Thursday, October 28, 2010

September 2010 FDA Clearances

Arthrocare Corp:        Parallax Contour Vertebral Augmentation Device

Centinel Spine:           Stalif Midline

LDR Spine:                  C-Plate, Anterior Cervical Plate

MSD:                             CD Horizon Spinal System
MSD:                             TSRH Spinal System

Novabone:                    Novabone Putty

Orthofix:                       Construx Mini PEEK Spacer System

Orthovita:                     Vitomatrix

Spine Smith:                 Cynch Spinal System - Visualif Interbody Fixation

Spine Wave:                 Staxx Xd System

Spinefrontier:               Vega Span Spinous Process Plate

Synthes LLC:                Norian Fast Set Putty

Theken Spine:              VuApod Intervertebral Body Fusion Device

Zimmer Spine:              Pathfinder II Minimally Invasive Pedicle Screw

51 comments:

  1. when is the liberal dr sanjay gupta from cnn going to do an exclusive on innovations in spine?

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  2. Where's the interbody cage made out of fried chicken at ?

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  3. Where's all that ATEC new technology??

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  4. Good for Synthes! Oh wait, they have to divest Norian by May...

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  5. For a relatively small name, Spinefrontier certainly has been frequently appearing in the "FDA Clearances" - now with an interspinous device. Anyone know anything about them?

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  6. Spine Frontier is just another little company. No pun intended to their very small stature management team (5'5" and under).
    Surgeon investors. Weak Aspen ISP knock off, crappy pedicle screw, facet screw and cervical plate. Lateral system is an off the shelf retractor and peek cage that is open on the proximal end for packing bone graft. Hardly novel!
    Looking for reps with relationships to flip and sell their stuff for average commissions.
    Wow, haven't heard that story before!!!

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  7. Nice! Thanks for sparing me from having to browse through a list of 100+ devices from industries that I could give two sh*ts about.

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  8. NUVA stock down 27% today.

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  9. 6:28: You are dead wrong on SpineFrontier. Just look at their website: "Innovation is the driving force at SpineFrontier™ because we want to focus on the needs of surgeons, enabling us to improve patient care through innovative and revolutionary technologies."

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  10. 12:34: I hope that your comment is sarcastic. Giving the final approval to let marketing guys write and publish words like "revolutionary." ???
    The management and staff should be reprimanded. It makes it all even less believable. They might as well use phrases like "super dooper cool."
    Unless their effort was to explain that their technology is revolting.
    Tell the surgeon investors they're losing on this deal. It'll never grow past their use.
    Sorry!

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  11. NUVA's revenue increased by 27% for the quarter. How much did your company grow during the same time period? Here's an even better question for ya'; did any other spine company with yearly revenues >$100 million grow at all during the quarter? Don't think so.

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  12. Any opinions on the Novabone product? How about Orthovita's Vitomatrix?

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  13. Orthovita is now in the dental game??

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  14. Novabone website says nothing as to what it is comprised of. oh it is "stimulative"..but so is prune juice

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  15. 2:26, Orthofix is 100million + and grew 20%. So there you go...

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  16. SpineFrontier surgeon driven, what a joke, surgeons are asking for knockoffs of everything they already have available to them! It should say surgeons who manufacture and sell products so they cane make some profits from their use!!

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  17. Spinefrontier let go 1/3 of their direct sales team this week.

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  18. 1/3 of their direct sales team = 1 salesman is looking for a job

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  19. Sensitive? Guy was just pointing out the fact that NUVA took a major hit on their stock price yesterday. (-28.53%)

    Or is no negative NUVA talk allowed here? Wouldnt surprise me.

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  20. sounds like a buying opportunity. Never underestimate the power of Mr. French to hype up Wall St. Who knows, perhaps an 18% stock bump on news that an appeal to the $60M judgement has been filed.

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  21. NUVA was downgraded due to lowered revenue guidance for the rest of the year. It's interesting that they cited "procedure cancellations" as one of the reasons for softening revenues. Has anyone else seen a rise in cancellations or it this just excuse making?

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  22. I believe the procedure cancellations may be true, however not because the patients are putting off surgery, but hoapital administrators are collectively beginning to disallow NUVA metal/monitoring. I have had conversations with admin in several states and several hospital networks who tell me that they are refusing to pay the high prices. A Baptist Healthcare purchasing dir. was bragging to me about squeezing 35% across the board on all metal vendors.....even said I better get to work on lowering my prices or I was out of there! With more and more surgeon practices being bought up by the hospitals the admin. are getting more and more dictatorial and feel newly empowered to mandate what the docs use and how much they are willing to pay for it.

