Sunday, February 28, 2010

The Suspense is Killing Us on Apatech

Recently, one of our readers commented that something big is supposed to happen on Wednesday, March 3rd at Apatech. TSB wants to know if our readers have heard anything to substantiate this little ditty? If so, let us know. Once again, thanks and enjoy the day, its beautiful and sunny outside.

Friday, February 26, 2010

If This is the Summit, We're All in Trouble

The word summit means the highest point attained. If yesterday's healthcare summit is any indication of how bogged down the government has become in minutiae, God help the American Healthcare System and its people. In all likelihood, it would probably be easier to climb "K2" or "Nanga Parbat." Sherpas have more direction than today's elected officials. What is absurd is that Everest has claimed less lives than the U.S. healthcare system even if one travels through the infamous death zone.

As an independent thinker and voter, TSB turned on the DVR last night and marveled in amazement at the pomp and circumstance that has come to be known as the Great American Healthcare Reform debate. It's embarrassing when grown men and women dance the minuet, while pandering to the needs of the American people.

Not once did I hear anyone address how the structure of the anti-trust laws have allowed the insurance industry to create a monopolized industry, allowing them to collude with one another, while controlling healthcare reimbursements and policy rates. Yes readers, there was a lot of perception deception by both parties when it comes down to the facts. Maybe, if both parties could get their facts straight, there could be some resolve to this bill.

What we found out is that there is some common ground but the challenge is a philosophical one as to what road we travel to arrive at reform. We heard fibs on premiums, misinformation of the CBO's analysis on coverage and cost, declarations that "reconciliation" has never been used for something like this, forgetting that it was used to push through both of W's tax cuts at a cost of $1.8 trillion, twice the cost of healthcare reform, how to deal with pre-existing conditions, and partisanship at its finest. Maybe part of the challenge for the POTUS is that he is attempting to promulgate bipartisanship in a town only know for partisanship.

Regardless, the one thing that we do know is that our healthcare system is costly and dysfunctional. How many of our readers are sick and tired of listening to these elected officials continue to hide behind their comments that we have the best healthcare system in the world. If we did, would we be having this debate? Would the system have spiraled out of financial control? If Americans believe that we have the best, then my advice is don't complain when your premiums escalate to the point of being unaffordable. Yet, this bill is not only about the concerns of healthy people, it is also applicable to those less fortunate, meaning that they are sick and need care, regardless of how accountable or irresponsible they have been for their own health. Isn't it absurd that after all this time, officials continue to argue that we should start over?

You don't have to like Obama, but the one thing you must respect about him is that he is providing the Republicans with an opportunity to offer intelligent and palpable solutions. If the Democrats resort to reconciliation, the Republicans only have themselves to blame. The bigger question is, why are we voting these people into office and then re-electing them if they continue to behave and legislate in the best interest of their own self-interest, while being influenced by lobbyists bribes?

Wednesday, February 24, 2010

A Call to Repeal the 1945 McCarron Ferguson Act

If the Congress with the encouragement by the 42nd POTUS (WJC) were able to repeal the 1932 Glass-Steagall Act with an assist going to Phil (Americans are whiners) Gramm which allowed commercial lenders to underwrite and trade financial instruments like mortgaged-backed securities, collateralized debt obligations and structured investment vehicles, why is it so difficult for the US Government to repeal the anti-trust exemptions for health insurance companies?

Why shouldn't insurance companies be forced to compete for our business? Considering that individual states are in collusion with the bank and insurance industry and never seem to hold back insurers from raising rates, its time to roll back and repeal the 1945 McCarron-Ferguson Act that exempted insurance companies from antitrust scrutiny and provided states the authority to regulate them but not regulating their rates.

Look at whom is calling the kettle black? The same elected officials that discuss creating a consumer-driven healthcare industry whereas the average person will have choice. We should have the choice to identify the best medical care based on outcomes for the cheapest price, yet, when it comes to the insurance industry our highly esteemed elected officials pander to the smell of insurance lobbyist dollars.

It's time that people start pressuring their local, state and federal legislators along with their state insurance commissioners to stop limiting the number of health insurance options for their constituents. It's us against them. Think of the absurdity that we spend our days arguing over free-markets, the legalities of what we can and cannot do in an industry that is manipulated and controlled by the powerful insurance lobbyists. Interestingly enough, the government places the onus on the providers for outcomes, yet, when the gatekeeper controls the opening and closing of the gate, the cards will always be stacked against those that provide healthcare.

Stay tuned, because tomorrow will a defining moment for both parties. If both parties cannot come to some resolve and play together in the sandbox defined as the US government, it may be time for us to identify people that will work in the best interest of the common man. TSB wants to know what our readers think?

