Weekend Op-Ed Piece

Have you ever wondered what would would happen to healthcare and our industry if patients (TSB likes that word better than the MBA invented word "consumer"), decided that its time to cut back on medical care and services because they would be responsible for a higher deductible when it comes to their personal healthcare and maintenance? Considering that every CEO whose company's spine revenue is flat, or moving along at a snails pace is crying "market pricing dynamics (another term for we can't gouge the system anymore because we are euthanizing ourselves with commodities)," could we be seeing the initial stages of underutilizing medical care in this country? So why are patient visits and surgical procedures, down from a year ago?

Besides the economy, maybe the reason is that patients are beginning to realize that they do not have to run to the doctor's office every time they feel an ache and pain? A depressed economy, the real definition of a double dip recession, will affect the way medical care is delivered in this country. I know that there are many readers that believe that the state of our economy and healthcare is attributed to the POTUS, but can we talk? The fact is that TSB's diagnosis sees a societal malignancy that is attributed to other political surgeons like Reagan, Bush, Clinton, Bush II and now BO. The current state of affairs did not occur within the last year and a half. Like any disease, this disease has been festering for a long time and now that it is cascading and exacerbated by an out of control society, we have no one else to blame but ourselves. Not only have Americans done a poor job of taking care of themselves, but they have done a poor job of taking care of their country. The same way that TSB makes fun of people like Fender, Will, Shappley, and Bennett, you know the usual suspects that people continue to hire within our industry, we the people continue to re-elect the Ben Nelson's (Insurance Background), Chris Dodd's (Banking), Charlie Rangell's, Nancy Pelosi's, Mitch McConnell's and Harry Reids. Vote these people out. These are people whose time has come and gone, and quite frankly could not give a rat's derriere about anyone else except themselves. Not only should there be term limits, there should be age limits in order to serve the people. But getting back to the gist of this post, maybe patient's are becoming prudent, and through education and the internet they are learning how to take better care of themselves?

Let's face facts, we are a medically addicted society! Just look at all the ridiculous advertisements on TV. My head hurts, take this pill. I have high blood pressure, take that pill. I have a heart condition, this pill will suffice. Need a new knee, try this one. Need a new hip, this is the one for you. I can't get laid, take this pill. Screw the sunset, how about just getting out of seperate bath tubs, it works for me. You get my point. Oh, and by the way, these are the side effects and in case these symptoms arise, call your doctor immediately! How insane are we? By taking care of ourselves, maybe, we will affect the cost of insurance premiums and the spiraling cost of healthcare by driving down the cost of delivery. It's simple economics. So many people are currently unemployed and unaccounted for, that anyone in their right mind would not incur additional expenditures. As more Americans are forced to buy into higher deductible plans by their employers (we have to take care of the shareholders first), many are re-thinking whether or not they need surgery or the need to run to the doctor when they sprain their ankle. Nature has a way of telling you whether you need care of not.

As the unemployment rate increases for the rank and file (remember those that fall through the cracks), everyone loses, meaning, less business across the board for everyone, including spine. How does anyone afford COBRA when the average cost for a single person is $5,5o0 and a family of four would have to pay $14,500 per year? Even if the government (the root of all evil, OOOOOH), subsidizes 65% of the premium, COBRA is prohibitively expensive, and besides the coverage only lasts 15 months, and people who lost their jobs since May do not qualify for the government subsidy.

Recently, some insurance companies reported their quarterly earnings and predicted that this under utilization will be a short-term situation. Maybe those people are just playing the old game of wishful thinking that they teach you when you go to a Deepak Chopra or Tony Roberts meeting. The fact is, that this environment is not going to change for a long time, and it will not be two years. So what is happening? The insurance companies are raising premium even as there is a decline in utilization of healthcare, their justification is the out-of-control cost of delivering healthcare. The mathematics is quite simple, higher insurance premiums and deductibles mean less doctor visits, less doctor visits mean less surgery, which in turn means less money for the doctor, the surgery center and the hospital, less testing means less money for the labs and MRI facilities, a decline in procedures will mean we need less help, which in turn means that there will be less money for all of us.

