NuVasive Is Alive and Well.

On Monday, November 30th, Alex Lukianov, CEO of NuVasive, held an investors conference call regarding XLIF reimbursement by Aetna, Cigna and United Healthcare. Lukianov's message was concise and to the point.

Coding for XLIF/ALIF is a straight forward code that has been established by NASS. NASS has been clear on how to code this procedure. The concern that surgeons are not being reimbursed has more to do with individual coding on a local level than on a national level. To NuVasive's knowledge, there have been no denials if the procedure is coded as an ALIF. It is NuVa's intention to have "thought leaders" or champion surgeons educate payors on what an XLIF approach entails.

As of this conference call , NuVa has had no conversations with the aforementioned payors. If anything, the confusion is being caused by the surgeons' themselves. The analysts were given an explanation as to how CMS establishes reimbursement based on Relative Value Units (RVU's). To date there are 8 Peer Review Articles with Comparative Outcomes available some time in 2010 and 2011.

Lukianov estimated that 30-35% of XLIF sales are covered by the three insurance companies mentioned. In closing it should make no difference to the payor whether the procedure is coded as an XLIF or ALIF. Interestingly enough non of the analysts asked whether there were any concern about post-op transient pain and whether this was contributing to the payors concerns. Well what would we expect from an analyst? Well it's back to the drawing board for those of you that have to compete with this procedural product. TSB wants to know what our readers think about this product?

The Year of Living Dangerously

No readers, this isn't about the 1982 Peter Weir film adopted from a book by the same name. As "the year of living dangerously" winds down, the question looms, what lies in store for spine in 2010? Based on recent articles, 2010 will be a year of change. On Monday, November 30th, NuVasive will hold a conference call to quell the recent "hullabaloo" regarding XLIF as a preemptive move to assuage the anxiety from the Street, and to reassure everyone that all is well with XLIF. TSB must pose some questions for our readers. If the insurance companies cannot distinguish the difference between an XLIF and ALIF, how is it that NuVasive can? Isn't that the platform this procedure was built upon? Is or isn't the XLIF a different procedural approach? Let's forget about coding for a minute, is it an ALIF, or, is it an XLIF? So in the spirit of intellectual debate, will this become a coding issue, or, a reimbursement issue? If the insurance industry has placed a bullseye on XLIF, this will be a challenge for NuVasive, considering this "procedural product" has been its major revenue generator. In the end, could this really be about lowering the reimbursement as a response by the payors to a host of new products introduced by the competition? Spare me the ours is better than theirs, TSB wants to know what our readers think?

It is interesting that after TSB posted "Requiem for NASS" there was an interview published with incoming NASS President Ray Baker, M.D. about the overall strength of the organization. Of course, Dr. Baker's position is that NASS is stronger than ever, would we expect otherwise? TSB would never argue with membership numbers, but as Peggy Lee once sang;

"Is that all their is, is that all their is,

if that's all there is my friends, then let's keep dancing,

let's break out the booze and have a party, if that's all..... there is?"

It's nice to know that NASS is willing to stand by their men, I'm sure Tammy Wynette would be proud, but it has been a challenging year for NASS. Do the names Kuklo, Polly, Wang and the recently convicted Kabins ring a bell? Granted Kuklo, Polly and Wang have different issues, yet, too much negative publicity has left this organization on the defensive, and will continue to leave many unanswered questions about the role that surgeons play (some rightfully so) influencing commercial enterprise. If the advertising industry is looking for a replacement for the late Billy Mays, there isn't a shortage of personal spokespeople in the aforemetioned group, excluding Kabins.

The industry will see a major shift in product development, engineering, manufacturing, and clinical studies. This has been in the works for the last three to five years considering that some articles make it sound as though this has been a recent phenomena. We will see more outsourcing to China, Korea, India, and Malaysia. This really isn't about the FDA, this is really about cutting the cost of R&D/engineering and manufacturing resulting in maximizing gross margins! Based on TSB's exposure to medical manufacturing in foreign countries, someone will have to be responsible to monitor quality manufacturing? Products still have to meet the same validation process. Inevitably, product safety comes back to the FDA. Before any judgement can be made, all one has to do is look at the healthcare system in many of these countries. This isn't really about who offers "breakthrough" medical care, this is about money!

So, as we head into a New Year, TSB must ask our readers, who will be the headliners, and who will be the legends? We want to know what you think?

NuVasive Reimbursement Issue

Recently, a few of our readers expressed interest and concern regarding reimbursement issues from major insurance companies (Aetna, Cigna and United Health) on the XLIF. Mike Matson originally reported this on November 20th. These companies have declared the XLIF unproven, and have stopped covering it. It perplexes TSB and hopefully many of our readers, why at this juncture has this become an issue with these payors? Since these insurers cover 66 million people, could it be that they are looking at this as a strategy to minimize payment on this product/procedure? Matson goes on to say that XLIF is billing as an ALIF because it is an anterior approach. But the real question is whether the insurance industry will be able to differentiate between a true ALIF and an XLIF based on hospital claims?

Will this news create an overhang on NUVA shares, or is this a strategy by the analysts to lower 2010 guidance. I have to side with NuVasive, unfortunately, there is one looming story that comes out of this report, it may be time for NuVasive to post results that insurance issues are not going to be an obstacle to beat its estimates.

Alex it's time to perform your magic! TSB wants to know what our readers think?

Thanksgiving Op-Ed Piece

When TSB was launched, our intent was and will always be to provide our readers with a forum to have an intelligent and academic platform affording all our readers a venue to express their opinions. This is not CafePharma! In addition, this blog is not a website subsidized by industry based advertising revenue, we do not sell data, or claim to offer business solutions, we do not have a vested interest in creating new markets or influencing equities, nor, do we charge a subscription rate to allow our readers to blog. The rationale for this model has enabled us to keep a neutral position on evaluating technology, management teams, and on the information provided in confidence by our followers, allowing our readers to keep their anonymity, as well as our critics. We attempt to perform as much due diligence as time allows. Yet, TSB does not expect our readers to agree with everything. The objective is to offer our readers an honest assessment of what is going on in the industry, and "what is heard on the street."

Recently, we have had much commentary and banter regarding a few "early-stage" companies, its management teams, and its investors. It seems that some ego's have been bruised. My polite response to these people is that if you are unhappy about what is being discussed, please don't read the blog, or when you wake up take a good look at yourself in the mirror. We must question those that express their animus by asking "is there any truth to what is being said?" Sometimes the truth is a difficult pill to swallow. Unlike other platforms TSB does not delete any comments, whether they critique TSB or its readers, as long as it is done in good taste.

