Tuesday, August 28, 2012

Mr. Big Stuff Who Do You Think You Are? MDT Sues NUVA

As Jeannie Knight once sang;

Because you wear all those fancy clothes (Cheetah's sing, "oh yeah")
And have a big fine car, oh yes you do now
Do you think I could give you my love now (Cheetah's, "oh yeah")
You think you are higher than every star above
Mr. Big Stuff, Who do you think you are?
Mr. Big Stuff ya never gonna get Medtronic's love

Yes fellow bloggers, it seems that Mr. Big Stuff is being taken to the rack one more time by his former colleagues and friends at Medtronic.  A little home cookin' is being served up to the now defunct oracle of spine Alex Lukianov (David Paul the baton has been passed) and his entourage at Nuvasive.  As has been reported in various media outlets, Medtronic has filed complaints against their former Superstar and his company claiming that CoRoent and Osteocel are infringing upon patents owned by Warsaw Orthopedics and Osteotech which were exclusively licensed to the Big Blue.

As a mere formality, Medtronic is asking for an injunction denying and preventing Mr. Big Stuff from producing its family of spinal implants and bone grafting material.  Medtronic is also requesting compensatory damages and legal fees.  TSB can see Ishrak singing to the Bear.

Dance with me, c'mon dance with me baby
Dance with me, c'mon dance pretty baby
I want you, and you want to be like me
So why can't we get together after the dance.

91 comments:

  1. Replies
    1. I love TheOriginalFirstGuy!

      Delete
    2. TheOriginalFirstGuyAugust 30, 2012 at 9:00 PM

      Thanks ,

      Love all of you too.

      TOFG

      Delete
  2. Why invest in innovation when you can invest in lawsuits? Let's see if they back hand Globus while they uppercut Nuva.

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  3. Medtronic's new marketing tagline: When you can't innovate, just litigate.

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  4. The end result will be MDT buying Nuva once their stock gets hammered down below $10. Why Nuva is still around is baffling. Low profits, lawsuits, no real innovation..except an approach.....what was it that people used to say about pigs and lipstick? The investors are like the college freshman that got drunk and lucky last night...it was fun, but.....waking up and wanting to chew off their arm, but they really need that arm.

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    Replies
    1. My bet is Zimmer buys Nuvasive and not Medtronic. Zimmer co-licenses the Michelson patents and something tells me Alex would prefer not to sell to Medtronic. My bet is the only thing holding it up are the management and attorneys at Zimmer who are skeptical of the spine market and scarred of their shadows.

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    2. many companies that can afford to co-license Michelson patents do.... OFIX is one more..

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    3. Orthofix with all the crap they are still mired in with bone stims and Blackstone fallout are in no position to buy a company much larger than they are that is losing money. Now Nuvasive ought to buy Orthofix, it would probably be less expensive than paying all the Medtronic lawsuits and with Orthofix's revenues and profits could start showing an overall profit.

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    4. Is that Robin Young "pushing" for another deal?

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    5. How is Zimmer going to buy Nuva, when they're going to buy Lanx?

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  5. 7:27, Dead on.

    Osteocel is hardly innovation. Take autograft, rinse it with saline, add cryoprotectant and viola, a sh*tty overpriced biologic product that doesn't work any better than cancellous chips.

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    Replies
    1. Is any biologic product, synthetic or DBM, better than cancellous chips?

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    2. Says the guy who lost business to Osteocel because he's too lazy to learn anything about it.

      *This is a response to 9:20am, not 12:47pm.

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    3. Viola is a musical instrument, why don't people understand that?

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    4. 8:01, you obviously understand nothing about the product you carry. WAY TO GO NUVA TRAINERS!!! Or is sales management to blame for hiring a moron?

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  6. Isn't this post the mud slinging that you said was going to cease on this blog?

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    Replies
    1. It's ok when TSB does it. This is public information, perhaps not the Mr. Big Stuff name.
      Alex brought this upon himself when he called out the Medtronic CEO at an investors conference. Doubt this will hurt NuVa.
      Interesting news is NuVa suing Globus and Choll Kim, as well as Andy C and Lanx.
      P.s. O+ is way to expensive for what it is. I couldn't sell that with a straight face.