If greed is not the demise of capitalism, maybe our national stupidity will bring us down. We don't respect one another's differences, we don't want to pay taxes, we pander to illegal aliens (yes business owners you are part of the problem), Spanish is becoming the language of choice (just dial 411 on your cell phone), we spend money without thinking about the potential long-term ramifications of becoming a banana republic, we export jobs and manufacturing to third world countries, we bail out the banks (socialism at its best), and all for the love of profits. In closing, take this time to smell the roses. I know, most of you will say that you have to generate 30% growth for your company, or you will lose your job. My answer to this is, you cannot squeeze blood out of a stone in the current economic climate. Executive management teams must stop living in the past, either they will change, or, the change will change them.

Synthes Continues to Grow, but, Spine is Sucking Wind!!!!

The Arbeitsgemeinschaft Fur Osteosynthesfragen (whenever TSB says that, I feel like I'm back in the old country yodeling off Jakob Mountain), reported its second quarter 2010 earnings today, and, like many of their counterparts, it seems the spine division offset a strong performance by Synthes Trauma and Cranio-Maxillo Facial. Of course Michael Orsinger in his infinite wisdom told the Street that this performance was offset by pricing pressures in the spine marketplace. TSB believes this has become the "jump on the bandwagon" excuse within the industry for those legacy companies that are "sucking wind." So, why are so many companies choking on the gas pipe? Could it be that there is nothing new in their portfolios? Could it be that many of these companies have kicked the tires on potential acquisitions and realized that there is nothing new?The former investors and management team at N-Spine and Spinal Solutions must be laughing all the way to the bank. Suckerrrrrrrrrrr!

The Big O (If only he had moves like Oscar Robertson) went on to commend the job that Synthes Trauma and CMF did. When the bastard step-child of the company (CMF) outperforms spine, you know there's trouble in paradise. Synthes is evolving into the second coming of Medtronic. Too big to move fast. In addition, how lame is the excuse that challenging economic and industry conditions continue to impact growth. Yes fellow bloggers, Synthes just like every other slim bucket organization is moving manufacturing over to China to minimize manufacturing cost. But wait until they find out that the Chinese are adept at copying implants and selling knock-offs in the Asian Markets. Surprise! Suprise! Surprise!

Once again, XLIFTS NuVasive!

NuVasive announced QII 2010 revenue of $119.6 million which was an astounding 35% increase over the $88.5 million for QII in 2009, and a 9.6% increase in revenue over QI of 2010 which was $109.1 million. With two quarters under their belt Lukianov has upped his prediction estimating $485 to $500 million by year end. Given that most of NuVa's products are "me too," it seems that XLIF and Osteocel have grown some big shoulders this year carrying the weight of the Big Bear's predications.

Considering that the guidance for this industry has been downgraded by every analyst under the hot summer sun, and the industry has been slow and flat (TSB is starting to sound like Tom Freidman), kudos must go out to the NuVasive Regional Managers and sales people that continue to accept the Czar's challenge. Talk about putting a bit of pressure on the troops, wait until winter comes. This may be NuVasive's greatest challenge since Adolf Hitler declared his intent to hit the USSR on August 11, 1939. If they continue their campaign to move up the ladder, the Czar must reward his troops with jeweled Faberge eggs and bottles of Chateau 1982 Pauillac. If Lukianov truly believes in patronage, you know what they say, "to the victor belongs the spoils." Besides a nice relaxing dinner at Dolce Pane E Vino would be worth it.

FDA Approves Amplify in 6 to 5 Vote

On Tuesday July 27th, 2010 a panel of FDA advisors voted 6 to 5, with 3 abstentions, that the benefits of MSD's experimental spinal fusion device (it's a device?), outweighs the risk. In a close vote, consenting panel advisors believed that the rhBMP-2 worked well enough to overcome major concerns that the studies may indicate a cancer risk for those receiving this material.

Considering that the Evil Empire's sales have been suffering, some analysts believe that this will be a shot in the arm for the company's revenue. The spine division had 3% growth last year, could this be mana from heaven? In addition, could this be the death knell for some of the early stage synthetic bone graft companies, if surgeons decide to jump on the Amplify love train?

The success rate for Amplify was 61% as compared to 56% for those receiving autograft. Results after five years found successful operations for 44% of Amplify patients versus 35% for standard care. I guess it goes to prove TSB's observation, if you have enough of capital and lobbying power anything is possible.

Will the FDA Execute or Issue a Stay?

