It has been a tough year for Orthovita. First, there was an article that questioned the clinical efficacy of treating vertebral compression fractures, then the analysts' became disenchanted, and downgraded their stock, and then, their stock plummeted from an all time high of $6 per share to $1.99. Lowell George and Little Feat once sang that "Time Loves a Hero." Based on the most recent publication in the September 15th, 2010 issue of Spine, things seem to be looking up for "la Vita." The completion of a multi-center trial that included 40 patients entitled, "Clinical Experience Using Cortoss for Treating Vertebral Compression Fractures" continues to lend substance and credibility to this technology. This prospective trial assessed the feasibility and clinical outcomes of Cortoss using two different techniques of Vertebroplasty and Kyphoplasty. Here are some of the findings;
- 40 patients were treated in two center
- Patients were followed up 24 months post-op
- Comparable pain relief and quality of life improvement were achieved with both vertebroplasty and kyphoplasty techniques with approximately 50% less volume required for vertebroplasty
- Cortoss trabecular interdigitation and bone bonding were observed in histology obtained 6 months following vertebral augmentation with kyphoplasty
The results of this study were the basis of Cortoss' clearance by the FDA. As we gear up for the Fall Class, TSB can hear the echo of John Fogerty in the back ground singing, "put me in coach, I'm ready to play today." TSB wants to know, how do you rate Cortoss? Single, Double, Triple, Home Run, or Grand Slam?
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ReplyDeleteSounds promising! I think the next major advancement in "biologics" will be the advent of an osteoconductive bone-void filler that has adhesive qualities. Can you imagine all of the various pathologies (not just spine!!) such a product could be used for? Sure, there are a few companies out there that claim to have created such a solution (Doctor's Research Group and Bone Solutions), but neither seems to have had much luck garnering significant attention; not from the medical community or the ortho-device industry. I've heard that DRG has been hindered as of late by money-woes, but I'm not sure what the deal is with BSI. I'm curious to know what the word on the street is about these two companies. Anyone else out there developing anything similar?
ReplyDeleteI have to think that Orthovita feels like the red-headed stepchild of biologics recently. They have been around the industry probably longer than most companies, have what some (and I do mention "some") consider the gold standard synthetic, and stand on the sidelines as Apatech gets scooped up for huge cash and Osteotech is acquired by a dominant force in devices. Have they ever made a profit?
ReplyDelete8:43am I will take you one step further, an osteoinductive/conductive product with those attributes
ReplyDeleteI pose the following question to the TSB readers...
ReplyDeleteWhat amount of patients denotes a "worthy" study to consider data from?
Granted, 40 patients is twice as high as the typical study that Orthovita produces but why not go yard and do a study of at least 100?
One critique I have always had of them is their smoke and mirrors techniques.. i.e. the fine print in their studies.
"Yes we achieve clinically comparable results to BMP II in these studies Dr., please ignore the fact that we placed a bone stimulator on every patient and put one to one BMA of which we have no clue how much osteoinductive activity there was because it varies from patient to patient."
My point is that I would like to see transparent LEVEL 1 data from this company with a solid number of patients enrolled.
End Rant....
This study was pretty biased, and I am surprised it made it past reviewers. Reasonable conclusion is no significant difference between cortoss and PMMA, so use PMMA, for procedures with dubious evidence supporting them (Lancet pro, NEJM against). Good luck with an osteoinductive/conductive product in an osteoporotic vertebral body, on its surface makes sense, but I doubt the biology is there - thus things like Kummels dz and little whispy old fractures.
ReplyDeleteVitoss is getting killed - Cortoss better have something behind it, or Orthovita is toast.
ReplyDeleteCortoast.
ReplyDeleteI heard they are looking at going private label or using a different sales/marketing team for Cortoss. The Vitoss reps are having a tough time getting it off the ground.
