Tuesday, August 31, 2010

Yeah or Nay? You Be the Judge

TSB thought that this would be an interesting topic to discuss, considering that those of us that contribute to our blog site agreed that there are distinctions between the issues and observations made by the journalist that published this article. So with that said, enjoy.

On August 28th, John Fauber of the Journal Sentinel, a Milwaukee, Wisconsin based on line publication, penned an article entitled; "Bone Fusion Protein Raises Questions About Doctors Financial Stakes." For whatever reason, there seems to be no love lost between Mr. Fauber and Tom Zdeblick, M.D. of Medtronic Fame.

In retrospect, this article sheds some light on the FDA process, Dr. Zdeblick, Medtronic and Infuse. In 2002, the FDA advisory panel had raised some concerns about nine of the doctors that had lobbied their research on the efficacy of BMP-2 in spinal fusions. Ironically, not only did each physician have a vested interest in the success of the product, their clinical outcomes were twice as good as doctors that did not have financial ties to its success.

Over the last few years concerns have been raised regarding the off-label use of Infuse, and the potential adverse reactions in patients. Yet, TSB believes that this is clearly a separate issue from how Dr. Zdeblick was compensated, mainly for his IP and expertise as a spine surgeon. Industry insiders are well aware of the recent stir about off-label use of Infuse in Anterior Cervical Discectomies, whereas in 2008, Medtronic was sued by the family of a California woman claiming the company had urged off-label use of its device after the FDA had warned doctors not to do so.

The story of BMP-2 continues to raise questions about whether doctors should be allowed to do clinical trial research involving products that might enrich them, or the companies that they work for. Dr. Richard Deyo finds it alarming that so many prominent surgeons have cozy relationships with companies. For the obvious reasons, Dr. Zdeblick is the primary target of this article, having received roughly $22 million dollars in royalties and payments from Medtronic since 2002. This may surprise some of our readers, but TSB has no problem with Dr. Z being compensated for his IP, time, and expertise. Whom else is the FDA going to listen to? Historically companies have used surgeons to line their pockets. Rogazinski, Charnley, Russell-Taylor etc.... are a few surgeons that contributed to the betterment of mankind and also to the revenue and profitability of the companies that they worked with. What concerns TSB is not the compensation, but the lack of oversight by an FDA panel as to the potential side effects of this pharmaceutical.. Yes, fellow readers, regardless that this product was approved as a device, it is still a pharmaceutical. Since carpentry plays a prominent role in preparing the disc space, could it be that teaching surgeons how not to use Infuse was Medtronic's faux pas from the start. Each of you know the industry adage, give a doctor a hammer and everything becomes a nail. Well if 2cc's worked well the first time, why not administer 6cc's and see what happens? Hopefully, surgeons have learned something over the years, that its not the Infuse that makes the procedure successful. If the FDA was that concerned with off-label use, they should have addressed it at the time of the application while scrutinizing this panacea. For Medtronic to claim that it did not advocate off-label use is debatable. But, how does one legally prove a "he said, she said scenario?"

What concerns the industry and probably hurts many of the surgeons affiliated with Medtronic, is that after years of defending its reputation in various whistleblower lawsuits, Medtronic now behaves as though it has become the moral and ethical compass for the industry. As it crusades for more oversight, it continues to obfuscates its behavior and hides behind the skirt of AdvaMed. So as Amplify begins its final journey for approval, many questions are being raised by Mr. Fauber as to whether the FDA is complicit in covering up the physicians whom consulted by redacting sections of its 2001 files that listed the financial disclosure of the Infuse investigators, claiming at first that this information was no longer available, then claiming that they erred and the information is available, but, that the information would be hard to find. Old news is old news, unless we learn something from past experiences.

The North American Spine Society is just as complicit it their inability to properly police its members from becoming a commercial advocate for specific companies or products. But TSB wouldn't expect otherwise. As a minority of surgeons spend too much time worrying about how much sales reps make, rather than can they prep the disc space properly. Maybe some due diligence on their own behavior would make them ask the question, "look at whom is calling the kettle black?" Like Dr. Zdeblick, TSB would have a clear conscience being paid $22 million dollars for my expertise or intellectual property. But this raises an even greater concern, whom do you think pays for these royalties? Doctors love to cry about how they are always getting screwed, unfortunately, its difficult to side with them when you read stories like the one about Dr. Zdeblick regardless whether you believe in free-markets or not. TSB wants to know what our readers think. Is this a fair attack on Dr. Zdeblick, or, do you believe in free and unfettered markets? In closing, its there a better way to manage these scenarios, or, is the problem that this industry just can't find a better sandbox to climb into?

