Nothing like some free advertising for Robing Young. March 1, 2011
commemorates the 6th annual Stem Cell Lalapalooza in NYC. Unfortunately this venue is not Ozzfest with bands like Kataklysm, California Wildebeest, or Devil Driver, but it has been know to resemble a Motley Crue. Concert Promoter Robin Young is expecting an SRO crowd for this event and has his elves working feverishly. The show will take place at the infamous Bridgewaters New York, in the bowels of the South Street Seaport, New York City, New York. Why not the Hammerstein Ballroom? Whether you are a skeptic or zealot, stem cells have taken front and center stage in the field of biologic's. There are an endless list of applications that researchers are studying. Baldness, blindness, traumatic brain injuries, parkinson's disease, dental applications, wound healing, bone marrow transplants, spinal cord injuries, osteoarthritis, to name a few. For those of you that read OTW, Robin has his mom burning the midnight coal, pumping out as many press releases as she can about this industry. Hopefully, she will not develop carpal tunnel syndrome. Yet, as we all know, there are still many questions that need to be identified regarding the efficacy of mesenchymal stem cells. What we have learned after many years of research is that they can communicate actively and intimately. Safety issues play a role in terms of processing, concentration, and whom are you harvesting those MSC's from. If you had your options, most of us would desire to have our own stem cells harvested, processed and delivered in real time. I can hear the PRP people screaming, what about us!!! Unfortunately, TSB believes that their isn't enough of revenue in harvesting a patients own stem cells considering that one is only able to charge for the processing equipment, and processing takes time. On the other hand, allogenic stem cells, those little babies derived from a deceased donor and processed to ensure safety have become a viable alternative. But the big question surrounding allogenic stem cells is how many of those cells are viable? How many of those cells have survived the cleansing process? The difference between autogenous and allogenic is that the donors need to be screened and tested for bacteria and any infectious agents that may replicate themselves within the cells of a living host. There is always the risk of tissue mismatch or infection but in this day and age processing for infection has become a moot point. Harvesting MSC's from bone marrow and adipose seems to be the current state of the art, and God only knows that there are plenty of fat people in the United States that could use a little lip-o-suction. Cultured stem cells derived from living donors need certain conditions that promote self-regenerating expansion of undifferentiated progenitor into cells required for transplant. So in closing remember, that in order to meet therapeutic requirements MSC's need to go through six stages:
Proliferation
Differentiation
Survival
Integration
Functionality
Not Harm the Recipient
As each year passes, more information is disseminated as to the efficacy of MSC's, but the question must be asked, at what price? Based on the current state of the economy, factoring in the many concerns that the healthcare industry has about escalating costs, will someone be able to deliver a product that will be cost effective? The immediate response is to compare it to INFUSE, unfortunately, that selling technique will no longer play in Peoria, and there are other viable options in the marketplace. So TSB wants to know are you coming or are you going?
Until there is more burden of proof about how they are able to achieve any of the 6 steps above in at least a type II clinical study, I will remain a skeptic. And as they are charging near Infuse prices for an unproven product, they should be able to support the aforementioned study. Trinity, Osteocel, Purogen, Nucell anyone listening?
ReplyDeleteTo quote Jonny E (the original spine blogger):
ReplyDelete"Stem cells are the technology of the future..... and they always will be"
George W. Bush was the keynote speaker at the Nuva National Sales Meeting in San Diego this past weekend. I don't care if you're a Democrat, a Republican, or even an Independent...you have to admit that is pretty bad ass!
ReplyDeleteNuva will be NoVa soon enough.
ReplyDeleteI guess all the other D-rate politicians were busy this weekend
ReplyDelete"Proliferation Differentiation Survival Integration Functionality Not Harm the Recipient"
ReplyDeleteTSB, you've got the order wrong. It all starts with survival, and that's where the present stem cell cocktails all fall on their ugly faces. There are much more fun ways to waste that much money.
On GW, I wonder how he got through the sentence containing "disc nucleus replacement"... Never thought much of him as a speaker, or a human being for that matter.
Stem cells for spinal fusion cases are a joke. They are unproven and they are charging close to the same amount as infuse which is a proven product. I have seen both used and of course the only one that has failed to do its job is, you guessed it, stem cells.
ReplyDelete9:32 what job are you looking for stem cells to do? Choke the patient to death with ectopic bone growth perhaps? My friend, the joke is on you, now get back to "selling" that Infuse crap to the docs your company bought!