The one question that must be asked is, why is it when small companies fail, have no idea how to implement a strategic plan and do not understand how to execute, it is always the fault of a distributor, middle manager, or the dynamics of the industry? Does anyone ever take responsibility on an executive level? Could it be that so many people are incompetent, or, could it be that you make poor decisions and lack good people management skills?

In closing, I would like to use this opportunity to wish all my readers a wonderful Thanksgiving! Keep reading, your voice counts and can make a difference!

Kabins Pleads Guilty in Las Vegas Medical Mafia Case!

Mark Kabins, M.D. has pled guilty to concealing fraud committed by his two co-defendants Howard Awand and attorney Noel Gage. Under the terms of his plea agreement Kabins received five years probation and six months of home detention. Kabins will be required to repay $3.5 million to Melodie Simon. In addition, Kabins could also be fined up to $250,000 under his agreement.

Kabins was facing up to 20 years in prison and a fine of $250, 000 for each count if convicted on all eight counts. In pleading guilty, Kabins admitted that he assisted John Thalgott, M.D. in surgery on Ms. Simon. He admitted that he knew that he could be sued and ask Howard Awand to persuade Gage not to sue him or Thalgott.

The question now becomes whom will the DOJ go after next, and will they put some closure on their current investigations into our industry? The fact remains that there is a connection between our industry and this type of behavior. Word on the street in Vegas is that Kabins and Awand may be willing to tell the Feds more than they ever expected. TSB wants to know what our readers think?

Orthofix Hangs its Hat on Trinity

On Monday, November 23, INVESTORS.com reported on Orthofix International's rebound, despite last year's setbacks caused by their acquisition of Blackstone Medical and the loss of their distribution agreement with Osiris. The company's third quarter revenues outperformed the analysts' prediction of $133 million.

Our readers must admit that this organization has done a tremendous job in distancing itself from Blackstone, and is making the effort to market its products with its own brand image. Don't look back in your rearview mirror. Orthofix is predicting that Trinity Evolution will grow revenue by as much as $100 million.

As inquisitive as our readers and TSB are, we must ask the question: "How viable is stem cell technology? Is this truly new technology or just another spin on something old? And, how many viable mesenchymal cells are there in the product?

If this company has proven one thing, it is that if you have the financial acumen to renegotiate your debt, even Lazarus can come back from the dead! PS: Word on the Street is that the OIG is coming after the "Three Amigos!"

What's Behind Door #3?

Unequal distribution of probability is notoriously difficult for people to solve correctly, and have led to numerous psychological studies. Behind one door you have a Ferrari, behind another door your have a Maserati, and behind the third door you have U.S. Spine! Which door would you pick?

Word on the Street is that there have been some additional changes made at U.S. Spine. Yes, readers, TSB has substantiated that during the summer there were at least ten employees given their walking orders! Today, rumor has it that Darrell Jackson and another sales manager were let go within the last couple of weeks. Darrell, if you're out there we want to hear your side of the story!

TSB has to ask the $3 million dollar question, what happens when you have an investor that comes from a different industry, has never worked in the industry let alone ever developed a product, starts to mandate how the company should be run, and has totally unrealistic revenue expectations? TOTAL CHAOS! Hey no offense, but just because you're good at basketball doesn't mean you'll be a great football player. Success breeds insanity and sometimes incompetence! Oh, VC's I could hear you groveling!

TSB was willing to give US Spine a reprieve, but it seems that this company can't get out of its own way. Word is that they are having trouble ponying up cash and delivering product to distributors. How many useless press releases will there be? TSB wants to know what our readers have heard?

Is Vertiflex Losing Its Flex?

Recently, TSB has heard a rumor on the street that there is something amiss at Vertiflex! Could there be trouble in paradise? Could the 'flex be losing some of its muscle? To our knowledge some of our sources have stated that it's not a question of solvency, yet, it seems that some integral employees have been shown the door. Sometimes you have to wonder whether the right people are leaving this operation.

Questions have been raised about their burn rate, and how this is affecting their ability to bring products to the market. If they are burning capital at an exceedingly high rate and failing to bring revenue in to offset expenditures, no matter who is affiliated with this company, there could be trouble looming on the horizon. The question remains if they need more cash who is willing to roll the dice on this venture?

Is there is a real weak link at this company? Based on what we hear, it may be the VP of R&D who seems to like to tout himself as a Master of the R&D Universe! How funny is it when you read that he was responsible for leading Interpore Cross to a company with a comprehensive product line. Most companies that begin to experience engine trouble start out by saying that the organization is changing strategic direction. The only problem with that excuse is that its like setting sail for Europe and half way across the Atlantic you decide you need to sail around the Cape Horn and any sailing buff knows that the climate gets cool in the southern latitudes. TSB wants to know what are readers have heard?

Requiem for NASS

The industry just finished a week of chest pumping, high fiving, and flexing its muscle in the greatest city in the United States, that's right readers, San Francisco. The consensus seems to be that this meeting SUCKED! No NASS this isn't TSB's opinion, these are the feelings of industry professionals. Do you hear that NASS and Spine Companies! Contrary to what the analysts' have to say, it was much of the same old, same old products. I'm sure that many of you believe that you are doing God's work! So what does the industry have to show for all this hoopla. We found out that Danek is going "back to the future" with the TSRH3Dx. You would think Robert Zemeckis was running the company, and Marty McFly and Dr. Emmett Brown were running R&D. Nice going boys! As TSB stated, pulling out old designs and re-inventing them is not innovation, its stagnation leading to more commodity products. Then we had DePuy announce the launch of another anterior cervical plate (and everyone thought we were crazy when we wanted to design this plate ten years ago). A uniplanar plate is just what the industry needed. Let's see, less metal, less screws means less cost, another senseless product to drive down the cost of cervical plating. How many different versions of a cervical plate do we need? Constrained, Semi-constrained, Hybrid, Dynamic, Buttress, Kick-Plate etc, etc, on so on! Amedica announced that it had launched new products only to find out that the company reached a distribution agreement with Integra Spine to distribute the old Tether Plate and Therics calcium phosphate material, old news must be good news. Custom Spine launched a product that was originally exhibited at the 2006 NASS meeting with an FDA disclaimer, along with another "me too" cervical plate. By the way CSI start looking for a new President time is not on your side. One has to wonder whether the industry needs a GPS to get it through these uncertain times. These meetings are beginning to look like an 25th Anniversary Alumni gathering at my old university. Sitting in a dentist's chair for two hours and getting a root canal is not this painful.