On Tuesday, July 27th, the FDA will convene an Advisory Panel meeting that will evaluate and question the clinical efficacy of Medtronic's Amplify rhBMP-2 Matrix. The FDA has some major concerns regarding the high number of cancer related incidents in patients that have been treated with the Amplify rhBMP-2 as compared to patients treated without it. For those of you that read our blog, many of you are aware of the cynical comments that have already been posted regarding the name Amplify. For those of you not familiar with our lexicon, the word Amplify means to make larger, greater, or stronger, to enlarge, to extend. And that my fellow readers is what the FDA is concerned with.

The FDA's concerns center on the IDE (Investigational Device Exemption) along with Medtronic's, Wyeth's and Medicare's data. In all likelihood the significance of this data and the reviewers evaluation will determine whether additional evaluations and analyses will be needed. The panel will have to take a position on whether they believe that there is a statistical significant rate of incidence of overall cancer and pancreatic events in patients treated with Amplify (the test group) as compared to the control group.

In addition, the panel is being asked to consider the difference between Medtronic's and Wyeth's clinical studies, the methodology, the location or placement of Amplify in the body, when the patient was treated, the dosing and concentration, length of follow-up and potential patient co-morbidity. What it comes down to fellow bloggers is that the Federalis are concerned about the number of reported pancreatic cancer events in patients treated with the magic dust. An interpretation of this data will focus on patient demographics, limitations, follow-up and validation of the study.

At this juncture we know that any rhBMP-2 is not recommended for use in women of child-bearing age, yet, the panel will also review secondary procedures due to failure where rhBMP-2 had been used. It will be interesting to see who steps up to the plate on behalf of the evil empire. Will it be the usual suspects? The panel members for the FDA will include three cancer experts and an expert in reproductive biology. Hopefully, the FDA will perform a much better and more thorough proctological examination on Amplify and for that matter Medtronic than they did on Infuse. TSB would like to think that surgeons would take pancreatic cancer a little more seriously, than they did having boney ingrowth into the spinal canal, but what do I know, considering that TSB has no financial interest in these products. TSB wants to know what our readers think?

Mad Men, Mad Industry - Sunday Op-Ed Piece

With the fourth season premier of "Mad Men" tonight on AMC, a cable drama set in the 60's advertising world, for those of our brethren across the pond, TSB started thinking about what would it take for America and the Medical Device Industry to capture the fundamentals of what once made this industry and country so great. At this stage of our evolution, we have to find comedy in how far we've come in such a short period of time by looking in the rear-view mirror. Many of our readers have the perception that TSB is antediluvian because of our disdain for louche behavior by those who call themselves leaders within the industry, yet, what would some of our readers do to go back to the old days when men drank a classic martini or a beer, rather than some tooty-fruity concoction that TSB sees some of you drinking at the bar? When you lit up a cigarette and no one was offended, and when you spanked your children when they didn't listen or did something wrong, rather than attempt to use some of that bullshit psychology that you've been taught to use by being your child's best friend rather than their parent.

Just like Sterling Cooper (the agency), many of us that have tenure in spine, are learning to start all over. Because just like Sterling Cooper, our industry is going to have to adapt to a new world and a new economy. Less is more. In many respects we will have to reign in our disreputable behavior if we are going to survive the last ten years. Just like the adversarial climate that exists in this country, today, we are a mirrored image of that hatred and intolerance. God only knows what awaits our future? But just like our children, who have their lives micro-managed by over doting parents calling them on their cell phone every twenty minutes, that have a life carved out of soccer at 10 a.m., t-ball at 12:00 p.m., a math tudor at 2 p.m., and fencing at 4:oo p.m. our industry is a microcosm of their lives. Maybe some of our Area VP's, Regional Manager's, CEO's and investors will take the time to watch this and learn that Mad Men is a reflection of our lives. Contracts are lost, the days of 20% growth end (hear me Stryker), people are not a seamless team, you don't have to account for every minute of your life because not everyone wants to buy your commodity product, and that your company is not the center of the universe. Yes, the characters on Mad Men are one-dimensional, but how many of you aren't? How much adult supervision do you really need?

Yes, fellow readers, we have made progress since the early days of spine when patient's were placed in full body casts, or even racked like Mel Gibson in Braveheart. But in our zeal for fame and fortune, we have driven the very essence of our humanity underground. You know when men were men and women were women. When multi-tasking was an idle concept rather than a neurotic disorder. When doctors wanted to be doctors except everything else than being a doctor. When salespeople sold and weren't considered brokers. So tune in tonight and remember who you are, you just might learn something about yourself.

Questions for Our Readers

How slow is business when one considers that even the Almighty Stryker reported flat sales for spine?

