Friday, July 16, 2010

Deja Vu? Forgetaboutit!

Recently, a loyal follower forwarded a press release to TSB regarding the non-exclusive distribution agreement between ETEX and Stryker Spine to sell and private label the Bio MatrX Structure and MatrX Generate Bone Graft Substitutes. TSB once attended a presentation by an existing CEO who constantly asked the potential investors in the room, is it new, is it true and will it really make a difference. I would love to have that guy up on the podium one day, and walk up to the microphone and ask him that question. Based on the make-up of BioMatrX Structure, what the market has is another synthetic bone graft substitute that claims to be highly porous, providing an osteoconductive scaffold, and high surface area to facilitate cell mediation for new bone remodeling. The sister product know as Bio MatrX Generate is another DBM delivered as a viscous putty that sets hard after closure. Have any of our readers ever heard the Crosby, Stills, Nash and Young song Deja Vu?

I could hear Stephen Stills singing in the distance, "Do you know? Don't you wonder? What's going on, down under you, We have all been here before, We have all been here before." So what's the big deal? Isn't this just another private labeling deal for ETEX? Is Stryker out on Tony Soprano's boat the Stugots searching for a patsy like Big Pussy? I mean let's be honest, OP-1 is FUBAR, $225 million later an HDE, they blew their opportunity to acquire Apatech having been beaten out by an industry outsider, and now, they have entered into a non-exclusive distribution agreement for spine. So why would Stryker enter into a non-exclusive if they really believed in this product, or, are they probing their own customers and market?

There are other products in the bone grafting market place that are hydrated utilizing sterile saline or bone marrow aspirate. So what's the big deal? Maybe some of our readers need to stop at Holsten's Restaurant in Bloomfield, New Jersey and ask Tony Soprano if he has leased the Stugot's to Stryker. TSB wants to know what our readers think, and will this make anyone shake in their boots?

"Another lonely park, another Sunday, why is it life turns out that way, just when you think you got a good thing, it seems to slip away."


26 comments:

  1. As a Alphatec agent we also sold it for a while under our "non exclusive". We did not sell enough now Stryker will try it. At almost $500 a cc it was expensive with no literature citing any efficacy of DBM and CaP.

    ReplyDelete
  2. TSB, I too am trying to figure this one out. Stryker orthopaedics carries Bone Source and internally developed HydroSet - Both competitive products to Etex and I dare say, equal or better to the 'BIO MatrX Structure'. Are you telling me that between all of the great R&D minds and their graduate degrees and doctorates at Stryker Biotech, Ortho, CMF, Spine, Mahwah, Ireland, Kalamazoo they cannot come up with a bone void filler of this type??? I am guessing that the divisional silos coming out of worldwide headquarters in Kalamazoo are getting higher, thicker and more intense. It seems that no one wants to play nice in the corporate sandbox, but rather desires all the glory to themselves. I would recommend Steve MacMillan start by knocking down a few walls, look inside SYK and actually have business units collaborate together. Isn't that supposed to be the benefit of the almighty, big bad ortho machines?

    ReplyDelete
  3. Anonymous 5:49

    You've got me stumped! Maybe the problem at Stryker is that they really haven't done anything out of the box except acquire companies over the last few years. It's easier to buy something than develop it organically. Let's face it, it's cheaper. I have always argued that legacy companies love out-of-the box thinkers until you go work for them. Internal people at Stryker spend way too much time in meetings and substantiating their own existence by kissing each others ass telling one another how wonderful they are.

    You know what my bud Matt Taibbi says;

    Conformity * (Fear + Consequences) / Balls = Duration of Worship

    ReplyDelete
  4. Just what the spine world needs, another bone void filler. This has been done already one hundred times before. Change the box and hype up the marketing story and you have another salt based calcium bone void filler.

    I agree with the poster above that talks about Stryker already having products that are equal to Etex's product offering. I don't think many Stryker distributors will pick up this line anyway. Many are still carrying Apatech at this time.

    As with most synthetics there is no data to support the Extex "me too" product. It is only worth the salt it is made up of. I think the best synthetic on the market right now is InQu. It actually mimics the MOA of BMP, but without the side effects. They have some solid data and they are coming out with a lot more.

    Everyone understands the limitations of the salt based calcium products. The same can be said for DBM's. Anything with TCP, HA, Calcium Phosphate, or Collagen is just solely an osteoconductive scaffold with no ability to recruit and differentiate stem cells.

    I really do not understand this move, but it is a non-exclusive arrangement meaning that the Stryker guys can carry anything they want. I think it waters down your brand if you partner up with a larger medical device company. If this product was worth the salt it was made of than they would not need to piggy back off of a corporate partnership like the one with Stryker.

    I would think that Stryker would look at developing their own unique biologic platform, now that OP-1 has been laid to rest. It takes time and a lot of money to bring a biologic to the market. I am sure that they are looking at their options.

    I have heard that Stryker and Depuy Spine are taking a hard look at ISTO as they would like the combination on InQu and Nuqu for the future. It will be interesting to see what unfolds at Stryker, but I do agree that they could do much better than the weak partnership with Etex.

    ReplyDelete
  5. As an independent we did not care for Alphatec being given the line, now Stryker?? We are out. Hell it took months to get paid as their cash flow is such they could only pay on receivables. Guess that is why they are having to go private label,cannot find independents to sell it. As 5:36 said..too expensive for what it allegedly does.

    ReplyDelete
  6. This comment has been removed by the author.

