NuVasive to carry Osteocel

I am considering taking a position with NuVasive and was reading up on their acquisition of Osiris's "Osteocel" product. Do you think this was a smart buy for NuVasive? Does anyone know how Osteocel is packaged (is it an allograft spacer, is it putty, paste, etc..)? Is this positioned to compete with allograft/PEEK or is it competing against DBM/INFUSE/beta tricalcium phosphate?

 

Osteocel is a putty. Like DMB but better. It uses stem cells and is osteoinductive, conductive and osteogenesis. So basically it's the best of both worlds when it comes to an allograft and autograft. It has the matrix in the demineralized bone matrix and proteins to stimulate bone growth and live stem cells in a higher concentration that you would get in an autograft. My Arthrex distributor was going to sell this a while back so I was trained on it. It was a while so that's all I remember.

 

Sounds like you work for NUVA with that spin on Osteocel. The truth of the matter is that Blackstone has been carrying this same product as Trinity for the last couple of years. Blackstone now markets this product as Trinity Evolution so now Nuvasive and Blackstone are carrying the same product. This product is nothing more than a glorified DBM, which is not very osteoinductive in the first place. If I were a patient I would never allow a combination of DBM and someone's frozen blood placed in my body. Basically the are placing frozen BMA on the DBM, to say that they have stem cells in the product is a marketing scheme to compete against BMP. They claim to have 50K MSC per cc, but many studies suggest that a min of 350K-400K of MSC are required to induce bone growth in humans. I have not seen any reliable studies on this particular product.

 

Get your facts straight buddy. Nuvasive's osteocel is the same product Blackstone has had for the last 3 years. But that product was called Trinity. Blackstone refused to buy it from Osiris, then Nuvasive stepped in. All because Blackstone knew that product had limitations and they were working on something better. Hence, Trinity Evolution. This new stem cell product is far superior and manufactured by MTF.
Nuvasive has no chance selling Osteocel against Trinity Evolution.

 

Funny because the Arthrex distributor in Chicago was selling Osteocel in 2007 along with Allosource. Might want to get YOUR facts straight. I made some good $$ using it to backfill in my sports med cases.

 

Where did you get your facts from???
1st - Osteocel and Trinity are the same product - 50,000 living cells per cc. Osteocel Plus which NuVasive has exclusive rights too (Trinity will go away June 30th - Osteocel at the end of year) has 250,000 living cells per cc. So it is five times more viable than Trinity or Osteocel. All three are collected and processed the same way, but Osteocel Plus set a higher standard for living cells per cc.
2nd - Blackstone shareholders pushed the company to sell off this division, so NuVasive purchased the technology from Osiris, which is the world leader in mesenchymal stem cell research. Trinity Evolutioni is being produced by MTF. Please list MTF's credentials in obtaining and regulating cellular tissue. (let me help you out, they have none)
3rd - What limitations are you takling about for Osteocel Plus??? Trinity, Osteocel, and now Osteocel Plus have been implanted in over 25,000 patients without any adverse reactions. To quote you, Trinity Evolution is a NEW stem cell product. How are they collecting and processing their samples? What studies do they have to back up this new technology? Oh wait, Dr. Steve Yocom completed the first procedure using Trinity Evolution on April 28, 2009. So what do you base your claims upon that Trinity Evolution is going to be far superior to Osteocel Plus?

Are you basing your opinions on the fact that Trinity Evolution is being produced by MTF that has NO experience in cellular tissue collection? Or are you basing your facts on a NEW product that has NO clinical history or documentation. My guess is you are basing your facts on what your manager has told you. Good luck on getting Trinity Evolution approved in your hospitals. I am sure the approval committee will agree with all the points you have made. Just tell them to trust you!

 

Just get back from the launch meeting? I dont know what kind of Koolaid they served up there, but you have just explained your sales platform for Osteocell plus. Thank you.
BTW, Im not impressed with it. "no experience in cell tissue harvesting"?????
Thats a winner. Good luck out there with your story!

 

OK... I am really interested in this Osteocel Plus product.
1) what is the main difference from Osteocel. Is it just that you now have 250k MSC/cc up from 50k MSC/cc which is up from the prior claim of 10k MSC/cc and the original 1K MSC/cc?
2) Is it that for the first time the product is referred to as a DBM? The original tissue registration for Osteocel/Trinity mentions nothing of demineralized bone let alone cortical bone. The new Osteocel Plus package insert still fails to mention demineralized bone or even the term cortical bone. Why so deceptive? Is it because DBM products require 510K clearance now? And neither Nuvasive/Blackstone/Osiris has this clearance. I mean Accell tried to skirt the 510K clearance for awhile before finally playing the game only to find out that their "new" DBM was really just Dynagraft with a new name.