And,

Is there anything new and exciting in the Spine World?

Biomet Spine - Give Us Liberty or Give It Death!

On Monday, Biomet reported that sales from spine related products rose 1% to $62 million last quarter. During a July 13th earnings call Jeff Binder commented that the company was looking to place an emphasis on "highly differentiated" products. So what is Biomet leaning on in the short-term? Binder stated that the company was hoping that the Polaris (a deformity system), the Solitaire (an anterior system), and the Trivium (a derotational system) would stimulate lagging spine sales.

Supposedly, "upgrades are coming, and some pretty neat product ideas" will come to market later in the year. But the question must be asked, is Biomet a real player in the spine market when you compare it to other legacy companies? Binder whom is regarded as one of the "good guys" in the industry has his hands full at this company. He inherited a spine management team that was dismantled by Dane Miller on that Black Monday when he flew into New Jersey and terminated the likes of Pastena, Bracco and the rest of the clan that wasn't really doing anything except milking their time. Prior to that, EBI spine was viewed as a dog, and to this day many in the industry do not really view them as a threat. Binder is hoping that by integrating the Trauma division to Warsaw, Poland during the second quarter, this will allow those lucky enough to remain in Parsippany, NJ to focus their efforts on spine. The trauma people just don't know how good life can get in Warsaw until they get there. TSB would recommend that they stop over at Bob's for dinner and Spike's Beach Grill (Volleyball is in) and have a drink on TSB. But remember, always be aware of who is lurking around you, DePuy and Zimmer spies are all around.

With sales lagging primarily due to an inability to deliver sexy products, Binder stated that the numbers were affected by pressure on pricing in the overall market. Here's a word of advice for Binder. Spend some of Blackstone's, Goldman Sachs, KKR & Co., and TPG's money! Dane Miller was a great leader for his time. Unfortunately, Dane was one of the cheapest CEO's that TSB ever met. He knew how to take care of himself along with his lifelong buddies including nice Lear Jets and CC memberships at Stonehedge in Winona Lake. Pay your employees some more money, stop recruiting people telling them the cost of living is cheaper in Warsaw, and lastly do something with your trays and instruments. Marketing is about making something look sexy and expensive, even if it's a dog. Just look at Synthes trays and instruments. But that's been one of Biomet's achilles heel. In the end Binder's job is to position this company for a potential future sale, considering that was in the discussion as far back as late 2006 and early 2007.

Spine has always been the bastard stepchild for this organization, hopefully the powers to be can figure out what to do and spin this company off its balance sheets. TSB wants to know what our readers think?

Slap My Wrist, I've Been A Bad Girl!

On July 2nd, 2010 the FDA issued and addressed a warning letter to Ms. Ann Prewett and Replication Medical. It seems Big Brother was made aware that Replication was marketing the EnGuard (I always think of the Three Muskateers when I hear that), without marketing clearance or approval in violation of the Act.

In all likelihood, the mea culpa was related to off-label use, claims made in marketing material and a White Paper. These claims were made outside the scope of their 510(k) clearance. The EnGuard was cleared with limitations as a cover for vessels (Aorta and Vena Cava) after anterior vertebral surgery. It seems like Annie Oakley could use some real help at Replication. Many of the companies with these barriers are having a tough go of getting these products into the marketplace. Obviously, anyone looking to sell these products has to have a surgeon in their territory that loves to perform 360's, and TSB is not talking about aerials. So it seems like the powers to be at Replication have until the this week to respond to the FDA. Good luck and you know what the FDA will say to you, "don't ever let this happen again." A slap on the wrist is better than getting slapped around.

Move Over Osteocel and Trinity, Allostem Is Here to Stay!

Headquartered in Denver, Colorado, Allosource is one of the five largest tissue banks in the country, and claims to be the world's largest producer of live cellular and stem cell grafts. Allosource is aggressively marketing Allostem which is an adipose derived mesenchymal stem cell product seeded on a demineralize 3D scaffold that is cryopreserved.

The osteoconductive substrate bone matrix is available in cancellous strips, dowels, cubes and particulate. Why adipose derived mesenchymal stem cells? If one believes what is reported, harvesting MSC from adipose is a much richer source per donor. This product can be utilized and applied in cages, fractures, non-unions, foot and ankle fusions. Is Allostem a legitimate threat to Osteocel and Trinity? Considering that Allostem has all the essential elements for natural bone regeneration does the industry have another player to contend with?

