Along comes the Apatech Express and it seems that a symbiotic relationship was fostered. From a psychiatrists analysis this is a relationship between two parties that are dependent upon one another and receive reinforcement that everything is going to be all right. Word on the Street is that Stryker has spoken to Apatech about acquiring their technology. Even to the extent of asking for a number. Most of our readers would know that there is truth to this, considering that many Stryker distributors/sales people are selling this product. The most entertaining comment that TSB has heard was that Apatech was asking 10X on revenue somewhere in the vicinity of $50 million, plus or minus. If there is any truth to that, we hope Stryker exhibits some sanity. But you know what they say, "desperate times call for desperate measures." TSB wants to know what our readers have heard?
Wednesday, February 3, 2010
Apatech and Stryker: Kabuki Theater
Is this a stylized classical Japanese dance drama, with both performers wearing their best make-up, Steve MacMillan played by Nakamura Shinobu and Steve Czick played by Ichimura Kakitsu? This is real Kabuki Theater. It's been ten years since OP-1 was acquired from Creative Biomolecules, and with that acquisition has come a host of accusations, indictments and convictions leaving Stryker Biotech and the Almighty Stryker standing alone at the biologic bus stop waiting for their next ride.
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after overpaying for a reprocessing company, one never knows. jb would have balked at this price. stevie mac, who knows. good product, but not that good.
ReplyDeleteGood product? Good marketing, very mediocre if not outright lousy product, limited data. And even the few animal studies that have been published exhibit some creative writing and interpretation to arrive at the positive conclusions. To see that requires careful reading, as Bohner has done.(Biomaterials 30 (2009) 6403–6406). If I were Stryker, I'd spend my money elsewhere
ReplyDeleteon acquistions- have heard from 2 industry reps that something is up at Globus!. They said they are letting some of the distributors go. Do not know if they are trying to move the Dist. to direct employees or not. One insider said that he was told that Globus had a deal for SYNTHES to buy them. ??? The other thought is was to do the IPO.
ReplyDeleteGlobus cannot do an IPO. They would not pass the required level of scrutiny.
ReplyDeleteSynthes buy Globus, man that is funny
ReplyDeleteI have to agree - good marketing spin, mediocre product at best.
ReplyDeleteI've had success using the product even in complex revision and tumor cases. They have tried to market it as a bone graft substitute and therefore have tried to price it closer to Infuse than other ceramics. Even though their preliminary data is good, its hard to swallow that kind of price leveraging.
ReplyDeleteSuccess because you see the stuff stick around on X-rays, or because it really healed? The 'success' of HA based on it being around for ever on X-rays is fairly well-understood. And what preliminary data did you see that are good? As Bohner very lucidly explained, their intra-articular rabbit model is inappropriate and has not been used by anybody else but them. Yet they call it "well established"....
ReplyDeleteA rabbit model? When are these companies going to step up to the plate and fund a real study? It's time to walk the walk if you intend on talking the talk
ReplyDeleteA real study like NuVasive and Osteocell? Biologics is a whores market where little data is needed to market and sell a product.
ReplyDeleteStryker needs to find a niche to play in and grow.
There are companies that have done real studies, even if some have presented the data somewhat selectively at times. One, OP-1 has been properly studied, and they tried the hardest indications possible, a large reason they did not get the expected and wanted results. But an A for trying! Infuse was properly studied, but clearly the results were not always completely reported. Presently, Biomimetics for one seems to be doing the right thing. We are still waiting with baited breath for the data comparing Actifuse and Infuse in PLF, which study was loudly announced about 4 years ago. Not that I would trust Apatech's reporting any more than I would MSD's. There should at least be some interim results by now, or is it one big dud? Donor stem cells are the new highly priced DBMs, with no discernible benefit over the previous generation, for which there is not much data either. They do fine in ACDF, where everything works, and mostly fail in PLF, which is no surprise. I see no reason to waste money on these cells, not even for a clinical study.....
ReplyDeleteyes, i would have to say "good" product. not great but good. I saw a revision acdf 8 weeks out, couldn't get the cage out in one piece, soild bone. definitely patient protoplasm working there.
ReplyDeleteSee the earlier comment by another anonymous about ACDFs. And solid remodeled bone in 8 weeks...that must have been quite a young patient. How did you distinguish that from the rather solid HA? And, by the way, why the revision?
ReplyDeleteApatech would show up as granular image on X-ray. Doubtful it would create a solid fusion in 8 weeks unless the patient was young and healthy or if you were doing the ACDF on a white rabbit. This leaves a lot of speculation if it's the HA you are seeing or actual bone. Apatech has a great marketing sceme but fail to leave out how they used studies from other companies to predicate their product. There is validity in silicate additions to promote bone growth but Apatech isn't showing truely convincing evidence yet. As far as the Apatech Infuse study, they will claim since infuse is used off-label, they won't show the studies. Show a great human study and I may be convinced, until then, Apatech seems like a good sales pitch with a great tan, white teeth and slicked back hair.
ReplyDeleteFirst of all, you obviously understand Actifuse's Method of Action about as much as you understand BMP-2, Osteocell MSC claims, or any other biologic on the market. Each company does have their own flavor of Kool-Aid in the form of osteobiologics. Regardless of which product you utilize for spinal fusion, you are bound to have some downfall - ie. ectopic bone growth, bone recalls (Osteocel Hep B), or macrophage/inflamatory response.
ReplyDeleteSecond of all, stick with what you know on these threads. You sound like every other hardware rep I work with in my OR - all you know is screw size, pitch, rod length, etc. Let us worry about what we use to treat our patients. That's why we went to MEDICAL SCHOOL!