ReplyDeleteInteresting comment 9:28. I agree, they are just hanging out there and nobody wants to invite them to the dance. Maybe the low stock price is an inducement to buy, but why would you? There are so many other competitive synthetics, none of which should ever be referred to as "the gold standard," but Vitoss could be said to be the most marketed. Their "studies" don't hold any water in my opinion. Prospective, randomized studies with recon CT's to validate the results is the only real evidence any of us should pay attention to. Otherwise it's all smoke and mirrors. A bunch of marketing and product folks getting a sales force excited about "how it works" and "how it's different" and "how the other guys are good, but our stuff is better." Evidence....evidence my friends.
Problem is that we are all so greedy that we wont allow the monies and time to be spent on such a study. We want sales results now. That's why we all have to concede to 40-60% off list price for such products. Hospital: "Show me it works better, or that we can get paid more and we'll talk. Otherwise meet the capitated price structure and we care less who uses it. However, I am not buying any stocking inventory, I still have a ton of Vitoss nobody is using anymore."
All the conjecture is interesting and promising to hear about SiN. But that's all it is, "Bunch of talk and a badge." It will be interesting if they or any other up and comers are willing to produce real evidence.
Excellent Post! TSB now knows that there is at least one other person in this world that doesn't buy into all the hoop-la and mumbo jumbo that companies spin around these technologies. You know what Rod Tidwell, world renown wide receiver would yell out; "Show me the money!" If not at least show me the proof.
ReplyDelete... as an aside, a great read is the "history of aspirin":
ReplyDeletehttp://en.wikipedia.org/wiki/History_of_aspirin
One has to ask if it would ever make it to market nowadays, without clinical studies, without a clear mechanism of action, for a new indication without incontrovertable evidence. The parallels are fascinating.
IDE study: 2 year follow up with Cortoss shows a 43% reduction in Adjacent Level Fractures compared to PMMA cement. I think that is pretty significant.
ReplyDeleteHave the IDE results been published? Cortoss has been around in Europe long enough that a 40 patient study is fairly insignificant ... especially one like this with multiple arms.
ReplyDeleteA few years ago, VITA disclosed in an annual report that they rejected a suitor with an approximate $4.50 offer per share. How many shareholders would take $4.50 and cash out right now?
Everyone should be impressed with their sales revenue for a fairly unremarkable product portfolio ... the problem is CORTOSS was supposed to be what attracted the big Spine companies in for a bidding war and ultimate buyout. So far ... nada . . . just disgruntled shareholders with a $2 stock.
They pay a ton of reps a 100K for 300K or less in sales. Pretty tuff to make money like that!
ReplyDelete43% percent reduction in "adjacent segment fractures" with identical results at 2 yrs. Sounds great.
ReplyDeleteAnd the rates were 18 vs 10%, not statistically significant (and thus should NOT be discussed unless to note that it is likely underpowered) nice manipulation of the numbers to show a 43% reduction. Prob. a difference of less than 5 patients.
ReplyDeleteTheir compensation structure is killing them. !10% on sales from $0k- $50k. From $50k -$70k its 20 % and from $70k-$100K and above its 25% back to $ 1 and that is for direct reps that are getting a $60k salary. They have approx 100 direct reps and I can tell you the top 25% of there reps are making $250k per yr. This does not even take into consideration the 1099's that are killing it. I'm not against good reps making $ but they are way too liberal with compensation. Top rep makes approx $600k per yr. For a Company that does about $98 mill a yr and he earns 2-3 times much as Tony Koblish for selling what amounts to foam. Wow. Cortoss is a great product but since VP and KP have been pushed out to the IR labs as an outpatient procedure docs want the lowest price possible. They don't care if the patient comes back with an adjacent level fracture, that's just built in business. PMMA has over 50 yrs history in Orthopedics Why change?
ReplyDeleteIDE STUDY: 256 Patients
ReplyDeletehttp://www.orthovita.com/cortoss/clinicalresearch.aspx
Who cares if you enroll 1000 patients in an IDE that needs to be "published" as a white paper and can't even make it into one of the lssr. journals? Look at all the crap that does make it in. Not hard to bamboozle guys that fall for the hard sell, or read things like "43% reduction in adjacent segment fractures, that sounds pretty signficant to me" even though that poster missed the part that says (Not statistically significant).
