Monday, January 31, 2011

Stem Cell Lalapalooza - NYC Here We Come

Nothing like some free advertising for Robing Young.  March 1, 2011
commemorates the 6th annual Stem Cell Lalapalooza in NYC.   Unfortunately this venue is not Ozzfest with bands like Kataklysm, California Wildebeest, or Devil Driver, but it has been know to resemble a Motley Crue. Concert Promoter Robin Young is expecting an SRO crowd for this event and has his elves working feverishly.   The show will take place at the infamous Bridgewaters New York, in the bowels of the South Street Seaport, New York City, New York.  Why not the Hammerstein Ballroom?    Whether you are a skeptic or zealot, stem cells have taken front and center stage in the field of biologic's.    There are an endless list of applications that researchers are studying.  Baldness, blindness, traumatic brain injuries, parkinson's disease, dental applications, wound healing, bone marrow transplants, spinal cord injuries, osteoarthritis, to name a few.  For those of you that read OTW, Robin has his mom burning the midnight coal, pumping out as many press releases as she can about this industry.  Hopefully, she will not develop carpal tunnel syndrome.  Yet, as we all know, there are still many questions that need to be identified regarding the efficacy of mesenchymal stem cells. What we have learned after many years of research is that they can communicate actively and intimately.  Safety issues play a role in terms of processing, concentration, and whom are you harvesting those MSC's from. If you had your options, most of us would desire to have our own stem cells harvested, processed and delivered in real time.  I can hear the PRP people screaming, what about us!!!  Unfortunately, TSB believes that their isn't enough of revenue in harvesting a patients own stem cells considering that one is only able to charge for the processing equipment, and processing takes time.  On the other hand, allogenic stem cells, those little babies derived from a deceased donor and processed to ensure safety have become a viable alternative.  But the big question surrounding allogenic stem cells is how many of those cells are viable?  How many of those cells have survived the cleansing process?  The difference between autogenous and allogenic is that the donors need to be screened and tested for bacteria and any infectious agents that may replicate themselves within the cells of a living host.  There is always the risk of tissue mismatch or infection but in this day and age processing for infection has become a moot point.  Harvesting MSC's from bone marrow and adipose seems to be the current state of the art, and God only knows that there are plenty of fat people in the United States that could use a little lip-o-suction.  Cultured stem cells derived from living donors need certain conditions that promote self-regenerating expansion of undifferentiated progenitor into cells required for transplant.   So in closing remember, that in order to meet therapeutic requirements MSC's need to go through six stages:

Proliferation
Differentiation
Survival
Integration
Functionality
Not Harm the Recipient

As each year passes, more information is disseminated as to the efficacy of MSC's, but the question must be asked, at what price?   Based on the current state of the economy, factoring in the many concerns that the healthcare industry has about escalating costs, will someone be able to deliver a product that will be cost effective?  The immediate response is to compare it to INFUSE, unfortunately, that selling technique will no longer play in Peoria, and there are other viable options in the marketplace.  So TSB wants to know are you coming or are you going?

Sunday, January 30, 2011

Who's NEXXT in Spine? 510(k) Clearances

As TSB was reviewing December's 2010's FDA Clearances of 510(k's) we stumbled upon a pedicle screw cleared for a company named NEXXT Spine.  Based in Indiana, NEXXT's tagline touts that it is "advancing the business of internal fixation.  Currently they have a cervical plate and pedicle screw.  The company is led by Andrew Elsbury, with Brian Wicker as the Head of Sales.  If anyone is interested in picking up some additional product or looking to help these guys jump into the marketplace head first give 'em a holler at 317.436.7801.  So with that here are the latest clearances;

Aesulap:  Laminoplasty Plating System (Big Market)
Carefusion: Enview
DePuy Spine: Concorde Curve System
DePuy Spine: Viper System
DePuy Spine: Expedium Spine System
Genesys Spine: Interbody Fusion System
Globus: Patriot Transcontinental M Spacers
MDT: TSRH Spinal System
MDT: Sustain Space Maintenance System
Medyssey:  Zenius Spinal System
Medyssey: Novell III Spinal Fixation/Adjustable Bridge Plate
NEXXT Spine: Inertia Pedicle Screw System
NUVA: Spherx II Mas Deformity Spinal System
Spinecraft: Apex Spine System w/CoCr Rods
Synthes Spine: Zero-P
Theken Spine: Cervical Standalone IVB Fusion Device (they're multiplying faster than a rabbit)
Zyga Technology: SImmetry SI Joint Fusion System (get it SI - SImmetry)

So here it is folks, read and weep.

