The $75 million settlement by Medtronic with the DOJ for allegedly (you have to love the law) advising hospitals and surgeons to perform VCFx procedures that could have been performed at outpatient facilities has created some consternation, and, a major shift in how the players in this space will move forward with their business plans. Recent studies substantiate the clinical efficacy and improvement in quality of life for patients when it comes to using Vertebroplasty as a modality of treatment. These papers contradict the recent government/insurance company funded hullabaloo over Vertebroplasty. Regardless of the challenges that this industry segment faces, investors continue to pour capital in vertebroplasty technologies witnessed by DFine closing $36.2 million in equity financing back in July. One company that has identified that it has to realign its strategic business plan because of Medtronic's shenanigans, is Orthovita. Like other companies within the industry, La Vita is having to modify its financial expectations and sales strategy as the industry continues to slow down. Analysts' reactions become predictable when strategic and financial challenges present themselves to any company. Yet, is this a bad thing for La Vita?
By moving vertebroplasty to an outpatient setting every company will have to accept the fact that reimbursements will be lower, and subject to more scrutiny because of Medtronic/Kyphon's alleged behavior. Many people criticize this blog site for various reasons, but this is an example of how the behavior of one, hurts the many that play in this space. The company with the best product (material and delivery system), for the best price, with the appropriate business distribution model will win the race for dollars and notoriety. Let's face facts, outside of a few front runners, the industry in general has shown minimal or flat growth. You don't have to believe TSB, just let the analysts' tell you. So maybe, this will be a wake call for each company looking for a piece of the vertebroplasty marketplace. Regardless, whether you like Cortoss, it has a place in the surgeon's armamentarium like Kyphon, DFine and other companies. The question will be who can reduce manufacturing cost, come up with the ideal distribution model and still competitively price their product. TSB wants to know what our readers think?
www.thelancet.com published online August 10, 2010
ReplyDelete"In a subgroup of patients with acute osteoporotic vertebral compression fractures and persistent pain, percutaneous vertebroplasty is effective and safe. Pain relief after vertebroplasty is immediate, is sustained for at least a year, and is significantly greater than that achieved with conservative treatment, at an acceptable cost."
The thrifty Netherlanders saving our bacon.... The acceptable cost does not include a 5000 dollar balloon though.....
Don't ever give me a vertebroplasty.
ReplyDeleteLittle risk of that. It costs money. But let me know again what you think once your mother is lying in bed 23/24, and getting hooked on Oxycontin while literally pissing away her last remaining bones.
ReplyDeleteI know how much you hate Medtronic, but let's remember that this lawsuit was as result of activity while it was Kyphon......so MDT bought themselves a fine. Try to be more objective when you're hurling your insults
ReplyDeleteActually if you really read what I post, I don't hate Medtronic. Would I compliment their biologics division after the acquisition of Osteotech? TSB believes it is the deal of the year. I just don't like their holier than thou attitude considering they invented the sham consulting agreement, and then hide behind AdvaMed. Don't spend too much time to figure out my objectivity 'cause I don't lose any sleep over others criticisms. It's a blog, and a pretty damn good one at that. Thanks for your objectivity.
ReplyDeleteTSB
ya TSB ! you put that blogger in his place!!
ReplyDeletegreat purchase. if my company purchased osteotech my sales would skyrocket, but then again they probably wouldn't give me the commission for it!
TSB,
ReplyDelete"It's a blog, and a pretty damn good one at that."
I agree, but what's with this newfound haughtiness?
This continues to be BAD NEWS for ATEC. They bet the farm on the expandle mesh technology for v-plasty. It's bad enough that it's still mired in the FDA... but, when/if it comes out the market will be so reduced... why bother.
ReplyDeletePlus, an expensive 'implant' they will never have margins on it.
Bye bye ATEC, Bye bye!
:D
ATEC will find a way to stick around. They have enough me-toos and a diverse enough portfolio (Copy cat or not) to make enough to keep revenues stable enough. Remember, isobar from scient'x still makes them a good amount of cash in Europe.
ReplyDeleteWhoopee-tee-doo
ReplyDeleteThey aren't profitable... stock will fall again. Hold on to your butt at the end of the year... that stock is going to be low...
Now, let me clear my throat...
The Frog will take ATEC down, don't you worry. There's a lot of hot air and chest pumping going on there.
ReplyDeleteMr TSB. You have a very informative and enjoyable blog. When you do "criticize" a company it is in a Fair and balanced way; and you leave the Forum open to counter-opinions. However, there are those who choose to use your blog to take any and every opportunity to "bash" certain companies and sling mud at individuals. I believe that if you were to delete the malicious attacks quickly, those anonymous posters would stop. Now while I do appreciate it is each and everyones perogative to read, or not read, this blog- I do believe it would serve this blog well to have some quality control. There is a reason newspapers do not print unsigned Letters to the Editor. I know this is a blog, a different vehicle than a newspaper; but all the same, those childish attacks really do make for poor quality. I have noticed that as us "reps" in the field discuss TSB, we have all agreed that the anonymous mudslingers have begun to turn your quality blog into a free- for- all bashing board. Please take back what was and is Rightfully yours and let's all again enjoy the informative, provacative, and enjoyable Spine Blogger that had us hooked from the beginning. Thanks, and Peace!
ReplyDeletewell 4:56, that was a nice post florence nightengale.
ReplyDeletesuck a fatty.
anyways....
why do you guys hate alphatec so much? what percent of market share do they have?? 1/100 of a percent???
