Tuesday, July 26, 2011

Storm Warning

On June 23, 2011 the FDA issued a warning letter to Pamela Layton, CEO of Parcell Laboratories in Newton, Massachusetts regarding their methods for processing the Alphatec PureGen Osteoprogenitor Cell Allograft.  The inspectional records that were reviewed were standard operating procedure by the FDA, including product summaries, instruction for use, medical and health history profiles, donor physical assesments, viral test results, fungal test results, sterility, eligible donor files, and ineligible donor files.  PureGen is intended for homologous use, meaning, to repair, replace or supplement a recipient's cells or tissue with an HCT/P (Human Cellular and Tissue/Products) that performs the same basic function in the recipient as it did in the donor.  PureGen is intended to be used for homologous repair, replacement, and reconstruction for musculoskeletal defects, and is not to be used systemically.

Basically what the FDA was saying was that the ELA cells do not meet the criteria in 21 CFR Part 1271 which states that the purpose of this part is to create a unified registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue based products and to establish donor eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable disease by the HCT/P.

If you are an establishment that manufactures HCT/P that are regulated solely under the authority of Section 361 of the PHS Act, this part requires that you register and list your HCT/P's with the FDA's Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P's enters into interstate commerce.  The HCT/P's that are regulated solely under the authority of Section 361 of the PHS Act.

The HCT/P's must meet the following criteria:

The HCT/P's are minimally manipulated, they are intended for homologous use, reflected by the labeling or other indications of the manufacturer's intent.  The HCT/P's do not involve the combination of cells or tissues with another article, except for water, crystalloids, or a sterilizing or preserving agent, providing these agents do not raise new clinical safety concerns.

The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary funcition or the HCT/P's have a systemic effect dependent upon the metabolic activity of living cells.

The HCT/P's are intended for autologous use, is for allogeneic use in 1st or 2nd degree blood relative, is for reproductive use, and if you are a domestic or foreign establishment that manufactures an HCT/P as described you must register with the FDA, you must submit to the FDA a list of each HCT/P manufactured and you must comply with other requirements.  Specifically what this letter states is that the product does not meet the criterion in 21 CFR 1271.10(a)(4)(ii)(b) because the product is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogenic use in a first or second degree blood relative.  As a result your ELA cells are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the ACt) [21 U.S.C. 321 (g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C.262 (i)].

The letter goes on to state in order to introduce or deliver for introduction a drug that is also a biologic product into interstate commerce, there must be a valid biologics license.  The license is only issued after there is a showing of safety and efficacy for the products intended use.  While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an Investigational New Drug application in effect as specified by FDA regulations.  PureGen OCA is not the subject of an approved biologics license application nor is there an IND in effect.  Based on this information, the FDA has determined that your actions violated the ACT and the PHS Act.

Could the potential exist that the parties involved were going for an easier approval process, you be the Judge and the Jury.  TSB wants to know what our bloggers think?






 

101 comments:

  1. Let's see...FIRST First, I'm the douche that yells first!

    Um...oh yeah...when's Globus going public?

    Random bash on Globus/Alphatec.

    Pithy comment on SynthPuy...

    Envy and loathing toward MSD...

    OK, that about does it, now we can all feel free to talk about stem cells and the impact of this action.

    GO!

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  2. Duhhhhh...saw that one coming.

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  3. When it first came out, I wondered how Alphatec could be some dumb....my first question, among others, was WHO THE HELL IS PARCELL LABS ANYWAY?????!!!!!!

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  4. can you say BORING!!!!!

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  5. NOW we know why Alphatec took Puregen off their Website a few weeks ago....somebody's got a BIG PROBLEM!!!!!!....lol

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  6. Sorry "BORING", hope it doesn't adversely affect those Puregen commissions you were counting on!!!!!

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  7. Alphabust just can't catch a break. Better ramp up the POD sales Mr. Jackson.

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  8. ATEC stock down over 8% today. Ouch. Pretty much wiped out all gains for the year. Couldn't happen to a nicer bunch of guys.

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  9. Instant karma: When you're a good guy, good things will happen to you. When you're a bad guy, bad things will happen to you. True for people, true for companies.

    This week's news out of Globus and Alphatec illustrate this perfectly.