One question that TSB must ask is why do we get the same old analysis from the analysts? Could it be that they lack the clinical knowledge to put their reputations on the line with potential emerging technologies? When will we ever get a coherent analysis on some of the facet technologies that are starting to make headway in the industry? And I am not talking about Facet Solutions either! Whether you agree with it or not there is a market. When will we get a real analysis regarding some of the bio-materials that are utilized in fusion? Is the industry that tainted that we rely on opinions from analysts that have a vested interest in the success or failure of a product?

TSB can guarantee that next year's meeting will be no different. It's time that things change or companies start to boycott NASS. What do our readers think?

Who Will be the Next Company to Fall?

As the Spine Road Kill Tour of 2009 comes to close, TSB must ask our readers, who will be the next early-growth stage company to fall? Will it be a matter of weeks or months before we see our next victim? Will we be singing, "Another One Bites the Dust?" Freddie Mercury where are you in heaven when we need you to lead us in angelic choral harmony?

Hopefully, if our source is correct, its time many of the VC's investing in these companies get a "check up from the neck up!" Hey, if your cash is burning a hole in your pocket, TSB is always willing to receive a nominal donation . Someone has to pay to keep the electricity on! TSB wants to know which companies could be selling their assets and heading for the beach?

PS; I'll give our readers a hint, I have written about them in a past blog!

Medtronic Launches TSRH 3Dx Spinal System

Multiplanar Adjusting Screw?

OSTEOGRIP Screw with dual lead thread pattern?

I think our readers have heard this story one too many times. I thought they launched this system back in 1987? Did our readers see the spin at their booth. I suspect all of you know the old saying what goes around, comes around. Our industry is becoming like Hollywood, looking to remake old movies with new actors.

Pleaaaseeeeeee Dr. Evil, give us a break!!!!!

PS: Didn't Pete Simonson design the old 3D Connector? The Multiplanar Screw is nothing more than a screw with a universal joint. One MSD distributor laughed at this product.

Is it NU and is it TRU does it LOC and does it FUSE?

As more and more entrants enter the race to sell their products for facet fusion, TSB would like to enlist our readers knowledge, and opinions, about some of these devices. Having an inquisitive personality has always been a short-coming of mine. Recently, we have been contacted by multiple companies regarding their facet fusion devices. In order to provide our readers, which does include patients, some positive feedback, TSB would like to know will some of these devices make a difference in alleviating associated back pain?

One of the first products to hit the market was TruFuse which was designed to address facet degeneration. TruFuse is a tapered dowel and when introduced caused a serious stir from the surgical community. VGI with VertiLoc was another design that claims the device resists rotation and can be locked in place after implantation. It seems that VerteLoc has done admirably in a volatile market. NuTECH came out with NuFix a allograft dowel manufactured out of the femur or tibia. Litigation! Litigation! Litigation! As of last week, another player debuted in this space, its name is Facet Fusion Technologies out of San Antonio, Texas. FFT's claim is that with a rectangular/wedged shaped design with simplistic instruments, this device can withstand shear forces much better than the aforementioned products. So in the spirit of democracy, and with due respect to some of the other facet technologies (US Spine, Spinal Elements and Facet Solutions) what do our readers think of these products, and if needed, would you have these products implanted in your own spine? TSB wants to know?

An Analyst's Point of View

Recently, Mike Matson of Wachovia Fargo Securities sent his 2009 NASS highlights to his readers. As good of a job as Mike does, one has to wonder about his analysis. There is no doubt that double digit growth awaits the legacy companies, yet, the question must be asked will many early growth stage companies offset this forecast? Ironically, the Street has re-aligned its guidance for the industry at 8-10%. I guess it comes down to the old saying that as the economy changes, the rules change by which you gauge success or failure. If early-growth stage companies are being forced to tighten their belts, how does this affect their ability for growth and new product development? How does one evaluate a company's efficiency when it takes three years to bring an articulating TLIF to the market or two years to bring a cervical plate to commercialization? This year's failures have resulted in tremendous losses for investors, especially when those investments were into multiple "me too" companies. While the margins for these youthful players remain high, so do the salaries for many of these companies that carry much "dead weight." Though there was an 18% increase in new firms at NASS, the question is who were these firms? Were they emerging technologies?

As healthcare reform continues to evolve, capped pricing and greater scrutiny on commodity spine products is becoming the rule and not the exception. Considering that our industry has become a waste land of "me too" products pedicle screws, cervical plates, interbody devices, including zero-profile products, and biologics (just look at all the announcements last week) how can the industry not expect for things to change in the not so distant future? Let's look at XLIF. As exceptional of a job as NuVasive does in educating surgeons on the benefits of an eXtreme Lateral approach, and utilizing champion surgeons, there are many companies that are going to make competitive inroads to NuVasive's market. There are other neuro-monitoring platforms, yet, to argue that yours is faster than the competitor's is a moot point considering that operating room time is budgeted as a fixed cost. Does Matson really believe that companies like Medtronic, Synthes, DePuy, and AlphaTec lack the intellectual, educational and financial firepower to arrive at an alternative modality of treatment?

It will be interesting to see how things change over the next year. As TSB has stated, many distributors are already feeling the effects of smaller companies cutting back on commissions. Obviously, those that do not agree keep singing the same old song, that this is a "relationship" business. Unfortunately, that song will only play so long, and survival will come down to pricing. Yes, readers, even companies like NuVasive will not be able to charge $5,000 for a piece of PEEK, especially when XLIF is an approach. TSB wants to know what our readers think is going to happen over the next few years.

2010 NASS - A Preview!

In the spirit of having some fun, after an arduous (do your feet hurt from all that standing?) yet boring week at NASS, TSB has some ideas to spruce up the 2010 NASS Meeting. TSB is not ready to divulge our identity. What we suggest is that many of the "early-growth to mid-cap" companies have their own meeting, considering that "spineless" NASS continues to pander to the Spine Cartel. Do you need a NASS representative coming to your booth on the last day with one hour left to the show asking, "what can we do different?" "Was this a good meeting for you?"