TSB wants to know what our readers think, and has anyone had any experience with this product?

Deja Vu? Forgetaboutit!

Recently, a loyal follower forwarded a press release to TSB regarding the non-exclusive distribution agreement between ETEX and Stryker Spine to sell and private label the Bio MatrX Structure and MatrX Generate Bone Graft Substitutes. TSB once attended a presentation by an existing CEO who constantly asked the potential investors in the room, is it new, is it true and will it really make a difference. I would love to have that guy up on the podium one day, and walk up to the microphone and ask him that question. Based on the make-up of BioMatrX Structure, what the market has is another synthetic bone graft substitute that claims to be highly porous, providing an osteoconductive scaffold, and high surface area to facilitate cell mediation for new bone remodeling. The sister product know as Bio MatrX Generate is another DBM delivered as a viscous putty that sets hard after closure. Have any of our readers ever heard the Crosby, Stills, Nash and Young song Deja Vu?

I could hear Stephen Stills singing in the distance, "Do you know? Don't you wonder? What's going on, down under you, We have all been here before, We have all been here before." So what's the big deal? Isn't this just another private labeling deal for ETEX? Is Stryker out on Tony Soprano's boat the Stugots searching for a patsy like Big Pussy? I mean let's be honest, OP-1 is FUBAR, $225 million later an HDE, they blew their opportunity to acquire Apatech having been beaten out by an industry outsider, and now, they have entered into a non-exclusive distribution agreement for spine. So why would Stryker enter into a non-exclusive if they really believed in this product, or, are they probing their own customers and market?

There are other products in the bone grafting market place that are hydrated utilizing sterile saline or bone marrow aspirate. So what's the big deal? Maybe some of our readers need to stop at Holsten's Restaurant in Bloomfield, New Jersey and ask Tony Soprano if he has leased the Stugot's to Stryker. TSB wants to know what our readers think, and will this make anyone shake in their boots?

"Another lonely park, another Sunday, why is it life turns out that way, just when you think you got a good thing, it seems to slip away."

IS IT PEEK, OR IS IT OXPEKK?

Today is the day fellow spineophiles! Oxford Performance Materials (OPM) is pleased to announce that a long-term implantable medical device manufactured with it OXPEKK-IG polymer has received clearance by the USFDA. The device is produced from OPM's radio opaque OXPEKK-IG. (Acronym Exhaustion) is produced by Kent Medical Devices a privately held Minnesota based company.

OPM has been in the commercial market in Europe, the Middle East and South America. Recently, the OXPEKK-IG polymer has received approval for the Korean market. So what is OXPEKK-IG? It is a high performance, ultra-pure thermoplastic with a modulus of elasticity similar to bone. Yes fellow spineophiles, it's PEKK not PEEK, a PolyEtherKetoneKetone (spell check worked this time), and is within the class of PAEK. So the bottom line is that this material has been used and implanted worldwide.

For those companies that may be interested in learning more about the biocompatibility of this material, data is available form OPM without any access fee. So in closing, we have a new player in the PEKK market and this material may be utilized for spinal cages (lookout Invibio), bone screws and k-wires, hip implant components, and knee replacement parts. So in closing, TSB has to ask our readers, are you down with OPP, or are you down with OXPEKK-IG?

Je voudrais un OXPEKK-IG pour mon cages!!!!!!!!!!!!!!

Requiem for the Big Z

Recently, TSB posted a job opening in the Twin Cities, much to our surprise many of our readers opined about the other company that plays in the spine market in Minnetonka (are they still there) by the name of Zimmer Spine. The big Z as they like to be called, entered into the spine market with the acquisition of Centerpulse AG in 2003. Several prominent publications recognized the ZC acquisition as the deal of the year. Mergers and Acquisitions along with Investors Dealers Digest couldn't contain themselves with their compliments. As one writer said, "the deal has all the makings of a sweeping epic." Oh where oh where are all those visionaries today? Could they really have meant that the deal had all the makings of a weeping epic?