Hi, Ho, Hi, Ho it's off to work I go! Have a great day!

Tuesday, February 23, 2010

Tran1: Tick Tock, Tick Tock

Trans 1 hosted its quarterly conference call to discuss its fourth quarter financial results. As of the end of the day their stock closed at $3.49, down from the $4.52 that was reported back on October 14th, 2009. Revenues for the fourth quarter were down to $6.3 million in '09 from $7.4 million in '08 a decrease of 15%. Though their operating expenses were down as a result of decreased commissions, there was a slight increase in expenses for R&D.

The challenge that this organization has had is to overcome the reimbursement issues surrounding AxiaLIF. This is the third quarter that there has been a decrease in revenue and performance. A full court press is being employed by Rick Randall, and his team is fervently educating and training their surgeon users. But with that said, the real question is how is the integration with Life Spine's MIS progressing? Supposedly this relationship was fostered to aid the company in securing additional pull-thru business?

A leaner sales force means a greater onus on the those people to ramp up their efforts while the CEO maps out a virtual strategic plan. Sounds a bit like the early stages of the Afghan war. Like any campaign, the burden can only be exercised with the addition of complimentary products/weapons and troops that offset the reimbursement challenges with AxiaLIF. But that is going to take additional capital, and until the reimbursement issue is resolved, TSB just does not see an escalation in troops. Given that the integration with Life Spine was recently announced, Trans 1 will be given the benefit of doubt this time, but the analysts will be closely watching the 2010 QI results.

The company also announced that its CFO, Michael Luetkemeyer will be stepping down on March 31st to pursue other opportunities. The only observation that TSB will make is that it's always interesting as to why someone that has been an integral part in financially building this company is looking to leave? Interestingly enough, it was reported late last year that Trans 1 had scaled back its sales force, and was having difficulty in making decisions about hiring engineers. So as Trans 1 moves into a new fiscal calendar, it will be interesting to see whether there will be a change in strategy in order survive the many challenges this company is facing.

TSB wants to know what our readers have heard on the street? Tick, Tock, Tick, Tock Trans 1 is on the Clock.

Monday, February 22, 2010

Bipartisan Healthcare or Divisive Sideshow?

On Thursday, February 25th, the Obama administration will hold a bipartisan meeting in the hopes of arriving at a solution to slow the growth of healthcare expenditures while controlling the number of uninsured patients in the US. As the obstructionists have so eloquently stated, the government has failed because they don't believe in free markets, incentives (aka outcomes or value based reimbursements) and the intelligence of the American public to make prudent choices about their health.

Considering that reimbursement has been based on volume/fee for service, the question that must be asked of our readers is how easily will it be to transition the system to one that is structured on successful outcomes or value based medicine? To align the the incentives of doctors, nurses, pharmaceutical companies and hospitals through value-based purchasing is easier said than done. So, in the spirit of debate, who is qualified and will establish the standard for a job well done? Who will come up with the criteria to measure outcomes, and how will that measurement take into account those physicians that treat patients that need medical attention but have associated medical problems? What type of metric will there be to evaluate fusion rates when the patient smokes, is an alcoholic, is obese, or is involved in substance abuse? What happens if the patient has been in a high-speed MVA, will the surgeon and hospital be penalized for having to stage the patients modality of treatment? Unfortunately, those that legislate on behalf of their constituents do not understand that sometimes this is rocket science, even if the individual claiming that medicine is not rocket science, is a former surgeon himself.

So how do we reduce cost, whereas we avoid higher taxes? Why is it that the government and the ABA have such a difficulty in enacting tort reform? If we are a people that believe in free-markets, then why can't we cross state lines to buy better or cheaper insurance? How does the industry delivery better technology, better care, and better outcomes at a cheaper cost? If the best that both parties have to offer is placing the onus on providers to prevent and manage illnesses while reducing complications and cost in the hope of providing data to measure patient outcomes shows how little politicians understand the complexities of modern medicine.

Do any of our readers find it disturbing that the focus of the debate and the onus of providing value based medicine is always on the provider and the patient? What about the escalating cost of healthcare insurance, witnessed by what was reported over the weekend from California regarding Anthem Blue Cross' increase of 25-39% for private subscribers? If the insurance industry is a risk-management business, why aren't people rewarded that have never had to use their health-care plans outside of going for an annual physical? For politicians to pontificate about not appointing Kafkaesque committees to measure quality adjusted life years but foster a climate of scientific research and pipelines for new modalities of treatment exhibits how little they understand about the complex cost of medicine.

