Monday, April 30, 2012

Going Long? Going Short? Or, Just Going?

As the world of spine continues to churn and burn, TSB would be interested in getting our readers perspective on some of the small companies that continue to grind it out in hopes of sustaining their existence, and eventually selling their respective ventures for some insane multiple that no longer exists?  TSB's observation is that there are many deals to be had for the Zimmer's or Biomet's that need something to make them a viable player in the spine marketplace.  Considering that Zimmer has all this cash, now may be the time to pull the trigger. The potential exists that by making the right acquisition these organizations would get some respect and move up a notch or two in the spine hierarchy.

The time may be right to pick up a great deal.  Regardless of some of the recent investments made in the industry, why would independent investors continue to sink money into some of the companies that continue to struggle? Some of these "dogs" have been around five to seven years, they continue to struggle in increasing revenue, they lack leadership and creativity in bringing some ground breaking technology to the market.  How scary is it when you hear of scenarios where prominent surgeons, the who's who, have been thinking of starting another "me too" company.  Why would anyone invest?  Because the surgeon is a well know individual? Does anyone believe that there is that much money to be made with another "me too?"

If a company is five years and out, it would be safe to assume that they have missed the boat. With the amount of hype that has surrounded some of these ventures, its a wonder that more companies haven't folded with the exception of those that have surgeon investors using their products.  And therein lies the problem.  When due diligence is performed on some of these companies, 60, 70, 80% of their revenues come from investors.  Why would anyone buy that company or look to invest into that business model? Haven't we all learning a lesson from the likes Orthofix being hoodwinked by Blackstone Medical?  Upon speaking with some CEO's, the valuations that they dream of having less to do with reality, and more to do with fantasy.

Recently TSB was having a conversation with an investor who told us that a company that his consortium had invested in, had burned through $20-30 million dollars in a four to five year period with a little or nothing to show for it in terms of revenue, and on top of this the CEO failed at two other ventures.  Is there something wrong with this picture?  Let's say you are an investor in this company, and the intent was to flip this on future IP that needs to go through an IDE, do you invest any more capital?

Who are some of the companies that continue to flounder and who are some of the companies that have the right technology that would help the Zimmer's and Biomet's in spine?  TSB wants to know what our readers think?

84 comments:

  1. I am looking for a bone graft that is comparae to Bacterin Osteo Sponge for cranial applications like craniotomies. Large strips in size, can anybody reccommend an alternative?

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    1. Need it to replace the section during a bifrontal craniotomy

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    2. call me crazy but don't they just use the bone flap(s)? Or something like the synthes custom PEEK flaps?

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    3. Depending on how large the defect is, most use a mesh with an HA cement. A strip will only be effective for a small area and provide no hard matrix for bone to grow into. Few companies have that cement product for a distributor out there Joel, do your homework. Sounds like the doc is just making you run your ass off to look for solutions while he's getting off watching you. Sometimes shit doesn't stick to the walls no matter how much you throw at it!

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    4. Biomet Indux Cancellous Strip is the same as the Bacterin sponge

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  2. Wy doesn't MSM create a true forum in addition to the blog for discussion and questions like this guy has. I know one of you tried,

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  3. TSB. Lets face it...with the management team DD has put together over at Zimmer Spine (6 presidents in the past 5 years), they could acquire MSD and fail. Until DD gets his head out of his ass and the investors, Spine is a lost pony for Zimmer. They have screwed up two acquisitions (Endius and Abbott) that both could have been a nice niche to the market. By trying to do the integration themselves they messed up a good thing and pissed off a lot of Docs and long term distributors. Biomet on the other hand is a totally different head case. Why move everything to Warsaw and leave Spine behind? What a mess that house is. Who is really running that ship over there???

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    1. Biomet left spine behind because it will be easier to sell or spin-off if it operates as a standalone unit. In other words, Biomet is looking to EXIT spine...not double-down as TSB advocates in this post.