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  10. Any word on what Stryker will do to place a rep or agent in the Northern California market?? Are they going direct? Have all the old reps jumped and went with Mark to Depuy along with the surgeons?

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  11. GLIF - BUST, Solus -problems out of the gate, Osseofix - U.S. Launch......never, Trestle - screws still backing out, Amnioshield - BUST, shareholder lawsuit, questionable business practices, and now PureGen. Who on earth would invest, work, or distribute for this train wreck? Everyone complains about NUVA, they are very well run compared to this dumper of a company.

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  12. 6:08

    Forgot JP Timm - _______ (fill in the blank)

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  13. Saw Pam Layton's presentation on Puregen, what a joke. If a OI score of 2 after how many thousands of $$$ in a biologic doesn't cause concern, the surgeons that use that product need to overcome their ignorance on Biologics. They seriously need an education. If you are counting on Alphatec to give you one, go ahead and tell you patients you have no idea what you are doing.

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  14. Hey 6:08 what is your excuse for NUVA stock drop this week? Such a well run company why would it tank?

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  15. Nuva confirmed revenue projections for the year, but revised profit forecast down on loan refinancing that recently took place. That is what sent shares down. At 29/share, it's a buy.
    At this point arguments about the management are ringing hollow. The knock used to be that they couldn't turn a profit, but now they do. Then, xlif doesn't fuse and doesn't help patients, also debunked. One trick pony? More like a company with a flagship product, but other commoditized products that are selling. Osteocel is also profitable.
    No company is perfect, but if I were a rep in this market, I wouldn't be concerned that the Nuvasive boat is sinking anytime soon.

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  16. Most of us paying attention have always thought that Parcell Labs and the amniotic derived cells didn't pass the sniff test for "homologous" use.

    Who has read the FDA letter? There are some very interesting points of notice such that this might have wider consequences than most think:
    "... because the product is dependent on the metabolic activity of living cells for its primary function and is not intended for autologous use or allogeneic use in a first or second degree blood relative. As a result, your ELA(R) cells are drugs under section 201(g)..."

    This would certainly seem to apply to all of the currently marketed "allogeneic stem cell" products as long as any of the cells are alive.

    Osteocel and Trinity promotion is all about the # of living cells and the trophic (ie metabolic) activity of those cells.

    (Hopefully) Gonna' get real interesting...

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  17. Off topic, but could anyone tell me of a good pediatric / adolescent deformity pedicle screw system that's not made by Medtronic, DePuy, Stryker, K2M, or Biomet?

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  18. Looking for the warning letter online and can't find it. Has it been published yet or are the excerpts from other news stories?

    Would appreciate a link to it if you have one. Thanks.

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  19. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/Enforcement/UntitledLetters/ucm264011.htm

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  20. Perhaps I'm missing something here! It sounds to me like the FDA has taken issue with the fact that there are living cells in the product! How long have surgeons been using fresh and cryopreserved allograft? Oh maybe a hundred years or more........ ..Perhaps cells from diseased knees are not the answer, but lets not throw the baby (cells) out with the bath water (pun intended)!!!!

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  21. http://www.parcelllabs.com/index.html

    I vote worst website of the year

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  22. Wondering if it is the mechanism of action they are claiming that has FDA concerned

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  23. Yes. Claiming the cells have any biological mechanism of action (why else would they be of value) seems to trip this trigger with FDA and therefore classify them as a drug.

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  24. question..how does this effect the BioD that Amedica is pushing?

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  25. BioD is non-homologous in addition to being "dependant on the metabolic activity of living cells."

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  26. I believe you could technically argue that neither Osteocel or Trinity meet TOTALLY the tissue regs...BUT keep in mind that essentially these "products" have their origins in a "full up" IND approved with all the FDA imposed preclinical,safety, processsing procedurs, etc packages submitted and approved by virtue of the granting of the IND that for some indications completed thru phase 3 clinicals (in this case to Orisis, with no efficacy however...but and excellent safety profile....nobody bring up Infuse...that was NOT treated as a drug...STUPID on FDA's part, but another story)....Puregen has NOTHING, ABSOLUTELY NOTHING submitting regarding these cells that are "processed" from live donors!!!! And in addtion that make claims regarding effacy and a mechanism of action that appears to be systemic (probably really isn't but that's their marketing...lol). When they introduced Puregen, I think EVERYONE thought, what the HELL were they thinking!!!!!!!!!!!

