Friday, May 29, 2009

The Odd Couple

Senator Grassley and Dr. Jeffrey Wang are embroiled in a tete-a-tete. Grassley is accusing Dr. Wang of obfuscating the truth about his compensation from a trio of companies. Of course, Medtronic as usual, is in the thick of things. Rather than comment on Dr.Wang's improprieties, the Spineblogger is more interested in discussing Senator Grassley (Rep). Why is the Senior Senator from Iowa spending so much time and taxpayer money on chasing small potatoes when there are bigger fish to fry? When the District Court in Boston unsealed a "qui tam" suit against Blackstone and the infamous Lyons Brothers, most of the industry felt that this would be the beginning of the end of sham consulting agreements between physicians and companies. Yes those consulting agreements really do exist. So why is Senator Grassley playing games when he should be riding the hide of the Department of Justice and the FBI for opening this can of worms and failing to act upon their investigation. Why is the government so enthusiastic about putting honest and hard working people's careers and livelihood at jeopardy? I believe that those individuals behind this suit have every right to have their day in court. Unfortunately, the spineless DOJ cannot get its act together. The recent monitoring by the former head of the DOJ in New Jersey was a sham. Chris Christie handed out a questionable position with compensation to an old ally of his, John Ashcroft. So as usual we sit on the side lines and must ask Senator Grassley; "Where's the Beef?" The SpineBlogger wants to know what you think!

Sunday, May 24, 2009

Dr. Kuklo, the Army, Senator Grassley and Medtronic

The latest news on Dr. Timothy Kuklo is that he has taken a leave of absence from his responsibilities as an Attending Surgeon at Washington University in St. Louis. It's entertaining whenever the SpineBlogger reads anything that a Spokesperson for the University puts out in response to the allegations against Dr. Kuklo. I do not know Dr. Kuklo, yet, I must say the few people that I have spoken to are at a loss for words as to why this is happening to him. Let's look at the Usual Suspects involved. First there is Medtronic Sofamor/Danek, aka the Evil Empire in the spine industry. Obviously since their initial encounters with the DOJ and Senator Grassley they still do not understand what transparency means. Oh yes they are saying all the right things but the question always remains, are they doing the right things? Does anyone care that a surgeon received compensation for trips that totaled $14K while working for the military/government? How would Senator Grassley like to run his own campaign and travel at his own cost to represent the people of Iowa? But there are forces at work that are difficult to comprehend. An outstanding surgeon that has saved the lives and limbs of many soldiers fighting a sensless war is being accused of forging the names and the data of a study that was published and then rescinded in JBJS (UK). Those are serious allegations, yet I must ask why target Dr. Kuklo and why at this juncture? Who is this infamous Dr. Anderson at Walter Reed? And what interest does he really have in this case? As for Senator Grassley, my advice is stop with the grandstanding and get down to business. If you are going to talk the talk and walk the walk then tell the DOJ to get off its high horse and clean up the industry by going after those that continue to taint the waters.......and you all know which companies those are.

Tuesday, May 19, 2009

Requiem for Archus - Who's Next?

It was announced today that Archus has laid off 45 employees and is taking on water. After raising $63 billion dollars in eight years, where o' where does all that money go? I know that testing and IDE's are expensive but this is ridiculous. Last month the Investors put in another $2, 275,000 USD with another $17,225,000USD to be sold via Bridge Financing. The SpineBlogger speculates that by raising this capital, Archus can maintain liquidity while anticipating an infusion of the remaining Bridge. But are investors willing to bet on an implant that has been in the works since 2001 during this economy? Based on the filing, Archus is willing to give equity in the form of stock with warrants. The question remains, is the Bridge Open or Closed?

The SpineBlogger wants to know what the readers think. Is the TFAS a viable modality of treatment? The SpineBlogger has seen this implant close up, and made an interesting observation to a colleague. Initially, the SAS stated that the way to treat patients with DDD was with an artificial disc. Then the medical community identified that with secondary facet degeneration the industry needed to address facet pain. The SpineBlogger believes that if we take out enough of the structural composition of the spine where pain is emanating and replace the disc and the posterior roof with hardware, the surgeon should be able to eliminate pain, eventually!

The question remains: Is this the beginning of the end of Archus? Impliant? Facet Solutions? We want to know what you think!

