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<p>[QUOTE="Concerned Scientist, post: 3012290"]What I look for in a biologic product is what the FDA looks for with a pre-market approval: safety and efficacy. </p><p>Get some good safety data out there and prove the whole immunodepletion process. This part should be easy enough for these products. </p><p>The efficacy is the real killer. Get solid prospecitve, blinded, randomized clinical trials in spine out to the typical 24 month data point. Have a real clinical control studied in the study at the same time - no historical control. </p><p>Be truthful about exactly what it is: If there is DBM in it, then why does the package insert not state it (Osteocel Plus). If it has 250,000 stem cells/cc, then why does the package insert say native cell population (bone marrow has at the high end 1,500 stem cells/cc). </p><p><br /></p><p>So far neither of these tissue products (the claim of DBM should push these products at least to a 510K if not really to a PMA process soon) meet my criteria of "would I put it in my own mother?"</p><p><br /></p><p>At best it approaches a DBM like product, but there are several DBM products out there with better pre-clinical evidence than these two products, i.e. Osteotech Grafton, Medtronic Progenix, and perhaps Synthes DBX.[/QUOTE]</p><p><br /></p>
[QUOTE="Concerned Scientist, post: 3012290"]What I look for in a biologic product is what the FDA looks for with a pre-market approval: safety and efficacy. Get some good safety data out there and prove the whole immunodepletion process. This part should be easy enough for these products. The efficacy is the real killer. Get solid prospecitve, blinded, randomized clinical trials in spine out to the typical 24 month data point. Have a real clinical control studied in the study at the same time - no historical control. Be truthful about exactly what it is: If there is DBM in it, then why does the package insert not state it (Osteocel Plus). If it has 250,000 stem cells/cc, then why does the package insert say native cell population (bone marrow has at the high end 1,500 stem cells/cc). So far neither of these tissue products (the claim of DBM should push these products at least to a 510K if not really to a PMA process soon) meet my criteria of "would I put it in my own mother?" At best it approaches a DBM like product, but there are several DBM products out there with better pre-clinical evidence than these two products, i.e. Osteotech Grafton, Medtronic Progenix, and perhaps Synthes DBX.[/QUOTE]
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Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
Osteocell Plus vs. Trinity Evolution
>
Cafepharma Message Boards | Pharma Sales, Device Sales, Lab Sales
Home
Forums
>
Medical Equipment/Device Sales
>
NuVasive
>
Osteocell Plus vs. Trinity Evolution
>