SiN is one of the first materials to challenge the monopoly that PEEK has not only in the market but within the industry. Holding companies hostage to a three year $225,000 to $250,000 licensing agreement, the time has come for someone to challenge Invibio's stranglehold on the market. In addition to challenging PEEK, Amedica will be provided with an opportunity to substantiate their claims and validate that their unique BioActive surface promotes bony ingrowth in and through the implant. The last company to have any material similar to this was Zimmer with its acquisition of trabecular metal in terms of their argument.
Kudos must go out to Amedica. Regardless, whether you like their portfolio or not, they are one of the few companies within our industry willing to put their money where their mouth is. TSB has heard many varying opinions to SiN, TSB wants to know what our readers think. Will this be a worthwhile investment, or could this come back and bite them in the derriere? TSB wants to know what are readers think?
Curious if this is a blind, randomized study or some more phony-bologna industry BS where the deck is stacked in favor of SiNi from the beginning.
ReplyDeleteI'll withhold my kudos until the details are revealed...
speaking of Invibio's monopoly of PEEK - isnt July the month that some other companies (solvay) are supposedly going to receive their FDA approval to market their plastic material for interbody grafts?
ReplyDeleteGreat point, 2:13! I think we know the answer or you can go to www.clinicaltrials.gov to find out this study is not listed. Hence, this is nothing more than a PR and sales scam.
ReplyDeleteOther than the licensing fee, is PEEK a problem? Are the fusion rates with PEEK so bad that we need a new material? PEEK implants have stolen the market from the Allograft interbodies, which was the gold standard for forever. This is because the PEEK interbody fusion rates are equivalent or better and come without some of the issues of bone (tissue tracking, potential for disease). I am glad that I don't have money in Amedica because it sure seems to me that it is a waste of money to prove that the SiN fusion rates are higher than the PEEK fusion rates. In the end let's face it, if SiN proves to be equivalent or slightly better than PEEK based on one companies self funded study does anybody really think the surgeons are going to start inviting Amedica to service all their interbody needs? I would be surprised but I have been wrong before. It just seems like it will be a lot of money to spend for not much return in the end, but maybe it just has to be done.
ReplyDeleteFLHR
ReplyDeleteto say "peek implants have stolen the market from the allograft interbodies" is a bit of an overstatement, no offense. i know many a surgeon who are quite loyal to allograft inerbodies; i agree their usage isn't necessarily expanding but i have not seen a marked drop off in their use even with the increase in PEEK usage
Keytone? I think you mean Keetone.
ReplyDeletefunny
nope...you mean ketone.
ReplyDeletePEEK is a wonderful material, but I'm sure it needs a competitor. Good luck to Amedica and crew.
ReplyDeleteResults-based practice is becoming the new buzz word. If they can prove equivalence and cost less, then more power to them.
BTW....What happened to the facet fusion page? Sounds like an interesting topic, but it is gone.
ReplyDeleteWhy isn't Amedica's legal team clamping down on this post? Didn't they do that previously for some ridiculous reason?
ReplyDeleteGotta love it when their HR team has nothing better to do...
Given that bone never has or ever will grow onto PEEK, isn't having a synthetic material that DOES a good thing? Doesn't it expand the fusion footprint dramatically, rather than merely just the graft window for bone to grow? And just because this isn't listed at clinicaltrials.gov doesn't mean this isn't a legitimate study with intent to prove something. I don't carry this product, however, I'm not going to junk it or the study intent just because I don't. Allograft bone resorption for higher risk patients/poor fusion rates is real, so these synthetic products are necessary, and we can certainly do better than PEEK! Best of luck, Amedica. It's about time for a porous ceramic to make a move in this space.
ReplyDelete@9:23AM, PEEK is a decent product, but not the holy grail, that filled a void 10 years ago. However, it didn't evolve and come to market because it was a fantastic bone healing substance, either. Let's face it, how many orthopedic implants are coated in PEEK (or any other non-porous-polymer-based-cell-repellent) so that they can heal faster/better? ZERO, duh. HA/and porous material are the gold-standard in orthopedics.
ReplyDeleteUnless you believe in ObamaCare and want to keep old technology the status quo... what's wrong with an evolutionary product/material coming of age?! Do we not want the best materials that are bioactive and porous(SiN) to be available?
(HA/BMP?)
Furthermore, the reponse above is correct. PEEK hasn't "stolen" the bone market, or even came close, from allograph- especially in ACDF and ALIF's. And, as far as I know there are not any studies out there that show "better" results for fusion with allograph vs. PEEK. If so, please site them, I'd be interested. (and if so, we're they on clinicaltrials.gov? LOL)
The biggest reason PEEK is used is because it is easy access, available, easier to manage (vs. tracking/etc) and the margins are higher. Thus, meaning that every company in spine is out there hawking it because they can make more money with less headache.
The biggest reason (deleted co.) came out with it back in the day was because bone (PL and some AL) was constantly on back-order and had quality issues as well (cracking). As stated above, PEEK was easy to make available (milled plastic) and filled 'the void' of that back-order issue, rapidly.
AND, by the way, the fabulous study done for it in spine and how it was cleared??! Oh, that's right, it was first cleared as a CEMENT SPACER and being used in the spine for well over a year (or more) before lobbying efforts with the FDA moved it up.
Just sayin...
8:51, your comment is spot on except for the obamacare remark, which is as douchebaggie as it is moronic. The federal government's aversion to innovation is a function of the Regen scandal and the subsequent knee jerk reaction by Congress. Obamacare was just a twinkle in Lenin's eye at that point, when we were still subject to Bushcare(less).
ReplyDeleteBy the way, Glenn Beck called. You've been nominated to join his anti-Obama circle jerk.
@12:58,
ReplyDeleteWell, you pick one sentence out of my epic tirade to call me a DB... that's funny. lmao
My apologies to you, I didn't think there could possibly be any Obama supporters in this blog... but, here you are...
I don't like Glenn Beck or circle jerks, so think I'll pass.
But, thanks for the one thing we agree on... the search for better IB fusion material/products is needed.
I don't think it will happen. I think it's better as it is going. Common let it be like that.
ReplyDelete10:54, I wasn't calling you a douchebag--I was characterizing your remark. But I do appreciate your attempt at self-reflection.
ReplyDeleteWhy would Amedica participate in a research study if they weren't supremely confident that the results would strongly favor their SiN material over Peek? Their ceramic spacers have been in the human body for a year or longer now. I imagine the doctors are coming back with compelling results that the company wants to publish on an objective, clinical manner. I think it is great and will be interested to see the study's findings.
ReplyDeleteI'll tell you why they would participate in the study ... look at all the free press they're getting!
ReplyDeleteYou have GOT to be kidding me if you think that SiN is going to produce better clinical results than PEEK. The reason that the ~70% success rate for lumbar fusion isn't 100% isn't because of sub-par materials. Wake up.
And for all the crying for Invibio's "stranglehold" hold PEEK (which is total crap, other vendors have PEEK), you think that a CERAMIC from a SINGLE SOURCE is going to be cheaper? Think for once. Amedica has all kinds of IP on it and you can't make a different version like everyone did to AcroMed, who patented a specific version. SiN is locked up by Amedica.
I hope everyone also realizes that Amedica made this material not for fusion devices, but for bearings. Then the market tanked for disc replacements and they had to do something, so they whipped up some crap about osseointegration.