Disc Dynamics R.I.P.

Are they reeling against the ropes? Could this be the next "Thrilla in Manilla?" No, " it looks like (Teddy Pendergrass God rest his SOUL) another spine TKO. " In 2000 Disc Dynamics secured $65 million to fund the development of DASCOR, a disc arthroplasty system.

DASCOR received its CE Mark in Europe and was sold on a limited basis in Europe over the past three years. Unable to obtain FDA approval to commence a pivotal study in the U.S., it seems DD has exhausted all possible funding and with its operating funds depleted, DD commenced a wind down of its business effective December 31st, 2009 and has terminated all of its employees and discontinued all financial support of clinical studies.

$65 million? Hopefully, some of those prudent investors will have learned their lesson. IST, Archus, Vertebron, Inion, Pegasus, and now Disc Dynamics.

"lookin' back over the years, we've all shed some tears

Told ourselves time and time again, this time we're gonna win

But another fight, things ain't right, we're losin' again

Takes a fool to lose twice, and start over again

Think I better let it go, looks like another spine TKO

$65 million? No wonder the CEO left when he had the opportunity. How many more crazy ideas will we see where investors will throw millions of dollars at companies that are run by people that do not posess the skills nor business acumen to bring a venture to fruition? TSB wants to know what our readers have heard and what they think the residual fallout will be for many of the companies that are underfunded?

Can Someone Make Up Their Mind?

Recently, OTW wrote an article about NASS "flexing its muscle" on behalf of NuVasive by notifying the five insurance carriers in question that supposedly have denied reimbursement on the basis that XLIF is investigational and experimental. TSB says "supposedly" since most of us are still confused as to what Alex Lukianov meant in his investors conference call when he said; "this is a local problem, not a national problem." If one has the H1N1 virus in Seattle, but it hasn't spread to Atlanta, is it a problem or not? As some of our colleagues have stated, "where there's smoke, there always is a fire, at least a little one.

But with that said, NuVasive should not have to be defending this procedure as investigational and experimental. A pre-emptive strategy is in place but they still have challenges with the carriers because they now will scrutinize the cost of this procedure. The problem lies in the marketing of this procedural system and there in lies the confusion with the insurance industry. Sometimes too much voodoo marketing comes back to bite you in an area below the equator.

Ironically, NASS has jump into the melee by writing a reasonable letter on behalf of its members and NUVA. So at least the market and the analysts can get back to some semblance of normalcy. Sometimes these people just love to manipulate the market considering that there have been reports of "shorting" NUVA's stock.

As we move into the new year, Lukianov has set the "bar" at a level that may be a bit harder to clear by his sales management team. Ever wonder why this company has such a high attrition rate? With reports coming out of Europe that there is some customer discourse, inventory concerns and the onus of convertible debt, the question remains, can NUVA continue to rely on XLIF and Osteocell (old technology with a new spin) to hit those numbers? TSB wants to know what our readers have heard on the street?

Pain Management: A Brave New World?

As more people look for alternative treatments to the back pain, one topic that has not received much attention is pain management. There are a myriad of diagnoses that are in order to identify what is the primary, secondary or tertiary reason someone needs medical care for back pain. Since it is human nature to seek conservative treatment before opting for surgery, the spine industry has seen an influx of new therapies and entrants. No longer is the orthopedic and neurosurgeon the primary gatekeeper, today we see more and more anesthesiologist (aka pain managers) and interventional radiologist participating in the patient's modality of treatment. With new markets come new opportunities. Why? Because physicians look for newer and potentially better ways of addressing pain, along with newer avenues to supplement their income. No different than you and I. Yes, readers while the Wall Street analysts focus on the legacy companies, 2010 can become the year of Pain Management.

Pain Management has evolved from hot and cold therapies, the advent of TENS units, electrical bone stimulators, and chiropractic care. Even in today's world we see more and more physicians aligning themselves with chiropractic care in their offices or centers. These are only a few modalities that aide patients in alleviating pain. We have more invasive procedures being performed by interventional radiologists and anesthesiologists in some cases with the assistance of orthopedic and neurosurgeons. As this dynamic unfolded, we have more and more physicians looking to perform surgical procedures in twenty-three hour stay ambulatory surgery centers or pain management centers.

Recently, TSB wrote a blog entitled; "Is it Nu, Is it Tru, does it Loc and does it Fuse?" The blog centered on the introduction of facet fusion dowels and a rectangular wedge that had been exhibited at NASS. The reader response was overwhelming. Some intelligent, some adversarial, some beyond the sublime. But regardless of your personal opinions about people involved in this market, it seems that these little companies are picking up more and more traction in today's uncertain healthcare environment. These companies included NuTech, TruFuse, VertiLoc, Facet Fusion Technologies and even Bacterin has entered the fray (I believe they were involved with the original NuTech). In addition, word on the street has been that even NuVasive is looking at this market.

