**2.1 Fiber generation**

The fibers described here are referred to as L-MDF (LifeNet Health-Moldable Demineralized Fibers, LifeNet Health, Virginia Beach, VA and clinically available as part of PliaFX® and OraGRAFT® Prime brands). The particular fibers studied below were prepared from human cortical long bones that were aseptically recovered from donors, debrided, and disassociated from marrow and trabecular bone. The resulting tissue was processed by a proprietary computer numerical controlled-milling method (CNC-milled) into long fibers and disinfected using a proprietary process. The fibers were then demineralized using proprietary procedures. Following demineralization, fiber samples were taken to quantify residual calcium levels (average 1.7%) using a calcium reagent kit (Eagle Diagnostics, Cedar Hill, TX).

The demineralized fibers were then freeze-dried, placed in final packaging, and treated via low-dose, low-temperature gamma irradiation, at a level necessary to achieve a sterility assurance level (SAL) of 10<sup>−</sup><sup>6</sup> .