Before the cost of healthcare is ever contained, the American public, which includes politicians will have to re-align their priorities not only from a personal health perspective but also from a financial perspective. This will mean not being influenced by every lobbyist that roams the hallowed halls of the Capitol Building. If the two most important aspects of this bill will be to reduce cost and provide coverage for more people, let's clean the slate and start with the insurance companies and address how we will pay for those that have no coverage, and who will take care of those that have minimum coverage? Unless the government continues to print money or raises taxes, how will we subsidize the uninsured? If government officials or think- tank gnomes don't believe that we pay attention to the rising cost of healthcare insurance, then they themselves are living in neverland.

The time has come that both parties start acting in the peoples interest, and not in their own interest, and that means placing America first. If the government was willing to bail out the "banksters" or gangsters of Wall Street, why do we Americans find it so difficult to bail out the uninsured? Why do we dump billions of dollars into Middle Eastern countries that could care less about democracy or human rights, while at the same time mortgage our children's future? It's an embarrassment when we call ourselves the richest country in the world, worry about everyone else's problems, yet have an inability to take care of our own challenges. The answer is simple, it's GREED and SELFISHNESS.

So there you have it readers, let's see what your perspective is on this issue. Take the time and think this through because your opinion and most importantly your vote is the only thing that will change healthcare, its time to get the politicians out of office that are not interested in finding a viable solution to an complex problem.

Wenzel Spine: Is This Another Up and Coming Spine Company?

Founded in 2008, and fully operational by the fall of 2009, Wenzel Spine Incorporated has launched its own unique technologies called the VariGrip, the VariFix, VariFix MAPS, and VariLift. Founded by Dr. Warren Neely, the company was named after his grandfather, Wenzel Gandy. Wenzel is currently run by Chad Neely, an entrepreneur. A local company the MAB is composed of David Attia, M.D., Thomas Kingman, M.D., and Frank Fichtel, M.D.

The VariGrip is a Hook System, The VariLift is an expandable cage available in Europe for the Cervical and Lumbar Spine, the VariAnchor, that is a sacral attachment along with the MAPS an acronym for Multi-Axial Positioning System designed for optimizing maximum strength with the pedicle, a system that requires minimal rod contouring and increased torsional strength that reduces the need for cross connectors.

So what do our readers think? Is this another up and coming spine company or is this another spine company, TSB wants to know what you think?

Friday, February 19, 2010

Register As a Follower, Create a Moniker and Don' t Be an Anonymous Reader

To all our readers:

In the spirit of debate, it behooves you to register as a follower and choose a moniker to identify yourself when you comment on our blogsite. TSB ensures you that if you register none of our readers nor TSB have access to your personal information, nor is your true identity divulged. The directions are simple:

1. To create an account click on the white "Follow Box" above the followers, on the right side of the blog page.

2. A screen will be displayed with a heading that says: "Follow the Spine Blogger" You will have the option to create an account with Google, Twitter, or Yahoo, and it doesn't have to be a Google account. Though, it is easiesr to register using your provide of choice, i.e., Google, Twitter or Yahoo.

3. Upon creating an account, you will be given the opportunity to create a moniker and select or download a personal photo is you choose.

4. You will also be asked if you would like to be a "public or private" follower, we would like for our readers to be public followers, yet, we respect those that choose to follow privately while wallowing in netherland.

5. Upon uploading a photo, click "Follow this Blog." You have now become a "Follower" with a moniker, making it easier to have dialogue with one another rather than everyone being Mr. or Mrs. Anonymous...

Once again, our objective is to allow other readers to address their opinion in response to your comments in regards to specific blogs. Thanks, Keep Reading and Let Your Voice Be Heard!

Thursday, February 18, 2010

Low Growth, Pricing Pressures, Government Cutbacks? What the Hell is Going On?

Why is everyone complaining about the state of healthcare in the U.S. ? A declaration must be made that the state of the healthcare industry is alive and breathing. The patient has been misdiagnosed. It's time to take 'em off the ventilator, and get back to doing what we do best, delivering the most advanced and complex healthcare delivery system in the world. Now I didn't say the best, I said the most advanced and complex.