ReplyDeleteLest we forget the amniotic stem cell and the newest player in town... ..BioDlogics with BioDfactor... ..More trusted than Nucel!
ReplyDelete10:19am, im just stating the facts big guy, sometimes the truth hurts, but keep pushing the stem sh##, means infuse business will continue to grow once the docs have to go back in and re-fuse what the stim sh## couldnt accomplish. You really dont have to buy docs to use infuse, on the other hand, how many docs are bought to use the stim sh##??
ReplyDeleteThe truth lies in the middle. I don't carry a stem cell product and I'm not an arrogant MSD rep. Infuse works, no doubt. But I have seen major issues where docs have abused and subsequently caused major issues of abnormal boney formations. I have a great CT of a cervical fusion using bmp and the massive bone that grew right into the canal. Infuse doesn't need to be for every patient, high risk for fusion no problem. But docs using the "nuke" every time I think need to be re-educated on the impotence of good carpentry.
ReplyDeleteAs far as stem cells go, yea it's a great media term with anecdotal evidence everywhere. But don't underestimate a docs own anecdotal evidence. For example, two surgeons decided to trial an autologous bone marrow concentrate system. They didn't have any data to go on but in their minds it made sense. It was an interesting conversation because I was really no threat. Anyway, they told me it saved the hospital money. I don't know if that's true if the previous post' are accurate with trying to charge the same as Infuse (laughable) Well, that was 18 months ago and they still use it. I assume they're happy with it or maybe they hate MSD that much, lol.
MSD, love em or hate em, Infuse works albeit very cost prohibitive.
And no, I'm not a rep that carries a stem cell product and acting otherwise. That's seems to be the first reaction when someone makes a positive comment liking a product they don't carry.
The beauty is that we are having these discussions. Biologics will continue to evolve and play a more critical role in medicine.
Purogen is $4100 in SC for a little jar of ELA (Early lineage Adult cells) and a knock-off ceramic product.
ReplyDeleteYou get what you pay for. Not much of any proven science on this stuff yet.
Like it or not this technology is like DBM was in the early 1990's. You knew there were BMPs in there and it made a difference. They have stepped up the game over the years and made some changes, the most notable have been carrier choices and how they process the DBM out. But then came along INFUSE and OP-1 with pharmocological levels of BMPs. They have been used often and sometimes with too much zealous.
Stem cells, bone marrow aspirate, they are in the same phase as the early 90's DBM. We have to wait and see if they can prove efficacy. Maybe the Mesoblast of the world can take them to a new level with millions of cultured cells per cc. Maybe not. But sticking a few stem cells in jar on a high density ceramic and calling it a fusion in a cervical and then trying to carry that over to lumbar or posterolateral is somewhat comical. Though sadly effective at times.
I think Stem cells are an upcoming technology and deserve the kind of discussion Robin Young is instigating on a forum. I am not sure how he is benefiting from that, financially or otherwise...its a different issue.
ReplyDeleteLike any other new product, especially biologics, there is plenty of skepticism. It is understandable because we do not know the efficacy of such technology in spine.
Plus, Infuse is being used off label in majority of cases, yet dominates the market. All this is despite few studies showing that outcome with infuse is similar to control (using no stimulating agents).
I hope Stem cells prove to be effective and present some competition to Infuse.
1:50, you are absolutely correct. The problem is that the technology is upcoming, not established. That means that there still is a lot of laboratory and animal work that needs to be done before the technology is ripe for a controlled release in humans, i.e. some studies. Because of the 'minimally manipulated tissue' rule, one of the weirder ones FDA has come up with, all this is ignored and the American patient is the Guinea pig.
ReplyDeleterobin young is connected to at least 3 of the companies at this meeting. everything he does has a bottom line attached to it. how about those ryortho awards....lmao
ReplyDeleteWell.....as they say...
ReplyDeleteThe only person making any money in Stem Cells is RY.
Amazing all the GW bashing from you limo liberals. Feel free to pay more taxes this year. But what do you expect from a bunch of reps who get their news from Bill Maher and John Stewart.
ReplyDeleteSame one's who also think they actually sell INFUSE. MDT thinks so highly of your efforts it's reflected in your comp structure. Wake up.
Happy Selling!
Minimally manipulated is a loop hole that allows the marketing of these products with lack of data to support claims. Who wouldn't love to see large randomized studies on this? Will it ever happen? Not bloody likely. Who actually signs off to buy Purogen for $4,100? Wow. What can ya say?
