System for Annulus Fibrosus Repair (SAFR) – a percutaneously implantable preformed biomaterial for the repair of defects caused by either degenerative disc disease or needle puncture during nucleus pulposus replacement procedures SAFR
OrthoSon has stopped most of its work on a biomaterial plug designed to repair tears in the spinal disc's outer ring, leaving only expulsion testing to be completed at Imperial College London. The project aimed to fix defects in the annulus fibrosus—the tough outer layer of the spinal disc—caused by degenerative disc disease or by needle punctures made during procedures to replace the gel-like nucleus pulposus. Without a reliable repair, disc material can leak out, causing pain and re-herniation. The plug was made from a polymer similar to OrthoSon’s existing nucleus augmentation device, but changes to its formulation left its stability uncertain, which could have skewed test results. If the device had been fully developed and proven safe, it could have given surgeons a minimally invasive way to seal disc defects after nucleus replacement, potentially reducing repeat surgeries and long-term back pain. However, with four of five work packages discontinued and the remaining work limited to refining and testing how well the plug resists being pushed out, the immediate practical impact is now minimal. The test method developed at Imperial College may still inform future device designs, but no clinical application is imminent.
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This project is important in OrthoSon’s future and will be continued at a later date. To this end it is critical to future developments that the test method developed by Dr. Nick Newell and Dr. Matthew Kibble at Imperial College London is completed for the device development to have future success. The current fixed design plug are supplied in phosphate buffered saline and while the polymer used is similar to OrthoSons existing nucleus augmentation device the changes made mean the stability of the polymer is unknown. This could add some uncertainty to test results so we propose to provide a regular supply for test development purposes. OrthoSon proposes continuing to support ICLs development efforts by putting half a day per week aside to produce test plugs of a fixed or minor design deviation. The proposed Change of Scope is to discontinue Work Packages WP1 (Initiation, material selection and geometry), WP3 (Pre-clinical product design and testing), WP4 (Long-term implantation study) and WP5 (Stability testing). In Work Package WP2 to remove Task T2.4 (Clinical oversight of method development), T2.5 (Fatigue and motion restoration mechanical testing) and Milestones M2.1 (Range of movement restoration demonstrated ex-vivo), M2.2 )Cyclic fatigue testing illustrates withstanding of mechanical force in use) and M2.3 (Demonstration of expulsion resistance) and Deliverable D2.2 (Cell infiltration study report) while Imperial College London complete remaining Tasks T2.2 (Expulsion method optimisation) and T2.3 (Expulsion testing of implant) completing Deliverable D2.1 (Characterisation testing report). With the work program being significantly reduced there will be a significant underspend on all categories.
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