If our readers, and industry professionals are willing to pony up a fee, TSB envisions opening the 2010 NASS Meeting with a Bon Jovi (for the right price with no scheduling conflict) Concert. Now that would be an opening reception! You think NASS would give something back to us after all the money that we have invested in a self-serving organization, and all the surgeons that have been bought and paid for. Who said medicine can't be fun? Doctors are not interested in looking at more "me too" products. They walk around like zombies after the first day, either hung over, having slept in, or have brought their girlfriends to the show, and end up paying nothing more than lip service to you because the powers to be at NASS ask them to. Based on what one of our readers stated, this meeting is starting to become a yawn, while another hoped that next year's meeting will not be Mickey Mouse like! NASS is only interested in taking your exhibitor fees and finding sponsors for breakfast, lunch or a computer kiosk, and rather than spending an inordinate amount of money for a 20'x20' or 10'x10' booth you could donate part of that money to charity and a night of partying. TSB will be willing to allow all participating companies to have a 6' table to hawk your 'wares for two hours prior to the concert. That's right my fellow spineophiles, we could take back this meeting from the Usual Suspects that have made this a unproductive and self-serving meeting!

TSB will have a virtual booth at the 2010 NASS Meeting. No one will be at the booth except for four 72" Samsung flat screens that will have a live blog updating all our readers on the meeting in real time. We will have roving reporters, bringing together investors and companies looking for capital. As a source of entertainment, we will be hiring a half-a-dozen Victoria Secrets Models that will be walking the floor passing out spineblogger.com ( for our new, in the works website) t-shirts.

In the event you become tired and irritable, TSB will accommodate attendees by offering a massage area in the center or our booth, by appointment only! There will be a complimentary wine bar and hors d'oeuvres. In closing, that would be a meeting worth attending, until then, its back to the grind on Monday. TSB wants to know what are readers think?

"We weren't born to follow, Come on and get up off your knees, When life is a bitter pill to swallow, You gotta hold on to what you believe, Believe that that the sun will shine tomorrow, and that's a saints and sinners pleas, we weren't born to follow, You gotta stand up for what you believe!"

2009 NASS Overview.

To our avid readers, TSB would like to know what our readers thought about NASS? Who were the companies that shined? Who were the companies that whined? And, most of all, who were the companies that dined?

In addition, which products did you think were cool and innovative? Which products did you think were going to make a difference in the lives of many patients? This is your chance to let the industry know what industry professionals like yourselves think! Considering that TSB has many patients that follow our blog, this would be a welcome service.

We look forward to your commentary! Save travels and to a successful close to a tumultuous year!

Cervical Care: Your Opinion Counts!

What do the following products have in common?

Synergy Disc Cervical TDR Synergy Disc Replacement Inc.

Mobi-C Cervical Artificial Disc (LDR)

PCM-V Porous Coated Motion with V Teeth (NuVasive)

NuNec Artificial Cervical Disc (Pioneer Surgical)

M6-C Artificial Disc (Spinal Kinetics)

They were all contestants in the Motion Preservation Category on Monday night. So how did the panel judge these devices? Did the panel and voters consider the overall system design which would include the implant and the instruments? TSB must say that each contestant substantiated their product by claiming to preserve segmental stability and flexibility to prevent further degeneration at adjacent levels. So what makes one disc better than the other? Considering that there isn't much retrospective data comparing the use of one system versus another, how do we know which is the best? So in order to judge these products vis-a-vis a real democratic process, TSB wants our readers to let our readers know which products deserve recognition. After your comments, TSB will let you know the winners.

Lumbar Care: Is This Innovation?

TSB has had a hectic week! In the spirit of competition, we wanted to review some of the products that were "in the running" at the Spine Technology Awards Banquet by category.

Since Lumbar Spine is the largest segment in our industry, we would like to provide our readers with a snap-shot of the entrants for this segment;

Alpha-Tec: Osseo Expandable Pedicle Screw

Biomet Spine: Polaris Deformity System and Trivium Derotation System

Custom Spine: AVID (Articulating Vertebral Interbody Device)

Disc Motion: InLign Multi-Axial Screw

Integra Spine: VuaPod

LDR Spine:ROI-A Cage with VerteBridge Plating System

Ouroboros: OSS Spinal System

Paradigm Spine: DSS Spinal Stabilization System

Pioneer Surgical: BacJac Interspinous Decompression System

Pioneer Surgical: NuBac Nucleus Replacement

Spinal Elements: Lucent Controlled Delivery Gun

Spine 21: Bionic Spacer

Spinous LLC: ANDRE (Aspirating Neurological Dissector & Retractor for controlled Exposure)

VTI: InterFuse Interbody Fusion Device

Woodweilding SA: Lumbar Minimally Invasive Care Biomaterial

If our readers look at the products, they ranged from Pedicle Screws, to Dynamic Stabilization Systems, Intervertebral Spacers, Instruments and Bio-materials. This was a wide range of products to choose from. Some old, some new, some borrowed, and some blue. As with many of these technologies, the reader must ask themselves; "Is This New? Is This True? and Will The Device Make a Difference?"

Does an expandable screw make a difference? There is no doubt that a screw of this design improves axial pullout load, but have we had a problem with pedicle screws pulling out? Isn't marketing a company's portfolio to the "aging population" an attempt to exploit senior citizens? It's almost as fickle as gender based knees. I guess its difficult to argue with a company that is on target to hit $100 million in revenue this year. Yet how much revenue will this product truly generate? And the question must be asked; how much of your business will you cannibalize?

How about an articulating TLIF device? To claim that current technologies have a smaller footprint, and require manual manipulation to insert a spacer in the optimal location is a fallacy. Approach and technique solves many challenges when inserting IBD's. Just look at the XLIF, or for that matter the new GLIF! This AVID also needs manual manipulation, by a very primitive looking instrument. There are many companies in the market that have spacers this size after this device is activated. Besides, when you have investor surgeons willing to present at NASS on behalf of the product, red-flags must be raised as to the claims regarding potential efficacy.

If there was any product that was interesting it had to be the Vertebridge Plating Technology and the InterFuse Device. TSB does not have any commercial interest in either of these products, nor affiliation with the management in these organizations. Yet, our readers must admit that there has been many questions raised about instrumentation when it comes to Zero-Profile instrumentation, and LDR seems to have found an easy 2-Step, 2-Instrument Implantation System. In addition, the InterFuse does have some cool features.

