The next question that must be answered is whether this is another material breakthrough that is more scientific marketing than substance? Is this really a game changer? Will the market see a company that will expand the use of SiN into coated ceramic pedicle screws? Based on Amedica's press release, the company makes it sound as though they are a bigger player in the spine market than they really are. If this acquisition positions them as a well balanced company, what were they really buying. Another pedicle screw? The opportunity to eliminate their licensing distribution agreement with Integra/Theken Spine for the Tether plate? The facet gun? Could that market be smaller than all the looney toon analysts' predict? Where is the leading edge technology for spine in this acquisition? Even if Amedica can develop a disc out of SiN, what effect will that have on an already cluttered artificial disc market. Will they tout that their disc will be the 5th or 6th generation disc?
In all likelihood, this acquisition was made to position themselves for an IPO, whenever this dogged economy gets back on its feet. This company has talked about IPO since last summer. Based on this acquisition, there isn't enough firepower in the current portfolio to position this for a sale to a legacy company. If anything, the potential of utilizing SiN in total joint implants is where the goose with the golden egg really lies. In closing, if Amedica really wants some credibility, why don't they disclose all the surgeons that are consultants and/or investors in this company? TSB believes that SiN can be a game breaker in recon, but spine? In addition, how much more will they drive up the cost of interbody devices, when there is an all out war in the marketplace surrounding the ASP of this product segment? TSB wants to know what you think.
The studies show that PEEK and Allograft bone have about the same fusion rates, but are superior to titanium--all other factors held constant. This is most likely due to stiffness. We all know that instrumented fusions have a higher success rate than non-instrumented fusions, etc, etc. Studies comparing materials in cervical fusions show that PEEK and bone have similar fusion rates, but that PEEK had a better restoration of disc height and lordosis. My guess is that SiN will cause stress shielding. Wolff's law has been proven in a great many studies since 1892. One would also think that bone adhering to the implant is a good thing, but the high modulus is not good for fusion quality.
ReplyDeleteI agree with MM, SiN has a performance advantage as a wear material in joints, but will under perform PEEK as an interbody spacer due to it's excessive stiffness.
Get ready...here comes the overly defensive amedica reps to defend their product to the death. They must have an awful lot personally invested in SiN's success judging from the comments they made on TSB's last post. Something along the lines of their reps "banging 99 hot chicks and our wives too". Haha...delusional to say the least.
ReplyDeleteAn interesting acquisition. I certainly hope Mr. Shapley negotiated a great deal. US Spine doesn't have anything special for the market. The facet gun was redesigned several times because it didn't work well. Besides the facet fusion market is not booming. Reviewing their executives, if Mr Sendro was part of the acquisition will he take the sales dept down the same dark and slimy road as he did at Blackstone and Vertebron? If so, Mr Shapley will also become close friends with the FBI.
ReplyDeleteDoubtful they have that many reps but regardless of your opinions, I don't think the statements are saying they are going to lead to better fusion rates. There is truth that fibrous tissue growth weakens the fusion and they have come up with a solution. Zimmer tried it, as well. I would like to see some clinical studies how this material compares to PEEK and titanium reducing fibrous tissue growth. Not sure stiffness is an issue, especially since PEEK is quite a bit stiffer than bone, too. Only time will tell.
ReplyDeleteNote to readers: there is no difference in fusion rates among FDA approved materials (Titanium, PEEK, SiN...). As many of you know, the first fusion "devices" were stainless steel ball bearings. Guess what... they worked... and thus, the beginnings of the evolution of the fusion procedure into a multi-billion dollar industry. Titanium was next because it sounded sexier. Fusion rates? About the same. Then, some brilliant marketing guys at Danek picked up PEEK. Fusion rates? About the same. SiN fusion rates? About the same. Anyone with the slightest clue about the fusion procedure knows it's all about the "carpentry" - careful preperation of the disc space/end plates, yada, yada. All of the fancy marketing nonsense that has popped up (modulus elasticity, stress shielding, bony in/on growth, etc.)... it's all just that - marketing nonsense. Show me the clinical studies proving modulus elasticity means something to fusion rates. Show me the clinical studies addressing stress shielding. They don't exist.
ReplyDeleteSpine... the industry of misinformation.
I am personally tired from hearing about the Amedica guys pumping their “technology” on this blog. Now we actually are giving them a forum to do so? Next, I am waiting to hear how this stuff cures cancer.
ReplyDeleteSo far, no one with SiN has been reported to have cancer. Can BMP say the same? I think not.
ReplyDelete2:33 - are you saying that SiN is not only a new material for cages, it is also a new biologic? That's pretty impressive - how can I learn more?
ReplyDeleteHey, not to change the subject but I just looked at a press release regarding ATEC and seems like they have quite a few licensing agreements in play. I'm interested to see where these guys are sitting in terms of actually great products. Let's face it, their website isn't exactly forthcoming this week with all of their lines. Sure they're waiting for NASS but curiousity is plaguing me. Also, is Globus done putting out products or do they have room to grow their line? So much "Build it and they will come!" Attitude.
ReplyDeleteThen again, "Forget it Jake, it's Chinatown?"