ReplyDeleteOne big (unintended) problem with this stem cell non-sense is that it chokes the ability to bring legitimate products to market. It must be a struggle to enroll a randomized IDE study in the face of rampant proliferation of off-label infuse, unsupported claims for magic stem cells and the marketeers telling patients that they will forever live in agony if they go with autograft. I bet one would struggle to enroll a study comparing stem cells to autograft, resulting a Catch-22 with respect to proving their efficacy. How's Mesoblast doing with that anyway?
Question for the board. Is autograft still the gold standard? When was the last time you saw a lumbar case involving iliac crest?
Wait, so MDT reps are liberals? Is that what knucklehead above is trying to say? This blog makes no sense, its the lunacy that draws me back like a moth to flame daily!!
ReplyDelete6:30
ReplyDeleteI have actually seen an uptick in Iliac crest harvesting with increasing insurance denials for off label BMP use.
6:30 again.
ReplyDeleteMesoblast on clintrial.gov:
http://clinicaltrials.gov/ct2/show/NCT00996073?term=Mesoblast&rank=1
Seems there are six sites striving to recruit just 24 subjects. Its only a 1 in 3 chance that you will draw the autograft group. Study started 9/09 and was still recruiting as of 9/10. Don't see any press releases on the their website indicating that they have enrolled those 24. They get credit for trying to do it the right way but stem cells are poised to be a long term victim of their short term success. I predict lack of data will either be their demise or cause the bottom to fall out on price. Insurance isn't going to pay $4,000 a dose without real clinical data. Count your Benjamins while you can.
6:33
ReplyDeleteThat's actually encouraging. I'm kind of surprised they aren't going to crushed cancellous or synthetics, mixed in a slurry of bone marrow, local bone, or whatever is laying around.
6.06: GW is waiting for the history books to establish his legacy. My crystal ball says that these books will conclude that he and his cabal (Cheney, Rumsfeld and the rest) have accelerated the demise of the American 'century' by about 25 years. Be happy that you still make some money that allows you to pay taxes. And be sure to vote for Sarah next time!
ReplyDeleteNothing beats autograft. Don't believe the hype...
ReplyDeleteWhat is the price range for InFuse?
ReplyDeletePrice range is anywhere from $1200 -$5000 (XXS-XL).
ReplyDeleteIndications also vary from OMF to Trauma to Spine.
They will soon have a new indication for posterior lateral with the Amplify product. I cant imagine it will do very well though at the price point its rumored to come in at (Higher than the others mentioned above) in this market. Its basically a higher dose of rHBMP-2 in a different carrier that is compression resistant.... (think mastergraft strips that you pour infuse on).
There is no doubt the product works, unfortunately it doubles the cost of surgery and is contributing to the spotlight being on spinal implant pricing these days.
(shrug)
6:30
ReplyDeleteWhat legitimate products are you talking about? If people are buying stem celss and not your legitimate products, how legit can they be. The jury is still out on stem cells, but there is clearly an interest among clinicians so the market will respond. Don't forget, the jury was still out on BMP in the beginning, but it did what it claimed so it is now the most widely used off label product in the industry. It works so well that they don't even have to pay the reps to sell it. Stem cells will probably not see that level of success, but they probably won't have the negative side effects either. The white papers will start to flow, then you'll see some independent studies. There are too many PhD's in academia that want to know what stem cells are capable of and all of the possibilities represent a huge economic opportunity for industry.
As was mentioned earlier, they are in the nacency of the product history. For goodness sake, we started by putting in "live" cells collected from a cadaver, in largely uncontrolled settings and no data to even suggest the cells were viable, or even stem cells and and it was a multimillion dollar market in a very short time.
With live donors, better screening, contolled collection, cryopreservation etc., the product will get better. And if it works, the marketeers will all be coming up with crazy ideas to "differentiate" (pun intended) their cell from the next guy. But if they work, the people who brought them to market early will hit paydirt as Medtronic did with Infuse.
It is a mistake to discount a product just because you don't have it. You have to admit that it makes sense intuitively to use stem cells, particularly in older patients who have very few. All the BMP in Memphis can't make an osteoblast without a stem cell. But if you load the area with stem cells and just a hint of a signal, then you have something to work with.
8:59
ReplyDeleteAMPLIFY has already been approved as an HDE for posterior lateral ince last Spring. They can't seem to get around the 10K price point and how to pay (or not pay) their reps.
Heads up for the reps- guys don't do any fancy marketing with AMPLIFY as long as it is approved just as HDE. Just remember the horrors of OP-1.