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    2. So what's the big deal calling AL Mr. Bigshot? There isn't a humble bone in that man's body

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  7. I want to know what the general opinion of selling cancellous strips are. My company started carrying this, and I don't know that comparing it to Infuse is "apples to apples". Thoughts?

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    Replies
    1. With a question like that, we will test the resolve of the TSB nation to be kinder and gentler.

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    2. Infuse is a pharmaceutical grade product with a specific engineered BMP (BMP-2) that is millions times higher than found in the body.
      Unless you have a pharmaceutical grade product that is supra-concentrated with a specific BMP or growth factor that is confirmed to elicit bone formation then don't ever try to compare an allograft product to Infuse. The levels of native BMPs and GFs found in allograft are millions times less than a pharmaceutical grade product such as Infuse.
      Now cancellous strips are marketed as being a demineralized scaffold, therefore possessing trace elements of native BMPs and GFs with a cancellous scaffold. a majority of the BMPs and GFs are not found in cancellous bone, this is why DBMs which are used for their inductive properties are taken from the cortical bone, not cancellous.

      Good luck promoting a cancellous strip as being inductive, comparative to Infuse or even minimally effective for anything but a costly scaffold.

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    3. That was very kind and gentle, but amazing that anyone in spine would ask the question. It may need to be the topic of the next post. I don't feel you can even get lucky in this business without a fairly full noggin of spinal knowledge, and this is a very basic biologic question. Unfortunatley, it isn't the only time I've heard reps confusing BMP to other graft materials, but I really assumed they were doing it intentionally because they didn't think the docs would know any better. How about it MSM, lets discuss training and abilities required to be an effective rep in this business and whether or not we need to be competent in the cases where things aren't going well or if its just good enough to turn dollars. Who's got stories of reps causing harm to patients due to their lack of knowledge? How common is it?

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    4. "The levels of native BMPs and GFs found in allograft are millions times less than a pharmaceutical grade product such as Infuse"

      Millions? Please tell me you aren't serious

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    5. The comment is serious and also accurate.

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    6. The average levels of BMP native in the body are commonly measured measured in pg or picograms.
      the average rhBMP is in mg. a large infuse is a concentrated rhBMP-2 at 12mg
      so when you look at donated tissue (allograft) that is processed, refined and concentrated, you may yield a few hundred pg of BMP2- at best 500-800pg/g.
      it is 10 billion pg to equal 10mg.
      a picogram is 1/billionth of a milligram.

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    7. Reps causing harm to patients?? Are you serious!

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    8. My initial question was from information provided to my by my company stating that cancellous strips/sponges when used with BMA are osteoconductive, oseoinductive, and osetogenic, with fusion rates comprable to INFUSE. That is what triggered my question. I am working to be a better informed rep, not an idiot rep reciting a line. I thank those of you who took my question seriously and have offered valuable feedback.

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    9. The key to the studies with the cancellous sponge is the data.
      -Were the sites paid and sponsored sites/surgeons where they may have been influenced by the data they presented...
      -Patient data- BMA and its osteogenic properties drop dramatically with age so patient selection is important.
      -number of patients and time determined to evaluate fusion
      -methods to determine fusion- independent CT analysis?
      -type of data- level 1, 2, 3,...
      -randomized, double blind, retrospective, prospective, comparative analysis

      -many factors go into play when looking at studies and "touting" them as worthy of the paper and ink you are carrying around. If this is similar data to the Bacterin sponge data comparing to Infuse fusion rates then I suggest not offering it...

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    10. Yes, we have been given the Bacterin paper to use. However, our product is from a different manufacturer. What is your criticism of the Bacterin paper?

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    11. 1- you are using another company's paper to use for your similar product...odd
      2- Bacterin is all pay for play- every doc is financially bound to use and sponsored. I wouldn't say the results are fair and unbiased...
      3- end of day- understand that you are not comparing an apples to apples product- the allograft sponge products are a scaffold with a trace element of inductive proteins (if any..) that rely on adding BMA to make them effective at the least. Infuse is a sythetically engineered supra-concentration of a confirmed isolated BMP to elicit bone formation. Be careful how you present any paper comparing the 2, especially if you are trying to make an assumption that your product is "similar" to the one used in the study....