As usual, Hansen Yuan's name was attached to a multitude of products. What hasn't he attached his name to over the last few years? For all of Hansen's tremendous contributions in the field of spine and neurosurgery, he has taken the commercialization of medicine to a new level.

At the end of the night the audience had to ask itself; were some of these products creative and innovative? What is the long-term significance of some of these technologies and do they have the staying power? Does this solve a clinical problem? Can this improve the standard of care? Will this technology be cost effective, not only clinically but also sociologically. Would you want that device implanted in your back?

In closing, many of the legacy companies, the real players in the industry in terms of market share, did not submit entries. These companies do not need to affiliate themselves with Robin Young to attain critical mass, or market presence. Many "mid-cap" companies were in attendance for the obvious reasons. Yet, it always comes down to publicity! Once again, this venue exhibited the incestuous pathology that exists in our industry. Until we find another platform, we have chosen our master! In closing TSB wants to know what our readers believe?

The Greatest Show on Earth!

In 1871 Dan Castellano and William Coup persuaded PT Barnum to lend his name and financial backing to the circus that they had already created. The circus was called "P.T. Barnum's Great Traveling Museum, Menagerie, Caravan, and Hippodrome." The moniker "Greatest Show on Earth" was later added.

Today, spine has it's own P.T. Barnum and "Greatest Show on Earth." Our P.T. Barnum is Tony Viscogliosi and the greatest show in spine is Paradigm Spine and Centinel Spine. TSB understands that you can't argue with success, especially when it comes down to raising capital. Yet, any "sane person" must ask; "How dysfunctional are these people?" The attrition rate at these companies is staggering when one looks at the collateral damage that is left in the wake of progress. Listening to the V Brothers speak is almost like listening to Lloyd Blankfein of Goldman Sachs tell the Sunday Times of London they are a virtuous organization, providing social utility and doing God's work. Can someone please give us a break! Enough with the stories about your childhood experiences molding who you are, and what your mission is in life. It's the insanity in your behavior that makes us wonder.

TSB always asks the same question, what is the definition of insanity. As Einstein said, "it's doing the same thing over and over again and expecting different results." Well, TSB was informed by a little bird that the V Brothers are at it again. The word on the street is that Michael Will is the new President at Centinel Spine. Haven't we seen this one man comedy act before? It was called "The Emperor Has No Clothes!" If there is any truth to this rumor, run for your lives because it is like the "giant vampire squid wrapped around the face of humanity, relentlessly jamming its blood funnel that smells like money!"

TSB is starting to wonder what's in the Kool-Aid on Park Avenue?

Who Says We're Not Commoditizing our Industry?

Recently, TSB has been challenged regarding an analysis that the Spine Industry is euthanizing itself. Ironically, today, Amedica announced the launch of four new products, just in the nick of time for NASS! These products include; the Concise Anterior Cervical Plating System, aka The Tether Plate, I get it they're going to fool the market place, Valeo Synthetic Putty, aka Therics Synthetic Bone Putty, in addition to silicon nitride VBR's. They're still calling it a VBR, that's funny.

After all the pomp and circumstance, Amedica hired a band to march down Main Street in Salt Lake City announcing Ben Shappley's arrival. This is how they expect to grow their business with, more "me too" products, let alone a few that are offered by another competitor. Randy Theken, you must be laughing all the way to the bank. I would loved to have been negotiating this deal because I would have made them commit to buying minimums. If this is leadership, it constitutes the blind leading the blind. Who knows maybe the next thing we hear is that they are attempting an IPO! You know what the definition of insanity is? No need to give our readers the answer! TSB wants to know whether our readers really care?

In closing remember what TSB is singing: Welcome back my friends to the show that never ends, we're so glad you could attend, come inside, come inside. Come with me the show's about to start guaranteed to blow your head apart! You've got to see the show, it's a dynamo, you've got to see the show it's rock and roll.

Spine Technology Awards Redux

Last night was a monumental moment for spine! The Spine Technology Awards came out of the womb after gestating in Robin Young for the last year. It was a long time to carry an award of that size, but Robin came through the delivery in a fine manner, and even looked great.

Is there a place for this type of ceremony in our industry? Absolutely! But, like most shows it will need some " major tweaking!" Considering that half the audience was gone midway through the program, changes will have to be effected. As usual, the "Crack Staff" at OTW will reconvene and figure it out. One question that TSB must ask is this another venue to provide companies within our industry a platform to sell their hardware and software?

A tribute was made to Charnley and Harrington, honoring their life-time contributions to the industry. Oh yes readers, the world has changed, considering fast-forward in "real-time," pioneering and prospecting is a thing of the past. Today, the industry moves faster than Chita Rivera's legs ever did. Besides, those early prospectors were not driven by today's declining U.S. dollar, and really did care about making a difference in patients lives. But that's not what today's blog is about.

Robin paid homage to the "Usual Suspects," many that are already known. Some awards went to Paradigm Spine DSS (surprised?) along with homage to the Vicogliosi's and Rudy Bertagnoli (my patients never complain about anything I implant). Alphatec and Healthpoint garnered two wins (another surprise?). Nuvasive PCM (Robin you're drinking too much expensive wine with Lukianov), while Paul McAfee was his usual pompous self giving his boy Brian Cunningham a shout out, Pioneer NUBAC (I believe that was the name, I was drinking) along with Hansen Yuan.

The most interesting award went to Applied Spine Technologies in the Motion Preservation Category for the StabilimaXX, a device that has had more failures than Robert Downey's drug rehab. Craig "lose the pink tie" Corrance was on hand to accept the award with former lead engineer JP "I bailed on AST in the middle of all the failures" Timms. At least Timms had the decency to acknowledge Professor Panjabi, PhD who should have gotten a life-time achievement award for his contributions in the field of spine biomechanics, instead of an award for a product that has not ever had a "whiff" of success.

Additionally, recognition must be given to Mike Sherman formerly of Sofamor Danek fame, now with MD Ventures, for being our entertainment for the evening having nodded off in the middle of the show. Thankfully, his hair covered his eyes, and if his head wasn't bobbing up and down, we would've never known he was asleep. In closing, TSB must admit, if I did a shot of tequila every time I heard Robin use the words "Innovative" or "Innovation," I would have passed out just like Sherman. And one final acknowledgement must be given to Matt (I need a win) Songer for submitting the most nominations on behalf of Pioneer Surgical.

