Wednesday, May 5, 2010

Will Trans 1 End Up Being This Industry's Version of the Trans Am?

A few weeks ago. OTW published an article celebrating the expansion of Trans 1 into a new building. The pomp and circumstance of this ceremony was a ribbon cutting ceremony with political and local dignitaries. Yet, on May 4th, 2010 TSON released in QI operating results with continued concern that rather than going in the right direction, it seems they could be showing signs that financially they are moving in the wrong direction. QI revenues of $6.7 million saw a 23% decrease over revenues of $8.7 in QI '09. With an estimated burn rate of $5 million per month TSON is probably looking for an infusion of capital to continue its quest for the holy grail.

It seems that the major concern that this company has had is "navigating the current reimbursement landscape." In other words, the company is still having issues with reimbursement on their product. A few months ago TSB wrote a post about Life Spine and TSON collaborating in the hope of propping up TSON's sales bag. Has this helped the company? Or, was this an error in judgement? Tick Tock, Tick, Tock. Is TSON on the clock? Could this be another Hydrocision in the making? TSB wants to know what our readers think?

One final question: Why are these small companies compelled to expand their operational facilities at a time when they need to conserve as much capital in an uncertain market with concerns regarding reimbursement. You know the old Chinese proverb: "No money, no funny."

17 comments:

  1. I'd say it's time for them to field a corp softball team and get the entire company hi-tech, ultra-breathable uniforms with their names hand-stitched on them (oh, wait, I am re-living another long since failed small-cap ortho co.).

    Hubris takes many forms apparently. Icarus flying to close to the sun, the gaggle of grifters we commonly know as investment bank traders, and the endless sea of executive management that play a little too close to Fernando Lamas' axiom that it is better to 'look good than to feel good.' (See poster boy John Thain).

    Maybe it's better to box up your personal effects in a well appointed facility with grossly excessive capacity than in one that makes you feel like the company you are: cobbled together.

    Even if real-estate in Wilmington is such a deal that the math pens out, I can't help but ask, if your re-arranging deck chairs on a sinking ship, does it really matter that you got the cushions for free?

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  2. My opinion is the same as this article, I had spine surgery years ago and was in a great amont of pain, but thanks to the advances in technology and great spine surgeon Los Angeles patients can have a quick recovery and little pain.

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  3. Is it me, or did Dr. Rogers just shamelessly promote his practice?

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  4. We've hit an all-time low/high...Great catch!

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  5. It is amazing how few comments this blog entry has received. Back on Feb. 23, MM's blogpost on Trans1 (http://spineblogger.blogspot.com/2010/02/tran1-tick-tock-tick-tock.html) elicited violent debate. I guess all the supporters have finally given up...

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  6. ..When Smith and Nephew managers are being hired for a start up spine company, the final "we-will-try-anything" phase has just arrived

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  7. This device is single handedly one of the worst things to ever have been done to patients in the field of spine surgery - and that is quite an achievement. Issues of reimbursement aside, the very real risk of bowel injury, infection, multiple revisions, colostomy, etc... make it untenable. As much as surgeons want to be the "MIS guy" in their area, its purely marketing. Once we see prospective, non-biased, comparative data, we can make broader recommendations about coverage and safety. Until then we are just "trying it out" on unsuspecting patients.

    This makes it tough for small startups to gain traction but its needed to protect our patients and our industry.

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  8. Single handedly the worst things to ever happen to spine. That comment is ignorant and lacks any support whatsoever. Gee, reimbursement issues make it the worst ever? There's plenty of products that have reimbursement issues. Multiple revisions? Please share with us YOUR clinical data to support that. Very real risk of bowel injury? The numbers don't support your claims. Less than 1% of the cases have that outcome. How many people die from complications with an ALIF? How many people have permanent footdrop with a TLIF? Let's compare the numbers shall we? I love the people that come on here and spew accusations yet don't provide any data to back their claims. Go to the FDA website and look at the complications for TranS1. Then come back and talk.

