No fellow bloggers, this isn't one of those Fairy Tales where the prince saves the damsel in distress. Matter of fact, it's more likely to be compared to a Greek tragedy of sizable proportion. Once upon a time, around November of 1998, Stryker went out and signed a irrevocable patent licensing agreement for OP-1 with Creative BioMolecules. If memory serves me correctly, the deal was for $222 million. Based on the daily report on the Weather Channel, a cold front came in somewhere near Kalamazoo. The Almighty Stryker announced that it had entered into a definitive agreement with the Olympus Corporation for the sale of its OP-1 family of products. My how the worm has turned.
The question that any casual observer must ask is, how badly mismanaged has this acquisition been from the beginning? Was the best that Stryker could do is get this pharmaceutical through the FDA as an HDE? Strategic planning and a delivery protocol came into play during the submission. The ensuing years laid to claim that spine and trauma surgeons were coaxed into using this off-label. Some former Stryker employees remember this being used by spine and trauma surgeons, dabbing this accelerant on a foam sponge to deliver this drug. After twelve years, one must wonder how much capital was INFUSED into this project, including the recent legal cost that Stryker has had to incur inorder to defend its reputation with the DOJ, for what transpired from its leadership team in Hopkinton, Massachusetts? Stryker has used the Sergeant Schultz defense, "I know nothin'" denying any knowledge of what was going on in the Bay State. Stryker will also rationalize that it was better to cut one's losses than continue on a road to nowhere. Considering the magnitude of the loss, I guess a loss is a loss. Based on its track record in biologics, hopefully, Stryker will find some competent people to provide the organization some guidance when it comes to biologics, or pharmaceuticals for that matter. There are many parallels between this management team and those that attempted to get Hydrocision's Spine Jet to the market. But then you reap what you sow. TSB wants to know what our readers think?
But what does Olympus want with OP-1? They have no orthopedic footprint in the US markets? Who sold them the koolaide?
ReplyDeleteMaybe they know something we don"t know?
ReplyDeleteFor just $60M, there's probably plenty of market opportunity in Japan alone to justify the purchase.
ReplyDeleteRIP Stryker
ReplyDeleteGood post, but curious about the tie in to Hydrocision. Forgive my ignorance, but is there a particular parallel you were looking to draw?
ReplyDeleteHydrocision's leadership (Doug, Lew, Steve, et al) have to be in the running for the most incompetant management team ever to run (into the ground) a company and a decent product. I'm always amazed how clowns like these continue to find themselves on boards or in charge of other companies...
ReplyDeleteI like to drop silent farts next to circulator nurses who think I make too much money. "Yes, 4 6.5 x 40mm screws "fart" and yeah, 2 45 mm rods "fart" and 4 caps. Great to see you again! Have a great day!!
ReplyDeleteStryker is notorious for poor decisions when it comes to new technology. This is what happens when you promote college jocks who did "awesome" on the gallop and have two years of sales expierence under their belts to vp of merger and acquisitions.
ReplyDeleteStryker completely dropped the ball with OP-1. Pilot study looked at uninstrumented lumbar fusions with a minimal dosage of putty. I get the no stress shielding idea with insitu fusions which can grow bone like nobody's business but come on. That's a tough thing to prove efficacy on when your competition at Danek got InFuse approved via instrumented (interbody cages)with a huge dose. Gee, was it going to fuse and have good results? FDA said it wasn't good enough and gave them a Humanitarian Device Exemption approval which to me is like being crowned the tallest midget. Yeah you have arrows to hunt with but only one quiver full. Kudos for trying to take the high road and prove that OP-1 alone was viable but Stryker didn't grease the skids getting product to market. It could have been their Holy Grail but instead it ended up as egg on their face. A lot of people paid a terrible price for the absolute mess that resulted. Good luck saving face on this situation.....
ReplyDeleteYep, stryker top management thought they would be pasting this crap on nails, hip stems, plates and screws by now, but as a previous post nailed it they have no clue with most new technology. Nice easy case study for business school types, with probably 300 million in or so and selling it for 60 mil.
ReplyDeleteIf only they had reformulated the product early on, so that the protein can actually do the job, they might have given Infuse a run for its money.
ReplyDeleteStryker....Remind me don't they make beds?
ReplyDeleteOP-1 and Infuse can RIP.... BMTI's Augment is going to eat their lunch when FDA gives it the greenlight in 2011. Better science, data, and technology at a fraction of the cost!
ReplyDeleteTSB, I heard today that Zimmer has finally hired a President for Spine. Some guy named Steve Healey that was at Disc Dynamics at one point. You ever run across him?
ReplyDeleteAugment??? beta-TGF right?? That'll be the day... Don't make me laugh.
ReplyDeleteAnon 11:57
ReplyDeleteThe late and great Peggy Lee once sang, "Is that all there is...." Well, this would be typical of Zimmer to hire someone like Healey. Steve was the CEO of a now defunct company called Disc Dynamics. This venture went nowhere, and if it is on a respirator, it would be beneficial to kill the patient. Healey left and went to a company named Lumen in the summer of '09. I always laugh at these big companies when they critique people for job hopping. What can one say about Zimmer, it breeds mediocrity. Look where the company is located, Warsaw Poland has more sophistication.
Wow, I am surprised no one has commented on the V-Bro's loss on this one. Word from inside their organization was this was a done deal for them and their sales force...Spine Seller
ReplyDeleteWhat ever happenend to Doyle???