2:52, evidently you haven’t been following this blog the past week or forgot. Here’s a hint - Look what happened to AST and follow it’s trail of former employees. ATEC’s licensing technology might make you look twice as did Stabilimax, but will it ever reach the market? I stand corrected- The Nexus (Geo Structure) did make it, but nobody wanted to resuscitate it. Wonder why? Enough said. Jesus Juice is better than Kool-Aid. Now back to the topic…
ReplyDeleteMea culpa 2:52! On a positive note. They do put food on the table for the vendors’ and their families & sum.
ReplyDeleteIt's interesting how many orthopedic implants are covered with PEEK.
ReplyDeleteZero.
Why? Because it prevents attachment.
How many ortho implants have porous coatings?
All of them.
Why? Because bone attaches to the porosity.
SiN total joints are based on more than just the wear factor. It is also based upon the fact that the "monolithic cup" attaches/heals to the bone on one side while allowing articulation on the other side. So, SiN is relevant in both spine and TJ. Bony attachment is the next evolution.
PEEK came on like wild fire to replace a problematic market with allograph bone. I remind you that it was a 510k'd as a cement restrictor for years and had no clinical papers to support it. Just great marketing and availability.
It was a good product, it was an evolution in materials and has served a purpose. And to that end, now is somewhat passe after 10 years. SiN and other materials being developed are the new wave. The only difference is that it is highly proprietary (not milled plastic). So, not everyone is going to offer it vs. PEEK that was slung to all vendors.
Holy crap are is the Amedica marketing department taking over this blog? Talk about inexperienced BS artists.
ReplyDeleteAnon 5:19PM Hey dipshit ... It's "allograft" not "allograph". That error alone discredits your entire post. One other freebie before you get completely embarrassed next week at NASS . . . Just because a material is used in Reconstructive procedures does not mean it is an acceptable material in Spine procedures.
Anon 9:52AM (probably the same dumbass as Anon 5:19PM) nice cut/paste from a prior thread . . . FYI . . . stainless steel balls were not implanted as fusion devices in the 60s . . . they were, in essence, Disc Replacement v1.0 (and hell no they didn't fuse).
Fellas, there are no peer reviewed published studies with SiN (yes morons I just did a PubMed search). Show me an unbiased user and in 6 months, his/her patient will be visiting another surgeon to take that crap out. It's too damn stiff.
To all the SiN snake oil peddlers, fusion and bony attachment are two very different things. If what worked so well in knees and hips was equally as good for the spine, then the artificial disc would have proven to be the future of spine like we were all promised it would....
ReplyDeleteThe spine is a very different animal than a total joint. bony on-growth sounds great, but without the actual fusion, the procedure will be limited by the strength of your SiN material. Thats right, the old race to fusion or failure is knocking at your door once again.
Now, like has already been stated, put your money where your mouth is, and put out a study that shows you are at least the equivalent to allograft or peek, and then we can talk. That said, I wager my money on the fact that all the millions of dollars you will spend will only show fusion rates as good as allograft or PEEK. What then?
don't worry, one of these Nitards will try to think of a new spin. They just will not stop until the fusions are shown to do no better or worse.
ReplyDeleteBoth sides of this argument are week, seems like amedica posts contend better fusion rates while the non-amedica side ignores what the material does. What advantage does being hydrophilic provide, what advantage does peek have over this. Each side claims to have a bigger dick, some guy has bigger veins in his dick than most on the previous post, in that case, I would recommend he visit a urologist a.s.a.p. Silicon Nitride sounds like it has potential, better consult with your companies biomechanical engineers and get the real scoup. After all is said, sure amedica will sell to the highest bidder, putting it in the hands of some of you. Seriously, this post is getting old and predictable.
ReplyDeleteBTW, Anon 5:54: YOU made a grammatical error in your first sentance. You, too, are discredited. Better brush up on your grammar before the next dip shit convention.
anon 7:35 - English Major ... check your first sentence .... pot meet kettle . . . misspelling COMMON EVERYDAY spine terminology is inexcusable and a mistake for rookie inexperienced reps/marketing morons and others that don't give a rip except to cover a case and restock a tray. These people make this mistake every single day (another common one is adding a "T" to the end ALIF, TLIF, et al). Typing "graph" vrs "graft" isn't a simple typo ... it shows your a dumbass (look at your keyboard, if you know how to type or if you peck you'll understand)
ReplyDeleteThe only weak case here is the position that SiN is effective as a spine interbody device. There is no data. There are no peer reviewed published studies to review. If SiN has better fusion rates, please post a link to the data. If SiN creates better patient outcomes, please post a link to the data.
Better question is if Amedica is such a promising company, why would they buy or even take anything US Spine has? That facet gun was novel 5 years ago, but they could never get it to work and it was quickly leap-frogged by true MIS facet fixation products. It tells me Amedica had some capitial to spend and needed some infusion of products FAST. Too bad they just picked up a bunch of headaches.
Are there any good spine companies out there?..who is this moron correcting everyones grammar?.....I thought we were here to express views not our physical shortcomings mr. Anon 8 pm......
