Granted, this is from Craig-Hallum's analyst and has disclosed potential conflicts. Goldman won't issuing an analysis for either company any time soon. A comparative chart preceeded the this narative showing Epifix closing wounds at a rate of 92% over twelve weeks versus 62% for Grafix.
Efficacy: From an efficacy standpoint, Epifix® in both the prospective and retrospective crossover study closed diabetic foot ulcers with greater success (see table above).
Safety: Epifix® safety profile is also superior with only one patient reporting an adverse event (pneumonia, which we would argue was unrelated to the treatment) vs. 19 in the primary Grafix® arm.
Ease of Use: Epifix®, has superior handling and storage qualities (room temperature for up to 5 years) when compared to Grafix® which is cryogenically frozen and requires a multi-step process to thaw.
Regulatory: Epifix® is regulated under 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act (which allows the Company to bypass the FDA’s lengthy PMA process). Osiris is claiming that Grafix® falls under the same regulations, however, the presence of living mesenchymal stem cells, or MSCs, is problematic as the FDA specifically states, “bone marrow-derived mesenchymal stem cells expanded in culture are more than minimally manipulated and therefore not a 361 HCT/P.” We believe that for Grafix® to be marketed in the U.S. Osiris will be required to obtain FDA approval which will be costly and time intensive.
Reimbursement: Both companies have Q and C codes, but only MDXG has garnered positive
reimbursement coverage (6/9 MACs and commercial in a few geographies).
In summary, the reported data on OSIR’s Grafix® is good, and we believe supports usage of amniotic tissue in the treatment of diaibetic foot ulcers. However, we believe that data from MDXG’s Epifix® studies are superior from both a safety and efficacy standpoint. This, along with Epifix’s easier storage/handling and falling under section 361 vs. a likely need
I think you'd better read the fine print on that so-called "study" before you declare the supremacy of Epifix. They only treated 13 patients with Epifix and then declared 92% efficacy. Maybe if they had only treated 1 patient they could of had 100% efficacy!
Other points that I noticed was that the Epifix trial patients were on average 5 years younger than the comparative Stardard of Care patients. And, the starting size of the wounds for the Epifix patients were much smaller and their Body Mass was much smaller. It seems that all of the Epifix patients had advantages in almost all measurement categories, before the trial even got underway.
I wouldn't get too excited about a seemingly loaded Epifix trial that only contained 13 vs 12 trial patients, all controlled by just one test site.
Osiris had a "real" trial with nearly one hundred patients located over 20 trial centers. Osiris had the kind of trial that Insurance companies can take to the bank.