Let's take a look at hospitals. On a recent business trip, TSB was mesmerized as to how many hospitals were adding new additions, new parking lots, new specialty centers, and expanding patient services to make their respective hospital the publics facility of choice. Marketing, marketing, marketing! TSB thought that healthcare was in trouble? It was even funnier when the Materials Manager/Purchasing Director was requesting that the company comp the facility free product so that the surgeon could evaluate the technology intra-operatively, in addition to having the product assessed by a product evaluation committee. So in my politically correct manner, TSB asked the purchasing director if the hospital's intent was not to charge the patient, nor their insurance company for utilization of the product? Duh!!!! In my most politically incorrect manner, I asked the Purchasing Director if I needed emergency care would the hospital allow me to evaluate their services by having whatever my initial medical needs be, addressed for free? What is it about hospitals and the "business people" that work in them that make us wonder whether they are not the source of the industry's problem? Maybe part of the problem is that we have too many MBA's spewing their theoretical BS in order to justify their existence? I thought we lived in a free-market economy. I thought competition was good, and that free-markets would determine the winners, and sort out the losers? I thought that the Purchasing Directors job was to negotiate and purchase product at the best available price in order to minimize cost, rather than "shake down" a company? Today, we hear that facilities on the West and East Coast are beginning to initiate a policy where they will only allow three major vendors to be used at their facilities. When did the purchasing director become an integral decision maker in what the physician can or can't use? If the excuse that we hear is that there are too many companies to deal with, maybe it's time that we start shutting down some hospitals considering that there are too many of them that offer the same services? Maybe, this is why healthcare is so out of control, there are too many cooks in the kitchen stirring the gravy.

Let's look at Physician Owned Specialty Hospitals (POSH). TSB thought that physicians were all in an uproar that they weren't making enough of money. Yet, in various pockets across the U.S., POSH (and I'm not talking POSH SPICE) facilities are opening with the justification that if you become a specialty-centric hospital, the hospital will be run financially efficient with better outcomes. If Physicians are complaining about reimbursements, where are they getting the capital to build some of these facilities? Obviously, any facility that focuses on providing care to one or two specialties, i.e. Orthopaedics or Neurosurgery can be profitable when you pick and choose the patients that you opt to operate on, while sending the patients that do not have coverage to your local public or non-profit hospital. Aren't you sending the message that its better for the government to take care of these people? So what's the beef? TSB, wants to know what our readers have been experiencing in the field and how it's effecting your ability to sell product?

Tuesday, February 16, 2010

Bacterin Completes $3 Million Private Placement

It was announced that Bacterin, the Bad Boyz of Biologics, secured a $3 million private placement of Secured Convertible Promissary Notes. So what does that mean? Middlebury Securities, LLC, the lender, has contracted with Bacterin to lend it $3 million on the condition that the company promises to repay the note.

Middlebury obviously performed due diligence on the company's cash flow and profit for repayment, but if Bacterin cannot repay the note, Middlebury will look to the security or collateral as a secondary source of repayment. Maybe, just maybe if Bacterin cannot repay the loan, Middlebury can seize control of the company. Considering that they performed their financial due diligence, maybe, someone will perform a management overhaul?

All one has to do is speak with former sales reps and managers that have been chewed up and spit out while being treated like dirt. You know the old expression, just because you knew how to invent something, doesn't mean you have the ability to run a company witnessed by the carousel that goes round and round at Bacterin.

Monday, February 15, 2010

TSB Alert - Attend Tomorrow's Stem Cell Meeting in NYC.

On Tuesday, February 16th, 2010, Robin Young and the crack staff at Orthopedics This Week will hold their annual Stem Cell Symposium in New York City. As with any emerging technology, the use of stems in spinal repair, trauma, reconstructive surgery, cartilage repair and maxillo-facial procedures requires education. The purpose of this symposium is to establish a fundamental understanding of cellular therapy while providing a commercial and scientific update. At this stage TSB would like to believe that the faculty for these meetings have been able to answer what are stem cells, whether there are any risk, and how stem cells function within the human body once they are implanted.

Yet, regardless of these answers the commercial potential is staggering, and at the end of the day this is why most of the attendees come to this meeting. An estimated $1 millon dollar market in 2005, today this market is estimated somewhere in the vicinity of $300 million. A staggering fete considering where we were a mere five years ago. Today, we have numerous companies that have some type of stem cell technology that is beneficial to the patient and surgeon. Within the next few years the U.S. market for stem cell products will be defined as over 4 million procedures annually . What will the potential market value be $ 8, $10, $12 billion and what will the revenue potential be?

Well readers, if you want to know the answers to these questions, TSB recommends that you attend tomorrow's meeting. See you there.

Sunday, February 14, 2010

Sunday Morning Op-Ed Piece

Last week's blog on "Seizing Control" exhibited the maelstrom that exists in the spine industry. Hopefully, the overriding message from our readers will not get lost in the Physician Owned Distributorship sideshow. Physicians hailing other physicians that have started their own POD's, is like Obama hailing Wall Street businessmen as being savvy and on top of their game. There is nothing genius about circumventing the laws and manipulating markets while potentially committing white collar crime. A paradox exists when physicians castigate medical malpractice attorneys, and then cry out for tort reform, while listening to attorneys tell them that their business model is perfectly legal. Eventually, this model will be tested in a court of law. The economic conditions and the state of healthcare is bringing out the anxious and angry climate that currently exists in our country. This is evident by the persuasive and passionate position by many of our readers. Regardless, the fact remains, that the cost of healthcare will be $4 trillion dollars per annum by 2012.