It got even funnier when you listened to Ray Elliott glisten how 6,500 employees and 100 full time people contributed to joining these two companies together. But what would anyone expect from PT Barnum? With that many people involved, one knew that this acquisition was doomed for failure. With all the glory goes the pain. Elliott, whom had been lauded by every wannabe in the industry had no idea what he was getting the almighty Z into. Selling Joints and make belief trauma products is one thing, competing in the spine market didn't match the Zimmer ethos. Ray Elliott was at the helm of the ship and had named Terry Schlotterback as the interim President of Centerpulse. Elliott did many wonderful things during his tenure at the Big Z, yet, the fact remains that Ray didn't know his derriere from the articulating aspect of his forearm and humerus when it came to spine. For all intense and purposes, Schlotterback was doing his old pal Ray a favor. By the way, Terry is a great guy. Centerpulse really didn't offer much innovation unless one considered the BAK cylindrical cage a game breaker. Unfortunately, the cylindrical cage went the way of the Edsel, and if you don't believe me ask Surgical Dynamics and Stryker Spine. The only people that truly prospered from these devices were named Charlie Ray and Gary Michelson (I'll determine the size of the print). The cylindrical cage became an albatross. Our readers know the old cliche, give a surgeon a hammer, everything becomes a nail. No one had the clinical, nor biomechanical wherewithal to see the future, just ask Stryker, they thought that they would be able to fill this device with OP-1 and never look back. But this post isn't about Stryker.

In 2008, Zimmer closed on the acquisition of Abbott Spine for $360 million in cash. Supposedly, this purchase was going to position Zimmer for sustained growth in the future. In terms of building critical mass, it has resulted in organized chaos. In fairness to David Dvorak, he inherited a logistical mess, in addition, having legal skills is quite different than having spine experience. The transition and integration process was FUBAR. But it only goes to reinforce the argument that large companies have the financial ability to purchase other companies, but lack real experience in transitioning, exhibiting uncertainty and a lack of transparency, resulting in anxiety on the part of its foot soldiers.

Yes, fellow readers the Big Z did acquire some nice products from Abbott that should have given them some fire power only to squander this opportunity with poor strategic planning. Are they really in the game, or are they sitting on the sidelines singing, "put me in coach, I'm ready to play today." TSB wants to know what our readers think?

Looking for a Job in the Twin Cities?

The Samuelson Resource Group is looking for a candidate to fill the role of a Brand Marketing Manager in the Twin Cities. For those of you whom failed geography, that would be in the Land of Lakes, Minneapolis/St. Paul, Minnesota. The individual in this role would be responsible branding new products in the synthetic spinal graft arena. If you're looking for a position that incorporates upstream and downstream marketing along with customer interaction, pays a nice base salary, and just might be the opportunity that you have long been seeking, pick up the phone or fire up your lap top and contact Claudia J. Samuelson at 612.721.2020 or send your resume to claudia@srgfinds.com. And when you speak to Claudia, tell her the Spineblogger sent you. Good Luck!

Everest Here They Come!

With the recent investment by WCAS resulting in being the majority shareholder at K2M, this company has now reloaded for another offensive. Before WCAS gets itchy about potentially getting involved in the strategic development of this company, Major and his expedition team should be given the opportunity to ramp up their IP and continue to enhance their portfolio. If I may paraphrase the old expression, too many cooks in the kitchen can spoil the broth. WCAS should be a reputable guide providing exceptional business acumen as active board members. With the addition of WCAS and Ferrer Freeman, K2M is an example of what happens when you're willing to deal, unlike some of the smaller struggling early-growth stage companies that either cannot get out of their own way, or are their own worst enemies.

As TSB has stated on numerous occasions, there are deals to be had and mucho dineros sitting on the sidelines, the only caveat is that you have to have something and give something to get something in return. Unfortunately, some of the CEO's that run many of these early growth stage companies have ears of stone and ego's that compensate for their lack of manhood. So in closing, K2M is a "playa" to be reckoned with now and in the near future. With all the hoopla about Globus, somewhere, somehow K2M is making an attempt to climb the summit with the help of some savvy sherpas.

PS: That has to be the best advertisement and video that this industry has ever seen. If that ain't the Schizz, TSB doesn't know what is.

K2M Acquired?

TSB has received numerous e-mails within the last 24 hours regarding the acquisition of K2M by Welsh, Carson, Anderson and Stowe for an undisclosed sum. WCAS has been touted as the largest and most successful PE firm that focuses on information and business services and healthcare. WCAS manages an estimated $20 billion.

TSB wants to know what our eyes and ears on the Street have heard. If true, this will be the biggest news and acquisition in a market that has been downgraded in terms of growth. So will WCAS be a winner? Will they be able to sustain marketshare considering how many surgeons that use K2M had some vested interest in this venture. Is the industry seeing a shift in the type of companies that are buying into spine? TSB wants to know what our readers think?

