestic and international clinical studies including protocol development, site initiation, monitoring, CRF management, and adverse event reporting.
Workshops, conference presentations and educational programs to disseminate clinical evidence and gather expert clinical feedback.
Management of relationships and operational transfer to external contract manufacturers to support design for manufacturing, quality integration, and production scaling.
Implementation and maintenance of QMS processes to meet ISO 13485/MDSAP and support regulatory submissions (EU MDR, Health Canada, U.S. FDA).
Conduct and support of bench testing, animal studies and mechanism-of-action investigations to support clinical translation.
Operational management of domestic and international clinical studies including protocol development, site initiation, monitoring, CRF management, and adverse event reporting.
Workshops, conference presentations and educational programs to disseminate clinical evidence and gather expert clinical feedback.
Management of relationships and operational transfer to external contract manufacturers to support design for manufacturing, quality integration, and production scaling.
Implementation and maintenance of QMS processes to meet ISO 13485/MDSAP and support regulatory submissions (EU MDR, Health Canada, U.S. FDA).
Conduct and support of bench testing, animal studies and mechanism-of-action investigations to support clinical translation.
Expertise Areas
- Clinical trial management
- Image-guided interventional therapies
- Medical device design and verification
- Regulatory compliance and QMS (ISO 13485/MDSAP, MDR, FDA pathways)
Key Technologies
- Intradiscal oxygen–ozone injection therapy
- Image-guided fluoroscopic interventional procedures
- Percutaneous injection and needle-delivery systems
- Gas generation and controlled gas-delivery systems
News & Updates
In December 2024, SpinaFX announced the successful completion of its Series B funding round, raising CAD $5.3 million to support regulatory approvals, commercialization, and innovation.
Participated in the 33rd Interdisciplinary Research Conference on Injectable Osteoarticular Biomaterials and Bone Augmentation held at the Fairmont Banff Springs Hotel in Banff, Alberta, Canada, engaging with specialists and industry leaders.
Held an educational workshop on advancing spine care during the GRIBOI 2025 conference in Banff, Alberta, Canada.
In June 2025, Jodi Menezes joined SpinaFX from Johnson & Johnson, bringing a decade of MedTech industry experience to lead clinical affairs.
A study published in The Spine Journal in 2022 recognized the potential of intradiscal oxygen-ozone therapy as a treatment for lumbar disc herniation with radiculopathy, showing promising results comparable to microdiscectomy.
In November 2022, SpinaFX achieved certification for its quality management system, enabling pursuit of regulatory approvals in various regions.
In December 2024, SpinaFX announced the successful completion of its Series B funding round, raising CAD $5.3 million to support regulatory approvals, commercialization, and innovation.
Participated in the 33rd Interdisciplinary Research Conference on Injectable Osteoarticular Biomaterials and Bone Augmentation held at the Fairmont Banff Springs Hotel in Banff, Alberta, Canada, engaging with specialists and industry leaders.
Held an educational workshop on advancing spine care during the GRIBOI 2025 conference in Banff, Alberta, Canada.
In June 2025, Jodi Menezes joined SpinaFX from Johnson & Johnson, bringing a decade of MedTech industry experience to lead clinical affairs.
A study published in The Spine Journal in 2022 recognized the potential of intradiscal oxygen-ozone therapy as a treatment for lumbar disc herniation with radiculopathy, showing promising results comparable to microdiscectomy.
In November 2022, SpinaFX achieved certification for its quality management system, enabling pursuit of regulatory approvals in various regions.