TSB believes that if there is an awards show next year many things will have to change, so I am off to my room to digest the information packet and review the other winners. See you on the floor on Wednesday, I'm off to Sonoma and Napa on Tuesday for a day of drinking wine.

Spine Technology Awards Tonight's the Night!

TSB would like to remind our readers that if you haven't purchased your tickets, tonight is the night of the Spine Technology Awards. This inaugural event will be held at The Place Hotel. The Palace is the grand dame of San Francisco hotels. This hotel was designed as an American counterpart to the grand hotels of Europe. The hotel survived the great earthquake of 1906.

Tonight is the night that the "Who's Who of Spine" will be in attendance for this extravaganza. TSB will be in attendance, and if not hungover, will attempt to do a live feed incognito. Who knows maybe Billy Bush may even show up with Access Hollywood. The Master of Ceremony is Robin Young. Though he is not the Italian tenor Enrico Caruso (who ironically stayed at the hotel in 1906) he will do his best to sing the praises of those individuals, companies and technologies that receive the prestigious Tiffany (we hope) award.

The categories include; Cervical Care, Lumbar Care, Motion Preservation, Biomaterials, Diagnostics and Imaging, MIS, Pain Management, and Emerging Technologies. There are only eight hours and counting until the show goes on! TSB would like to know what technologies and devices strike are readers fancy? PS: Great rooms at The Palace! See you there!

Monday's Op Ed Piece

With NASS just days away, TSB took the time to reflect on the spine industry. With the near collapse of the U.S. economy, the dynamics of the industry has changed. This economic shake-up has left us with a few less companies, justifiably so, and some companies that are teetering on the brink of extinction, or looking for creative ways to survive. We have seen physicians become the target of the Government and the media, Wall Street realign the guidance for the industry, and companies evaluating their business models. So where is spine as we head into our annual party?

Over the last twenty years there has been an eruption of Vesuvian magnitude in the spine industry. Inevitably this has led to many changes in the way that companies and physicians view themselves. Today, they spend their days in a race, identifying and evolving product while finding new modalities of treatment, regardless whether a device truly benefits the patient. This is not to say that much of what has transpired over the last twenty years hasn't benefited the patient. Endless stories abound from patients who claim that their surgeon has been "God-like," or, that products from a specific company saved them from a life of pain. Sensible people do attribute this to the expanding commercialization of medicine. Yet, with this seismic explosion comes a dizzying array of treatments for all types of ailments.

Most of our readers understand the process to bring a product to the marketplace. This includes raising capital, developing or buying the technology, randomized trials (IDE), examining statistical significance, clearing the regulatory pathway, and peer review in academic journals. Yet, once we know that a certain modality of treatment works, we rely upon physicians to determine which patients the device should be used on, and when to use it. It becomes the surgeon's responsibility to make that determination, one that requires sound judgement. But what happens when a surgeon has a vested interest in the success of a product, or is an owner in a company, or is getting paid to use the device? Does this have the potential to obfuscate sound judgement? We know that human beings can be unduly influenced by having an interest in the success or failure of a product, especially when money is involved. This is not to say that money is bad, but it can obscure one's objectivity. Just look at what goes on Capitol Hill with lobbyist influence! It could be as deleterious as someone that writes about the industry and never questions the validity and efficacy of a product, the ethics of the industry, or has a financial interest in the success of a technology? Ever wonder why what is advocated by one surgeon, is frowned upon by another? Ever wonder why one surgeon has a greater surgical case load than another? Could it really be that one surgeon is that more talented than another? It does make you wonder!

Entrepreneurs have contributed to the success of spine, considering that without their interest some of the same technologies that we sell today would have never made it to the market. But, has this "mania" led to the unethical behavior that exists in today's industry? If surgeons become "salesmen" or public relations experts for a product that they have invested in, or are being paid by a company to use a product, is this good for medicine? TSB cannot answer that question, that must be answered by our readers and the American Public. The total disc boom created what many in our industry still call "Entrepreneurial Fever!" The dynamics of the economy has changed peoples expectations. It's interesting to sit around a dinner table and listen to surgeons criticize the TARP program and condemn Wall Street when their own behavior leaves much to be desired. Sometimes you feel like saying; "look at who is calling the kettle black!" Today, we even have the "the patron saint of spine surgery," Charles Rosen, M.D. being featured on television magazine shows like "Extra" discussing the effects of spinal surgery using specific products.

This past weekend the House narrowly passed a Healthcare Plan that will create a fierce debate and battle in the Senate before some type of public option is enacted. Based on what has transpired over the last few months it will be interesting to see the final version. Whether we believe in it or not, some form of an option is needed to salvage a system that needs major reconstructive surgery! Enough with the diagnoses, its time to operate! Unfortunately, no one is willing to make a concession whether it is the insurance industry, physicians, hospitals or device manufacturers. TSB sees a lot of finger pointing when the patient is on life support. Yet, Someone is going to have to pay the price for a healthcare system out of control. But will our industry suffer from a government run option?

Based on what Steve Findlay, a senior health policy analyst at Consumer Union in Washington said this weekend, "as more Americans get health care coverage and money flows into the system, new revenue streams will flow into the system for medical device companies." Not that different than industry visionary Robin Young stated a month ago. If our industry truly believes in resuscitating itself, the patient needs a new modality of treatment, it will take a new paradigm in human nature, and finding new and less expensive ways to bring emerging technologies to maximize our profitability. Until then the only person that suffers is the patient. So as you walk around the Moscone Convention Center, stop and smell the roses, because in all likelihood we will see a different industry the same time next year. See you all at NASS! TSB wants to know what our readers think?

Quantum Orthopaedics, Nope! Spinal Elements!

Mosaic: arbitrary patterns resembling a composition made of diverse elements. TSB is not speaking about a decoration made of stone or small glass, TSB is speaking of Spinal Elements which was the front runner pioneering a device and concept that has been the platform for all zero profile implants. The Mosaic was the first all in one device that combines interbody support with a tension band, designed in 2, 3, and 4 hole configurations. This product has stood the test of time.

