10051703System 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 SAFRClosedCollaborative R&DInnovate UKThis 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.