But isn't our behavior a mirror image of our society? We have become advocates in behaving like our highly esteemed politicians and bankers. You know whom I am speaking about, "The those rules don't apply to me generation." The same way that the Street has learned to skirt the rules and manipulate financial instruments by creating credit default swaps, securitizing mortgages and collateralize debt obligations, we continue to look for opportunities where passing the problem that exists in healthcare is easier than dealing with it. Many or our readers can call TSB a cynical platform, yet, we believe that our hope lies with a younger generation that frowns upon the type of behavior that our generation condones.

On a lighter note, TSB was wondering when some industry literati was going to pen a historical perspective on the spine industry. Our vote for the title would be, "A History of Spine, Too Much Monkey Business." We must speculate that someone is either writing, or putting together an outline for future publication. The timing would be perfect considering that nowadays there is no standard in publishing witnessed by the many books that have been published by politicians and businesspeople on every possible subject. Who knows maybe it will be Robin Young? Will it be Hansen Yuan? Will it be Stephen Hochshuler? Will it be Alexis Lukianov? Who knows?

Friday, February 12, 2010

Orthovita's Cortoss: We Won't Get Fooled Again

Late last summer, Orthovita took a tremendous hit in its stock price when two studies published in the New England Journal of Medicine suggested that vertebroplasty procedures offered patients no clinical benefit. Having withstood this attack, "La Vita" is poised to hold its long-term potential. Obviously, the criticism rattled the analysts and "La Vita's stock price fell from an all time high of $6.91 back to the mid $3 range. The hypnotized never lie. But what do you expect from the analysts, considering that they are fair weather forecasters. You know what they say, "when the going gets tough, the tough get going." Could these articles have been strategically published to take the winds out of "La Vita's" sails?

As this product starts to pick up its momentum, watch as the analysts upgrade this stock as a "buy." Hopefully, the boyz from Malvern will not squander this opportunity and sit on their laurels, nows the time to turn up the volume. TSB wants to know what our readers think?

"I'll tip my hat to the new constitution, take a bow for the new revolution, smile and grin at the change all around, pick up my guitar and play, just like yesterday, then I'll get on my knees and pray, We don't get fooled again

Thursday, February 11, 2010

Physician Collusion or Government Delusion?

Collusion: A secret agreement for fraudulent or treacherous purposes, a conspiracy. A secret understanding between two or more parties to gain something illegally. To defraud another of his or her rights.

Does this sound like the Independent Practice Association in Garfield County, Colorado? Or, does this sound like what United Healthcare does when it sells its Ingenix data base to other insurance companies so that they can utilize the data to control reimbursements in various markets? Have any of our readers ever looked at the Ingenix database? Didn't the NYAG Andrew Cuomo accuse the company and win a judgement against United Healthcare for using the popular Ingenix database to fraudulently lower the cost for out-of-network care? How about that conflict of interest?

Anti-trust laws were originally intended to prevent collusion and price fixing. It's time that the U.S. Congress stop colluding with the insurance industry and even the playing field for healthcare providers. The Federal Trade Commission should be embarrassed to accuse physicians of price fixing in Colorado. Anti-competitive negotiating tactics? Is the government kidding? Look at whom is calling the kettle black.

If there is one aspect to this case that made the IPA's negotiating tactics suspect, it was their demand that a COLA be included in the contracts. Unfortunately, a cost of living adjustment is a no-no, let alone use that strategy to raise reimbursements. If anything, physicians are entitled to an inflationary adjustment, but even with IA's, the insurance industry looks to avoid having to pay this out.

Orchestration: To compose, to manipulate by means of thorough planning.

Does this sound like what the IPA was doing, or does this sound like what the insurance industry is doing? Yes, doctors, TSB is a physician advocate. Yet, until physicians legally challenge the anti-trust laws, they will be treated like second class citizens. It's time that NASS, AANS, CNS and the AAOS stop wasting their time and money with lobbyists and AdvaMed and challenge the law. If you really want to get angry at someone, try diverting your frustrations and anger at the insurance industry. William McGuire, M.D., the former CEO of United Healthcare walked away with a $300 million dollar golden parachute, while illegally backdating stock, and not a peep was heard.

It's time that the public and American corporations start looking for alternative insurance carriers. The best thing we can do is hurt them, where it hurts most by finding another carrier.

Tuesday, February 9, 2010

Seizing Control or Are We Spinning Out of Control?

