Spinal tech developer Spineology today released 12-month results from a study of its OptiMesh deployable implant designed for use in instrumented lumbar interbody fusion procedures to treat degenerative disc disease.
Results from the Scout trial were presented at the annual meeting of the International Society for the Advancement of Spine Surgery in Toronto, the St. Paul, Minn.-based company said.
“We are grateful to Dr. Chi and all the Scout investigators for their dedication in helping us to complete this important clinical trial. We look forward to completing the patient follow-up and gaining the market clearance that will allow us to market this unique fusion device to spine surgeons and their patients,” CEO John Booth said in a press release.
Spineology’s OptiMesh implant is a porous graft containment mesh designed to be deployed within the disc space as it’s filled to allow the packed bone graft to conform to vertebral body endplates. The system allows for disc space preparation and implant placement through a small cannula, the company said.
Data from the trial indicated that the device was safe and effective, with statistically significant improvements in low back pain scores and functional limitations at six and 12 months, as recorded by the Visual Analog Scale and Oswestry Disability index.
At the one-year mark, 100% of subjects examined achieved fusion, verified by computed tomography scans interpreted by two independent radiologists. A total 93% of patients at one year reported excellent or good satisfaction with their surgery, with no serious device-related adverse events reported, the company said.
“These favorable interim results indicate the Spineology system’s potential to provide good arthrodesis and pain relief while minimizing tissue trauma. We have seen shorter operating times, less blood loss, shorter hospital stays and excellent satisfaction for the patients treated in this trial,” study author Dr. John Chi of Harvard Medical School said in a press release.
Spineology said it is hopeful that data from the Scout trial will support a regulatory submission to the FDA as the company seeks expanded indications to allow the OptiMesh device to be used with bone graft and supplemental fixation in support of lumbar interbody fusion for treating painful degenerative disc disease.
Last September, Spineology said it raised $5 million through a convertible debenture, with funds slated to support continued commercialization, product development and clinical research.