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    2. Who would want to buy Biomet spine and why? Market share acquisitions are rarely as successful as planned, not that Biomet has that much market share to begin with. So I do not see a reason for one of the major players that has the money to buy Biomet. Not sure how many of the smaller companies have the capital needed to purchase a Biomet to give them a full line. Agreed it is odd that they have left Spine in NJ, but not sure where they a headed with this division.

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    3. 6:52pm, Biomet is known for seemingly strange moves like this. Once upon a time the company was publicly traded just like Zimmer and J&J. Then, just a handful of years after going public, it shocked the industry by going private. I'm sure that the plan is to once again go public someday, and if that is indeed the case, they would probably first like to divest (probably via a spinoff...not a sale to a competitor) the money losing assets such as spine.

      Sincerely,
      3:15pm

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    4. Biomet Spine is the most poorly managed company in the industry has been for years. Distributors are among the dirtiest in the industry, can’t decide what sales model works direct led to indirect leading to mega distributors now they are running a hybrid sales force. Management is as dirty as Kim Kardashians vagina, how many doctors wives can be paid, look at the mighty midget controlling the whole SE

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  4. TSB, you're on to something here.

    If these larger companies were to acquire the right mix of small companies in a timely fashion (meaning now, not 12-18 mos. from now), this would put a huge hole in the supply chain of the POD entities. This is why there is a mad scramble for the POD's to find smaller players (i.e. manufacturers) that can supply $125-250 screws (to the POD), so the POD can keep the end-user supplied and still clear a largesse margin for the surgeons. This investment would be money well spent and these small companies are looking for a realistic price out of the market. If no acquisitions and the pro-POD developments (like in NH Senate) continue their favorable support, the POD's will continue to make share gains (by estimates of 25% now). Price erosion will be severe as the traditional markets will vie with the surgeon's business. The winner, in many places, will be the smart hospital administrator that sees the opportunity to play the price game to an industry leveling position....where the managed care, payers, hospitals will prevail! What say TSB?

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    1. I thought NH passed a ban on POD like entities, what pro-POD development are you talking about? Did that bill fail to pass?

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    2. LET ME CLEAR UP YOUR MIS-INFORMATION ON NEW HAMPSHIRE.

      The New Hampshire Senate Committee on Health and Human Services convened on April 19 to discuss HB 1725. PDP Holdings secured a Washington, DC lobbying firm as well as a former US congressman from NH to defeat or neutralize this effort by the large Spine and Orthopedic manufacturers who presumably want to plant a flag for propaganda and to get momentum for other state efforts. No absolute decisions yet, but the closed door comments indicate the NH Medical Society may make an example of some politicians (aka old implant reps). From information privy inside the closed doors, all five members of the Senate Health and Human Services Committee were opposed to the bill. As written, this bill will not pass in this form, and may be defeated in its entirety, or amended to bring more favorable language for review. The Senate and House would, presumably then conference to amend language related to prohibition on referrals to a more sedated, simple disclosure of the surgeon's interest in a supply chain operation. The House supporters will certainly bring pressure to bear, as expected, and the typical political wheel will turn to the point that we are confident that the process will become too complex and lack the political muster to go up against the NH Medical Community. This may be just what the OIG, CMS and US Senate Finance Committee needed to get their motor runnin'.

      As a recap, the New Hampshire legislation passed in the NH House in early April. The House of Representatives of the New Hampshire State legislature adopted HB 1725, prohibiting physicians from referring any patient for a surgical procedure involving an implantable item or device if the physician has an ownership interest in any entity involved in the manufacture or distribution of the device. The bill applies to all implantables regulated by the FDA, from total joints to cardiac devices to intraocular lenses. As written, it would apply to a wide range of financial relationships, and would effectively preclude any implant supply chain model with physician participation. A hearing in the NH Senate Committee took place April 19. PDP is collaborating with the NH Medical Society, NH Hospital Association and the health insurance providers which strongly opposes the legislation.

      To be continued.....

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    3. Continued....