This is smoke and mirrors. If in fact you got a DBM product and you add some "cells" to it. (By the way the package inserts only go so far as the "native cell population." Not once do they mention Mesenchymal stem cells. Even the original Osteocel brochure only mentioned the word stem cells in the logo of Osiris Therapeutics: A stem cell company.) We all know what a native amount of stem cells is in the human bone marrow 1-1.5k/cc at best. How do you get 50k-250k? Oh yeah, the concentration step in the manufacturing process. Wait isn't this minimally manipulated tissue? The bigger this gets the more attention it gets. A DBM product (if this is what it is) with artificially high stem cells for the native bone is a NEW product. We can skip the 510K clearance of pre-1976 like product and go straight to the PMA process. See you in a few years after you finally do some clinical research on using your actual product (not culture expanded stem cells) versus an actual control (a novel concept).

Let's assume that it isn't a DBM (which still only offers those exposed BMPs to a minimal amount, like nanograms/cc) and that you still skirt the system be pooling your stem cells in the human donor and concentrating them. How many MSC are in the human body on average if you harvested every last piece of cancellous bone from the body? Recall that Osteocel Plus has 250k MSC/cc. Well a little math using 580cc of cancellous bone (the average amount in a human body and that assumes everything instead of just the pelvis, long bones, and vertebrae) and a high native amount of 1,000-1,500 MSC/cc (see Muschler et al and the original Trinity/Osteocel monograph - oh and by the way we are talking stem cells per 1 cc of cancellous bone not bone marrow aspirate numbers, which still only get to 2,300/cc because they draw bone marrow from more than just the immediate 1cc of bone graft), you only have 580K to 870K MSC per donor. So at 250K/cc you can get a maximum of 2.3-3.5cc of bone graft per donor. And since no donors are mixed. How could you ever have a 5, 10, or 15cc graft product size? Again there may be 250k/cc but they cannot all be MSC. If they are then you are culture exanding, and that definitely would be out of bounds, hence Osiris considering a Osteocel-XC product.

Again smoke and mirrors. If Nuvasive/Osiris/Blackstone is going to make claims like 250k MSC/cc or that it is a DBM, then back it up. I wonder why you find no data on the Nuvasive webpage. What are they hiding? What has Osiris been hiding all these years? Get some real clinical studies and publish them in real journals. I will happily shut up if you can actually back up what your product is and end this marketing confusion nonsense that does nothing but hurt the patients the doctors care for in a lame attempt to get some sales revenue.

 

You truly are an idiot. Osteocel "plus" is the EXACT same product as Osteocel and Trinity. You've just put a new label on the existing inventory. Nice marketing ploy to claim 250k over what Blackstone claimed (50K) It's the EXACT same product!!!!!!!!! Blackstone made the market for MSC's and they know how to sell the science. Why the hell do you think MTF partnered with them!!!! Boy, it's really gonna be hard for you to sell against a better product and a sales force that knows 10 times more about the science than you do. Good luck buddy!!!!!!!!

 

So ... Osteocel and Trinity are the same product as Osteocel Plus? I take it Trinity Evolution is (will be) the next gen product made with MTF instead of Allosource. Doesn't Osiris have some patents on the stem cell portion of the technology? How can Blackstone/MTF get around those? Is Trinity Evolution a DBM product? I am confused.

 

concerned scientist my azz!
You aint BS'n anyone.

 

Again. Insults but no answers. If the product has so much backing it, then why not give some examples? Why not outline what exactly it is? Is it a DBM or not? If so, why is the package insert less than forthright? One would think that if you had ways to refute these questions then you would have done so by now. Yet you return to insults.

(And yes I am a scientist/engineer by training. And yes I am concerned for the patient's well being and the potential fraud being perpetrated against them if the product cannot meet what is claimed or if there is not enough evidence that the product is beneficial to them.)

 

Can you read????? I said Osteocel Plus is five times more viable than Trinity and Osteocel. All three (Trinity, Osteocel, and Osteocel Plus) are processed the same way.

How is Trinity Evolution processed?

Who has more credibility when it comes to cellular tissue (bone) collection? MTF or Osris? Plus MTF will not enter into a long term agreement with Blackstone on Trinity Evolution? Why?

Who owns the IP rights to Trinity, Osteocel, and Osteocel Plus? Hint: It is not Blackstone or Orthofix. Does Blackstone or Orthofix have any IP rights on cellular bone matrix technology? Let me help you, NO.