SE will be releasing a retrospective two year follow-up in the first quarter of 2010. In all likelihood, this will be the first retrospective data presented on the efficacy of this type of device. This will be an important report, since "zero-profile" devices have yet to prove that non-union rates are not the same as an interbody device without anterior fixation. Recently SE had a paper published by Choll Kim, M.D. of San Diego that discussed the simplicity, versatility and ease of use when implanting this device into multiple levels without associated dysphagia. This device allows the surgeon the option to address multiple levels off-label. In addition, there has been documentation and biomechanical testing to substantiate torsional stability. A device that can be inserted with a minimally invasive approach, reducing surgical time, no plate sizing, no plate bending, and with a proven track record we're not talking about Quantum Orthopaedics, we're talking Spinal Elements. TSB wants to know what our readers think? Stop by the SE Booth next week, who know's you may even run into TSB. Cheers!

Is the FDA the Good Guy? The Bad Guy? Or Are They Just Trying to do Their Job?

Wednesday's 5-1 Vote by an independent panel for the FDA has raised some serious questions not only about how the FDA does its business, but also about our industry. TSB believes that our readers understand that the Fed's role in the process is to regulate firms that manufacturer medical devices, while at the same time, it "protects" the American public by ensuring the operating accuracy of a device. Device classifications depend not only on intended use, but also on indications for use. Yet, some of our readers feel that the process is criminal and its intent is to financially punish the industry? TSB must ask our readers, what is the role of the FDA? To paraphrase one of our bloggers, "it is to protect consumers and make sure the technology in question is safe and efficacious!" At the same time, the FDA is the gatekeeper to our industry's financial enterprise. Maybe the FDA is really not as hyper-protective as we would like to believe. If one looks at the Yin and Yang of this debate, maybe the FDA has been lax in their standards over the last few years? All our readers have to do is read about the Menaflex fiasco to understand the aberrant culture that exists at the Agency, or ask themselves is INFUSE a pharmaceutical product or a device?

As an industry, we have won many battles with the FDA by creatively tailoring language in the submission process on intent and indications of devices. If Dynamic Stabilization can play a role in the treatment of DDD by favorably altering the movement, and load transmission of the spinal motion segment without fusing the segment, is this a new modality of treatment? How is this a supplement or adjunct to fusion? Our readers must answer that question! If instability or abnormal movement is the main cause of back pain, fusion would alway be successful in relieving back pain, yet, this has not been the experience. With the introduction of pedicle screws, inter-body devices and the 360, successful fusion rates have increased, but have failed to improve the overall clinical success rates. TSB understands the argument that "potentially" this product could minimize adjacent disc degeneration by controlling motion, but how much motion? And how much load should be shared by the system to unload the damage disc? Did God create us equally in size, shape and looks?

Based on what one of our readers posted, it seems Zimmer itself is confused. What does "It offers a unique approach to stabilization and immobilization of the spine and pain relief" really mean? And what does " it provides immobilization and stabilization of spine segments" mean? Just attend the Castellvi program in the Keys, and one starts to wonder whether the surgeons themselves understand how to use this device. Do any of these panelist understand the discrepancy in the kinematics between the implant and the motion segment? Or, are they relying on the input of a cadre of academicians and biomechanical experts? Mainly Panjabi, Goel Ferraro, et al????

Put yourself in the position of the FDA. How difficult is it to discern what is clinically relevant and what is clinical marketing? Today, we have surgeons testifying on behalf of the companies and devices that have a vested interest in the products approval and success. Can one potentially lose their objectivity when millions of dollars are at stake? If you and I sat on the panel, what would be the first question we asked? I venture to say that most of you know the answer! Then, we would proceed to evaluate the technology and the data. What makes this such a hot topic is that Spine is always looking for a new product to build momentum, and TDA has lost some of the wind behind its sails. Spine is a burgeoning industry, based on its margins and profitability, that is why it has become the darling of Wall Street. Investors with and without any medical experience have infused a tremendous amount of capital and time into this product segment. Unfortunately, this is a product that needs time and retrospective clinical data to prove its efficacy. At the end of the day, if most of these patients end up with a fusion what have we accomplished? TSB wants to know what our readers believe?

To The Texas Investment Group

Could you resend the e-mail that you sent me tonight. I apologize for the inconvenience.

TSB

Globus Medical: Is it the Streets or the Feds Darling?

Globus Medical announced that it had set another revenue record for the third quarter. The company generated $66.2 million in sales resulting in a 46% increase comparably to QIII 2008.

Yet, TSB must ask the $200 million dollar quesiton; How does a company grow as quickly as Globus Medical has over the last three years? Let me count the ways.

Do any of our readers believe that this is a "squeaky clean" company? Originally when this company was started, David Paul committed as many mortal sins as an individual can, witnessed by the litigation between Synthes and Globus. In my old neighborhood, this type of behavior would have been handled by breaking some legs. I guess Hansjoerg Wyss is getting old! How many surgeon investors are there? Isn't this company similar in its business model to K2M Spine? How many creative consulting agreements does this company have on the books? 20? 30? 50? How many start-up practices has this company subsidized?

Regardless whether our readers agree with the strategy and tactics employed by the Golden Child, you can't argue with success! As Globus continues to increases revenue, TSB believes that the only strategy left for this company is to take it public. Unfortunately, this is not the year to do it. As the economy continues to exhibit a rebound in 2010, next year may be the time to hop on the Acela and pay a visit to Goldman Sachs. I mean if you are going to continue making a splash who else should underwrite the initial public offering. TSB wants to know what our readers think?

Dynesys Is Thrown Out at the Plate!!!!! The FDA Wins at Least for the Moment!

A panel of medical experts, aka the FDA advisory committee recommended against the wider use of the Dynesys Spinal System. In a 5-1 vote, the FDA stated that Zimmer's data was unclear and that some changes should have been made to the clinical trial.

TSB thought that Dynesys was rounding third and heading home as a device that could have stand-alone use. Much to our chagrin and in the spirit of the sixth game of the World Series, Dynesys was thrown out at the plate!

In closing the FDA declared that the device holds promise. TSB must ask our readers, what does that mean? How vague can the FDA get?

To All My Readers

Within the last few days, someone is posting comments under the name Musculoskeletal and Musculoskeletal Man. These comments are not being made by TSB! I am asking the individual that is posting under my moniker to stop using my alias. In addition please do not make derogatory comments about other people. This was the second comment posted today, November 4th at 2:46 p.m. in reference to the article entitled; "Is VTI's UPLIF UPlifting?"

If you are not interested in contributing in a professional manner your posts will be monitored and deleted. TSB would like to send our apologies to Robin Young! If this individual is interested in making derogatory comments, please log onto CafePharma!