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    12. Not sure who's posting what, but the basic question re: apples to apples is that you are in an apples to oranges situation. BMP is an inductive protein signal that differentiates stem cells into osteoblasts (among other things). It requires that stem cells be present and that a scaffold is available. The cancellous strips are osteoconductive matrices that support bone growth, if it is already present. Some claim osteoinductivity due to trace amounts of BMP (see amounts in above post) and/or ectopic bone growth in an animal model (which doesn't mean it will happen in humans necessarily). You CAN compare fusion rates between graft materials and BMP and the differences will vary, mostly based on who sponsored the study. The bottom line is that BMP WILL grow bone, but that is not always without complications. Cancellous strips (or any DBM or synthetic ceramic) will grow bone most of the time if the biology is already there. BMP has very limited FDA indications and the vast majority of BMP use is off label. Thems the facts.

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  8. so essentially Medtronic alleges that they are the only company who should be allowed to sell an interbody device?

    7:27 hasn't everyone on this blog stated that innovation in spine has stalled for the most part? Wouldn't that mean that the approach is one of the more innovated things in recent memory?

    9:20 Osteocel isn't an innovation, because it was originally Trinity

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    Replies
    1. So Trinity is a POS too??? SHOCKER!!!

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    2. Osteocel is the original Trinity...not the new Trinity Evolution- different product, different way of processing, verifiable cells, totally different.

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    3. Same POS product, same lame process, same sh*tty results. Hence the royalties paid by OFIX to NUVA.

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  9. Does anybody know which manufacturers pay the highest commissions, and how much?

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    Replies
    1. In general, the less market share and the lower the quality, the higher the commission rates. Simple supply and demand. If you control a large book of business then you can get whoever you are talking to to up the ante a bit, but if a company is offering high points, there is a reason. Don't shop for a company based on points, find products that your surgeon can use effectively with a good track record (low hardware failure rate that you will have to find out from someone other than the mfg) and then start negotiating points.

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    2. 12:56 is correct. Beware of the AMENDIAs out there who offer you 45% and then try to steal your surgeon with a ratty consulting agreement. It's their business model and other dirtbags do the same. Just get good innovative sh*t and sell with manufacturers you can trust. Trust/peace of mind is worth the points.

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  10. Hmmm... Medtronic Spine DOWN 5%, INFUSE Revenue DOWN 19%
    What can you do but sue?

    The only reason Medtronic keeps digging up these patents (one which expires next year) is to distract Nuvasive, take the focus and $$ away from R&D and product innovation.

    By the way, Osteocel Plus has delivered outstanding results since 2005.
    It's priced at a premium for a reason.

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    Replies
    1. Osteocel Plus is a joke. It is a "less processed" allograft product. dead tissue that is not so cleaned..period. If there is a fusion with that crap it's solely by happenstance!

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  11. Speaking of Biologics, Puregen from AlphaWRECK does no work, and we all know that here at the home base. Cover it up for as long as we can. Nice job!

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    Replies
    1. Didn't AlphaWreck get a warning letter from the FDA regarding PureGen? But they still advertise it as a allograft on their website? I smell patient lawsuits or doors being chained up. Where is Fat Bastard?

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  12. Osteocel has delivered "outstanding results"??

    For whom?

    For Nuvasive? Ok, yes, selling something overpriced usually does.

    For patients? Care to backup that claim with ANY level 1 proof?
    Ok, how about level 2 ?
    No?
    Level 3?

    Not much in the way of quantifiable "outstanding results" then for human spine patients.

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    Replies
    1. Agree with 9:46

      I love approaching Osteocel surgeons because they know Osteocel doesn't work and their hospitals are used to paying a premium. Just look at the top Osteocel users over the years and how they no longer use Osteocel.

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    2. Will not, that is.