ReplyDeleteMaybe they couldn't raise the money. Isn't there anyone out there that wants to give these guys more money so they can smoke cohiba's, drink cristal, make barbeque sauce and where purple ties?
ReplyDeleteActually, the Spine president would be in cold MN with frequent jaunts to that backwoods flat land of Warsaw, IN. That being said, Zimmer Spine hasn't been able to hold down a president for over 5 years. Unfortunately even with great direction, that organization isn't going anywhere in market share
ReplyDeletewhen i squirt infuse juice in my eye, i grow a erection that lasts longer than viagra.
ReplyDeleteoff label user.
BMTI Augment is crap. Zero osteoinduction capability - why else did they go for fusion in the foot? Rumor has it the one animal study they did perform with a significant sized defect cost the former CSO his job due to shitty performance. What a snowjob this company has performed on the public. It's not worth 1/10 it's value! Good luck building out a sales force!
ReplyDeleteI put infuse in my ice cubes and regrow my liver as I sip on my scotch on the lmp-rocks.
ReplyDeleteI thought Paul Gravline was the new Zimmer pres?
ReplyDeleteDoes this open the door to a new biologic acquisition for Stryker? With the over all
ReplyDeletefoot print of the company a strong bio line should be a quick grabber of market share.
Whats out there?
They should've bought Apatech when they had the chance
ReplyDeletePaul Graveline is a nice guy, unfortunately he never knew how differentiate his ass from his elbow. Just the Truth.
ReplyDeleteYeah, Apatech, looks god on film.
ReplyDeletelooks like they are buying amedica
ReplyDeleteWho's buying Amedica? Stryker?
ReplyDeleteThey're BAAAAAACCCKKK. The Amedica tout machine! Sorry to disappoint you, but nobody is buying Amedica anytime soon. Your magic metal is, at best, a niche player.
ReplyDeleteZimmer Spine ~ looking at there last few quarters of sales and hearing how they took a crap on many successful loyal field personnel this year ... I can't imagine why Dvorak or the shareholders will keep dumping $ into this franchise. It must have been bad for the ex-Stryker folks to sign on to this death march. Morale is awful. They have no exclusive distributors because they can't survive or compete with that horrible bag.
Paul Graveline? Are you kidding, the guy is a total DICK.
ReplyDeleteSounds like a purge at Stryker Spine senior management? What's the story? Is this related to OP1 sale? Didn't Gravline work there before? TSB, are the stable of old recycled presidents lining up?
ReplyDeleteI guess Mike Mogul can't bring in anymore of his fraternity brothers. Is that nitwit Jeff Smith still there. A true genius.
ReplyDeleteWhat? Zimmer has a spine division?
ReplyDelete@ 11:17
ReplyDeleteNothing to do with OP1 sale. Most current/recent Spine execs inherited the OP1 disaster... couldn't convince McMillan and co to pony up more cash for Spine... damn fine stretchers though!
Jay Lawson just split for Doctor's Research Group (Kryptonite). He inherited a SYK Spine with little in the pipeline... Execs wouldn't give him cash to build infrastructure, or abiliity to acquire anything substantial and/or game changing (NUVA or Globus).
Graveline: good guy (Sales VP NOT President) who was present during solid growth years @ SYK Spine. Translation: pay top-dollar to competitive teams w/ big revenue and long-term relationships.
A sad state of affairs for Stryker Spine folks that made big career moves and are now left w/ little hope for the future.
RIP Stryker Spine
FYI Good Spine Fellows:
ReplyDeleteStryker holds the patent for: Prosthetic devices having enhanced osteogenic properties
United States Patent 5344654
A prosthetic device comprising a prosthesis coated with substantially pure osteogenic protein is disclosed. A method for biologically fixing prosthetic devices in vivo is also disclosed. In this method, a prosthesis is implanted in an individual in contact with a substantially pure osteogenic protein, enhancing the strength of the bond between the prosthesis and the existing bone at the joining site.
http://www.freepatentsonline.com/5344654.html
Inventors:
Rueger, David C. (Hopkinton, MA)
Kuberasampath, Thangavel (Medway, MA)
Oppermann, Hermann (Medway, MA)
Ozkaynak, Engin (Milford, MA)
Application Number:
07/901703
Publication Date:
09/06/1994
Filing Date:
06/16/1992
Export Citation:
Click for automatic bibliography generation
Assignee:
Stryker Corporation (Kalamazoo, MI)
Does anyone have the skinny on Stryker Spine's CerviCore Disk clinical trial. I have scoured the internet looking for updates and abstracts without any luck. Also, FDA and WHO clinical trial databases have redacted everything about this study. I cannot find a PMA# or IDE - 510(k) application - it is as if it does not exist in the FDA world -- but there are plenty of ads about the study -- but nothing authoritive. Just recruiting sites. I am wondering if they coated the cervical CerviCore prothesis with OP and a few clinical trial subjects died or became diabled? It is as if this clinical trial and study fell off the face of the FDA building about the same time the FDA started investigating Stryker Bioteck in re Stryker's OP follies?
ReplyDeleteThis comment has been removed by the author.
ReplyDeleteZimmer Spine is in total dissaray and has shit on their LOYAL agents! Its no wonder that more than half of the agents that have been with them since Spien Tech have left. Sad, soooo sad.
ReplyDelete