Monday, August 30, 2010

Deal or No Deal: Vertiflex Divests Itself of An Asset?


Howie Mandell and I just got off the phone, and he asked whether TSB's readers would have answered, Deal or No Deal? Granted there are no beauties standing behind this attache case. Yet, TSB has been inundated with e-mails from loyal readers regarding the Exactech acquisition of the Silverbolt Minimally Invasive System, a valuable asset that Vertiflex was looking to divest itself of, in layman's terms, sell off? Before providing TSB readers with our analysis of the deal, one question must be posed to our readers, how valuable of an asset was Silverbolt if you were looking to divest yourself of this platform? An asset is usually something useful, desirable, and convertible into cash. Yes, Nation, the deal was done and that's all that truly matters to Vertiflex. But, if it was a true asset why would you get rid of it? The obvious answer would be that someone else thought your MIS platform was worth more than you did. It is even funnier when Canaccord Genuity's analysts' state that this acquisition further strengthens Exactech's spine portfolio. No offense, but did anyone really believe that Exactech had a strong spine portfolio to begin with?

In all likelihood, the reason Vertiflex sold off Silverbolt is because it was looking to transform itself into a company known for its focus, dedicating their cause to the full commercial launch of Superion, with the intent of selling that off. In addition, they probably need capital to subsidize an executive team that has more lieutenants than Tony Soprano did. At least the Banda Bing provided some social utility. But how can anyone blame Vertiflex? This is not a bad strategy in today's market where capital is scarce and tantamount to survival. Silverbolt was probably an Aerialbot that Optimus Prime, is that Earl Fender or Moti Altarac, could not breathe life into. So how much of Vertiflex did Exactech exactly purchase? How much did they pay for a platform that had minimal market share? Does the stock have any value? Do any of our readers think that the image OrthoSpineNews utilitzed on theirs blog site was a subliminal message? A fish taking the bait? TSB wants to know what our readers think?

Tuesday, August 24, 2010

A New Precedent, or Just Another Witch Hunt?


On July 8th, 2010, the HHS Office of Inspector General (OIG) announced settlement of a civil monetary penalty and Medicare exclusion case with United Shockwave Services, LLC, United Prostate Centers, LLC, and United Urology Centers, LLC, a group of physician owned companies. The companies collectively agreed to pay $ 7,359,000 to settle this case. So why is TSB writing about a case that involved physician owned urological companies? Because this case could establish a precedent for future investigations and litigations that the OIG and DOJ pursue. which could include physician owned distributorships, especially when it comes to spine and orthopaedics.

The OIG believed that the conduct by the above mentioned parties violated laws by "leveraging patient referrals to obtain contract business from hospitals." The language in this settlement indicates an increased interest in fraud and abuse risks posed by other types of Physician Owned Companies. Kickback concerns exist when companies link investment opportunities to the ability to generate business, and offer return on investment that are disproportionate to business risk. These concerns seem particularly applicable to the business model employed by Physician Owned Implant Companies.

Whether organized as sellers or distributors of manufactured products, group purchasing organizations, or, commissioned sales agents (physician owned distributorships), the concern that the OIG has, is that these business models leverage referrals of physician-owners/investors into contracts with hospitals where the physicians perform their procedures to implant devices in turn receiving profits for their relationship with a company or distributor. So the question must be posed to our readers;

Are physician-owned intermediaries shell entities with no real infrastructure, or capital investment, a legitimate business model?

Is this behavior unlawful, whereas, physicians are controlling the selection of implants based on financial remuneration for their decisions?

Does this behavior/business model violate anti-kickback laws?

Does this business model distort a physician's ability to make prudent clinical decisions?

Do these business models actually keep cost down?

Does this business model have a negative effect on competition?

These are questions that are being asked within many legal circles, considering, that many of these models have played a significant role in companies developing new business. In addition, it seems many of the legacy companies are viewing this business model with disdain, considering that they are under a much larger microscope than an early-growth stage company. TSB wants to know what our readers think?