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    3. Outstanding results for surgeons, and ultimately their patients. I personally have seen some fuse as early as 3 months out. 6 months more common. Have several post op CT's showing bone growth and fusion.

      Sorry guys. The stuff works.

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    4. Sure, but is no better than DBM with crushed cancellous......just a lot more expensive.

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    5. The fact that Osteocel will fuse some patients just shows that you don't always need something fancy to fuse all patients. That and I want to have my back surgery with the surgeons you say get good results with Osteocel because they must be awesome surgeons...except, I would want them to use something with some real efficacy behind it to help my chances.

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  13. Pigs get fat, hogs get slaughtered. Here comes "Nuvatronic".

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  14. Zimmer buys OFIX

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  15. Rumor has it the Globus Jet was in Warsaw last night. Could Zimmer or Biomet be upping thier Spine portfolio?

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    Replies
    1. Globus could be doing some spine shopping themselves.

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    2. Why would they be interested in buying Biomet Spine or Zimmer Spine?

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    3. That is true about their jet's flight activity, but it flew several legs that day and this week. It was in the Warsaw area for only a short period. Regardless, intresting.

      Bet it had something to do with this:

      http://orthostreams.com/2012/08/medtronic-sues-nuvasive-again-over-spine-patents/

      BTW - Cessna Citiation 680, nice aircraft! Cute company logo on the tail as well.

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  16. Do be downhearted the market's growing....!

    Global Spine Surgery Devices Market Will Grow to $14.8 B by 2017

    http://medicaldevicesummit.com/Main/News/Global-Spine-Surgery-Devices-Market-Will-Grow-to-1-903.aspx

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  17. Ok. This thread is dead. Moving on...

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  18. Anyone now why Chris Eddy left Nuvasive?

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    Replies
    1. CE is a tremendously nice guy....but it takes between 18 & 24 months for execs to figure out he is not capable of leading a boy scout troop. he is now at alphatec, the last of the companies he can fool into a high paying up front salary.....give it another 24 months when he hasnt hired any talent, he hasnt increased sales thru relationships and any rep worth keeping is ready to leave or gets hired away......kind of sad, but he is a very big reason a lot of us get screwed.....over promising and under performing.

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  19. Nuvasive is a pack of back stabbers!

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  20. Who are the realistic take-over targets in 2013?

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  21. All private companies - LDR, Lanx, SpineArt, Spinal Motion, Cerapedics - all legitimately unique platforms or market positions. The question will be value, deal structure (milestones), & expectation of portfolio & sales force integration or lack thereof. Some other interesting candidates are Baxano, SI Bone, and Zyga.

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    1. I would add Paradigm to the list - if the coflex data is as good as it appears to be, it will be hard to ignore. Most of what you listed includes 4-6th to market discs, which will be competing against macro headwinds, such as general disdain for MoM (in the case of Spinal Motion).

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    2. What about K2? Unique company with some solid products and others that are truly differentiated. I think they would be high on the list.

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    3. The challenge I have with K2 is that most of the big boys have over-lapping product lines with a lower cost distribution structure (for the most part). So, the universe of potential acquirers that can actually afford a premium & still want to pay a premium are few & far between. I like their products, I just think it will be a while for their stars to line up.

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  22. There will certainly be some movement in the mergers and acquisition arena from the likes of Zimmer, Biomet, and Stryker. These companies will be forced to respond to the completed merger between DePuy and Synthes. Going to look a lot like 1998 - 2001 when JnJ started the ball rolling by acquiring DePuy.
    Should be a fruitful time for the smaller companies to harvest talent from the big boys.

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    1. I think J&J made a loud & clear statement - the future is about "access". They've used this approach in most all of their other surgical device businesses. The only way to compete will be truly differentiated technology with Level 1 data. Otherwise, they have the product line, sales force, balance sheet & bundling capabilities to knock out mid tier & small players, including (eventually) PODS. Medtronic will be able to fight, as will Stryker. Nuvasive & Globus less so, but still formidable. Zimmer and Biomet better do something because they will wither away, as will Orthofix.