Again, good luck on getting Trinity Evolution approved in your accounts!! First successful implant April 28, 2009. Come July 1, 2009, Trinity Evolution will have to lay all their cards on the table.

I am sure YOU will be able to convince your accounts to approve Trinity Evolution based on your superior product knowledge. Simply saying Trinity Evolution will replace Trinity will not get it done (or at least not in my accounts).

(Concerned Scienctist, go online and look at the package insert for Osteocel Plus. It is not misleading. Also try and find one for Trinity Evolution because everyone would like to know more about this product besides they collecting samples from younger patients. Again, we will have to wait until July 1st)

 

Quit avoiding the question dumbass. How is the "plus" processed differently in order to make it so much more "viable"!!!!????

 

I don't give a rat's ass if you think I have answered your question or not. Trinity and Osteocel guarantee's at least 50,000 living stem cells per cc. That is bottom number they use for their product. Osteocel Plus guarantee's at least 250,000 living stem cells per cc. That is a fact. Look it up on the internet and compare the products for yourself "knowledge boy or girl"

What are you so upset about? Your superior knowledge of adult stem cells and excellent sales skills are going to get Trinity Evolution approved. Right! I was you would answer one of the questions I have poised to you about Trinity Evolution.

All I know is that in my area, Trinity Evolution will not be allowed to take the place of Trinity. Osteocel Plus will be used because of the proven technology and yes, it is five times more viable over later generations of cellular bone matrix. (July 1st, is coming fast)

"Don't go away mad, just GO AWAY"

 

True, the package insert may not be misleading. It is likely the only honest answer coming forth. Your answers/claims are where the problem lies.

250,000 or 50,000 or whatever number you want to come up with next is no where on the package insert. Neither are the words "stem cells." "Native cell population" is what it says. A lot more other cells there than a few random mesenchymal stem cells. Try at least 20 million plus nucleated cells for starters.

Also, for some strange reason the terms demineralized bone does not appear on it either. Cortical bone is not on it either. Funny how that is?

SO you really have cancellous bone graft with some ground bone matrix with a native cell population. Sounds like that is worth $5000 (15cc).


(Oh and by the way Allosource processes the tissue now not Osiris. Although Osiris has some pretty cool other technology with cultured stem cells, this product line has nothing to do with that. In fact, most of your highlighted articles all have cultured stem cells and no actual Osteocel product.)

 

keep going, this is brilliant

 

ok, so your PI says "more MSC's per cc. Please tell me how it is processed differently than Trinity, or for that matter, plain old Osteocell? Why is this such a difficult question? If you can give me a good answer, I will switch all of my users to Osteocell plus.
You cant, because there is none. It is all smoke and mirrors. Now go back to your one hit wonder xlif case.

 

Osteocel Plus Package Insert
Description
"Osteocel Plus (Cellular Bone Matrix) HCT/P is a formulation of cryopreserved cancellous chips, viable cancellous matrix and ground bone matrix. The native cell population retained as a result of the proprietary process has the potential to differentiate inot tissues of mesenchymal origin, including bone. Note: though well charcterized in the scientific literature, preservation of these cells in the product may not be indicative of clinical outcome."

OK. Let's break this down a bit (unfortunately you cannot post the package insert as an attachement but if someone has a link that would be excellent).

Where does it say cortical bone? How about demineralization? NO WHERE.

Where are growth factors for bone stored - cortical bone. How are they exposed? Demineralization. Is demineralized tissue considered minimally manipulated? NO. Oh, that is a problem.

"Native Cell population," huh? I thought it was up to 250,000 MSCs/cc. Instead, a much more scant reference to random native cells with the "potential" to change into (differentiate may be too big a word for some) tissues of mesenchymal origin. Wait does that mean that they could turn into cartilage and adipose (fat) tissue as well? How many MSCs are native again? About 500-1500/cc depending on donor.


Check out the new article out of JBJS 91:1073-1083. 2009. "Mesenchymal Stem Cell Concentration and Bone Repair: Potential Pitfalls from Bench to Bediside"
It is enlightening. It leaves some room for wishful thinking and objectively outlines the results of the study. But at these levels of stem cells (up to 20,000/cc) in a rat model at that, there is a long road to climb. Perhaps, this is why Osteocel does not have any of its own product published in respected journals. You might just get a glimpse of the wizard behind the curtain.

 

On a slightly modified, but somewhat related topic... I hear that hospitals are struggling with the price increase Medtronic pushed through for InFuse earlier this year. As a result, Osteocel has been getting more looks and ganing market share. Can anyone verify? Comments please!