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  27. To 12:53 Osteocel/Trinity salesman:
    You say "I believe you could technically argue that neither Osteocel or Trinity meet TOTALLY the tissue regs...BUT" ... hmm..."neither Totally meet..regs? "? Golly, but close enough to sell sell sell?
    Think the FDA might want to revisit this area?
    With all the intentional vagueness, fudging the lines and definitions associated with "these products" as you call them, that if they are products they should be more closely scrutinized, no? After all they are not just hunks of virgin frozen tissue anymore. These "Products that arent products", they are really indeed still just minimally manipulated so they dont have to supply studies?.. how darn convenient. What is minimally? This lack of transparency may be outed and will prove to be an embarrassment in the near future. Repeat after me..."Sales at any Cost"

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  28. 2:30--

    Thanks for the "smart ass" comment...I am NOT a Osteocel/Trinty Salesman...if I was, I sure wouldn't bring up what I did...lol. Maybe the FDA would like to revisit this area...I was simply pointing out possible matters that may have weighed into the decision that the FDA made...I assume you are not a Alphatec salesman.

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  29. The Amedica product is a total joke. How can they state in their literature that this product is "a structural allograft". Are you kidding me?

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  30. The only Alphatec sales people I know are surgeons selling to themselves.

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  31. So who looked at NUVA's earnings report and noticed that something is fishy. $5.4 mil quarterly earnings, while just the top 6 execs average comp per quarter is combined $9.9 mil.

    http://www.reuters.com/finance/stocks/officerProfile?symbol=NUVA.O&officerId=486183

    How long before there is some investor activism to clean that up. Who would buy stock in a company that pays executives so handsomely for returning so little to the investor?

    If 2:30's comment is accurate...is there an Osteocel warning letter somewhere on the horizon? If they lose that, and if BMP is on the downward spiral...what do you put in those huge cages? Iliac crest?

    Are the days of the purple dancing bears numbered?

    Name Fiscal Year Total
    Alexis Lukianov
    6,196,220

    Keith Valentine
    3,219,480

    Michael Lambert
    2,340,000

    Patrick Miles
    2,422,640

    Jason Hannon
    1,993,080

    Jeffrey Rydin
    2,229,370

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  32. How can I find out who owns K2m, Alphatech, Globus, Custom Spnie, etc?

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  33. Why did bacterin fire Pat Klingler today??

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  34. 3:33

    Nice post, there are several others on the previous blog which confirm your sentiment.

    As they say in the business world: "Pigs get fat, hogs get slaughtered".

    Nuva's day is coming: $60million lawsuit re: Neurovision, in a pissing contest w/ Medtronic, continuing to bleed money,, but the rich keep getting richer.

    All the AVPs who were promoted & are all sitting on stock which is well underwater at this point must be pretty happy. Better yet are all the ESPP shares which employees,, ummm "shareowners",, have purchased w/ their hard earned money and find them all in the red!! Nothing like investing into your own company and LOSING money!! Tragic.

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  35. To me very high management team pay makes NuVasive a great acquisition target for a Stryker/Zimmer/SmithNeph. With an acquisition the buyer can eliminate/reduce redundancies and eliminate duplicate positions. At the salaries above, that is significant money YoY. Sure doesn't make me want to buy NUVA stock though.

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  36. Same reason as all the others, he disagreed with Cook. BONE now sinking past $2.00..who cares.

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  37. 3:47-
    You must be a idiot. If you want to know whom owns anybody just pick up the frigin phone and call their main number and ask for Executive Office. K2m, Alphatec, Globus to Crap Spine...I mean Custom Spine...is not even in the same league of circus acts...get real!

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  38. Gosh you seem cranky.... Didn't get any this month, eh?