      Harvesting talent is only a short-term (2-3 years) solution. The fact is we are in the midst of massive price & margin erosion, radically changing sales comp plans, & re-definition of the "relationship sell". The "Spine Company of the Future" doesn't harbor the legacy business model flaws & will thrive in a new environment - but herein lies the dilemma... The Spine Company of the Future needed to be positioning itself & taking actions 3-4 years ago to be ready for the next 3 years. Today is already too late.

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    2. Come on 10:05A.
      More of the "smaller companies won't be around because only the big companies can dance through the mine fields of ASP erosion and FDA hurdles and, and, and...".
      I've heard the same crap for the past 25 plus years. Guess what, the small to mid-tier companies are still here. Will some fail and close up shop? Absolutely. Will some be purchased by the industry leaders? Yes. And will some of the small and mid-tier companies merge together? You bet. But the fact is, smaller companies will always be around. Why, you ask. Because there will be those who function within the industry that become tired of the corporate excuses and inability to respond and innovate and will start up their own company to answer a niche need. Pure and simple.
      Here's a question to all the legacy company employees who believe " big company infrastructure" is the only way to go. When's the last time a big company has truly innovated a product? The fact is, almost all innovation comes from those outside the established politburo elite. This is true of not just spine, or medical device companies, it is a simple reality of all industries.
      So this Labor Day weekend as you reflect on all your past labors and planned future conquest, tip a glass to those who had the courage to breakout on their own with the hopes of creating a better widget. It is this type of individual that will provide the fuel for our next "innovative" fueled growth phase.

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    3. 6:04 post by: J
      Since there has been an outcry to stop posting anonymously.

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  23. Best insights I've seen here in a while. Keep it coming.

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  24. Heard Nuvasive just lost another big hitter customer in the NY area? Amazing how docs continue to jump ship here.

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  25. does any one think Titan spine is a good company. How about the exec team

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    Replies
    1. Steve Cichy..one of the best in this industry! Their product has a very compelling argument.

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    2. Are you kidding me? Since you work for them Tim and or Jon.... Is it legal to make the doctors PA the distributor

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  26. What about Choice Spine?

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    Replies
    1. Whatever happened to Paradigm Spine and their PMA for Coflex?

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    2. The PMA has not been approved. Paradigm is heading to bankruptcy.

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    3. as all other recent pma failures the data does not prove the indication.

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  27. What about SpineWave?

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  28. All the above slowly swirling down the drain weighed down by too much cost and not enough revenue. RIP

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  29. Nuvasive fired their distributor in Las Vegas, NV. They'll step on anyone to make more money!

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  30. Regional managers everywhere are fighting to save their jobs and are basically the biggest scum bags on earth the way they do business. Failed at sales themselves or else would have never taken a regional job number one. And secondly, never go in a sales all or bring one relationship to the table during their reign as manager. Complete bums! Pathetic!

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  31. @6:32 Hey, speak for youreself. I'm a tremendous manager, the best at Nuvasive!
    All the best, Roger Yapp

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  32. 6:04 Smaller companies are able to jump through the FDA hoops just as easy. Look at FDA letters, seems lately its just a slap on the wrist, move on. The larger companies of the spine market have more products therefore more patients at risk so of course they will dig deeper but it appears everyone is just enough in compliance to keep their doors open. Smaller companies are able to innovate no doubt about it but for every new "innovated" device, there is always a patient that is the first. Ill raise the question of, how can a product be tested sufficiently (in compliance to ISO and FDA standards) yet still cause "potential" patient harm? Companies need to test their equipment more before releasing, not mark up first malfunction as surgeon misuse which It seems most companies are quick to do so. Look at the small companies that are growing rapidly, when competing with Nuvasive, Medtronic, Stryker, do they really take their time to dot their "I's" and cross their "T's" ?Everyone has the skeletons in their closet, the question is: what companies are better at hiding them.

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    Replies
    1. @7:19
      What was your point? You rambled all about in your comparison contrast of small vs big but essentially said they're all the same.

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  33. Roger Yapp, a legend in his own mind

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  34. I would like to propose a toast... To the memory of TSB. He was a good lad. If he was still with us, he would surely have written something by now. Rest in peace.

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