Saturday, January 29, 2011

Living On The Fault Line

No one can run when it finally comes down
Nobody knows what is stirring under ground
Caruso stumbled
While the city tumbled down
The palace was in splinters
Theodore was leaving town
Livin' on the fault line.................................

No fellow bloggers,  unfortunately TSB is not singing about the San Andreas fault line, and I am not talking about the sliding boundary between the Pacific Plate and the North American Plate.  Rather than slice the state of California in two, we're talking about slicing Cardo Medical into one piece.  On January 25th, 2011 Cardo Medical Incorporated, that bastion of technology and innovation, announced that they had signed an asset purchase agreement with Arthrex to sell its joint arthroplasty division. With the sale of this division and the capital received, Cardo will continue to explore alternatives for its spine division.  Who is guiding this company,  Lewis and Clark, Henson and Peary, Abbott and Costello? The question must be asked, "what spine division?"  In the words of my sidekick Skippy Spine, WTF? If Vertebron couldn't make it with that scrap metal, what does Cardo expect to do? Inexperienced and delusional, this company is being navigated into treacherous waters and they don't hear the tsunami warning.  Times must be bad at Cardo sensing that the fault line is ready to go when you expect a "me too" vanilla cervical plate, and a pedicle screw that has had more problems than a long stint at rehab with Charlie Sheen.  The funny thing is,  Charlie will probably rehabilitate himself faster than Cardo will ever do anything with that pedicle screw, and when that happens the escort industry will experience its first recession.  But getting back to Cardo's pedicle screw, that rod reducer was nothing more than BS, and you know what they say, you can't make Beef Wellington out of BS.

So the question must be asked, Is this the next company to fall in spine?  But then has this ever been a spine company or is this another surgeon's lame attempt at calling oneself an entrepreneur and innovator?  Why would you sell your only valuable asset?  Cardo's company slogan must be, "you've gotta believe."  Hey, where's Tug McGraw when you need him?  If and when this happens, you can chalk it up to another surgeon's champagne wishes and caviar dreams .  God, it must be great to have money to piss into the wind, just watch for the recoil.  So what's going on at Cardo when you sell your Uni-system, your TKA system and your Press Fit THA System?  It's called selling your assets that have value in return for some cash because no one is interested in that dog of a pedicle screw and cervical plate.  Mark Twain once said, "the rumors of my death have been greatly exaggerated," well fellow bloggers, this time it may be real.

Pegasus Biologics (RIP)
Vertebron (RIP)
IST (RIP)
Archus (RIP)
Osteotech (Acquired)
Facet Solutions (Acquired)
US Spine (Acquired)
Inion (RIP)
Applied Spine (RIP)
Impliant ?????
DMT???????
Cardo Medical ?????

Yes fellow bloggers we have had a bit of consolidation in the spine , the question is who is next, which one of these one trick ponies awaits their fate? Will some of these companies be euthanized or......

Through early morning fog I see
Visions of the things to be
The pains that are withheld for me
I realize and I can see
That suicide is painless

Tuesday, January 25, 2011

Chuck E's in Love

How come he don't come and P.I.P with me
Down at the meter no more?
How come he turned off the T.V.?
And hanged the sign on the door?
Well we call and we call, "How come?' we say
Hey, what could make a boy behave this-a-way, yeah?
And he learned all of the lines, now, and every time
He's gonna s-s-s-stutter when he talks
And it's true, it's true?  He sure has acquired this kinda cool and inspired sorta jazz
when he walks
Where's his Pioneer jacket and blue jeans
If this ain't healthy, its some kinda clean


