Friday, May 28, 2010

The Spine Industry: Point, Counterpoint

As the economy begins to exhibit signs of a recovery, at least in the stock market, the question must be asked, will this raise investor confidence to invest in the spine industry, as well as, increase the potential for some companies to go public? Considering that Wall Streets shenanigans of a couple of years ago not only effected the US economy, but had a reverberating afffect abroad, one must speculate whether we are on the road to recover, or will it take more time? Where's Crazy Cramer when you need him? TSB usually leaves those questions to be answered by our mentor Nouriel Roubini.

The aftershocks of what transpired has not only hurt Main Street, it has also hurt many start-up and early-growth stage companies on Spine Street. The end result has been that investors have been discrete at investing capital in many of these companies due to the end of a climate of irrational exuberance. Yes, there is plenty of capital sitting on the sidelines. But the reality is that if you want to continue building a baby that isn't perceived to be quite as beautiful as you think it is, you are going to have to do it by leveraging or risking your own assets rather than someone else's. There are many people in our industry that are know-it-all's especially when they are not accountable for their own capital.

With healthcare continually on the government's radar, it will take investor confidence and access to credit to help many of these fledgling companies. At this juncture, TSB does not see that happening as easily as some believe. But let's be honest, this is not a bad situation to be in because the market forces will weed out the weak, and allow those that have legitimate technology to survive. No this isn't an assault on all those half-assed companies that exist within the industry, this is reality. Maybe its time they start tightening their belts and stop paying themselves salaries as if they were still employed at MSD, DePuy, Stryker, or Synthes. The rules of engagement change when you lack capital as ammunition. Spare us the rationale that if compensation is not in line, you will not be able to retain talented people. If talent is defined by the usual suspects that continue to be offered leadership positions after failing or leaving legacy organizations, no wonder these companies are in trouble. It boggles the mind that investors and board members continue to offer leadership positions to people that managed at large companies. These people do not have the skills to work in an environment that needs speed and agility when it comes to raising capital, developing product and executing strategy and tactics. Many of these individuals have come from the proverbial elephant that needs months if not years to execute a decision.

Not only are some of these early growth stage companies bound to go under because of the unavailability of capital, they will primarily go under because of poor money management and the looming device excise tax that is awaiting them if legislation is enacted. Contrary to what some analysts' say, isn't it absurd that a company can generate hundreds of millions of dollars and not be profitable? It can also be argued that outside of a handful of companies there is truly nothing emerging coming out of the spine sector, that's why there's been a surge in the biologic arena. To state that new jobs come out of these companies is debatable at best. The modus operandi at most of these companies is to hire, fire, hire and fire. If that constitutes creating jobs, then they are creating jobs. To argue that market forces are driving product development, capital and jobs outside the US is another excuse. Stop worrying about the shareholders and let them make some sacrifices and you won't be complaining. Using these early growth stage companies as an example is just an excuse by those that are looking to maximize their profitability.


Recently one of our colleagues stated that he was dumbfounded as to why his organization could not raise capital with the potential that existed with their IP. Maybe the challenge is understanding that if you are generating $7 million in revenue and asking for $10 to develop your portfolio, you are going to have to give up a large equity position to your investor. If you are not willing to, the end result is a stalemate. Unfortunately some of these device entrepreneurs don't understand that investors didn't become wealthy because they were giving their money away. Remember, they didn't get their by buying your snake oil. Sometimes reality is a bitch.


Yes fellow readers, its going to take innovation. But that innovation is not going to come from the development of newer and improved technology, its going to take innovation in how you lead your organization, how you managed your capital, and whether you are willing to change your revenue expectations. 8% growth for a company like Medtronic is excellent growth when you generate hundreds of millions of dollars in spine sales, 8% growth for a $7 million dollar company is mediocre at best. TSB wants to know what our readers think?

Monday, May 24, 2010

Summer of 2010

Recently, TSB was speaking to one of our sources only to be notified that Medtronic Sofamor Danek is planning a year end assault on the spine industry. Usually the Taliban hibernate for the winter. Their research and development team along with marketing are supposedly preparing for an autumn/winter offensive. Hopefully, they will not be received the same way that Battle Company was received in the Korengal Valley in Afghanistan. The Evil Empire has been pretty quiet. Up until recently, they were probably still licking their wounds from the ass-kicking that they took from Michelson. In fairness to the Darth Vader of the industry, their legal department probably has been evaluating all that IP, considering that they haven't done anything innovative unless you consider cosmetic surgery on the TSRH3D innovation.