      Presently this issue has been receiving a considerable amount of review in Washington, DC related to the Senate Finance Committee initiating oversight discussion and review last june 2011. The NH bill is obviously at cross purposes to everything that is going on nationally, where the OIG, the Senate Finance Committee, the GAO, and CMS are working to promote physician-owned models that contribute to the reduction of costs, whether through supply chain savings or through bundled payment and other crafty reimbursement models, while identifying any models that present regulatory concerns. The NH bill is clearly anti-competitive and protective of the interests of large manufacturers at the expense of surgeons, patients, hospitals, employers, insurers, and states.

      Of interest, the bill was sponsored by a House member that formerly was a large Spine manufacturer's rep, whose territory included NH and surrounding locales. The House member assigned the bill to the committee he chaired instead of to the House Committee on Healthcare, and was fast-tracked to the floor of the House. The healthcare attorneys immediately sighted some irregularities and suspected that an agenda was at play behind the bill, which spirited their actions to dissuade passage of the bill at all costs. As we dug deeper, the political aides have implied that there are no tangible efforts to create physician-owned implant entities in New Hampshire. The transparent purpose of finding a friendly sponsor in a state with no physician-owned entities on the horizon was to enable the large, controlling manufacturers to use passage of such a bill as momentum in other states as well as more ammunition to intimidate physicians, hospitals and others from pursuing alternative supply chain models in other states.

      We are encouraged that PDP Holdings is actively working with the New Hampshire Medical Society, New Hampshire Hospital Association and health insurance providers to kill the legislation in the New Hampshire Senate, or to potentially amend it to provide for disclosure of ownership interests consistent with the Federal Sunshine Act legislation, thereby removing language on prohibition. Even though the Sunshine Act legislation has its own limitations still to be resolved, it does buy time to influence discussion within the halls of government. PDP's commitment to step forward on this bill and to encourage (hopefully strong-arm) more supportive voices in the NH legislature as developments in Washington come to fruition, should be a flicker of great news to the rest of the POD country fighting for their own.

      THREE CHEERS FOR PDP HOLDINGS FOR PLANTING THE FLAG FOR POD'S!!!!

      NOW ON TO CARLSBAD FOR A FREE-FOR-ALL DISCUSSION AT THE JUNE STEGO MEETING!

      BRING IT ON MR. BINDER & YOUR BROTHERS FROM MEDTRONIC, DEPUY, STRYKER AND THE LIKE!

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    4. Who wrote that, clearly it was copied and pasted. I think you will have a hard time convincing anyone that the Senate Finance Comm is encouraging POD's after reading their request to the OIG.

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    5. To the supporters above and elsewhere, here is a final tally on the New Hampshire battle...

      We are pleased to report that the New Hampshire Senate soundly rejected HB 1725, the physician implant self-referral ban that passed the NH House in late March. With the support of the NH Medical Society, and the assistance of a former NH U.S. Congressman affiliated with our DC consultants, we educated senators as to the anti-competitive motives of the sponsor of the bill (a still-active device rep) and the benefits of our model for hospitals, payors, and patients. Some legacy manufacturers and their reps had already begun to make reference to the legislation as evidence of regulatory hostility to our model to discourage consideration of partnering with PDP. With the defeat of the bill in the Senate, we can respond that it is evidence instead that an educated legislature will recognize the benefits of our model and will reject efforts to protect the legacy manufacturers from competition.

      HB 1725 would have prohibited physicians from referring any patient for a surgical procedure involving an implantable item or device if the physician has an ownership interest in any entity involved in the manufacture or distribution of the device. The bill applied to all implantables regulated by the FDA, from total joints to cardiac devices to intraocular lenses. Moreover, it would have applied to a wide range of financial relationships, and would have precluded any implant supply chain model with physician participation.

      The bill initiated with an active DuPuy sales rep whose territory included several New England States, and was then fast-tracked it to the floor of the House. Health care attorneys immediately suspected that there was an agenda behind the bill, because no one was aware of any effort to create physician-owned implant entities in New Hampshire. The transparent purpose of finding a friendly sponsor in a state with no physician entities on the horizon was to enable the legacy manufacturers to use passage of such a bill as momentum in other states as well as more ammunition to intimidate physicians, hospitals and others from pursuing alternative supply models in other states.

