The biologic material market is highly competitive witnessed by the many players that tout their product as the ultimate panacea for fusion. Some even claim things that they do not need to substantiate. So what makes this product unique? NovaBone differentiates itself from other bone fillers because it is osteostimulative. NB induces bone growth via a cascade of events that culminates in the signaling, proliferation and differentiation of osteoblasts to the defect? Sounds familiar?
Unlike INFUSE, NovaBone only forms new bone at the implantation site. Other spine and musculoskeletal websites have given players like Orthovita, Apatech, INFUSE, and Stryker Biotech publicity about their platforms, unfortunately, TSB believes that they should at least provide NB with some visibility. Charles Caleb Colton once said; "Imitation is the sincerest form of flattery." Word on the street is that this company is led by a team of professionals. TSB believes that this is a company that should be closely watched in 2010 based on their technology and management team. TSB wants to know what our readers think considering NB is another option to offer your surgeons.
"Osteostimulative"? Please. There has been reps stating this product is osteoinductive which is pure BS.
ReplyDeleteSo I must ask the commentator: Are you a MSD employee, Orthovita, Apatech etc..... or are you a physician. At least our readers would like to know? Obviously, NB has a story like your company or the company whose products you use! Thank for you comments!
ReplyDeleteTSB, your posting intrigued me. Novabone has been cleared by FDA since 2002, yet a search on PubMed reveals a total of exactly one clinical article. It is from France, with a different glass, tested in adolescent idiopathis scoliosis. That is one of the easier applications for a graft. All other human articles are in peridontal / oromaxillar applications, an area which FDA agrees has no real bearing on other graft applications. One of the most respected experts on bone, Dr. Bauer from the Cleveland Clinic, recently published the folowing article, which should give one pause:
ReplyDeleteJ Biomed Mater Res A. 2009 Feb 20. [Epub ahead of print]
Evaluation of a silica-containing bone graft substitute in a vertebral defect model.
Kobayashi H, Turner AS, Seim HB 3rd, Kawamoto T, Bauer TW.
Department of Anatomic Pathology, The Cleveland Clinic Foundation, Cleveland, Ohio.
Orthopedic and spine surgeons are in need of supplements or replacements for autograft. We investigated the histological properties of three formulations of Calcium Sodium Phosphosilicate [calcium sodium phosphosilicate putty with or without autograft and NovaBone 45S5 Bioglass particulate (NovaBone, LLC, Jacksonville, FL)] using a sheep vertebral bone void model. Bone voids were surgically created in L3, L4, and L5 in each of 22 sheep, and the voids were filled with one of the tested biomaterials or left empty as a control. Histological evaluations were performed at either: 0, 6, or 12 weeks after surgery. Undecalcified sections were digitized, and the areas of the original defect and new bone were quantified. Decalcified sections were evaluated qualitatively. Histomorphometry showed a significant increase in the amount of bone between 6 and 12 weeks in all groups, but there was no significant difference in new bone formation among the formulations or between any formulation and the empty defects. The granules of all three formulations were associated with an inflammatory reaction. Many of the particles appear to have a hollow center, and the narrow tunnel through the center of the particles was sometimes associated with acute inflammation especially at 6 weeks. These particles were also associated with chronic inflammation at both 6 and 12 weeks, although the extent of inflammation decreased between 6 and 12 weeks. The search for the optimum bone graft substitute/extender will continue. (c) 2009 Wiley Periodicals, Inc. J Biomed Mater Res, 2009.
TSB, Unlike Infuse, NB grows new bone? Wasn't aware Infuse only grows "old" bone.
ReplyDeleteHere's a study:
Silicon-substituted calcium phosphates – A critical viewq,qq
Marc Bohner*
And let us know when osteostimulative, or whatever spin you want to put on it, becomes a real mechanism of action.
Anonymous, To TSBs defense...you have to read the whole sentence. His 'new' bone comment is, I beleive, referencing the ectopic bone formation Infuse has been documented to cause in and around the implantation site.
ReplyDeleteTSB, interesting endorsement, slightly atypical in my estimation. Is there innovation here? Also interested in understanding the definition of a 'professional' management team. I assume it is, in rough proximation, the antithesis of all management teams you have railed on in previous postings.
