I had a lively debate on the OSIR board regading Epifix vs Grafix. Epifix is a better choice to treat ulcers in terms of cost, physician ease of use and patient outcomes and I will explain below.
Lets first take a brief look at Grafix. The folks will tell you that "live" cells within the product makes it superior. Let me remind you that we are looking at getting from point A to point B (non healed to healed ulcers). For ulcers, there is no credible evidence that "live" cells within a scaffold provide any clinical significance over Epfix when treating ulcers. We are also talking about potentially different mechanisms of action between the products. Would you paint your car and claim it's better at getting from point A to point B?
Peer reviewed data reveals a 92% heal rate within 6 weeks for Epifix vs 62% percent that closed for Grafix. Mind you this isn't head to head data and one cannot scientifically claim superiority without one.
Back to Grafix, I will make the claim that Grafix may be more expensive and time consuming. Govertment workers are paid a flat fee and look to complete work in the least amount of time. Physicians in the private sector are not compensated for extra time spent on the products in terms of reimbursement. Reimbursements continue to fall (see CMS's new rule for Dermagraft). Physicians/clinics need to see more patients in less time. With that in mind:
Grafix requires freezing. It takes clinic staff time to store and freeze Grafix and then dethaw. The staff needs to plan which particular size and amount of grafts to have ready the next day. Many grafts are utilized at the last minute, with a particular size due, patients do not show up to clinic. This leads to waste = money lost. Not to mention that physicians claim that it takes longer to apply Grafix vs traditional grafts.
Epifix is ready to go on the shelves for immediate use. A FAR better choice for a busy practice and the market speaks
Strut, I admire your debate on the OSIR board and you admirably defended Epifix against Grafix. Epifix is currently taking market share from the other old wound care products, Dermagraft and Apligraft. You have made some good points, some true and some not quite so true. Epifix is easier to use since it only needs to be refrigerated where Grafix must be stored frozen and thawed prior to usage. Many hospitals and wound care clinics have a ready supply of Grafix on hand and it does come in three different sizes. The cost of both Grafix and Epifix are about the same. Supposedly less time is needed to close most severe wound with Grafix, hence less applications. Most of the time only one application is needed. With time, costs will decrease with economy of scale leaving the autogolous method toocostly even if it may be a better method of stem cell delivery. Grafix is more difficult to use but once a doctor has used it a couple of times, it becomes easier, at least this is what one of my doctor contacts states. Two major advantages of Grafix is it's anti inflammatory nature and little or no scarring after usage. Any wound care product is good if it is successful. I do believe Grafix has it's advantages over Epifix on the hard to heal wounds because it is a living tissue with stem cells to promote the healing and time of closure process. Until there is a comparable and realistic trial between Grafix and Epifix, no one can truly say which one is superior. Bottomline, assuming both products are treated as biosurgery products, there is plenty of wound care business to be shared.
Tensgut, the OSIR people seem to walk with a chip on their shoulder since a Grafix multi center study was published just a FEW days ago. I didn't hear a mention of any other compelling Grafix data until this study. Did you?
Look, studies get many physicians to adopt a product. Generally, empirical evidence keeps them on board. Epifix is so ahead in terms of adoption that Grafix shouldn't even be in the conversation. The ball game right now is Epifix vs Dermagraft and Aplgraf.
I watched your debate from afar and sorry dude, you lost. Why - the foundation of your arguement is a single center 25 patient trial. The whole market cap of this company was built on Parker Petit connections and now it will shrink on the public exposure of Parker's reputation. Sorry.
The OSIR people are active with the thumbs. Here is what hasn't been disputed. Feel free to dispute below:
1) Epfix, not Grafix is taking the marketshare from Dermagraft and Apligraf. The market speaks.
2) Epifix has peer reviwed data. 92% within 6 weeks.
3) Grafix had no compelling data until a FEW days ago. What significant evidence did Grafix have with payers before?
4) Potentially different Mechanisms of Action. What matters is getting from A to B aka results, not product features. Product features is marketing until its demonstrated clinically and peer reviewed
5) Grafix can lead to waste (as I described above). The very thing that the new CMS proposal is trying to eliminate
6) Grafix takes longer to apply and has a learning curve. Good look convincing physicians who are already 2 hours behind in wound clinic.
7) There is no proof that "live" stem cells provide clinical significance over Epifix. It may not even be necessary in getting from A to B for ulcers.
I speak to key opinion leaders in the field. They care about benefits not features. How does the product benefit them in terms of saving time and patient outcomes. That actually sales 101.
Don't get me wrong, I think that OSIR has a solid pipeline for many applications. But for treating ulcers, Epifix is just a better choice.
Epifix continues to take marketshare from the leaders, Dermagraft and Apligraf. Shire and Organogenesis are hemorrhaging. Look at the company reports and the loss of revenue for the competition. They are losing marketshare to Epifix due to cost, physician ease of use and patient outcomes.
This is where the money is made. A 1-2 billion market for Epifix. There is incredible value in Epifix ALONE.