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  23. You know, just because you don't see the cancellations happening in your tiny little part of the country, doesn't mean it isn't happening elsewhere. I'm in Texas and I have DEFINITELY seen a huge increase in cancellations over the past few months...most of which occur because patients can't come up with the money for copays or because they simply can't get their insurance companies to give approval. I don't work for NuVasive, but I can certainly say that they aren't the only ones seeing this problem. To deny that this occurring is sort of like denying that the holocaust was real. It's blatantly obvious to anyone with their eyes open.

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  24. Orthofix; your spine division sold more than $100 million in 2009? I find that very hard to believe. Does that number include back-braces and spinal stimulators?

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  25. to 10:37: I did not mean to imply that patients were not canceling....and obviously patient cancelations are not issues exclusive to Nuvasive, but I did say that there are other factors at play that make NUVA especially vulnerable i.e. price. I know people from Texas think everything is "bigger in Texas" hence your reference to my "tiny part of the country". I AM in Texas as well as 4 other states and I am seeing this in all of them. I am curious to know as you write "it's blatantly obvious to anyone with their eyes open" where you get your information from. Do you rely on interviews with patients, and then follow up with their insurance companies to confirm, or are you simply relying on info fed to you from your referring surgeons??

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  26. NUVA has lost ground in monitoring in NC as well. Were I a fusion patient Neuro Monitoring would be an important request. This is yet another example of the impact that welfare healthcare has an a market.

    Vetebroplasty, Neuro-montoring, bone growth stimulators......

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  27. 12:48pm, once again you're making an assumption about the rest of the country based on what you are seeing in your territory (I don't care how many states you are in...that's even more reason for me to think that you are out of touch with what's really going on at the local level). You say that NuVasive is known for having high pricing. Perhaps that was true a few years ago, but that's simply not the case anymore. All of the reps in my territory (including myself) were forced to drop their prices by about 30% a little over a year ago to match the newly discounted pricing set by NuVasive.

    And to answer your question, I get my info about the cancellations from multiple sources including the hospital staff, materials manager, hospital admins, and yes, I get info from the surgeons too. Not real sure why this would be so surprising to you. You must not have very good relationships with your surgeons if you think you can't trust them when they tell you why a case has been cancelled on the day of the surgery.

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  28. 1:48pm, your post about NeuroMonitoring having a place in the "welfare healthcare" market makes me wonder if you even know what NeuroMonitoring is. You do realize that NM is not a standalone procedure, correct?

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  29. 2:19pm, you should actually read the posts....I said I am speaking with hospital systems not single hospitals, therefore I am referring to a hell of alot more than just one territory. The question about where you get your info was rhetorical and you lied when you answered that! Hospitals are not privy to what goes on in surgeons' clinics and do not have a clue as to why patients are canceled. You are the one who must not have a clue!

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  30. 3:09 pm You should note that I did mention neuromonitoring in relation to a fusion procedure not a stand alone procedure.. My remark about the "welfare Healthcare" was intended to relate the idea that socialism limits technology to save money ie. The attack on vetebroplasty by some and bone growth simulators by (blue cross)....this is systemic of a failing system and things will get worse.

    One would have to be very dense to not understand my point. All of this technology is effective but with 1/3 the population over 65years in the next 10 years $ cost is the factor.

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  31. Amen 7:59! Paying for the zero liability voter's healthcare isn't cheap! The gov't will put the brakes on approving new ip so that we are all dropping the price on are products that are now commodities.
    How's that hopey changey crap working for you now!

    The problem with socialism is that eventually you run out of other people's money.

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  32. Socialism and welfare here is the way we take good care of our workers comp patients.... If you don't know how good read the article "Long-term Outcomes of Lumbar Fusion Among Workers' Compensation Subjects: An Historical Cohort Study" in Spine.

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  33. Amen 8:30! Bring back the Republicans for another eight years, because those spray-tanned douchebags were soooooo great for America! Better yet, vote for their inbred offspring, the tea party, so that China can invade us while President Palin is distracted by the view of Russia from her backyard.

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  34. douchebags?? in-bred offspring?? wow you are really great at name calling. Why don't you try and make a valid argument related to policy and maybe we could have a real discussion?