      The bill was at cross purposes to everything that is going on in Washington, where the OIG, the Senate Finance Committee, the GAO, and CMS are working to encourage physician models that contribute to the reduction of costs, whether through supply chain savings or through bundled payment and other innovative reimbursement models, while identifying any models that present regulatory concerns.

      We will monitor and respond to any efforts to introduce similar legislation in other states.

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    6. Not even close. This is a horrible misrepresentation of the language in the Bill and incorrect. Amendments only prohibit the formation of PODs and physicians making their implant choice for their patient based upon their financial gain. If PDP Holdings wants to gain any respectability for your model, you need to stick to the facts and promote your program as a way to pay surgeons for using a device they prescribe. Then we could have a meaningful discussion about the merits of models that do that.

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  5. Zimmer is already trying to squeeze out all of the direct employees by cutting comp significantly. Could this be to cut some of the fat to make room for a new aquisition? It is more likely that this is the first of many steps for them to finaly exit the spine market all together. It has become a former Stryker boys club and most of them had little to no success with Stryker and the ones that did don't seem to know why or how.

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  6. With almost 4 years of declining sales YOY and Quarter over Quarter? Zimmer Spine is an absolute joke. dD has had oversight of this debacle for over 7 years (group pres and global pres). What's equally pathetic is your local Z Spine rep ... In qualified, poorly trained, and led by a giant collection of losers and retreads.

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    1. Hit the nail on the head.

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    2. Jeff Paulson is the group president of spine and has been for the last 2 and half years. In qualified is not even a word in proper english, but I am sure you are quite skilled and well trained even if lacking in articulation. They have a few solid reps in my area and the local manager is OK, but the AVP is a Stryker retread that fits the mold you mention.

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    3. Uhhhh prior to Paulsen ... It was a short timer and DD who occupied the group pres roles. DD was group pres prior to being promoted for paying the largest fine to the FDA and implementing growth killing compliance programs.

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    4. Pretty sad when then only products Dvorak can point to are a 12 year old TM cervical CT scatter implant and a 12 year old Trinidad plate with a window. That's innovation!!! Congrats on buying Endius and Abbott and going backwards in 4 years. Only the losers are staying on that sinking ship.

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  7. Does Ulrich have expandable PEEK? Anyone know??

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    1. No just that hard to see thru Ti. Outdated

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    2. Does't the Ulrich VBR expand? Or it that Ti too? Have a case next week maybe and looking for something.

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    3. plenty of expandable vbr's .and made of PEEK

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    4. Does it compare to Spine Source then?

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  8. What's the word on Paradigm Spine (Coflex-F)? Me too or unique technology? Possible acquisition?

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  9. Coflex isn't getting pma approved. Another spine pma failure.

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    1. What are you smoking - best PMA the FDA has seen. Watch for the approval in the next 4 months, if not sooner.

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    2. I saw the patient information used for the CoFlex study in Europe when I was asked for a second opinion. Instead of an informed consent there was a significantly biased consent. Amazed the IRB let that one through. If that's reflective of the IDE here in the States this by definition will not be the best PMA FDA has ever seen.

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    3. Agreed. The PMA has serious issues and will sit in the FDA queue for a while.

      Paradigm is doing very poorly. There has been high turnover and revenue is very poor. They have been raising money (again) and running into difficulty finding additional investors.

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    4. I actually heard the opposite. large funding and pma approval coming soon.

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    5. Actually you didn't. The company is having serious issues and struggles to stay afloat.

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    6. pma is obviously important. well see

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  10. AOI 15 million and nothing to show

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  11. I heard Coflex pma is doomed. Submitted over a year ago and it is not going well.

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    1. Average pma is 3 yrs, but there hasn't been a spine pma in 5 yrs. a lot of spine pmas are in trouble or dead on arrival. I think coflex has 2-3 years to go before we know. There are a lot of pmas that have been at FDA years longer than coflex.

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  12. One small company that will be around is Spinal Elements. Best company I have ever been associated with from top to bottom. The product line might be a little thin, they are working on that in a very controlled way, but customer service and management are the best I have ever worked with!

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    1. Nice try Todd!