TSB can only report what's been heard on the street, blog articles are not an endorsement, unfortunately, TSB cannot only write posts about NuVasive's challenge with XLIF and potential reimbursement issues. If we wrote about Apatech, readers would attack Apatech, if we wrote about Orthovita, readers would attack 'Vita. We have no vested interest in the company just looking for new topics so our readers can have an intelligent conversation about what's going on in the industry. Sorry that we offended our readers by giving NB some visibility. "It's my party and I could cry if I want to!"
ReplyDeleteLet's be honest we could punch holes in everyone's product like INFUSE growing bone in the canal which many surgeons failed to discuss because of their commercial ties to Medtronic. So, tell our readers whose biologic is so unique and don't lecture us on stem cells its another product with a little smoke and a lot of mirrors.
The biologics 'game' grew up before it was mature, so 'smoke' and a lot of 'mirrors' is what this market is all about. I think this is apparent in the veracity and volume of comments that immediately follow any post you have on the subject.
ReplyDeleteBut now seriously, dude, I have been reading your posts for some time, I think I have come to appreciate your tone and style. Unless this is an unattributed cut and paste job, this ain't some mere rumbling on the street, or idle chat-room / blogosphere-evesdropped rummination. This, in my humble opinion (spelled out for dramatic effect) is an endorsement.
Ain't no crying here brother, just trying to keep the cape crusader honest.
Now back to that management team...
Common Sense Man, thanks for the commentary, if you ever looking for a role as the Cape Crusaders sidekick TSB has a red outfit for you! Peace, and see you in Gotham City!
ReplyDeleteTSB is not ashamed to admit that he has a consistent penchant for truly unique, patient-centric and physician-friendly devices that come from well-managed companies. Nothing wrong with that, is there? Keep in mind that TSB did request readers' opinions. What the heck is wrong with putting a product out there for discussion? Call it a plug, but at least he's allowing for an open forum where the goods, bads and uglies can duke it out over what's best for the patient and industry. If you don't like it, start up your own blog. Keep up the great work, TSB.
ReplyDeleteBtw I'd much rather see primate and human prospective, randomized trials bear out solid and predictable fusions rates with Nova. Sheep are too easy. Hmm, that sounded like a farmer joke. Separately throw Nova and a close competitor in each of the gutters and track the results. If Nova's as good as you think or they say, the positive results will only help their sales, right?
TSB, NBP LLC was spun off by US biomaterials, which now (november 2009) declared its intent to liquidate itself. The common thread for both companies is Mr. Wotiz, chairman of USB and mentioned as the owner of NBP LLC. Below is a mention in the Jacksonville Business journal from 4 years ago. Funny how that last quote still is as true today as it was then...
ReplyDeleteJACKSONVILLE, Friday, November 11, 2005 -- You might say Art Wotiz is part of the backbone of biotechnology.
NovaBone Products LLC, Wotiz's three-year-old company with 11 employees split between Jacksonville and Alachua County, makes a synthetic bone graft material called NovaBone that is being used effectively in spinal fusions.
NovaBone -- a granular substance that accelerates healing and bone growth -- was created from technology developed at and licensed from the University of Florida. The technology was initially geared toward dental applications, but Wotiz's company bought the rights to pursue its potential for bone grafting in 2002.
"The challenge when we got it was there was plenty of clinical data in oral applications," Wotiz said, "but very little data for orthopedic indications."
SPINEGUY, I completely agree with your sentiment and perspective on the TSB. To that end, and to honor the spirit of this forum as you outlined, I don my makeshift Ultimate Blogging Championship gloves to ask you and anyone the following question:
ReplyDeleteCan you please provide the evidence or examples that Novabone represents a "...truly unique, patient-centric and physician-friendly device(s) that come(s) from [a] well-managed company."
I really don't see it, but if it exists, you are right, there is absolutely nothing wrong with it. Right now, what I see, is a single technology company that was on the leading edge in the lab, but has been outpaced to the market. In my estimation, it is they (in the great tradition of free market market follies) that look late to the game. Now if they have made osteostimulative ceramics 'patient-centric', I may indeed be wrong.
As an FYI, CommonSense Man did blog. Unfortunately the market for pendantic rants on social decorum wasn't as robust as I thought. For now I pilot fish on TSB!
Cheers!