Love that comment about the tan! Just like Globus. There is validity in silicate having beneficial effects, but only in the right concentrations. Actifuse starts of with a homeopathic level of silicate inside the HA, and only a tiny fraction of that homeopathic concentration is released from the virtually insoluble rock. Smoke in mirrors, yet again.
ReplyDeleteJust read one of the many articles by the father of it all, Larry Hench: "The effect of glass dosage (0.001 g ml-1 to 0.015 g ml-1) on the in vitro dynamic dissolution behavior of melt-derived 45S5 and sol-gel-derived 58S bioactive glasses, in simulated body fluid (SBF) at 37 °C, was evaluated. These glasses differ significantly in texture, especially the specific surface area and porosity, as a result of differences in manufacturing route. The concentrations of elements (Si, Ca, P, and Na) leached from the glasses into the dissolution medium, from 1 to 22 h, were evaluated with the use of induced coupled plasma analysis (ICP). The reacted powders were analyzed with the use of FTIR to observe the formation of a hydroxycarbonate apatite layer on the surface. The results show that the rate of HCA formation on both gel- and melt-derived bioactive glass powders in vitro depends on the concentration of the powders in solution. This result must be taken into account when carrying out in vitro cell-culture studies to simulate conditions in vivo and in experiments using extracts of the bioactive glass powders."
Hey, since when was MEDICAL SCHOOL a guarantee for brains, knowledge and understanding? Let's stay civilized here. And before you burst an artery, I went there and finished it myself. And one suggestion, maybe you should change reps.
ReplyDeleteI believe if it was just smoke and mirrors, would it cause this much conversation?
ReplyDeleteThere are many different biologics/ceramics/puttys/pastes/granules and on and on that can get the job done. We all know that any product with bone or HA incorporated via mixing or in the product as developed, you will not truly know the fusion is bone or a substitute. The only true way is trust the patient and the physician on if the patient is fused or at least has less pain.
ReplyDeleteMany of these products work, whether it is BMP2, BMP7, DBM, Actifuse, Therics Putty, or InQu (look them up). Regardless, these companies need human studies!
But back to the point at hand, Stryker just needs to develop something for less than $50m on their own or buy a company that has more than a bone substitute. Come on, you can 510k almost anything in 6 months.
Isn't the true guide a race to fusion or failure? Will the "indutive" material promote fusion before the hardware fails?
ReplyDeleteThere are just as many bone substitutes on the market as there are hardware companies.
The one that peddles the best gets the win, not the one with the best clinical data.
You may as well combine the last two TSB posts. Both Stryker and Zimmer are highly successful Ortho comapnies . . . and oh by the way, they have a spine division. Both have done a poor job in providing focus to develop their spine divisions, in acquisitions, building a top notch sales force . . . or engaging surgeons. As for the big Z, come on, who saw the Endius and Abbbot acquisitions as being impactful? All they did was bring on more surgeon consultants and no viable technology. As for Stryker, I have had more than one surgeon tell me their solution to solving problems is to throw a party and ignore the main issue. Not exactly the feedback Mahwah wants to hear . . . but very much reality. If either of those (may as well include J&J in the conversation) could get out of the own way by hiring a great management team, they could be HUGELY successful. Imagine what Lukianov could do with a DePuy Spine (so long as Basking Ridge stayed out of it!) MSD would stand up and take notice. For now, they will all continue to grow market rate at best and get passed by with the likes of NuVa, Globus, and others. However, we should see a trend of acquistions in the near future. Just like the total joint world 10+ years ago, some of the bigs will swallow the smalls creating a landscape of 6+ major players. Place you bets now!
ReplyDeleteOn a different subject apparently FDA has decided to initiate directed inspections for the 16 companies who recieved 522 orders last year. Coupled with FDA's position on issueing more warning letters, it will be curious to see what the fallout is. Has anyone else heard anything about this?
ReplyDelete(1) of the largest exclusive distrubuters jumped ship because the owners apparently went psycho. The reps are trying to become direct but there is an issue with a non-compete.
ReplyDeleteScrambling like eggs to cover cases.
Wednesday, March 3rd.... somethings going on at Apatech, big meeting for all management/ sales force. Maybe the spine blogger gave stryker an idea. Should we be looking for the "sold" sign on Apatech's front lawn with a big stryker moving truck pulling up?
ReplyDeleteI don't even sell Actifuse but I know just by reading their pamphlets that a few of you seem to have the mode of Action wrong.. they never claim that Silicate is leached out of it.. Phosphate is replaced by silicate ions molecularly and that aids in it having a negative surface charge which attracts all the proteins (fibronectin/vitronectin etc) in a more organized fashion.. The actifuse rep has been laughing at all the vitoss people for passing around an email "debunking Actifuse" stating that Actifuse "leaches" out silicate... they (orthovita) could have just read Actifuses web site a few times...its all magic to me anyway.. the Bone marrow Aspirate spin down + something with Hyaluronic Acid makes the most sense to me..and Add actifuse or some DBM putty to get good handling characteristics.. my 2 cents.
ReplyDeleteDoes anyone know how the Baxter people are now doing selling Actifuse?
ReplyDeleteHas the non-resorbing issue been resolved?
Thanks
Wow, I love theater and few days ago have collected my new theater dance dress from at PIJ. Its really amazing to collect something new from there. Now I wanna to collect Kabuki mask from there. Thanks for your review.
ReplyDeletehttp://bit.ly/X9c7YE