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    2. Please will someone buy us. Please

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    3. Spinal Elements...ARE YOU HIGH! They have whored themselves out to everyone. There is probably over 10 companies that have some sort of SE prodcut in their bag as they can't seem to sell it directly to customers. Their ACDF peek/plate combo prodcut is a joke. Have seem over 5 revisions with it due to screws just spinning in the graft. The Magnum gun is a joke as well. So please.....

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    4. Not sure what they have more of turnover or "corporate clients". I expect to see their acf at Home Depot next

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    5. Not buying it, SEI is a great company and I know of a couple of agents that are doing 5-6 million with the line. They take great care of agents and respond in a moments notice. Sounds like you guys might be scared of a good thing.......

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  13. Kyphon news:
    http://www.asicentral.com/asp/open/apps/news/industrynews.aspx?id=4972

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  14. Zimmer has everyone running for the door, at least if they aquire someone there will be jobs for them at Zimmer since there will be no one left. Sad to see where they are today after the potential with the Abbott aquisition.

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  15. What about K2? Any ideas on where they are going?? With the new cash reserve, and "big brother" watching, will they keep moving up or crash and burn??

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  16. What about x-spine? How does their X-90 look like out there?

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    1. X90 is a good alternative to k2 mesa.

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    2. You've got to be kidding. The X90 is no where near the technology of the Mesa system. Two completely different systems.

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  17. Is Spine Wave considered a small company? How does their portfolio stack up?

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  18. I think Alphatec will cleanup up and be a powerhouse now that the old management is gone.

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    1. Wrong, the Rat-Fink in engineering is still an unorganized shyster.

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    2. What management at Alphatec is gone?

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    3. Why is it when all the sales managers are ousted, everything will improve? Is not the one who made all the decisions ie the President still there? It seems shit does roll down hill and the top never seem to pay the price for their incompetence

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  19. I wonder if ZS is even allowed to tap into the coffers of Z holding--which has a substantial amount of cash on hand and even more coming in each quarter. So it's hard to put too much blame on ZS management if they can't even go shopping--but what would they buy--its all 'me2' no differentiation to set them apart. ADR's (good luck with PMA and reimbursement), biologics (nothing proven yet)?? K2M looks pretty? perhaps they have been focusing in emerging markets like apple's success in China recently?? They have a good brand name in ortho they (dd) just shouldn't let ZS fall off the map even further.

    Bigger question is: where is medtronic spine heading?? next move?? they need to use some of coporate's multi-billion dollar acquisition budget to start some consolidation before J&J stomps them.

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  20. Wow - look at all these great small companies with innovative technology being profiled here...

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  21. Can someone please tell me what the shortest length globus thoracolumbar Plif cages come in? I have a guy that does bilateral plif cages and he needs something shorter than a 22mm length. Any globus offering g in like a 20mm?

    Thank you for the help!

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    1. If you're a rep..get a clue

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    2. lol, i love it when a doctor comes up with a problem that doesn't exist....

      LIGHTBULB!!

      I know, lets let him "invent" a 20 mm plif cage with the $H&* company that you currently carry

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  22. Life Spine has several cool implants. They seem to have a lot in the funnel.
    What is the deal in Chicago?

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    1. Nice try Mike!

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    2. It is a nice strategy! Since we put it out, we have had 47 sales calls for interest in a position (and still streaming). And yes, we will sell to the market through any portal that delivers our product to the hospital.

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  23. Overheard from a Depuy Rep in OR lounge. Once this merger is complete my control over my territory and my customers will increase ten-fold. Ten fold is an exageration, isn't it ?? Guess his docs gave up free will to follow him. Monopolies and Vending machine screws. Depuy is socializing medicine??

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  24. Considering leaving my position w/ top 5 spine company for start-up SI-Bone...hefty comp plan, company equity, new market segment, etc. Foolish?

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    1. It is hard to read this one. Short term the money and equity is inviting, but like any newer segment in healthcare that spikes in popularity there will be scrutiny by insurance companies for approval. Why are they doing a very expensive outcome study on iFuse technology…could it be they are getting push back already? If there is any validity in this product segment there will be several competitors on their heals as well. Globus just got FDA approval for their SI fusion device, but Globus is copying everybody. I know some surgeons who have been trained where I am and they are on the fence with this technology. In other areas it is taking off. Access your market and make your decision.