Monday, August 23, 2010

510(k)s for July

For those of our readers that haven't seen the most recent list of 510(k)s approved for the Spine Industry here they are;

** Denotes Summary Available from FDA

Aesculap S4 Cervical Occipital Plate Spinal System**
Sibd Spinal System

Allure Spine Spondylos Spinal Fixation System **
ATEC Anterior Lumbar Plating System**

Biomet Spine: Gallery Laminoplasty Fixation System**
Blackstone Medical: Firebird Spinal Fixation System**

Dio Medical (Korean) Fixpine II System**

Genesys Spine: TiLock Pedicle Screw System**

K2m: Aleutian Ibf System** (Spacer System)

Medicrea: Impix Lumbar Interbody Device**

NuVasive: Facet Screw System**

Spine Smith Partners: Spinesmith Cynch Spinal System**
Spineart: Juliet Ol**
Spineart: Romeo Posterior Osteosynthesis System**
Stryker Spine: Modification to Radius Spinal System**

Thursday, August 19, 2010

A Strategic Shift in Vertebroplasty?


The $75 million settlement by Medtronic with the DOJ for allegedly (you have to love the law) advising hospitals and surgeons to perform VCFx procedures that could have been performed at outpatient facilities has created some consternation, and, a major shift in how the players in this space will move forward with their business plans. Recent studies substantiate the clinical efficacy and improvement in quality of life for patients when it comes to using Vertebroplasty as a modality of treatment. These papers contradict the recent government/insurance company funded hullabaloo over Vertebroplasty. Regardless of the challenges that this industry segment faces, investors continue to pour capital in vertebroplasty technologies witnessed by DFine closing $36.2 million in equity financing back in July. One company that has identified that it has to realign its strategic business plan because of Medtronic's shenanigans, is Orthovita. Like other companies within the industry, La Vita is having to modify its financial expectations and sales strategy as the industry continues to slow down. Analysts' reactions become predictable when strategic and financial challenges present themselves to any company. Yet, is this a bad thing for La Vita?

By moving vertebroplasty to an outpatient setting every company will have to accept the fact that reimbursements will be lower, and subject to more scrutiny because of Medtronic/Kyphon's alleged behavior. Many people criticize this blog site for various reasons, but this is an example of how the behavior of one, hurts the many that play in this space. The company with the best product (material and delivery system), for the best price, with the appropriate business distribution model will win the race for dollars and notoriety. Let's face facts, outside of a few front runners, the industry in general has shown minimal or flat growth. You don't have to believe TSB, just let the analysts' tell you. So maybe, this will be a wake call for each company looking for a piece of the vertebroplasty marketplace. Regardless, whether you like Cortoss, it has a place in the surgeon's armamentarium like Kyphon, DFine and other companies. The question will be who can reduce manufacturing cost, come up with the ideal distribution model and still competitively price their product. TSB wants to know what our readers think?

Tuesday, August 17, 2010

So Why Did Medtronic Buy Osteotech?

TSB is not oblivious to the Medtronic/Osteotech deal. TSB didn't want to be accused of rumor mongering by some other websites. So the question must be asked, why did MSD buy Osteotech?

Let me count the ways. A quick analysis revealed that OT wasn't doing as good of a job with sales as predicted. If one looked at the revenue for the first six months in fiscal 2010, it was flat, if not losing a bit of ground compared to 2009. In addition, there were dissident investors building momentum when it came to the overall make-up of the board and the company's management team. One has to wonder if some of them were singing, "how long has this been going on?" In all likelihood, it was an opportunity to cash out while the going was good, or as good as it gets.

So why did MSD buy OT? As the bearer of the torch for BMP's, maybe MSD realized that not all surgeons will drink the BMP kool-aid regardless of the results, or the non-published results when it comes to Infuse. MSD really didn't have a great DBM, unless one considers Progenix a good product. In retrospect, Grafton was a pretty good product. One must admit, it was one of the first products to be widely accepted by orthopaedic surgeons during its heyday. Unfortunately for Osteotech, they really didn't have a defined strategy as to whom or what Osteotech would grow up to be. Remember the Mark Burrell fiasco when he came over from MSD after he lost his distributorship? He was going to bring them into the hardware market. That fizzled like a dud on the Fourth of July. OT also had trouble finding good people.

MSD has added a complimentary portfolio that will allow them to expand into trauma, oncology, joint replacement, and of course enhance its position in spine. With its marketing prowess, and feet on the street, MSD should be able to take advantage of this golden opportunity to increase their already stellar biologic sales by capitalizing on the relationships that OT brings to the table. Could this be a strategic move in anticipation of the FDA panels final approval or disapproval for Amplify. Only time will tell, TSB wants to know what our readers think?

Another Love TKO

It was announced today, that Paradigm BioDevices, Incorported a Boston based manufacturer of minimally invasive orthopedic and spinal instrumentation, and the national distributor of novel and zero profile spinal fusion technologies was granted favorable rectification of a contract that existed between PBD and Surgicraft LTD a wholly owned subsidiary of Centinel Spine, LLC, a portfolio company of Viscogliosi Brothers, LLC.