On Monday, February 8th, OTW (www. ryortho. com) published an excellent article by Walter Eisner entitled; "Seizing Control." Dr. John Steinman, D.O. an orthopaedic surgeon was interviewed for this article and declared that he and his colleagues at Arrowhead Orthopaedic Group in Redlands, California decided to address the escalating cost of implants by cutting out the middleman (aka, the salesperson) in the value chain of medical devices. Citing escalating implant prices, decreasing reimbursements for physicians, and declining hospital profits, this band of physicians decided to take matters into their own hands, and "cut the fat" out of the equation by starting their own physician owned distributorship, aka POD.

Many of our readers know our position regarding POD's. POD's are a fundamental threat to our livelihood. But first let's look at Dr. Steinman's rationale for escalating implant prices, decreasing reimbursements for physicians, and declining hospital profits. To blame the escalating cost of healthcare on the salesperson is unadulterated non-sense. (For civilities sake, I'll let Steinman discern what I really mean). Anyone that has tenure within this industry will remember when doctors were doctors, and didn't want to be anything else but being a doctor. Dr. Steinman and his colleagues have probably spent tens of thousands of dollars for a legal opinion for the freedom to operate this business model on the Left Coast because of their beliefs that the decision makers over which device to use are not the purchasers, and, that there is an absence of effective price negotiation and price control. As an FYI Dr. Steinman, pricing pressures have effected every company in the device industry whether it is a reconstruction, trauma, or spine company, TSB must question if he is working in the same healthcare environment that most of us do? Frankly, Steinman thinks that distributors and product reps are overpaid.

Considering that many surgeons spend their time complaining about decreasing reimbursements, should salespeople be insulted by Dr. Steinman's comments? For Dr. Steinman's education, many of us work as hard as he does, and yes Dr. Steinman, our livelihood has been effected by what's going on in healthcare. Just like in your profession, there are people in our industry that are overpaid. Unfortunately, you and your colleagues are looking for solutions in all the wrong places. CEO's make tens of millions of dollars a year, so, why don't you pick a fight with those people? The answer is because it's easier to pick on the little guy. Let's face it, you don't have the "cohonies" to fight the big guys! Everything is relative. In today's environment companies are looking for new and innovative ways to decrease the salesperson's commissions as their margins are cut into by pricing pressures. Remember the old saying, "we have a responsibility to our shareholders."

But let's talk about decreasing reimbursement. What have you and your colleagues done about the ever rising cost of healthcare in this country and your declining reimbursements? Nothing! Have you challenged the anti-trust laws and how they affect your ability to have an equal footing in healthcare? No! Have you considered a medical strike to show the government and the insurance industry that you will not stand idle while they tear apart healthcare in this country? No! Have you marched on Washington and challenged the Congress regarding Medicare cuts? No! You talk a big game, but cower like children when it comes to standing up to the big boys. A real activist stands up for his beliefs, but TSB would not expect anything less from a generation that has a sense of entitlement. You would rather feed the beast, and hire pedigree lobbyist to fight your fight. Since when did surgeons start worrying about declining hospital profits? You honestly believe that the hospital is your ally? Did Mr. Eisner really mean that your practice is in Disneyland? Maybe, you should start by evaluating the people mismanaging your hospitals that take exorbitant salaries and stock options, and brow beat us to discount our products and still continue to run facilities into tremendous financial debt. Maybe, just maybe, you need to spend more time fighting tort reform, the insurance industry, and the federal government in your quest to address the escalating cost of implants, your inequity in reimbursements and your hospitals inability to be profitable. Using the salesperson as a means to an end is rather poor judgement on your part. Besides, you're just looking for another avenue to make more money.

The next time TSB hears some spine surgeon complaining about the anesthesiologist or the interventional radiologist doing a case that you believe they should not be doing, I'm just going to stand back and laugh at you. TSB wants to know what our readers think?

Monday, February 8, 2010

Zimmer and Stryker Spine Sluggish

Zimmer and Stryker Spine reported that they continue to struggle with slow growth in spine revenues. Zimmer's difficulties are attributed to reimbursement challenges for the Dynesys Dynamic Stabilization System and their integration of Abbott Spine. When will these companies learn that anyone can buy a company, there is an art to integrating another company into your culture?

Zimmer has applied to the Center for Medicare Services for a new add-on payment for the Dynesys. An add-on payment is meant to provide hospitals with an additional reimbursement for using "innovative" devices whose value is not yet determined or represented under the CMS, DRG system. In 2004, Dynesys was cleared as an adjunct to fusion, today, the company is seeking PMA approval as a non-fusion device. Professor Dvorak was quoted as saying that the integration of Abbott is coming to a close, but, Zimmer will see some revenue "dis-synergy" (duh, they must have taught that in law school) and disruption in their spine business.