ReplyDelete7:46 Just curious why you think having G. Bush at an NSM is "bad ass"??
ReplyDeleteThe guy's a dope. May actually go down as one of the worst presidents in history. What else does he have to do w/ his time? Lukianov is SO pro-Republican and so badly looking for support of his anti-health care reform views, that the fee,,, uhhhhhh, donation, for Bush's time was probably nothing more than a political contribution to the Republican party.
5:45
ReplyDeleteA dope. Are you that simple? It goes to show that you're unable to think for yourself and take your talking points from Keith O. You are in fact watching the worst President since Jimmy Carter run our country into the ground. Bush policies are still being employed because they work. Stop being so naive and try thinking for yourself. Dope!
Laughing at 6:23
ReplyDeleteJust another ignorant Republican living in denial,, Yes, I agree that Obama may not be a solid answer either; however, he was handed a shit sandwich when he took office. As for running our country into the ground,,, it didn't happen overnight; it began under Bush.
DOPE.
All the banking bullshit on Wall St,, Who's responsibility was that? BUSH.
DOPE.
Yep, REAL solid while he was at the wheel,,
DOPE.
"Bush policies are still being employed because they work"?? Give me a break,, Almost every finance guru agrees that the recession began sometime in late 2007,, most say it began in the 4th qtr of that year. Who was just leaving office? Yep, you guessed it, your boy GWB. But in your eyes he must not have anything to do with the beginning of the recession after his 8 pathetic years in office??
DOPE.
Your comments above show just how ignorant you truly are to the reasons why the economy has been in the shitter for the last several years.
You're probably also the guy who still tries to sell a pedicle screw by trying to convince a doc that yours won't cross-thread. No wait, what am I thinking,, sell?? I know you, You're just a case coverage guy for DePuy or Medtronic who struggles to fill out a charge sheet since as you clearly can't think on your own.
Try putting some thought into your next response,,, DOPE.
Who cares what side of the fence you are on. The real issue here is that NuVasive paid 150K+ for a guest speaker at their NSM. What a waste of money. They spend it like it's going out of style, watch out, one day soon it will end. One day really really soon.
ReplyDeleteAgreed.
ReplyDeleteHowever, everything Lukianov does is big,, ("Big, BIG, REALLY BIG as he likes to say) & over the top.
So this type of expenditure is not unexpected or surprising. What is amazing though is that after missing the # so badly in Q3, the board doesn't say a word. Seriously,, you miss your # that badly and no one on the board or any number of other members of the investment community w/ large stakes in Nuvasive even questions the way money is spent at that company?
Any wonder the shorts love to pound it & will continue to do so for the forseeable future.
Shorting this stock is the best thing that anyone can do.
ReplyDeleteI could not agree more. After missing our number that badly we spend AT LEAST 2 million on the NSM. Makes me wanna barf and I work at NuVasive.
ReplyDeleteIt's a beautiful thing,,
ReplyDeleteWhile Nuvasive "shareowners",, uhhhhh, employees, get fleeced by losing roughly 30-35% on the value of their stock options since the Q3 earnings call, Alex, et al brings in GWB at $150K to speak at the NSM. This is not to mention all of the options that have been granted or purchased over the last several quarters which are now CLEARLY underwater,,
All the while, the Sr. Management team continues to ring the cash register by cashing out thousands of the options that were granted to them long ago,,
Instead of the ridiculous "Cheetah Ball", how about offering each Cheetah a bonus check in lieu of all the options that they're sitting on w/ a strike price of $43+??
2011 will be an intersting year for this crew.
I am sitting on 50K worth of options that were granted to me at $45. And I go to the NSM and see the amount of money that is spent. I, too, wanted to "barf" as the above poster said. Out of greed, this company will fail. And even though I work here and have had a good run, I hate to say that NuVa deserves everything that it is getting right now. I can get another job in spine tomorrow, but to watch what I saw at the meeting last weekend was nothing short of disgusting.
ReplyDeleteAgree w/ 12:45 & :59,,
ReplyDeleteNothing like a CEO who boasts about the company's mission efforts in So. Africa,, only to openly flaunt that he took his family to the World Cup during his "mission" trip to Africa.
Really?? What was the REAL priority & focus for that trip? Was it helping those in need or rooting for Spain? Hmmmmmmmm,,,, Something smells a little rotten in La Jolla,,
Hello, hello,,, DOJ, are you listening?