As per PBD's President and CEO Mike O'Neill, the high court ruled that Surgicraft did not honor its contractual obligations. Surgicraft has already defaulted on a court order to remunerate PBD. A subsequent hearing has been placed on the docket to assess further damages and legal fees due PBD.

With all the capital that V3 has raised over the last year, you would think it was time to pony up and move on considering that this was handled poorly from the start. But you know what the late T Pendergrass would've sang;

"Lookin' back over my years, I guess I've shed some tears
Told myself time and time again this time I'm gonna win
But another fight, things ain't right, I'm losin' again
Takes a fool to lose twice and start all over again,
Think I better let it go, looks like another love TKO."

TSB would say that David finally slay Goliath on its own home court. Now the question is, will they pay up? TSB wants to know what our readers think?

Wednesday, August 11, 2010

Roy Jacobs Files Class Action on Behalf of Shareholders

On Wednesday, July 11, 2010, Roy Jacobs & Associates announced that it has filed a class action complaint in United States District Court for the Southern District of California on behalf of purchasers of the common stock of Alphatec Holdings, Incorporated. The complaint is centered around alleged claims for securities fraud pursuant to federal securities laws. The complaint was filed against ATEC and certain of its officers, directors and controlling persons.

Game On!


Spine Nation:

Yesterday, we posted a blog regarding the news about the on-going investigation by Kahn, Swick & Foti into AlphaTec Holdings LLC to determine whether it had violated federal securities laws by issuing false and misleading statements to its shareholders. Ironically, what transpired was a tete-a-tete between various commentators and of course the usual attack on TSB. TSB would not expect anything otherwise. It is easier to deflect your anger at the blog post or TSB, rather than address the issue at hand, have an intelligent discussion about the potential ramifications for ATEC, and of course the behavior of the Board of Directors. Obviously, accountability is a noun that doesn't exist within our industry.

It seems that Kahn, Swick & Foti are not the only law firm that has a special interest in ATEC. Jacobs & Associates is also investigating possible claims for violation of federal securities laws on behalf of purchasers of ATEC common stock. In one fell swoop, tens of millions of dollars in shareholder value was wiped out. In addition to KS&F and Jacobs & Associates, there is a third law firm that is spearheading its own investigation into these alleged claims. So how did ATEC get to this point.

On December 17th, 2009 the Company announced that it was going to acquire Scient'x, S.A. a company owned by Healthpoint Capital Partners and affiliates, Healthpoint Capital which also held 38% of the Company's shares, in an all stock transaction. Ironically, five of the nine ATEC directors are affiliated with Healthpoint Capital. On December 17, 2009, the Company disseminated an aggressive full year 2010 guidance stating that the Company anticipated annualized pro forma revenues of $220 million to $225 million. Shares rose 8% on this news. This guidance was influential in causing ATEC's shares to trade at high prices, so that ATEC could sell shares in a follow-on offering and so that Healthpoint Capital could sell off a substantial part of its shares in that same offering.

Upon closing the Scient'x acquisition, on April 12th ATEC announced a follow-on public offering whereas the Company would sell 8 million shares and Healthpoint Capital would sell 8 million shares. The offering was priced at $5.00. This offering allowed Healthpoint Capital to sell off a significant number of its AlphaTec shares.

On August 6th, the ATEC stock crashed. Why? It seems aggressive projections lacked a reasonable basis, in that they appear to have been based on unrealistic calculations as to the speed of integrating the Scient'x acquisition, the effect of negative pricing trends within the industry, and the ability to replace lost revenue when it divested its Asian distributor at the time of the Scient'x acquisition.

As TSB stated in an earlier post, it seems that negative industry pricing has become the mantra of every CEO within our industry. Yet, how difficult was the integration of Scient'x? We're not talking about a Styker/Howmedica sized integration. Didn't anyone at ATEC anticipate the effect of having to replace lost revenue when it divested its Asian distributor? TSB could understand executive management forecasting conservatively in a sluggish market, considering analysts' even lowered their expected guidance to single digits for the industry. Yet, such an aggressive number leaves many unanswered questions. Let's give ATEC the benefit of the doubt, unfortunately, everyone knows the old expression, "where there's smoke there's fire."

If you purchased ATEC stock between December 18, 2009 through August 5, 2010, and have a loss, whether or not you still hold shares, or if you bought in the April 2010 offering, or held ATEC shares prior to December 18, 2009, and still hold your shares and are interested in discussing you rights free of charge call Roy L. Jacobs at 888.884.4490 or e-mail Mr. Jacobs at rjacobs@jacobsclasslaw.com, or contact lewis.kahn@ksfcounsel.com, or call Mr. Kahn toll free at 866.467.1400 x-200.

