Basically Epifix and Grafix are essentially the same product, each derived from minimally manipulated placenta tissue. Each product has its pluses and minuses. Epifix apparently is easier to use, readily available and can be stored/refrigerated for an extended period of time. The tissue itself is no longer alive and any potential fetal stem cells are also not alive. Grafix must be thawed before it can be used to reactivate the living tissue/stem cells and it is initially more difficult to apply. It is also off the shelf and has an extended shelf life as long as it stays frozen. Do the reactivated stem cells make a difference? I believe they do have a positive impact to turbocharge and heal the inflamed wound faster and with greater efficacy than Epifix. As far as I know, there has not been a trial comparing Epifix to Grafix. I know the recent Grafix trial was very professional and positive, the Epifix trial was very small and the results suspect. But if both biosurgery products heal wounds at the same cost with the same rate of effectiveness and shortness of healing time, then Epifix could be a superior product. This is what I do know. I have been talking to a specific doctor who has used Grafix well over 100 times in his practice and all of his patients wounds closed with no amputations. Does anyone on this board know a doctor that has used Epifix over 100 times with a 100% success rate?
Sorry tensgut, looks like I was right. When OSIR posters were slandering MDXG (from FDA letter) , I wrote months ago on your board that the living cells of Grafix might raise scrutiny and to be careful what you wish for. Now OSIR will be required to fund trials that meet FDA's criteria for DFUs. Grafix cannot be a big player for a while. I think it makes some sense why OSIR liquidated a product now. They will need a few million for this venture.
FDA, tissue reference group
"A human amniotic membrane product for wound covering, and containing viable cells that are retained in the product to support and promote soft tissue repair and wound healing, is not regulated solely under section 361 of the Public Health Service Act because it is dependent upon the metabolic activity of living cells for its primary function and is not for autologous or allogeneic use in a first-degree or second-degree relative."
Tensgut, good to see you again. Physicians remain unsure what particular growth factors (EGF, TGF, VEGF, PDGF, etc) may be contributing to wound healing to a degree. I don't think there is any clinical significance whether or not a graft may be "alive" or not when we know that the growth factors are aiding in wound healing.
Epifix will be the leader because physicians are looking for solutions that will will maximize their time. Ease of use (time spent applying) and the fact that the staff does not have to plan the day before to thaw a product that may or may not be used. Busy wound clinics are unpredictable and patients don't always show up for their appointments. Add in the recent CMS proposal on graft limitations (government effort to reduce waste to find cost savings to fund Obamacare) and it points to Epifix being more economical as well.
You could get a 100% success rate with Grafix or Epifix depending on the physician methodology, patient population, protocol, etc. That might explain some of the differences in healing %s among the Epifix / Grafix studies.
Strut, I commend you on your anti-bashing and thoughtfulness. I recently visited the Osiris headquarters in Columbia, MD at the annual shareholders meeting and have seen part of their quality control procedures. I was able to ask a lot of questions to management and to participating doctors during their demonstrations. Grafix is cryo-preserved at minus 59 degrees Fahrenheit. It stays in the cryogenic freezer until ready for use. The thawing time is about 5 minutes. I saw where individual samples of Grafix (Ovation) were analyzed under a high powered microscope to make sure that the MSC's and other growth factors were still active and viable. There was a demonstration where Grafix was applied to a plaster cast foot with a "diabetic foot ulcer". The procedure for applying Grafix to the wound was a couple of minutes. The excess Grafix could either be cut or simply folded over the open wound.
Grafix stays in the freezer until needed so it does not matter if the patient shows up or not. As far as cost is concerned, I believe that the cost for Grafix and Epifix is somewhat comparable. I believe the only real advantage of Grafix over Epifix, is that Grafix will have a higher healing rate for the really hard to heal wounds where amputation could have been a serious consideration.
There is plenty of room for both products as both products are superior to all of the old technology wound closing products. Epifix does have the head start and has a much greater and powerful sales force resulting in greater sales at the present time. Both companies should capture a greater percentage of market share as doctors start using these novel products.
So, I repeat, does anyone on this board know of one or more physicians that has used Epifix over 100 times in his/her practice with a 100% success rate, including the very hard to heal patients?