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    2. Be careful. The learning curve is straight up. Having to conceptualize the placement of the dowels in 3D with using two C arms at same time is not easy task to get the dowels properly placed.

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    3. What about considering working for Zyga Tech? Looks like their system is designed to prep the joint before using their implants. It will be interesting to see the results and compare the two.

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  25. Having worked for companies of all sizes in spine I can see two possible scenarios.

    1. Investors are clinically stupid

    One company I worked for changed their focus every 3 yrs. They would sell the investors on a product and a short time later then tell them that product was no longer viable, but they had a new one! The investors not only kept releasing money, they actually allowed the company to raised more!

    Do investors not think to research anything independantly? It seems that CEO's can say anything and the investors accept it. There are easy methods that would take half a day to investigate if a company is working properly and efficently, and those steps were never taken at the companies I worked at.

    2. Investors need a tax haven

    What a great way to write off some extra cash and lower your tax burden, or hide some money...

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  26. I agree with TBS…it is now or never for Zimmer. But if you were Zimmer, who would buy? Seriously, who would you buy that would really be a game changer?

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    1. They don't need a game changer. There are enough holes in their offering that filling most any one of them with a decent product would be an improvement.

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    2. Zimmer has a ton of cash.
      What if they bought NuVa or Globus?
      Buying LDR would not fill enough gaps for them.

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    3. One thing you all are under estimating things. A lot of these smaller companies have delusions of grandeur to be the next Danek. Also, most think they are more than they are worth.

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    4. Zimmer doesn't have the balls to buy NuVa or Globus.

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  27. What management at Alphatec is gone?

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  28. LDR is dying on the vine. Even the few good distributors they had are jumping ship. No one likes yanking the fish hook out of a vertebral body. If they were smart - they would come up with a copectomy device to capilize on the disasterplasty revisions.

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    1. To the contrary, things are going well at LDR. New products have been released over the past few quarters and more are scheduled to release in upcoming quarters. New surgeons continue to adopt the technology and clinical results have been positive. There has been some change in distributors however not related to product or company issues and nothing out of the ordinary. LDR remains a bright spot in an otherwise bleak industry.

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  29. zimmer?????? 2 words Paul Graveline. HAHAHAHAHHAAHAHHA HAHAHAHHAHHAHAHAHAHHHAHAH. I can t breathe HAHAHAHAHAHAHHA i think im going to throw up HAHHAHAHAHAHAHAHAH cramps ouch!

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    1. leagle.com/xmlResult.aspx?xmldoc=In%20FCO%2020120215106.xml&docbase=CSLWAR3-2007-CURR

      What will happen?

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  30. Zimmer collects spine products like an old lady collects little porcelain dolls. Zimmer needs to buy either Globus, K2M, or Lanx and just let them run the division.

    Globus is building a very strong product portfolio, albeit on the backs of other companies designs, but they make small improvements that seem to impress the surgeons just enough. GMI would provide the biggest product offering to Zimmer Spine: lateral, deformity, an approved dynamic system, expandable cages, artificial discs, zero profile stand-alones, Kyphoplasty, and a true MIS system.

    K2M has focused on deformity and in doing so has developed a very strong niche market for themselves to expand upon. This acquisition would provide market share in a segment that is exceedingly difficult to gain access to (especially peds). Their new lateral system is sure to turn heads, and they are working on some secret game changing system that they are all very excited about.

    Lanx has a decent product offering and apparently a lot in the pipeline. They are making serious moves in the marketplace with some big competitive hires. Zimmer would gain a spinous process spacer, add another average pedicle screw system to the list, more peek options, and the most awesome lateral system Andrew Cappuccino can come up with.

    All in all I think GMI would be the best fit for ZS but knowing Davorack he'll probably buy Nexxt Spine or Amendia Spine.

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  31. How about gone. ZS just cut it's A team out of Austin and France. Only teams which made product which made money. What a joke.

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