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  9. One cannot be that naive. Of course their website, or the FDA website will have lower complications that what happens in the "real" world. Do you really think that the majority of spine surgeons report their complications?? I don't think so. And if you think they do then I have a bridge to sell you. Even the most competent surgeons with this device have had at least one episode of infection or bowel injury with this product. If they have done 5 or 10 or these cases is one or two infections and 1 or 2 bowel injuries acceptable?? Does that really equal less than 1%?

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  10. You obviously haven't worked with a surgeon that has done many of these. I have worked with 2 surgeons that have done roughly 75 cases with no bowel injuries. I have worked with another 5 that have done more than 20 cases with no bowel injuries. As for infections, there have been some skin infections, but that's hardly unique to this product. Your comments tell me that you are either naive when it comes to this product or you have some sort of personal bias against it.

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  11. I would encourage the representative/distributor/employee for Trans1 and any other interested parties to go to the FDA Maude Website and Search for complications. You will be impressed with how many bowel injuries are reported.

    http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

    Clearly less than 1% not accurate. Low complication rates are typically documented by designing surgeons and companies. Once a technology is released to the general public these complication rates typically increase. I wish we had hard and fast numbers to compare. Unfortunately we don't. But please, dont try to push marketing numbers as real data. Also, what is an acceptable rate of bowel injury, infection, and colostomies for an elective low back pain operation.

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  12. What is an acceptable rate of death, permanent nerve damage, bowel injury (not Trans1, newsflash - others have them too), thigh pain, and the list goes on and on. The website you listed shows 98 events since the companies been around. So at around 10,000 cases - seems like about 1% to me.

    The fact that this company gets attacked the way it does on this site is probably evidence that it's having success in the market and taking business from those that attack it. I really doubt that people are just watching out for humanity in hopes that the poor patient or surgeon won't choose this procedure. If Trans1 is so insignificant, they why don't people waste their time talking about another spine company or topic?

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  13. Question to Anonymous 5:50 P.M.

    First of all, where is the attack on this company when the post does a cogent analysis of their revenue for the last five quarters? How thin skinned are you? On October 14th, 2009 and in January TSB posted revenue results and reimbursement challenges, and in January about their collaborative efforts with Life Spine. So, where are the attacks? Has TSB ever stated that the product sucks? No! Has TSB ever stated that this product could not produce good results? No! Never once have we stated anything negative about the product, nor questioned the effectiveness of the procedure. Now when it comes down to the leadership at this company, that is a different story. So in hindsight maybe you need to stop getting your panties in a knot and read with your mind and not your emotions. Once again, thanks for your comments and remember it's a blog and everyone is entitled to their opinion.

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  14. Trans1 is a sinking ship. Period.

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  15. I think everyone should not just focus on the procedure, but look at what a train wreck this company is. Trans1 has had declining sales since Q1 of 2009. Every time an earnings call is made, they announce bad news and continue to blame reimbursement. There is zero accountability on the executive team. The only changes that have occurred since the hiring of Ken Reali are the firings of several employees. The stock is around $3 - having opened at $25. NO ONE has ever been held accountable for that. Sure, they let Mike Leutkemeyer, the former CFO go - but they are paying his full salary and benefits for the rest of 2010. How preposterous is that? He has done nothing but suck money out of the company since his start date. He had not implemented one single strategy that improved the business. Directors at this company in general are arrogant and paranoid, and the wheels are starting to come off. The company is being audited by the FDA soon, and a warning letter is sure to result.

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  16. i've had tranS1 surgery and have since had tailbone problem and i'm unable to sit. pain specialist have given me 3 injections but no luck. the screw is somewhat crooked, not vertically aligned. could that be my problem?

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  17. I am surgical sales representative that formerly represented the Axialif product. As a representative, I once believed in the product. However, following a mass exodus of all of the mid-level managment that supported my distributor, I started to question the results.

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