Tuesday, August 10, 2010

ATEC: The Heat Is On

No TSB Nation, this isn't about Glenn Frey of the Eagles. This could possibly turn into a Fish Fry. On August 9th, 2010 it was reported that the law firm of Kahn, Swick & Foti, (KSF)LLC announced the investigation into AlphaTec Holdings, LLC to determine whether it had violated federal securities laws by issuing false and misleading statements to its shareholders. All this comes on the tail end of ATEC stock dropping over 40% on Friday, August 6, 2010. The excuse for this so-so performance was attributed to the device maker stating that sales were slowing down. In morning trading (8/6) the stock dove head first to $1.91 per share closing at $2.51.

Dirk Kuyper, ATEC's President and CEO performed an Aztec Two-Step when he informed analysts' that the company was please with its long-term business prospects, its growth rate was well below what was expected. The obvious excuse was pricing pressure, yet, the new whipping boy has become the FDA which Kuyper asserts makes the timing of market releases of key technologies uncertain. Lastly, Kuyper spoke of the complexities of integrating Scient'x into the company's operations.

It seems KSF believes that allegedly there must be some improprieties and insider trading going on at the director level at ATEC based on the cashing out party that has been taking place. Nation, what do you think? Could this be the start of something beautiful? Or, is this an all to do about nothing? You know what Cary Grant once said; "and there I suddenly found my articulate self in a dazzling land of smiling, jostling people wearing and not wearing all sorts of costumes and doing all sorts of clever things. And that's when I knew! What other life could there be but that of an actor." Yes, Nation, there are a few nefarious actors, let's see where this goes.

Nation: Question for our Readers

Recently, an anonymous source wrote TSB and asked that we pose the following question; "has anyone in TSB Nation (doctors are you listening) heard any complaints regarding a high incidence of peroneal neuralgia's following a 1-level fusion utilizing the StaXX cage in conjunction with an ISPD? It seems that there have been reports of patient complaining of a burning sensation on the foot and lower leg. Could the possibility be that the nerve-root is being overstretched? TSB wants to know what our readers have heard. You know what Linda Richman of Coffee Talk use to say; "Talk amongst yourselves." Or you can call in on 555-4444.

Another One Bites the Dust?

Spine Nation:

Rumors are swirling, if not accurate, that Hydrocision is no longer the Hydrocision we've come to know and love. It has been reported that the company, and whatever technology remains, was acquired by an outside group of investors. What is more troubling is the fact that this transaction lacked the pomp and circumstance that many in the industry anticipated. Seems like the well must have finally dried up for a once promising product. If true, TSB wonders how bad was the multiple on a company that probably generated $3-$5 million in sales, and TSB is being generous with those figures. And that my friends is revenue after five years.

In all likelihood, it was a fire sale. Fire sales are usually preceded by constant turnover in management, downsizing, a lack of operating capital, and lack of direction. Just look at the website, there really hasn't been any activity or maintenance on their site since 2009. The patient lingered for many years battling financial, clinical, and reimbursement issues. Maybe there will be some lessons learned, but then again, that would be wishful thinking. As Einstein once said, the definition of insanity is doing the same thing over and over while expecting different results. If the Board was providing oversight, it should return its Board Fees. Sometimes it makes you wonder.

"Are you happy, are you satisfied, How long can you stand the heat, Out of the doorway the bullets rip, to the sound of the beat,.....Another one bites the dust, Another one bites the dust."

Friday, August 6, 2010

Bacterin: The Company that take a Lickin' and Keeps on Tickin'

Dear Department of Justice:

From the Bacterin Website, click on Healthcare Professionals, scroll down to Opportunities and click on that:

"Bacterin has assembled a vast group of surgeons from throughout the country to assist us with training other surgeons on Bacterin products, working with research and development personnel to develop new products, and providing consultation as requested. We have established an excellent core of surgeons, each with extensive expertise in their respective areas including Foot and Ankle, Spine/Neurosurgery, Sports Medicine and general orthopedics which will cover trauma, oncology and pediatric disciplines.

If you are interested in being a consultant for the company or performing a clinical study utilizing Bacterin products, you know what Bob Barker use to say, Come on down."

Oh, and by the way we raised, $9.2 million dollars to expand the sales forces and to use as working capital.

Spine Nation: I don't believe I have ever seen anything as brazen as this, what do our readers think?