    ReplyDelete
  7. Inqu, MOA of BMP, really....really??

    510k says it is a BVF. Not an autograft replacement.

    ReplyDelete
  8. interesting contradictions
    so stryker has signed a deal with Etex ?? where is the product and if they did are the distributors going to admit that Actifuse is junk ?
    This will be fun to watch as Etex gains momentum while the local stryker hired guns probably have been trashing it........
    now they will change their story
    BTW there are some real difference between other calcium phosphates and this nano C C Phosphate but finding surgeons that care is the challenge

    ReplyDelete
  9. The surgeons care but the hospitals do not. Etex isn't willing to lower their prices and as a result they are being shut out of large facilities.

    ReplyDelete
  10. Wait till the two from EmpiCare running Etex arrive for your training. You will be told to set aside six to eight hours and take multiple written tests. Seemed like overkill for mixing saline with a powder. Not sure if Apatech has much to be concerned about as long as Covidien lets them keep it.

    ReplyDelete
  11. 6:19,

    InQu same as BMP without the side effects? If side effects mean bone growth than you are right. I used that 12 times and my CT scans don't show bone in them after 100 days. Never had that problem with BMP.

    ReplyDelete
  12. Yup, meant Baxter. I was reading the insert for DuraSeal and typed Covidien. Can't chew gum and walk at same time either.

    ReplyDelete
  13. this product is irrelevant. kryptonite will eat its lunch (and dinner too!)

    ReplyDelete
  14. Hyaluronic acid (HyA) and resorbable poly(lactide-co-glycolide) (PLGA) has been known to cause irritation in other bio-absorbable implants, InQu is nothing new and does it really grow bone? As for Apatech, again, Hydroxyapatite takes how long to absorb? Is that bone growth they see six months later, 12 months? Or is that the non-absorbed hydroxyapatite? None of these products are BMP, nor do they come close. Guaranteed bone growth...go with the BMP, want a scaffold? Any bTCP with a good porousity will work as well as the others. Whatever the ETEX stuff is... good luck, again, nothing new, just something for Stryker guys to get excited about in training until they get back in the field and find out it's not that special.

    ReplyDelete
  15. Does Stryker Spine have a single product that is considered innovative?

    ReplyDelete
  16. Simple answer to a simple question. No.

    ReplyDelete
  17. 6:29pm....Kryptonite?. You aren't serious are you? You can glue cups and saucers at spine/neuro meetings all you want but it can't change the fact that it took you 5+ years to get a 510k indication for cranial defects. By default I presume you need this stuff like you'd need a hole in the head.

    ReplyDelete
  18. Is there any data in Inqu? The website says it's been shown to be equivalent to autograft when mixed with local bone. Strangely there is no reference supporting that claim.

    ReplyDelete
  19. David, the key component in that study is local bone.... makes sense local bone is equivalent to autograft! I think they also would claim that allograft may be equivalent to bone chips! And they would be correct with those generalities.

    ReplyDelete
  20. 7:18 pm--
    Do you mean PLLA implants (rather than PLGA) and the issues with irritation? Don't know of PLGA implants and issues with irritation, although I'd like to know about them if you can point to specific ones.

    I believe ISTO used preclinical fusion data to show equivalence for their indication--saw a poster on it a couple years ago. Not sure if it's published yet.

    ReplyDelete
  21. Who are you guys? Always out for SYK blood. Not every company can be on the front lines of innovation. They stick to the basics, are conservative to the core, and would deem it financially irresponible to shoulder the risk that is often part of true innovation. Some of this mindset is probably as a result of the OP-1 debacle.

    I agree that the ETEX agreement is neither sexy nor exciting. What it is, is another decent product in the bag of the most aggresive sales force in the spine industry. Still, I do find it comical that they are going to have to shift the marketing spin to the, "Big 5".

    ReplyDelete
  22. It’s clear the comment posters here are working for ISTO, Medtronic and DRG. Please stop with the marketing plugs for InQu, Infuse and Kryptonite. Let’s stick to the issue at hand. Does ETEX offer anything new or exciting?… NO. Furthermore, simply changing the name of a product for marketing purposes doesn’t make it any better. It didn’t work before and it won’t work now.

    Good luck to Stryker and ETEX alike in the sales of these products, but as we all know, the only action they’re going to get is from relationships. No Surgeon is going to support a product of this type based on science and efficacy and no hospital is going to let it in at its current price.

    As a side note, Kryptonite guy – your post is ridiculous and you know it. Stick to your indications… cranial defects. When the FDA gives you approval for fusion procedures you can start trash talking.

    ReplyDelete
  23. uh...- look at apatechs website, it is not HA especially not corraline HA (which stays forever) Actifuse is not hydroxyapetite, it is a silicate substituted calcium phosphate, substituted on a molecular level making it a whole different compound.. following your logic then H2o and h2o2 are the same because h2o2 has h2o in it....drink up:) INQU-- only saw a dog study with the radiographs read by the same doc doing the study---suspect.. no facts but intuitively spinning down the patients BMA and introducing it to the site makes sense though.. in for some clinical results.

    ReplyDelete
  24. Fuck Brian Ennis. CEO of ETEX. there going down. no one respect him in the company. hes all bark and no bite. thats why stryker pull out of etex.

    ReplyDelete
  25. ETEX is an okay product,

    it works only okay,

    It is WAY overpriced and management is incompetent.

    Why the Korean parent company doesn’t correct the American problem is laughable,

    ReplyDelete