I'm tired of people attacking TSB. I have been in spine only 7 yrs. TSB's views are spot on. I have worked for Seaspine from 03'-06 and Globus from '07 to '09 and Orthovita. The previous two companies do very little business without consulting or pay to play type deals. Orthovita has a great material in Cortoss but try to convince a purchasing manager that $100 worth of PMMA is better than $800 worth of Cortoss and you will lose that battle all day long even with the unpublished clinical data you can show them. I'll save you guys all the " Well you suck at sales if you can do that" talk. The other knock on OTEC I have is there are only 3, yes count it 3 allografts with Level 1 Peer Reviewed, Published Human Clincal, Randomized Prospective data in the market.
ReplyDeleteCare to guess? Infuse, OP-1, Vitoss.
Do all the reserach you want . This is the highest standard.
This comment has been removed by a blog administrator.
ReplyDeleteAnyone who thinks Infuse, Op-1, and Vitoss are allografts is an idiot.
ReplyDeleteThe first two are proteins and Vitoss is a ceramic.
This is the problem out there, people selling products they have no clue what they are. Read the inserts.
Whoo hoo, im drunk!
there's a protein in fried chicken osteotech was looking into. medtronic must have seen that as the future. great foresighters.
ReplyDeleteATEC's Osteofix has no chance whatsoever, not then, not now. I've met clinicians who were NOT part of a paid study or on a consulting agreement who used it. After just a few patients they abandoned it. The implant does make a nice charm for a bracelet or a necklace though.
ReplyDeleteTSB, if you think the OSTE/MDT is the deal of the year you must believe that that CMS advisory meeting in September is going to go in the wrong direction for MDT. Otherwise this is just a weird deal.
ReplyDeleteTo put a historical perspective on MDT; they were a solid, reliable, ethical, dependable and slightly boring Minnesotan company when they were just in pacemakers.
With the acquisition of Sofamor-Danek they became responsible for one of the more blatant pay-for-play organizations in the device arena. Apparently that story sort of repeated itself with the Kyphon acquisition. In both cases, proper due diligence before the acquisition must have brought these facts to light, yet MDT went ahead anyhow. So to completely separate MDT from the Kyphon issues since they happened before the takeover is disingenuous.
As other posters have observed, many new companies now have degrees from the 'Danek School of Spine Business', and its model has become widely practiced and is even considered ethically acceptable. We'll have to live with it until the government grows real teeth.
How is it that ATEC is being trashed in this thread? Osseofix isn't even available here? Why wouldn't a product allowing less cement use be a viable alternative, also allowing a more structural restoration and maintenance of vertebral body height? Just asking, but definitely tired of Kyphon's monopoly?
ReplyDeleteI would agree, that to separate MDT from Kyphon is disingenuous, but, one must admit that with MDT's marketing dollars and current distribution model, they should hit a grand slam with this acquisition. Considering that the cost of BMP's is under tremendous scrutiny, this could be a preemptive move allowing MDT to explore other acquisitions, i.e. a trauma or a recon company. Remember, unless you have something breakthrough in spine, we are still in a zero-xum market. If you had access to MDT's cash would you sit on the sidelines in the current economic climate? There are deals to be had, just look at the multiple on Osteotech, it was a steal. As to why Osteotech, it's just not about the DBM, it gives them access to bone and their relationship with RTI is so-so at best. RTI has enough of their own issues. Considering that Grafton and DBX are on every hospitals shelf and available for any trauma case in the middle of the night, this deal opens other market opportunities for MDT. Gosh, for someone who is accused of bashing MDT every opportunity TSB must be having an outta body experience.
ReplyDeleteVery well written and explained. Gave a brief view on verbroplasty. Thanks for sharing. Keep posting.
ReplyDeletecan someone help my understand the draw of Cortoss for vertebroplasty? Hospitals are being asked to pay $1200 for the cement and delivery (which has broken during the case numerous times). Unpublished data without statistical significance.
ReplyDeleteNot seeing it around here at all except a few cases by experimental radiologists. Is there a place for this stuff? Doesn't Kyphon have a cheap HA cement out now?
Data have been presented at numerous meetings; no doubt there's a manuscript in the works. There is statistical significance, which is surprising as the study was done like any other FDA study, that is to show non-inferiority over the control treatment. I have not heard anything about broken delivery systems.
ReplyDeleteHey...6:52.... the drunk guy....Nice response on the whole POS Vitoss thing. I'm drunk too. Most of the people on here are. Pretty sure it's a requirement for Globus and Lanx reps.
ReplyDelete10:07- Yes the data shows non-inferiority for pain control, but isn't that a low bar for $1200 cement? They are trying to sell me subsequent fracture reduction, but their unpublished study says that there is no statisical significance in sub fx vs. PMMA. haven't tried it yet, so can't comment on delivery system, but it looks awkward
ReplyDeleteAnyone else see that Kyphon was down 20% over the past quarter? Ship is sinking fast.
ReplyDelete9.16, data show superiority (statistically) of Cortoss for early pain and late function over PMMA, even though study was designed as non-inferiority. That is pretty strong. That refracture data don't reach significance is not surprising at all; study was not designed for this endpoint. Looking at the differences between the materials there is a rational explanation for the difference. And statistics are not everything. Kallmes and Buchbinder designed the perfect statistical protocol and fell on their faces when it came to in- and exclusion criteria, enrollment and clinical definitions used.
ReplyDeleteI'm new to the spine business (as an investment analyst) so can someone explain the pay-to-play model that the spine companies use? Is it used in instruments, biologics, vertebro/kypho? Which, if not all? Thanks!
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ReplyDelete