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)
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
Clinical trial operations and site training
Operational management of domestic and international clinical studies including protocol development, site initiation, monitoring, CRF management, and adverse event reporting.
Medical education and KOL engagement
Workshops, conference presentations and educational programs to disseminate clinical evidence and gather expert clinical feedback.
Contract manufacturing coordination and transfer
Management of relationships and operational transfer to external contract manufacturers to support design for manufacturing, quality integration, and production scaling.
Regulatory and quality management implementation
Implementation and maintenance of QMS processes to meet ISO 13485/MDSAP and support regulatory submissions (EU MDR, Health Canada, U.S. FDA).
Preclinical study support and translational R&D
Conduct and support of bench testing, animal studies and mechanism-of-action investigations to support clinical translation.
Clinical trial operations and site training
Operational management of domestic and international clinical studies including protocol development, site initiation, monitoring, CRF management, and adverse event reporting.
Medical education and KOL engagement
Workshops, conference presentations and educational programs to disseminate clinical evidence and gather expert clinical feedback.
Contract manufacturing coordination and transfer
Management of relationships and operational transfer to external contract manufacturers to support design for manufacturing, quality integration, and production scaling.
Regulatory and quality management implementation
Implementation and maintenance of QMS processes to meet ISO 13485/MDSAP and support regulatory submissions (EU MDR, Health Canada, U.S. FDA).
Preclinical study support and translational R&D
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