Word on the street has been that Cardo Medical has performed due diligence on US Spine and
issued a letter of intent to acquire US Spine. Does anyone wonder if there is some connection between Paul Sendro and the powers to be at Cardo? Could this be another femme fatale, hypnotizing a company and its executives who have no spine experience whatsoever? At best Cardo is a "cherry" in the spine industry, meaning they need some real battle scars. Wouldn't it be better for Cardo to focus on its core business, than risk another acquisition? But what is their core business? Knees? One has to wonder if Cardo is truly interested in building a multi-dimensional company, or influencing its stock price? This is another company that cannot get out of its own way. Even if Vertebron was a steal, at best, they acquired a cervical plate because the Vertebron pedicle screw was and is a horse hobbling on three legs (hopefully they took it out to pasture and put it out of its misery), along with some mediocre IP. Whether they would know what to do with another spine acquisition is questionable at best. Hobnobbing in Beverly Hills is a lot different than running a company. Are we potentially witnessing a merger and acquisition boom in the industry? If I am US Spine, remember what Steve Miller said, "Take the money and run!!!!!!!"

Supposedly, the other rumor is that Amedica was evaluating its options for an acquisition. Yet, upon performing due diligence on multiple early growth stage companies, supposedly they decided to take a pass. With Bobby Buttrell's former ties to Feel Like a Million Lew , in all likelihood they evaluated the potential of a Custom Spine acquisition only to walk away shaking their heads. It's not a question that they weren't interested, it was probably the delusional valuation that made them laugh. You know what they say, if you drink enough of your own kool-aid or is it smoke enough of your own hookah, you start to behave like Timothy Leary. Besides, wasn't the Big A looking to utilize its silicon nitride for recon applications? If their product is that good, why waste your time in the spine sector where the market opportunities are much smaller than in general ortho?

To quote Sly Stone, "End of the Spring and here she comes back, Hi, Hi, Hi there, them Summer days, those Summer days, That's when I had most of my fun, back high, high, high high there, them summer days, those summer days." So as we approach the beginning of another summer let's see what transpires with some of these companies, help may be on its way. TSB wants to know what our readers have heard.


Sunday, May 23, 2010

Hey Medtronic.....It's Time to Move......Over

With the controversy surrounding vertebroplasty/kyphoplasty procedures for VCFx, TSB thought it would be interesting to ask our readers, which company has the best system and why, what has transpired since the infamous paper subsidized by a government agency critiquing vertebroplasty, and, have their been additional issues surrounding reimbursement.

It seems that Medtronic/Kyphon is taking on an assault in the marketing place from companies like Osseon, DFine, and Orthovita regardless of the subtle differences in technologies. In addition much has been said about AlphaTec's Osseo Fix which is currently being used in Europe. Will this product make its way across the pond? So in the spirit of debate, we want to know what our readers have heard and know. Who know's, maybe we will influence some poor soul's decision to opt for the best delivery system the industry has to offer.

Thursday, May 20, 2010

Public Outcry!!!!!

Last night TSB received an e-mail from a hiring recruiter regarding job opportunities for sales professionals at a specific company. The message stated, "As you know Company X is hiring sales professionals, therefore, is it possible to place a message regarding our job opportunities." A pretty innocent request by any standard, considering that TSB has offered our platform as a way to advertise jobs. TSB even went out of the way to give this company a reluctant plug. Much to our surprise, the head of HR fired off a letter this morning requesting that we delete this immediately since we did not have their permission to post this. What was stated was that this "company was uncomfortable with the post," and, TSB published it without their permission. So, we must ask the question, why was the e-mail sent? In addition, there was never a mention of blind post? So what's the big deal? Are you looking for sales people or not?

TSB must suspect that the backlash from our readers must have made the HR director weak in the knees, along with the management team at this company. God forbid we post on TSB, ooooh, it must be the boogeyman. But this reaction brings us to a much bigger question. Do any of these companies or managers ever look at our readers response as constructive criticism, or, does everyone have an axe to grind? I mean everyone cannot have an axe to grind. To paraphrase the Dali Lama, "it takes less energy to be nice, than it does to be a prick." Hopefully, the people and investors at this company will learn a valuable lesson of how they are perceived within the industry. By the way, if you're looking for a sales opportunity, just e-mail us at spineblogger@me.com and we will pass it on to a credible search firm.