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  35. Yes, let's have a real discussion about the merits of "hopey changey crap" versus the wonderful renaissance ushered by eight years of Republican rule. Dipsh*t.

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  36. The Obama administration is the worst and most unqualified administration in American history. The republicians arent much better, but they are better than those left wing liberal mental disorder nut cases.

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  37. This isn't about Republican or Democrat, or if it was Pelosi, Bush, Barney Frank, or the boogey man's fault. It is about whether you want to be able to be an entrepreneur and live your life the way you want to, or hand your money over to the government so they can run your life for you.
    Because you know we be too stupid to govern ourselves. Ain't that right douchbag!?

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  38. Waaaaaaaaah, big government is threatening my 90% margins and my ability to fleece consumers with overpriced, overprescribed procedures. Booohooohooo!

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  39. Your right, I'll just quit working or risking my capital to advance science, industry, or anything else this country has blown all others away in. I'll let smart guys like you pay for my cigarettes, ho hos, and healthcare until you finally destroy what this country was founded on and has made it great.

    Who is John Galt?

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  40. Band together brothers and put the screws to our leach sucking facilities!

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  41. Sorry to interupt the playground spat, but does anyone have any feedback on Osteoselect and Osteosponge from Bacterin (you know - that dodgy company that keeps recycling its sales force). Just read their publication comparing it to Infuse - although was`nt sure if it was the product or the bone marrow aspirate doing the job....Any thoughts welcome please.

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  42. NUVA's stock is getting smashed for a few simple, clear, and appropriate reasons.

    1) The amazing growth rate they've been putting up forever is coming to an end. This has a huge negative impact on the financial models for future profits which is what is supposed to derive market value once you factor out emotion, etc.
    2) They reduced their guidance mid-quarter and then missed and re-reduced less than 6 weeks later. They blamed it on cancelled cases (not reported by any peers). Their credibility has been destroyed by virtue of their being a) clueless about their business, or b) dishonest. In either case, they'll get a big discount for it going forward.

    No growth Quarter over Quarter.
    Everyone now has a lateral device. Reimbursement challenges specifit to NUVA as well as generic to the whole space.

    Even executing at Cheetah Speed, they're never going to get back to the old growth rates and therefore the company isn't worth as much as it was before they reported.

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  43. Your facts are a bit off 5:09AM;

    They actually upped their guidance at mid year then subsequently downgraded based on trend of cancelled cases. This trend is reported by several ortho companies (check on stryker, wright, depuy etc.).clueless about spine? Are you kidding me? Name a more knowledgeable spine management team.. .no doubt they face strong headwinds but a $400M penalty on a $10-15M adjustment for a company that is now trading at a little over 2x sales is an investment bargain...Alex sells this thing in next 6 months because he knows the party is winding down and they had a good run....

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  44. 5:37, we're in general agreement as you summarized nicely, "...the party is winding down and they had a good run," we simply differ around subtles and interprepations of the facts which are:

    9/14/10 press release, NUVA reduces guidance.

    10/28/10 Quarterly earnings press release, NUVA misses and reduces guidance again.

    I didn't suggest they're clueless about spine (they're not!) but possibly about their business - specifically very near term revenue expectations. Remember I suggested the options of either a) clueless or b) dishonest and left it to everyone to reach their own conclusion. Whichever conclusion one reaches it's a credibility issue for management.

    NUVA has been kicking ass and taking names for a very long time, they're starting to run out of asses and names.

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  45. Funny,
    If i ever listed "cancelled procedures" as an excuse for declining sales, my boss would tell me to "try again".

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  46. Any news on Arthrocare spine? Heard they fired all direct reps and management consist of 2 or 3 guys?

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  47. that new sponge from advanced biologics has a ton more bmps than osteosponge. just saw the first sales piece in my area

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  48. Word from some our our surgeons is that spinefrontier's ISP plate is the best on the market. Check it out, I haven't seen it yet, but there's some interest for it out there.

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  49. SpineFrontier does have the better innovative profits according to the Surgeons. Their Sponous Process Plate is called the best yet by surgeons throughout

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  50. You Mary Kay peddlers should be ashamed of yourselves for ripping off Americans with your junk tech.

    Why the Fed's don't bust up your medical mafia and put you in jail for disabling Americans is beyond me.

    Oh thats right....they're getting the $$$ too.

    Carry on...keep robbing America.

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