Facet Fusion Wars: Fact or Fiction

Lately, TSB has received numerous e-mails from our readers claiming that something is brewing in the facet fusion technology arena. Followers have stated that there is a facet fusion company that has retained a litigation law firm that is sending warning letters to distributors claiming that the products they are selling violate their client's patents. If so, do these patents relate to the shape of the allograft? If word on the street is true, TSB finds it rather peculiar that someone would employ a litigation law firm to send out patent infringemnet letters at roughly a $150 cost per letter in order to disrupt the competitions sales.

But that brings up bigger questions, has anyone seen any retrospective data on the efficacy of these products? Is there a selection criteria? Does anyone have a minimally invasive technique utilizing dilators? Is this product Neuro or Orthocentric? It seems that something is brewing within this product segment based on the multitude of e-mails that we are receiving. So TSB wants to know, what have our readers heard on the street, and who is the company that is attempting to make all this noise?

Amedica and SUNY Upstate Medical Center: A Marriage Made in Heaven?

On July 1st, 2010 Amedica announced that it had entered into a partnership with SUNY Upstate Medical Center to conduct a research study that will evaluate the company's silicon nitride in comparison to PEEK (Poly-Ether-Ether-Ketone). This two year study will evaluate the fusion rates between these two materials.

SiN is one of the first materials to challenge the monopoly that PEEK has not only in the market but within the industry. Holding companies hostage to a three year $225,000 to $250,000 licensing agreement, the time has come for someone to challenge Invibio's stranglehold on the market. In addition to challenging PEEK, Amedica will be provided with an opportunity to substantiate their claims and validate that their unique BioActive surface promotes bony ingrowth in and through the implant. The last company to have any material similar to this was Zimmer with its acquisition of trabecular metal in terms of their argument.

Kudos must go out to Amedica. Regardless, whether you like their portfolio or not, they are one of the few companies within our industry willing to put their money where their mouth is. TSB has heard many varying opinions to SiN, TSB wants to know what our readers think. Will this be a worthwhile investment, or could this come back and bite them in the derriere? TSB wants to know what are readers think?

Today, Declare Your Independence!

To the tens of thousands of readers and followers that provide this blog site with the visibility and critical mass to make it one of the most successful sites in the industry, have a great 4th of July. We know who you are. Regardless of some of our differences, your opinions count.

Put some shrimp on the barbe, grill some burgers and dogs and don't forget to eat your veggies, but most of all break open and have a few cold ones, because we still live in the greatest country in the world, if we didn't, we wouldn't have so many immigrants coming here thinking that the streets are lined with gold.

To a great second half of the year!

Cheers

TSB

Lanx: The Saga Continues

Good morning bloggers! TSB apologizes for not getting more posts out this week. Fortunately, we had to follow up a multitude of e-mail leads on the status of Michael DeMane and the potential of he leading Lanx as its CEO. Before TSB comments on the situation, we would like to personally thank those bloggers that provided us with this story prior to its public release.



On Wednesday, June 30th, 2010 Lanx announced via its publicist that Michael DeMane has declined to assume the role of Chaiman and CEO of Lanx, but no Thanx. He will assist the company as a consultant. Michael, TSB hopes you take them for everything that you can get, considering that companies that hire consultants to lead them as an interim leader are poorly led and managed witnessed by the US Spine debacle.



In seven years since its inception, Lanx has had more turnover than any other company in the industry. Companies like Lanx lack true leadership being run by surgeons and individuals with no people skills. So what does this say about Lanx and some of our bloggers that reacted to our original post regarding DeMane? Maybe Lanx should become a case study at the Harvard Business School?



Lanx possesses a strong and comprehensive portfolio? Well, if you are Goldman Sachs you believe that because you wouldn't understand product you only understand numbers. A company built on one product, the Aspen, playing in a zero sum market equals eventual inertia. A deep management team? If you call constant turnover deep, then Lanx is deep in turnover. Anyone can hire a publicist to paint rosey pictures of an organization that is in such a state of disarray regardless of its success that its truly at a crossroad, meaning that it will take a complete restructuring of the leadership team which includes getting rid of the original founders. Either buy them out, or die a slow death.



As for our fellow bloggers reaction to our original post, remember one of our favorite expressions, "what you see if not necessarily what you get." TSB wants to know what our readers thing?