On the other hand, Stryker's CFO Curt Hartman stated that US sales for spine were up 4%. In his most macho CFO manner he is quoted as saying that this is "clearly below our historical average in the market (hello Curt). Pricing pressures, product launch delays and gaps in product offerings? Curt (stick to finance) Hartman is quoted as saying; "Probably the biggest thing we're missing is a ........ great cervical plate offering." Was that a question, or, was he guessing, and is he serious? Just what the industry needs is another cervical plate offering. Steve, you don't mind that I call you Steve? You need to rein in Mr. Hartman. Don't worry, the analysts will give you a pass considering what just happened with the economy. One word of advice, if you decide to buy something, think about the integration process, based on the fiasco with the Howmedica acquisition we don't want to see Stryker has some revenue dis-synergy.

Who Is Baxano?

So, TSB must ask our readers, Who is Baxano? As per their website, they are a company whose mission statement is to develop "innovative tools" that restore spine function, preserve healthy tissue, and enable a better quality of life for the patients they serve. The only question that TSB must ask how many patients are they serving, and is there a reimbursement issue for this product?

Could the investors Prospect Venture Partners, Three Arch Partners, and Kearney Venture Partners have rolled the dice on this technology? They call this technique "Precision Lumbar Decompression from the inside out." How precise does the surgeon have to be? What happens if the surgeon doesn't have excellent three dimensional capabilities? I would guess that hand-eye coordination plays an important role in utilizing this system. The question to our readers is, is the IO-Flex System as easy as Baxano claims?

Remember a company by the name of Hydrocision? They were going to change the way things were done with a product called the Spine Jet. Much to everyone's chagrin, they put the cart before they had the horses. No reimbursement code led to resistance by the hospitals, forget about the surgeons that have advocated this technology or are on their payroll. How much could this technology be priced at? $2,500 - $3,500 per procedure. You know what they say in the world of healthcare, "no reimbursement, no interested in using product." TSB wants to know what our readers know?

Biologics Redux

Based on the overwhelming response from our readers, TSB felt that it would be beneficial to revisit our discussion about grafting material in light of the fact that on February 16th, 2009 Robin Young will be holding his fifth annual Stem Cell Symposium at the South Street Seaport in New York City, New York.

Whenever TSB hears Robin utter the words "Stem Cells," a flashback to the movie Gladiator enters one's psyche where Commodus, the son of Marcus Aurelius (aka Caesar), speaks to Maximus about the Senate "pouring honey potion in your ear and one day you'll wake up and all you'll say is, Stem Cells, Stem Cells." Because these are the new buzz words in biologics. TSB does not dispute the science, yet, there is much more that needs to be identified and validated before we adore Stem Cells with the biologic crown. Whenever one sings the praises of a NuVasive, Orthofix, Wright Medical, or Osiris, one has to wonder if this is nothing more than another Joel Osteen moment, an evangelical preacher leading his flock to the promised land.

For some reason, many years ago it seems that the industry was sold on the fact that autograft was no longer a viable option. The rationale was it was too expensive to harvest iliac crest bone graft, it increased the patient's morbidity rate, it increased the cost of the procedure, it increased the operative time, it increased the length of stay for the patient, the patient experienced post-op pain for months on end, and most of all, it questioned the surgeons skills at harvesting bone graft. You get the point. It does take patience and good surgical technique to harvest iliac crest bone. These were all legitimate concerns.

Yet, most of us would agree that surgeons would use whatever is being sold by their favorite rep without substantiating the rationale for its use. It probably comes down to convenience much more so than science. To claim that BMP-2 produces equivalent results to iliac crest bone graft is a bit of sophistry considering that our industry has never fully disclosed the many issues and challenges that surgeons had with the initial dosing of InFuse as far back as 2002. TSB would be curious to know how much of an inconvenience, and how much of a cost did the industry incur to take care of those patients? Today, using it in the cervical spine is off-limits based on the most recent MDR's.

Our readers are correct when they report that no other bone graft substitute has been thoroughly studied as BMP-2 has by the surgeons within our industry. Boden himself became the poster child for InFuse. Considering that this is really a pharmaceutical rather than a biologic, BMP-2 has set the bar for exorbitant pricing, and with that pricing will come the same pricing for products that dub themselves "Stem Cells."

But wait a minute, the hospital industry is much more savvy than we ever thought. Today, they have scrutinized the cost of biologics, especially, BMP-2 whereas they are mandating alternative options for surgeons use. They are no longer willing to pay $5,000 a level for BMP let alone $3,000 per level for synthetics in major markets or purchasing groups. Yes, there are those that have the ability to sell product for $3,000 per 10cc's, but the market is slowly but surely shrinking.

So as you sit there and listen next week, ask yourself some questions, is this old technology with a new spin, or is this new technology with an old spin. TSB wants to know what our readers think?