ReplyDeleteNASS will be coming up in a couple of weeks. What surprises or new products will we hear about before or during the meeting? One would think the talk will center around the market slow down and healthcare reform and its affect on the spinal market. Will the market continue to slow down or will it stablize before the end of this year?
ReplyDelete5:28 funny that you highlight the 43% stat and the study on the site is boasting the VAS and ODI scores. Statistical significants is what is important.
ReplyDeleteIf it's so good, why isn't it flying off the shelves? How long has it been on the market? How many trade shows has it been pushed at? I have been to most and haven't heard "Cortoss is the talk of the show."
However, kudos to VITA for putting out the study on Cortoss. More companies should do the same and stand by their results.
I think the questions and comments of others here are; is there any similar prospective, randomized study on Vitoss? VITA's cash cow. Or is it just a bunch of white paper rhetoric?
Vita came out with a good product 5 yrs too late. Now it's relegated to IR suites and low prices. If memory serves me correct wasn't ActiFuse once called ApaPore? You know way back in the stone ages before the great invention of the marketing term "osteostimulative"? Back then it was an HA that didn't resorb and I believe in EU it is still classified as a non resorbable product. Can anyone confirm that? Apparently Si makes HA resorb... They must make ActiFuse in the same kitchen where the guy in "My Cousin Vinny" makes his grits. Everyone talks about Amedica and SiNi. Titan Spine has a Ti product that also allows "bony on growth, in growth, interdigitation" whatever term you choose to use. It's less expensive, has a large graft chamber AND large windows ant/post and on the lateral sides that allow for re-vascularization. I don't believe that Amedica offers that benefit which is crucial to bone remodeling. I only bring this up to point out why all the hub bub about Amedica? I have yet to see anything new and exciting in the last 5 yrs. Dynamic Stabilization = Jumbo Shrimp and I believe there are still about 40 companies out there looking for an indication for it. Once they find that then all they have to do is get coding. Can anyone say Dynesis? -pretty sure I spelled that wrong for the grammar police- Biologics are the new frontier, but who is even close to getting anything to market with an on label use? The injectible nucleus replacements have potential if someone can actually come up with one that stands up to the rigors of the spine. Ditto using stem cells to grow new nucleus, annulus or bone. Until then boys keep selling those pedicle screws, cervical plates and interbody devices that's how you will make a living! Good Luck and Good Selling to all!
ReplyDeleteThank god, someone that understands that all the "emerging technolgies" are total crap. Nucleus replacement? Regeneration? C'mon people...maybe in the future, but nowhere close to that now. If it's my back - nonop....
ReplyDeleteAnonymous 11:38
ReplyDeleteThank you for a dose of reality, but most of all a dose of sanity. Unfortunately, many of the hucksters involved in pumping up the volume on these products are all about the benjamin s rather than about changing outcomes. Amen Brother 11:38
Shame on you, TSB! Why did you fail to capitilize on such a prime opportunity for a song lyric?
ReplyDeletehttp://www.youtube.com/watch?v=TcckWzjJMIg
I heard that Globus was looking at Orthovita.
ReplyDeleteI heard that Globus is getting their pants sued off by NuVasive. Look for that news in tomorrow morning's paper. ;)
ReplyDeleteWhats up with the Orthovita reps telling surgeons to put the Infuse (BMP) on their vitoss foam instead of squirting it on the Infuse Collagen sponge? Oh yeah it hold the BMP better than the collagen sponge. WTF is this all about? Anyone else seeing this???
ReplyDeleteThat's been going on since 2005, where have you been?
ReplyDeleteI have heard about it but I guess when you actually witness it in the OR it hits home. Pretty balsy if you ask me...........
ReplyDeleteWhat's up with Medtronic reps suggesting surgeons put InFuse on Mastergraft instead of the collagen sponge?
ReplyDeleteIts misbranding no matter what you are squirting it on.
ReplyDeleteHave you ever seen a revision where Vitoss was used the first time...it's a sales buzz-kill. It looks like a bowl full of white oatmeal and no fusion. Hocus Pocus if you ask me!
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