FAQ DirectGen™ Allograft

What is DirectGen Allograft made from?DirectGen has been harvested from donated cadaveric tissues that have been sourced and processed by AlloSource Tissue Bank in accordance with FDA and industry requirements. Each lot of DirectGen has been sourced from a single donor.

How has DirectGen been processed?DirectGen has been processed via AlloSource’s proprietary AlloTrue™ process. This computer-controlled process meets (or exceeds) all requirements as set forth by the FDA and AATB (American Association of Tissue Banks). Furthermore, DirectGen has been terminally sterilized via low dosage gamma radiation to an SAL (Sterility Assurance Level) of 10-6. This sterilization method has been validated in accordance to ISO 11137. Post Sterilization, DirectGen undergoes a final QA review prior to to being released. This final review includes Osteoinductivity testing (via BMP-2assay) for each of lot Demineralized Allograft product.

What safety measures are in place to mitigate any chances of disease transmission with this donated tissue? Each donor undergoes a rigorous screening and testing process in accordance to FDA and ATTB standards. This process includes both review of donors’ medical history, and serological and microbiological testing of the donated tissue. The tissue is then aseptically cleaned and processed via AlloSource’s proprietary AlloTrue process. Finally, each lot of processed tissue undergoes a rigorous post-processing review before it is sent off to be terminally sterilized via gamma radiation.

Has AlloSource had any previous cases of diseases transmission reported with it’sAllograft products? No, AllloSource has not had a confirmed case of disease transmission from allografts in its 17-year history.

What is the mechanism by which DirectGen promotes new bone growth?The Mineralized Allograft product contains both the mineral and organic content of the dontated bone. This provides the graft site with a 3-dimensional scaffold for in-growth of new bone as well as a source of calcium phopsphate and collagen to assist in new bone development. The Demineralized Allograft product has had the mineral content of the bone removed. This process results in exposing the naturally occurring growth factors in the bone (BMP) which in turn helps to induce differentiation of undifferentiated pluripotenial cells to an osteoblast phenotype.

FAQ DirectGen™ Allograft

What is the recommended preparation method for DirectGen?DirectGen should be left to hydrate in a sterile isotonic solution for up to 30 minutes. It also recommended that DirectGen should be mixed with patients own blood whenever possible. When hydrated DirectGen can be easily handled which allows for precise placement of material in the graft site.

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What are the primary clinical differences between the different options?• Mineralized Cortical bone is denser/less porous, resulting in slower resorption which makes this tissue type ideal for

maintaining space/volume in grafting sites over a more extended period of time

• Mineralized Cancellous bone is more porous and has significantly more surface area than cortical bone. This additional surface area presents cells with more area to deposit new bone and results in a more rapid turn-over of the graft site.

• The Mineralized Blended product is a 50:50 mixture of Cortical and Cancellous bone. This product is intended to provide the clinician with the benefits of both tissue types in a conveniently pre-mixed product.

• The Demineralized Cortical bone has been processed to expose the bone morphogenic proteins (BMPs) within the bone matrix. This results in the graft material that has the potential to induce cell differentiation and new bone formation.

What is the shelf life for DirectGen?DirectGen has a maximum shelf of 5 years (from date product is packaged).

Does DirectGen require any Special Storage conditions?No, product can be stored at room temperature (15-30°C).

Is DirectGen Mineralized Allograft radiopaque?Yes, which allows the clinician to easily monintor the progress of the turn-over of the DirectGen material.