ReplyDeleteGood deal Amedica in a tough spine market...few choices out there that are clean well run companies that were short on capital .......hope u make a billion and shut up these neophytes...look that word up--English prof.......
MM, pleeeeeeease post about something else besides SiN!! It seems like that's all that has been talked about on this site for weeks. Even when you post about something unrelated, you still have the random comments from the Amedica scrubs saying sh*t like, "hey, what about that SiN stuff? I think those guys over at Amedica are really on to something." Then, like clock-work, another Amedica douche chimes-in, and next thing you know everyone is arguing about SiN. I mean, come on! This is getting rediculous. Let's talk about something new already!!
ReplyDeleteSiN sounds like it may have some advantages, but just as many weaknesses. I'm a Missouri kinda guy...show me. PEEK works, and works well. How does this material excede PEEk and at what cost? How much is a SiN implant? Quote me the list price of your miracle implant. Because price is king in most places. Time to put up or shut up.
ReplyDeleteI bet Amedica is so leveraged by this purchase that they are ripe for a buy-out from one of the majors. Medtronic, Depuy, Synthes? who is gonna scoop up this new tech?
ReplyDeletewhat a bunch of dicks on here! every subject on this site ends up as poster vs poster. (all anonymous, of course). very sad and just shows that most of the reps in the spine industry are egotistical dicks!
ReplyDeleteTo Anon 7:35 You have to discredit yourself; you wrote-
ReplyDelete(("BTW, Anon 5:54: YOU made a grammatical error in your first sentance. You, too, are discredited. Better brush up on your grammar before the next dip shit convention."))
Next time before you get out your red marking pen and grade everyone else; get out a dictionary and look up "sentence". Also, starting the sentence with "better" , as in You better... hmmm Where did you get your GED?
You reveal yourself as a "tool"
Great stuff here, guys! Really great stuff, making the industry look worse by the minute. Grow up.
ReplyDeleteI've been told that Medtronic has sued Amedica in europe over their broad SiN patents. If this is true, then Medtronic will continue to bash Amedica's products until they purchase the company. Then the Medtronic Rep's will tell us SiN is the holy grail of spine.
ReplyDeleteHey, 8:00, maybe you should take the same English 101 course as 7:35. For example, 'et al' should be et al. (al. is the contraction of the Latin word "alia" or "alii"). Also, 'your' should be "you're" in 'it shows your a dumbass...."
ReplyDeletePeople in glass houses....
SKELITE will eliminate SiN, not a buyout of Amedica!
ReplyDeleteThis comment has been removed by a blog administrator.
ReplyDeleteLOL!!! I am cracking up at these posts. Forget reading the funnies in the morning.....I'll just pack my bowl lean back and spark one up as I read this hilarious BS.
ReplyDeletePuff, Puff, Puff........INHALE
Gearshift/Feeler/Tap/Screw
ReplyDeletethat's how it all started... ? runnin' trays.. providing specs and technical support... now it's gotten very sophisticated And very rotten at the same time. The quality of rep training has gone down the tubes with an inversely proportional increase in the amount of BullS**T that is spread about systems and biologics and so on. ~somewhere in this mess patients have to be cared for properly. let's hope to God some goodness filters down.
Mr TSB, thanks for the venue; and also for trying to inspire dialog on our industry, even if so many continue to degrade it .
As the Joker said "This town needs an enema"
Now go ahead- someone call me a sissy or some other disparaging name.. It's expected on here...
@ 8:10 Nope, won't call you a sissy, but a Newbie. Some of us remember whey they bought the instrument and implant sets and drilled pedicles with power. No trays to run and surgeons with brass balls! Ahhh, the good old days!
ReplyDelete@8:37 yes I heard about those days... The golden days of Spine, when reps were trained in Spine and Biomechanics .... and the surgeons had a special relationship with the rep, not the fleeting ones of today. yes, us newbies envy you pioneers and your good old days..
ReplyDeleteSo here's the bigger question, to be answered especially by the seasoned reps on the board - are "the good old days" of surgeon-relationship loyalty over? Are they retreating? Have they been supplemented by the surgeons relationship with his bank account (tied to some consulting fees or other nonsense)?
ReplyDeleteHave Spine changed for good?
*Has, not *Have ... for the grammar police. My bad.
ReplyDeleteI am sick of the amedicrap postings! Jon over Weight I mean termite, get to work!
ReplyDeleteDoes anyone know how the U.S. Spine numbers worked out? Did anyone attached/employed/invested make out alright or was it a money loser all the way through?
ReplyDeleteeveryone lost their shirts and more
ReplyDeleteThe horse and buggy were replaced by the automobile and PEEK will be replaced by any and EVERY other material that demonstrates bone attachment. The sad reality is, the body doesn't like plastic and bone doesn't attach to PEEK. So, to all you PEEK cheerleaders out there... you had better start selling your inventory of horse whips because, in a few years, there won't be much of a market left for them.
ReplyDeleteAmedica will never publish their studies. SiN shows fibrous encapsulation similar to PEEK in an ovine model. Anyone who has half a brain and has seen the investor presentation from their last 14 rounds of funding could tell you that.
ReplyDelete