Saturday, February 6, 2010

Spine Blogger Alert - Who Dat Graft Material

Recently, there has been a rash of promotional articles regarding the field of biologics. Any reader that is a skeptic must acknowledge that one has to wonder what the underlying motivation is of those writers that are proponents of marketing this arena as the new frontier in spine. Understandably, it's difficult getting excited about another screw, plate or piece of PEEK. Could it be that these thespians truly understand the science and therefore can lay claim to substantiate the efficacy of these technologies? Could it be that they have an investment in some of these companies and are looking to further commercialize a specific company's technology? Or, could it be that this is a segment that needs definition.

Every company in this sector claims that their product is better utilizing biologic and synthetic buzz words like mesenchymal stem cells, demineralized bone matrix, tri-calcium phosphate, silicate substituted calcium phosphate, allograft with stem cells, bone morphogenic proteins, osteoblast mitosis, osteocyte differentiation, to name a view. So in the spirit of debate, TSB wants to know what are readers believe is the best biologic product in the market versus the best synthetic by substantiating its efficacy? And please, do not quote any cervical fusion studies because we all know that you can spit into the C-Spine and it will heal.

Wednesday, February 3, 2010

Apatech and Stryker: Kabuki Theater

Is this a stylized classical Japanese dance drama, with both performers wearing their best make-up, Steve MacMillan played by Nakamura Shinobu and Steve Czick played by Ichimura Kakitsu? This is real Kabuki Theater. It's been ten years since OP-1 was acquired from Creative Biomolecules, and with that acquisition has come a host of accusations, indictments and convictions leaving Stryker Biotech and the Almighty Stryker standing alone at the biologic bus stop waiting for their next ride.

Along comes the Apatech Express and it seems that a symbiotic relationship was fostered. From a psychiatrists analysis this is a relationship between two parties that are dependent upon one another and receive reinforcement that everything is going to be all right. Word on the Street is that Stryker has spoken to Apatech about acquiring their technology. Even to the extent of asking for a number. Most of our readers would know that there is truth to this, considering that many Stryker distributors/sales people are selling this product. The most entertaining comment that TSB has heard was that Apatech was asking 10X on revenue somewhere in the vicinity of $50 million, plus or minus. If there is any truth to that, we hope Stryker exhibits some sanity. But you know what they say, "desperate times call for desperate measures." TSB wants to know what our readers have heard?

Is Zimmer Window Shopping

On Monday evening, February 1, 2010, TSB received a phone call from one of our industry sources stating that there was some grumbling at Biomet that the Big Z was looking at this company as a potential acquisition. Anything is possible when you look at the current state of our industry. Let's be practical, how many of the start-up or early-growth stage companies are viable acquisition options? Most of them have "me-too" products and in all likelihood are sustained by surgeon investor or consultant revenues. This business model is frowned upon by many investors. Usually, the first question that is asked by an investor is "what percentage of your revenue comes from investor or consulting surgeons?" In addition, if these companies had IP equating to emerging or "breakthrough" technologies, the investors would have welcomed them with open arms long ago. The reason many of these "me too" companies are undercapitalized is because of a crowded marketplace, questionable technology at best, ego's that Freud would have studied with amazement, in addition to mediocre or terrible management teams.

The legacy companies within our industry are not looking for a minimum increase in market share when evaluating a potential acquisition. They are seeking an established product portfolio that will further strengthen their position in hips, knees, trauma and spine, at least the companies that tout themselves as offering the option of "one-stop" shopping. So where does that leave Zimmer?

Zimmer Spine leaves much to the imagination in terms of a product portfolio. Spine Tech and Spinal Concepts still has not placed them on the same ground that their legacy company breathrens stand on. Our guess is that at best the Big Z is sniffing around or window shopping at best. TSB wants to know if anyone has heard otherwise?

Tuesday, February 2, 2010

501 Pedicle Screws and Counting

My Abacus does not have enough of beads on its wires to count this high.

On February 2nd, AlphaTec Spine announced that it had received CE Mark approval for the commercial sale of this device in the European Union. The powers to be at AlphaTec claim that this device is innovative because it is intended to significantly increase the pullout and holding strength of this screw.

Obviously, the marketing spin on this device is that it was designed with the intent of addressing a need for patients that have the "Aging Spine." The reality is that this is an expandable screw that locks the screw into the neck of the pedicle. Hmmmmm, sounds familar to another platform that surfaced a few years ago by a company named Expandable Orthopedics.

So here's our question to our readers, Is this truly an innovative device, and will it effect the clinical outcomes for lumbar fusions? Or, is this another attempt to market a product that really won't make a difference? Our staff has not heard of any surgeons complaining about screw pullout, what have our readers heard. This is your opportunity to bring your opinions to the public. You know what they say, Is it new? Is it True? And, Will it make a difference?