Ps. My cape size is Medium*
*Can't help but think about 'The Incredibles' here. I image TSBs unexpected downfall coming as the result of his cape getting caught in some 'me-too' company's Swiss-Turn Machine.
Common Sense Guy thanks for your commentary! Just reporting what has been heard on the street. One question for our readers, do they really believe in the science that they are attempting to sell on a daily basis, or, is it all about the dead presidents?
ReplyDeleteMost sales people cannot substantiate the science behind what they sell, they carry grafting material as pull thru business for their hardware to add revenue. Does anyone really believe that stem cell products are unique? How many viable mesenchymal cells are there? Let's be honest, you can spit into the cervical spine and it would heal. It a big game like TSB said, its a little smoke and a lot of mirrors.
These cell based companies are just irresponsibly throwing around buzz words like stem cell, bmp, etc. By doing this they are creating alot of hype, when in actuality they are just drinking the koolaid, and have no clue what they are putting in these patients.
ReplyDeleteI agree with TSB, how many viable cells are there? And is it possible to have 10,15, and 20cc sizes of viable stem cells from the same donor?
Yes, stem cells are unique. They are harvested from a freshly dead donor, washed and dried, the ones with certain cluster of differentiation (CD) characteristics on their membrane are selectively removed to prevent an immune response against the cells, the remaining ones are loaded on some allograft cancellous bone, deep frozen, sold for a chunk of cash, thawed, puttified, implanted and then go an make bone.
ReplyDeleteThat is at least what the product literature describes. There are many valid scientific reasons why things might unfold a little differently than stated. Here are just a few:
1. Mesenchymal stem cells can differentiate in many other types of cells than osteoblasts, such as chondroblasts, myoblasts and fat cells. There is no particular incentive here to make them go the bone route;
2. There are many factors influencing if, how, when and to what the MSCs will differentiate, or not. Important factors here include food, water and air. In many applications in spine one or more of these factors are lacking. So even when the cells were still viable when they were moved into their new home, they will be dead soon thereafter. And by the way, the undertakers that remove these dead cells leave behind fibrous tissue…;
3. As the cells divide and mature, the CD – proteins on the surface change. Some of these changed CDs will wake up the immune system, and the cells here again are goners;
4. There always is a risk of disease transmission with donor tissues, as was evidenced by a recent FDA recall of Osteocell Plus. The risk for live cells appears higher than for dead bone. Donors are screened, however, as they no longer can speak, their screening is solely based on some lab tests for known diseases. One has to hope that the tests used are reliable, and that no donor arrives with Hepatitis D, E or F, Mad Dog’s Disease or East Mississippi virus.
Allograft stem cells: Old wine in a new bottle, or, DBM in a new wrapper. But definitely more expensive.
Common Sense Man:
ReplyDeleteSorry I missed your blog. The "social decorum" leaves much to the imagination. No offence intended by my previous comment. More reactionary and directed to other flamebots who are offended by TSB's opinions and info. Your voice is one of reason and impartiality. And Edna Mode would agree with your cape design assessment, I'm sure. Here's to keepin it real.
Interesting discussion. I am a large distributor in the spinal implant field. We were having issues with Actifuse as several of our surgeons that went back and did revisions would see the product in the gutters two to three years later and the product never resorbed. It looked like beach sand. The problem was that it is radiopaque and it was impossible to monitor new bone growth without taking a CT scan at 12 months. We came to a conclusion that it was a lot of smoke and mirrors and they misrepresented what the product could actually do. We switched over to InQu about 12 months ago and the results have been outstanding.
ReplyDeleteInQu is radiolucent so you can assess the fusion as it is taking place. It works like Infuse with respect to mechanism of action, but without the side effects. They proved equivalence to autograft in the Boden posterolateral model, not only radiographically, but biomechanically as well.
The product has been well received and they are growing very fast. ISTO is also working on a juvenile cartilage based platform to look at regenerating the spinal disc. They also have a product with Zimmer to regenerate hyaline cartilage in the knee. They are one of the hottest companies out there right now. I would love to learn more about them if you can get an interview with the Company and write something up on them.
well run company?? you got to be kidding me, Spine Blogger. The Company & product has been around for 9 years and is still only a blip in the VERY small pond. that does not indicate a well run company.
ReplyDelete