Friday, May 15, 2009

Pegasus Biologics - The Usual Suspect

In Greek Mythology, Pegasus was a winged horse sired by Poseidan, and foaled (given birth to) by the Gorgon Medusa (every picture tells a story don't it). The Gorgon Medusa was a vicious monster with sharp fangs. She was so strong that just by looking at her one would turn into stone. Well guess what, with "Kaiser Soze aka Michael Will" riding Pegasus, the horse had its wings clipped today at around 11:00 a.m. PST and turned into stone. The word came down to the employees in the most professional manner that has been exhibited on numerous occasions by these start-up or early stage companies "turn off the lights the party's over! (there goes my reference to Don Meredith again). The company was declared insolvent, unable to satisfy creditors or discharge liabilities, either because its liabilities exceed assets or because of its inability to pay debts as they mature. In other words the company has been bankrupted. When the promise of a capital infusion collapsed at the eleventh hour, Verbal Kint conferenced all of his employees letting them know that they should return their samples (as per their signed agreements), and notify their customers that the company cannot sell anymore product. So who cares if these foot soldiers become collateral damage? Who cares if they have children to feed? Who cares if they have mortgages to pay? Who cares that the job market SUCKS! What a leadership team! Caveat Emptor! When you read their bios one has to laugh. The majority of these people had no experience in running a biologics company let alone setting up a successful distribution network. It goes to my argument that just because you have money or fame doesn't mean you know what you are doing or that you have people skills. But the SpineBlogger has a bigger question to ask the readers, how do some of these people continue to get hired in leadership positions? I still haven't figured out how to say the same thing over and over in twenty different ways and not say anything at all. This is truly an art. Could it be that the Emperor was finally stripped of his hypnotic abilities? Probably not! Marx and Engels once stated; "Workers of the World Unite!" It's time that the industry rid itself of these Usual Suspects. Now once and for all will the real Kaiser Soze stand up!

Sunday, May 10, 2009

2009 AANS - How can you not love San Diego>

The SpineBlogger had the opportunity to attend the AANS in San Diego. As per the commentary from surgeons and industry professionals alike, this meeting needs to be euthanized. The patient was on life support witnessed by what a few neuro-surgeons observed. And God only knows how to diagnose a patient. This has become another spinal implant meeting with no neuro-vascular companies. If there were a few non-hardware companies they were well hidden behind Danek, Globus, Synthes, Zimmer, DePuy etc..... So what's the skinny? As I walked down the aisle, and I'm not talking marriage here, there were companies with many of the same "me too" products. Let me count the ways. There was X-Spine, Spine Source, US Spine, Custom Spine/Hydrocision (I'll get to them later), Vertecor, aka Innovative Interbody, Ulrich, Choice Spine, Spine Wave and a whole array of biologic companies. I do not include the Seven Sisters better known as the "SS" of the industry because these companies are playing in a different market. Yet, let's look at these hardware companies. How many more Pedicle Screws does the industry need? They all seem to make the same claims, i.e. more screw head angulation, better screw thread profile, low-profile screw heads, yet, SpineBlogger continues to ask the age old question that a Middle Eastern Sage stated at the meeting; "Is it new? Is it true? Does it make a difference?" Hmmmmm! I think not! These products do not enhance fusion anymore than what's out there. Maybe if you drink enough of your own Kool-Aid (do I conjure up visions of Jim Jones) you can go to bed having fairy tale dreams of some company acquiring your technology for 5X. So what's going on? It is quite evident that the Capital Express has left the station. No more leveraging other peoples monies. It's time to suck it up, come up with some new IP and start being responsible for managing your own companies. Either you're interested in building a company or you still think the party is going on. Everyone talks a big game when they leverage someone else's capital. Many of these private companies are owned, or have surgeon investors. SpineBlogger noticed the proximity of the Hydrocision booth and Custom Spine. Rumor has it that Hydrocision is in financial distress. No coincidence that Lew (how big is this guy's ego?) Bennett is President of Custom Spine and a Board of Director for Hydrocision. Someone asked; "Is this guy still alive?" He's like a Timex, he takes a lickin' and keeps on tickin'. Spine Wave needs a Cross Connector, can anyone help? X-Spine needs lumbar interbody implants, Vertecor is looking for distributors and consultants, and Doug Daniels/Hydrocision needs an infusion of cash. The usual rumor mill had Synthes going after Globus, and Globus still in litigation with Medtronic. After all was said and done, I could only reminisce to the days when Don Meredith (former Dallas Cowboy great) use to sign off on Monday Night Football; "Turn off the lights, the parties over!" If you were at the meeting, SpineBlogger wants to hear your take on this meeting.