There is much controversy surrounding this modality of treatment. These allografts are manufactured out of cortical bone since it is very difficult to machine cancellous bone due to its spongy nature. In addition, most of us continue to obsess about fusion. If it doesn't fuse the facet, it's not doing its job. Along with these companies we have seen US Spine, Trans1 and Facet Solutions offer alternatives to facet pain management. So the question must be asked of our readers, are these companies going away? Or, are they taking advantage of an entirely new market that has the potential to grow regardless of how in-the-box many of us are in our thought process.

Considering that the facet has features similar to other joints in our body, is the only alternative fusion, or are we looking at this in the wrong way? The company that comes up with the best access instrumentation for percutaneous implantation and implant design could be the winner in a race that none of us know what the final outcome will be. TSB wants to know what our readers think?

Kabins Sentenced - Justice Served or Just a Joke?

It was reported today that a federal judge sentenced Mark Kabins for his role in the so-called Medical Mafia conspiracy in the City of Lost Wages. Kabins will spend five years on probation with home confinement for the first six months and pay Melodie Simon $3.5 million dollars for medical malpractice which resulted in her paralysis.

Kabins pled guilty last year to misprison of a felony, meaning he knew about the crime being committed but failed to report it. Of course he knew of the crime because he was an accessory and a co-conspirator.

TSB wonders what the Vegas Distributor for Blackstone/Orthofix will do for the next six months while Kabins stews at home. If you know of anyone in Vegas that needs back surgery spread the word, Kabins is a criminal. You know the old saying, what goes around, comes around.

The World is Flat, the Market is Hot and the Spine Industry is Crowded!

"The expansion of Custom Spine's sales management team shows the company's dedication to future growth and providing the market with unique spine solutions."

- Lew Bennett-

This isn't a blog about the Thomas Friedman's best seller, this could be the story about a company that is delusional. Our readers must admit that it is "unique" that an octogenarian running a "me too" company is quoted as saying that CS is providing "unique spinal solutions to the market." Unique? The definition of unique is "having no like or equal, unparalleled or incomparable." Have any of our readers looked at the CS website? Not a very unique product portfolio. Lew, this company isn't Sofamor Danek thirty years ago and honestly your grasp on the English lexicon leaves much to be desired. Custom Spine is another one of those "me too" companies that we always write about. One analyst described it as " not much smoke and a lot of mirrors."

Why would a potential distributor want to work for a company that self-anointed itself "a pioneering leader in the spine market creating the next generation of surgeon friendly implants and instruments that provide superior performance." Donnie Deutsch were are you when someone needs a real marketeer? Word on the street was that they terminated their second largest distributor and replaced them with scrub techs at a bargain basement price, and reduced their largest distributors commissions by 10% in order to increase their operating income.

Another "me too" pedicle screw, a cervical plate that only has 5 degrees of superior/inferior angulation and more PEEK products, sounds like something truly unique and pioneering is going on at this company, it all likelihood, it is Lew himself. TSB wants to know what our readers think?

Trans1 and Life Spine: One Night Stand or Long Term Love Affair?

On October 30th, 2009, TSB reported that Trans1 (TSON) was on the clock in identifying a product that would compliment the AxiaLIF and help in gaining pull thru business. Recently it was reported that TSON and Life Spine had entered into a distribution agreement. In addition, TSON has reported that in all likelihood it will fail to meet its forecasted guidance for the Street for this quarter. Strategically, this should buy TSON some time in continuing their full court press in educating surgeons and addressing their challenges with AxiaLIF.

Contrary, to what many analysts have been saying, this decision should help TSON with some contingencies. Most analysts that we speak with continue to temper their exuberance about this company, in the same way that they are not that enamored with amount of convertible debt that NuVasive carries, but that's a different story for another day. The key to creating a successful synergy will be contingent on Life Spine's product, the Avatar, performing better than some of their other products. Product education will be the key for the 60 plus direct sales reps that sell TSON and there will definitely be a learning curve on the intra-operative nuances of the Avatar. In all likelihood there will be a transitional period before their sales people have the ability to generate sales. Yet, there is no guarantee that those surgeons utilizing AxiaLIF will want to use or like to use the Avatar.

Contingent on the structure of this licensing/distribution agreement TSON could win or it could potentially create turmoil within their sales ranks. TSON and Life Spine, one night stand or long term love affair? TSB wants to know what our readers think?

Breakthrough in Gene Therapy for Ankylosing Spondylitis

The BBC new reported on Monday, Januray 11th, that two genes have been identified by a consortium of scientist from Oxford University (England), the University of Queensland (Australia), and the University of Texas that have a strong connection to Ankylosing Spondylitis, better known as AS.

The disease can result in a person becoming fixed in a bent position looking down at their feet. The identification of these two genes (ERAP1 and IL23R) could help in developing a modality of treatment for this condition.

Currently treatment involves pain killers and physiotherapy although some patients are treated with costly antibodies. The study found six regions of the genome that were associated with AS. ERAP1 is thought to control inflammation while IL23R has been implicated in psoriasis and inflammatory bowel disease.

There are many theories as to what causes AS but understanding which genes involved could lead to a new treatment. Gene Therapy, the future of spine? Kudos to those scientist that labor behind the curtain hoping to make real advancements in spine care that will make a difference.