As Rickie Lee Jones once sang, Chuck E's in Love with his expatriate Pioneer buddies.  It was reported on OrthoSpineNews that Chuck Reynold's also known as "Cat o' Nine Lives" landed his dream position as VP of Sales with Spine Smith and Ceiling Technologies.  It's kind of funny that OSN only reports hirees that they place, but what can one expect from an executive search firm?  Interestingly in the preceding blog post, someone commented that the problem with spine is that there is no continuity when it comes to employment.  They marveled that five years was considered a lifetime.  Well look at Chuck.......Bristol Meyers, Synthes, Osteotech, Surgical Dynamics, Globus, Lanx, Pioneer and now Spine Smith all in a fifteen to twenty year career.    What does that tell you about management in this industry?  As for Chuck, it's game on.  He will have to leverage all those consultancies that he and his Lanx friends initiated to walk the walk and talk the talk, because if he can't pull his markers this time, he will walk the plank like most in this industry do when they can't deliver those unrealistic expectations.  As for an "innovative product portfolio" you've got to be kidding.   SS's has major gaps in its portfolio.

TSB wants to know, will Chuck E be loved, or, will he eventually walk the plank?

TransEnterix Lands Rich Mueller as CTO

On January 24th, 2011 TE announced that it had hired Rich (you don't mind if I call you Rich) Mueller as CTO.  TransEnterix is a company that specializes in the development of minimally invasive surgical devices situated in Research Triangle Park, North Carolina, also better known as the Raleigh area.

You know that famous saying, "one man's loss is another man's treasure."  Well Todd Pope, CEO of TE has landed himself someone that truly knows the business and is one of the good guys in our industry.  Rich gave five years (a lifetime) of his and his family's life to NuVasive, and as much as one has to love the San Diego area, it was time to move on.  In addition to having NuVasive on his resume, Rich spent many years working at Theken (pronounced Taken if I may add and don't you forget it) Surgical as an integral member in developing their pedicle screw system and other systems.

In addition to the aforementioned companies, Rich also worked for Volk Optical and Proctor and Gamble. Good luck in your future endeavors, Go Tarheel's Go!

Thursday, January 20, 2011

Medtronic to Host PEEK Lab

Spine Nation:

It was reported on the Street that the "Evil Empire" will be holding a lab for spine surgeons this weekend in Memphis on the use of PEEK Rods.  Looks like there will be a windfall this weekend for the Pole Dancers at Platinum Plus.   PEEK RODS?  So the first question that must be asked is, Why PEEK Rods?  And if so, are PEEK Screws that far behind?  But the bigger question that must be asked is, "will PEEK Rods improve the clinical outcomes?  TSB and one of our sources on the Street had an interesting conversation about MDT this afternoon.  What happens to a company when it becomes the market leader and no longer offers innovation and is purely marketing driven?  Do you launch TSRH 3D at the North American Spine Society Meeting and call it innovation?  Do you launch another cervical plate?  Do you launch a resorbable plate only to have it cannibalize an already cannibalized portfolio?  Has Medtronic become the Apple of the Industry?

Medtronic may be the leader in terms of market share, but with the exception of INFUSE, what has it done lately?  Hawkins never liked spine, if not for the margins.  If he had his druthers, he probably rather not play in this arena, but that's no longer his concern.  At a time that hospitals are capping pricing for lumbar fusions, how will PEEK Rods drive down the price of a procedure?   If anything, PEEK will drive up the cost.   Getting excited about PEEK Rods is like getting excited about Trans 1's Butt Bolt.  You know the product that everyone loves to hype yet questions remain about the efficacy of cleaning the disc space and the end plates so that the surgeon can achieve boney apposition.  So TSB wants to know what our bloggers think.  Are your surgeons game for Memphis?  Do they like Bar-B-Que?  Are they Blues aficionado's?  Do they like coming home with Stripper perfume?  TSB wants to know what y'all think?

Tuesday, January 18, 2011

This Weeks' Survey

Based on the many questions that TSB receives on a weekly basis via e-mail,  those of us that contribute to our blog site have decided that we will submit some of your questions to solicit your response on the current state of the art.

Today's questions:

Will Biologics ever eliminate the need for hardware?
Are Stem Cells an answer, or another step in the evolution of biologics?

And as a follow up, who has some of the best biologic platforms, and why?


As usual, thanks for your input, your voice needs to be heard.