Synthes: The New Model Citizen!

I guess Synthes has learned its lesson about doing things the right way. Unfortunately, it took litigation on behalf of the DOJ and three untimely deaths to teach them a lesson. Today, Synthes announced that the FDA has classified a recall of the Synex II as a Class I device. Essentially meaning that this products poses an imminent hazard to the health of a patient if this device was implanted.

The voluntary recall, unlike Norian, was initiated after six adverse events were reported related to this device. The reports note that there was moderate to severe loss of vertebral body replacement height, meaning the central body component was failing to hold up six to fifteen months post-op. Adverse issues include neural injury, increased pain, spinal kyphosis, failure of supplemental fixation, and need for revision surgery.

Synthes has advised their customers to cease and desist utilizing this product. Patients that have had this device implanted should speak to their physicians immediately. If you know of anyone that has had this device implanted please pass this on notification on to them immediately.

Zero-P, No it's Not L'il Wayne's Side Kick!

Zero-P, it sounds like a Hip-Hop or Rap artist! It's the latest craze spreading through the spine industry. Using Cervical Plates with Cervical PEEK has become out of vogue. Spinal Elements can take credit for being the first legitimate commercial product to create a shift in treating cervical related disease. Yet, when SurgiCraft, a British based medical device company launched the STALIF TT PEEK, a stand alone ALIF device with screws, it set off a frenzy of spinal implants that would be built off these platforms. Since that time, it has become apparent that companies in our industry have been off to the races, attempting to beat one another to the market with a sleeker and more user friendly design. This product not only had ALIF applications, the design opened an entire new modality of treatment for the cervical market place. With the commoditization of cervical plates, resulting in hospitals paying on average of $1,000 - $1,500 per procedure (someone selling in NY told us that some hospitals have capped plates at $865 for one and two levels) these products have allowed spine companies to once again maximize their profits. Yet, one of the major concerns seems to be the simplicity and efficacy of the instruments. As with most implants, instrumentation is the key to an immediate revenue explosion. Realistically, how different are many of the implants that we sell? TSB argues that it always comes down to the instruments.

In retrospect there were some companies that attempted to get into this market segment. The companies that failed were Scient'x and Interpore Cross. If my memory serves me, Interpore's product was called the Vanguard. Today we have multiple companies that offer so-called zero profile cervical products. These include; Mosaic by Spinal Elements, which set the precedent for cervical devices and is still considered to be a good product. Bricon, a German company has a product called Cervical-C or Shark Cage, LDR has a product called ROI-C with its VerteBRIDGE plating technology. TSB must ask is there any biomechanical data on the efficacy of those blades that are used to stabilize this device? Centinel has the STALIF-C which has been struggling because of the V Brothers inability to transition anything smoothly. Synthes has the Zero-P, and Globus has a product of their own. In addition, to these devices there are a few smaller ventures that are playing in this space.

The most common complications associated with the anterior approach to the c-spine are sore throat and dysphagia. Yet, chronic dysphagia or hoarseness is an uncommon complication associated with injury to one of the recurrent laryngeal nerves. This type of injury may cause problems with swallowing and potential aspiration. But the question must be asked, have these post-op complications been a by product of surgical approach and soft-tissue management, or has the implant really been the culprit? TSB wants to know what our readers think?

Is VTI's UPLIF UPLIFting?

Recently, OTW published an article that talks about how "cool" and innovative the UPLIF is. Hey Robin, "cool" is a word out of the sixties, you're showing your age. In the interest of innovation and design, TSB is going to ask our readers to be the jury on VTI's UPLIF. So here are the questions:

Has anyone outside of the consulting surgeons had their surgeons use this product?

How long does it take to implant?

Is this design innovative and cool? (I threw that one in for Robin)

Are there any concerns that this design will effectively fill the disc space?

Does this device have the ability to distract or "jack up" (my inner city roots) the foramen?

How easy was it to "track" this device or slide it in comparison to a regular PLIF?

How much does this device cost?

PS: Robin is taking a beating in a poll sponsored by www.orthospinenews.blogspot.com. Since its election day across this great country, get out and give him a vote. He can't go down in a rout to my hippie friend JE. Let your voices be heard. TSB wants to know what its readers think?

Dynesys: Rounding Third and Heading Home!

The FDA announced on Monday that the Dynesys Spinal System was as effective as the Silhouette Spinal Fixation System in more than 300 patients with nerve damage and spinal stenosis. If approved on Wednesday, this will be the first product approved for non-fusion use in the United States.

The success rate for patients that had the Dynesys implanted was 52% as compared to 40% for those patients that had the Silhouette implanted. The data indicated that Dynesys alleviated leg pain in 87% of the patients compared to 73% that had the Silhouette implanted. Even with this good news, there were some questions raised about potential bias in the evaluation saying a majority of the patients in the study were treated by researchers with a financial interest in the company.

The FDA released documents on Monday which stated that there might be bias from compensation when payments or stock holdings were analyzed for any influence in the proposed new use of the product. Currently, the product is marketed as an adjunct to fusion. One analysis by the FDA found a positive correlation between payments made to doctors and success rates for the device. Zimmer had no comment on the financial compensation issue. In the spirit of the World Series, Dynesys is rounding third and heading home! TSB wants to know what our readers think?

Life Spine: An Endless Enigma

Enigma: the MW dictionary defines the word as puzzling or an inexplicable occurrence or situation, a contradicting character. If our readers log in to Life Spine's website, TSB must ask whether there is a contradiction between what is said, and what it really offers. To paraphrase LS's credo on its Home Page, it claims; " Life Spine is focused on bringing innovative technologies to serve the surgical communities." Yet, the reader must wonder whether there is a contradiction between what is said and what is truly offered?

With its Matrix like product offering, starting out with the NEO cervical plate (Keanu Reeves must cringe), this company takes you through a labyrinth of one "me too" product with the door opening, to another endless offering in terms of true innovation. By the looks of things, and word on the street, these products do not offer procedural efficiencies and efficacies, just ask the end-users. TSB admires innovation, yet, this portfolio seems to contain stagnation! Knowing that this company is ruled by an emperor doesn't help the cause. Known as a company with a tremendous attrition rate in management, poor performing products, and some shady dealings is it a matter of time before we see another "me too" company go south for the winter? TSB wants to know what our readers think?