A lil rotten? Ya think? No, Alex would never do that. O wait, I think that I received an email with a picture of him and his family at that game. They were on a spine mission trip, interesting, that wasn't mentioned in the email.
ReplyDeleteThe perfect NUVA NSM would have had purple vuvuzelas on all the tables as well as a full production of the broadway musical "Memphis" for all to see!!
ReplyDeleteOh wait, the company wide emails have that covered,,
I was there at the NSM and GWB was absolutely incredible - charismatic, motivational, witty, and just plain down to earth. Nuvasive is a great company with a lot of good ideas and you must think so too or we wouldn't ALWAYS be such a topic of conversation on this BLOG. Nuva is not perfect but neither is any other company in this market. Bottom line is that in 14 short years, NUVA is the 4th largest spine in the country with the largest margin of growth in 2010. We may have missed our 3rd quarter numbers, but every other company in the Top 5 was stagnant! Look in the mirror.
ReplyDeleteTSB loves W, I'm not the one complaining about his appearance rather I applaud Alex for the motivational tactic.
ReplyDeleteMr. French is pure genius. He has truly made chicken salad out of chicken shit. Great vision and execution of the American Dream...
ReplyDeleteOK 7:24 I've been putting some serious thought into what you've said above.
ReplyDeleteYour compelling argument:
All the banking bullshit on Wall St,, Who's responsibility was that?
Is brilliant and has got me thinking maybe it is ALL W's fault. I feel so much better blaming him for everything. It's so cathartic I can't believe I haven't tried this before. And now I feel like Sarah Palin is also EVERYTHING that's wrong with this country. My God it's like a weight being lifted from my shoulders or maybe off my shoulders...it's hard to tell. I feel light headed and airy now. Like I've been smoking dope.
Now I get it.
Thanks ya DOPE! I'm cured.
GO Dubya!
Alex is the dope to mismanage NUVA money to support his political agenda. Regardless of your beliefs, you should keep politics out of the workplace. It's extremely unprofessional. Alex needs to learn some things. Perhaps that purple kook-aid is spiked...
ReplyDeleteNeed motivation? Get Lou Hotlz (though he may have lost it a bit and the first few rows will need an umbrella).
Agree with the poster above....Apparently all of the reps at the Nuvasive NSM wore t-shirts that said The Surge and had dog tags on as well. I find it pretty offensive that Nuvasive reps are running around acting like they are soldiers ready for "The Surge". Give me a f'ing break. What a bunch of toolbags.
ReplyDeleteMaybe the shirts should have said the scourge. You have to love a bunch of grown up making macho like at a NSM. The first minute a room full of pussy's would hear automatic weapons and mortars coming in they would run for their lives. Leave it to Nuvasive play act, they are a by product of their leader.
ReplyDeleteScott Davis must work for NuVasive. Anybody see Dilbert this morning?
ReplyDeletehttp://www.dilbert.com/
I heard Valentine fired someone at the NSM for comments about W. He's a f'ing loser too just like Alex.
ReplyDeleteIs Nuvasive the new Alphatec? I think so...
ReplyDeleteLike I said, it seems as if everyone loves to talk bad about Nuvasive. Don't worry, I would be insanely jealous to if I worked for ANY other company. Eat our DUST!
ReplyDelete6:53 sounds like all the guys that defend ATEC on here. Looks like 6:25 may have a good point.
ReplyDeletePUREGEN IS GOING TO TAKE OVER THE WORLD!!!
Yep, we'll eat your dust. Right after we watch another movie about the Sr. Management team patting themselves on the back some more,,
ReplyDeleteLet them keep telling themselves how great they are; Wall St. provided a swift dose of reality in October,, more of that is yet to come.
For those that are drinking purple kool-aid by the gallon,, Just ask yourselves why Kevin O'Boyle abandon ship when he did??
Nuvasive counsel: TSB is really Lou Holtz. You should contact Lou and figure out what the hell to do when you are over rated and headed for a beat down in 2011. Also, what do you do when your star player (Osteocel) is living a lie of being the messiah.
ReplyDeleteThis blog should be called the Douche Blogger. So many pretender, never-was haters on the outside looking in. How many posters are here just trying to illicit a slide because they shorted a particular stock. If there are analysts looking at this site, know one thing: there is virtually no factual content to be had in this correspondence. Moreover, most of the commentary is diametrically opposed to what actual market trends.
ReplyDeleteIronic that someone that calls this the Douche Blogger would be blogging on it himself?
ReplyDelete