Peace, Love and Understanding!
TSB

Tuesday, May 18, 2010

Hospitals Settle for Inpatient Rather Than Outpatient Surgery

"Whistle while you work, and cheerfully together we can tidy up the place, so hum a merry tune it won't take long when there's a song to help you set the pace."

On May 17th, 2010 it was reported that a whistleblower lawsuit that sparked a DOJ investigation into the Medicare billing of hospitals for kyphoplasty has resulted in the government recouping $20 million from eighteen hospitals.

The hospitals that recently settled the whistleblowers complaint included;

St. Francis Hospital, Beech Grove, Indiana $3.16 million
Deaconess Hospital, Evansville, Indiana $2.1 million
St. Vincent's East, Birmingham, Alabama $1.46 million
St. John's Hospital System, Anderson, Indian $826,256
St. Vincent's Birmingham Hospital, Birmingham, Alabama $422,748
Providence Hospital, Mobile, Alabama $381,713

In April three Health East Hospitals in the St. Paul, Minnesota area paid the federal government a total of $2.28 million to settle the whistleblower allegations. Medtronic Spine LLC paid $75 million in 2008 to settle a qui tam lawsuit brought by the same whistleblowers. Medtronic had acquired Kyphon which developed and sold the equipment and materials used to perform kyphoplasty and promoted the procedure as a money maker for the hospitals if they billed Medicare for inpatient rather than outpatient surgery.

The "Relators" aka Whistleblowers are entitled to 15-25% of what is recovered. Hopefully, Mssrs. Patrick and Bates can eventually ride off into the sunset hopefully to relieve themselves of the stench that is left over from their affiliation with the Evil Empire.

IPod, IPhone, ITouch, IFuse, IPad

Recently, one of our readers expressed interest in a company by the name of IFuse, asking the question, is this a viable procedure? In the interest of developing some dialogue amongst our readers, and providing this company some visibility, TSB must ask our readers, is there a place for this device in the surgeon's armamentarium, or, is this another product that is looking to expand on an already limited but existing market?

From a historical perspective, orthopaedic surgeons have been performing percutaneous iliosacral screw fixation for years, especially in trauma. Because of the potential for soft tissue complications with open posterior exposures, the concept of limiting the amount of surgical dissection for fusion and fixation has become popular. Since this procedure (IFuse) is performed percutaneously a thorough understanding of the sacral radiographic anatomy is demanded. Why? Because there is no chance to guide or confirm implant placement by direct palpation or direct visualization. Three major structures are at risk of injury whenever using a guide wire, drill bit or implant, these include the iliac artery, the superior artery and the S1 root canals and their foramina.

Based on the biomechanical testing, this implant provides the surgeon with an implant that can withstand greater bending and shear loads than traditional cannulated screws. So in the spirit of debate, is there a place for this product or is this another one of those one-trick pony's looking for a procedure, or, is this another one of those implants that can be used to stage a patient to ultimate posterior fusion?

Maybe, SI Bone can hook up with Apple and make the IFuse Surgical Technique an application on the IPhone? It would save the company the headache of developing a distribution network and the cost of sales? Could this be the future? I think I will call Steve Jobs.

Wednesday, May 12, 2010

Spine Blogger Survey

Recently, TSB was speaking to an industry source when the topic turned to some of the early-growth stage companies that seem to be floundering. Our intent is to turn this topic over to our readers and let their expertise and analysis be heard by the tens of thousands of readers that visit this site and contribute to its success on a monthly basis. So in the spirit of debate, we ask our readers, who will be the next company to fall, or, be bought? Who is a dog? And, who is a thoroughbred? Why?

Considering that this site is frequented by many investors. This is a golden opportunity for them to hear from the "real people" that have a clinical understanding of technology and outcomes, versus the "spinsters" that either analyze or have a vested interest in a company, or a technology in succeeding. So let your voices be heard! Is it a Vertiflex? Is it a Trans 1? Is it an Applied Spine? Is it a Disc Motion?

Let Your Voices Be Heard