What are the pros / cons between the two? Efficacy, ease of use? Are they basically the same? What do physicians think?
c'mon ABH cronies! this is a lay up for the spinsters! tell us again exactly what your in house study concluded?
No real big story there. The letter is addressing the processing, not the product efficacy. This also occured almost a year after receiving a positive survey from the FDA inspectors. Unfortunately, it didn't stop them from making and selling the products. They are all over my area. Shire's attempt to shut them down failed miserably.
It will be interesting to see if the FDA continues to let them advertise their products for off label uses. FDA is very specific on how these products can be used and but it seems like the companies in this space don't care what FDA or TRG says: http://www.fda.gov/biologicsbloodvaccines/tissuetissueproducts/regulationoftissues/ucm152857.htm There will be a reckoning eventually...
Key words in the 2012 update are "and" as well as "living". The focus here is all on Grafix and their living MSCs and has nothing to do with EpiFix. EpiFx is good to go.
Well you were correct. By the time Grafix hits the market Epifix will be so ahead of the game that it will be a challenge to convince a doctor to try a product that has to be cryopreserved. That's a step backwards from a time management standpoint and not to mention there is no proven extra benefit of using MSCs on wounds. Maybe for other applications but calling it "living" is just marketing hype for wounds. Living is not benefit, its a feature.
try and do a simple search on the role of MSC's and their involvement in wound care. You obviously sell for a freeze dried company who has brain washed you. Do a little research before you post stupid comments.
This is good for us in the amniotic tissue space. Stem cells should come from the patient no reason to have them in the graft. That's all I'm saying: Osiris says Grafix trial met primary, secondary, safety endpoints Osiris Therapeutics announced that Dr. Matthew Regulski, Medical Director of the Wound Institute of New Jersey, will present clinical trial data, including secondary endpoints, from Osiris’ multi-center, randomized, controlled clinical trial evaluating the safety and effectiveness of Grafix in patients with chronic diabetic foot ulcers tomorrow, November 20, at the 10th Annual Desert Foot High Risk Diabetic Foot Conference. The trial met all primary, secondary and safety endpoints and demonstrated a statistically significant reduction in infections and hospitalizations for patients treated with Grafix compared to conventional therapy. During the Desert Foot Conference, nine other clinical and scientific posters will be presented by investigators including the presentation of a 34-patient study evaluating wound closure in venous leg ulcers treated with Grafix. In that study, 71% obtained complete wound closure defined as re-epithelialization of the entire wound with 100% of the wounds remaining closed with mean follow-up time of 20.2 months, Osiris said.
MiMedx Follow Up Study Of DFU Patients Shows 94% Of Patients Remained Healed After Nine To Twelve Months MARIETTA, Ga., Nov. 19, 2013 /PRNewswire/ -- MiMedx Group, Inc. (MDXG), an integrated developer, manufacturer and marketer of patent protected regenerative biomaterials and bioimplants processed from human amniotic membrane, announced today that its study "Dehydrated Human Amnion/Chorion Membrane Allografts in Patients with Chronic Diabetic Foot Ulcers: A Long-term Follow-up Study" has been accepted for publication in Wound Medicine. The study manuscript was authored by Charles M. Zelen, DPM, FACFAS, FACFAOM, FAPWCA; Thomas E. Serena MD, FACS; and Donald E. Fetterolf, MD, MBA, FACP. This study is the long term follow-up from a previously completed randomized controlled trial (RCT) involving patients with diabetic foot ulcers (DFU). In this follow up study, the patients whose DFU wounds healed after treatment with EpiFix® in the initial RCT and the subsequent crossover study were examined. Eighteen of 22 eligible patients returned for follow-up examination, which was conducted 9 to 12 months after primary wound closure with EpiFix®. Clinical record review was conducted with IRB approval and patient consent. Of the eighteen patients studied, only one patient had recurrent DFU during the follow-up period, while 17, or 94.4%, remained fully healed. These findings support the long-term effectiveness of dehydrated human amnion/chorion membrane ("dHACM") for treatment of DFU. The study concluded that dHACM is a clinically viable and economically feasible treatment option that should be considered by clinicians who treat diabetic pedal ulcers. Parker H. "Pete" Petit, Chairman and CEO said, "The identification and implementation of an ideal treatment regimen for DFUs is an increasingly common issue faced by clinicians. Therapies that promote rapid and complete healing, thus reducing the risk for infection and amputation, can substantially improve quality of life while decreasing financial burdens. A competitor recently announced that the clinical study of their products showed that only 52% of their patients both healed in 12 weeks and remained healed at the subsequent 12 week follow-up. An optimal treatment for DFU would be one that supports both rapid and long-term healing. With 94.4% of DFUs remaining healed approximately one year after treatment, we believe our EpiFix® allograft is a clinically effective and economic solution to these needs." Bill Taylor, President and COO, stated, "Human amniotic membrane has been used as an allograft to treat wounds for over a century. However, our proprietary PURION® process has led to the development of our EpiFix® dHACM allograft. Studies have shown strong clinical and cost effectiveness of EpiFix® for healing of DFUs, Venus leg ulcers, and wounds that have failed to heal with other treatment modalities with minimal, if any, waste. Use of competitive skin substitutes routinely result in waste of over 80% of their graft because they come in only one very large size, which is generally at least 15 times greater than the median DFU. EpiFix® has size appropriate grafts and consequently, there is very little waste." "This clinical study is one of many in our series of publications that chronicle the clinical and cost effectiveness of our PURION® processed EpiFix® allografts," concluded Petit. The follow-up study is expected to be e-published during the last week of November in Wound Medicine (http://www.elsevier.com/journals/wound-medicine/2213-9095). The initial RCT entitled "A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers," was published in the International Wound Journal, and the electronic publication can be found at http://onlinelibrary.wiley.com/doi/10.1111/iwj.12097/full. The subsequent "crossover" study, "An evaluation of healing with the use of dehydrated human amniotic membrane allografts in patients with chronic diabetic foot ulcers," was published in Journal of Wound Care, and the electronic publication can be found at http://mimedx.com/r-and-d/clinical-publications.