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  39. I see some spinial doctors in here, I wanted to ask a question to the spinial doctors if you don't mind. First let me say I have been fighting for my SSI since I fell 38 ft out of a tree and landed on my back on a ladder and that was back in 2008 and I still can't get it now here is what's wrong but yet they say I can still work please tell me how I'm supose to do that with these proublems:
    Cervical spine x-ravs demonstrate a 10 degree left sidebending at C3. There is a 6.
    degree side bending with the left first rib and C7 transverse process elevation,
    indicative of thoracic outlet compression syndrome. There are anterior osteophytes
    if the vertebral bodies of C5, C6, and C7. There is uncovertebral jolnt hypertrophy
    and facet arthropathy at all cervical levels, especially C3, C4, and CS. This explains
    his upper extremity paraesthesias and TOCS pain. These symptoms co-exist with
    his cervical radiculopathy from the cervical spine.
    Thoracic spine x-ravs demonstrate a 10 degree left sidebending at T12, a 10 degree
    right sidebending at TS and a 10 degree left sidebending at T4. Multilevel
    degenerative disc disease is seen at all thoracic levels, especially at the apex of his
    thoracic kyphosis. There ls minor anterior lipping and spurring at TS, T6, and T7.
    There is osteophytosis noted at TS-9 with a spontaneous fusion occurring on the
    right side at that level.
    lumbar spine x-ravs demonstrate a 10 degree left sidebending at L4. There is no
    pelvic obliquity noted. There is extensive degenerative disc disease, particularly at
    L4-S and LS~SI. There are posterior wedge compression deformities noted at the
    l4-S and LS-Sl discs, resulting foraminal stenosis at those levels. This explains his
    . LS and 51 radiculopathv. The transverse processes at LS have formed a .
    pseudoarthrosis with the top of the sacrum and the medial border of the iliac. This
    explains hls mechanical low back pain.
    353.0 Thoracic Outlet Syndrome
    716.99 Facet Arthropathy
    722.51 DDD Thoracic/thoracolumbar
    723.3 Cervicobrachial pain
    723.4 Radiculopathy-cervical
    724.1 Thoracic spine pain
    724.2 Lumbosacral pain
    724.4 Lumbar/lumbosacral radiculopathy
    724.6 Lumbosacral Instability
    756.12 Spondylolisthesis
    780.50 Disturbed sleep
    780.53 Sleep Apnea with Hypersomnia
    806.2 Thoracic compression fracture
    721.3 DJD Lumbar
    722.52 DDD Lumbar.
    And can I ever be fixed?

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  40. ObamaCare says you're fine, here are your meds, go on dissability or go on foodstamps, no surgery though, vote for us Demunists, we take care of you.

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  41. With Infuse heading down the tubes and allogeneic stem cells also hitting an inflection point, what is the go to biologic? Dbm is outdated and the silicated synthetics just being smoke and mirrors, is there another biologic that will rise up?

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  42. Spineblogger, you may want to put a no medical advice rule for the blog. Believe it or not, there can be liability for advice given in forums. Not to mention we really don't want patients with genuine problems around here seeing the seedy underbelly of our business!

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  43. 3:36

    If anyone reading this blog is taking an anonymous sources comments as medical advice, they need much more than a medical doctor. As TSB recommends to anyone forwarding medical questions to our e-mail address, "please seek help from a medical professional, and if you are not happy seek a second and or third opinion.".

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  44. 12:55 am

    Hit the nail on the head.

    The challenge is the fraud-DA only requires some companies to safely handle tissue and others to go through the rigor of 510k. Because of the lack of consistent oversight, predication, and severe lack of level-1 or -2 data there is virtually no pathway away from Infuse.

    The FDA has put the market in quite the quandary

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  45. 9:28
    "rigor of a 510k" ?
    What are you talking about? There is no rigor in a 510k, no studies or evidence of efficacy needed.
    The issue being raised, is now finally the FDA is looking closely at manipulated tissue claims, and holding the manufacturers to the law. This will invite scrutiny of Osteocel and Trinity.
    The FDA required a rigorous PMA for Infuse, and despite what is settled regarding published reporting of adverse effects, it was proven efficacious in level 1 studies to the most rigorous standards of proof as required by the FDA

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  46. I think 9:28 was referring to safety, how the FDA requires some tissue products to at least show safety and go through a 510k, while others slip through either by gray areas or by deliberate obfuscation, like Osteocel and Trinity?

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  47. The way I read it, as posted "only requires some companies to safely handle tissue and others to go through the rigor of a 510k." ie Osteocel and Trinity avoided 510k, while FDA now requires 510k on DBM products.
    Isn't there DBM in Osteocel Plus?

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  48. I can recall for years, the MSD reps hand walking in human tissue that was kept in the back of who knows where for days and months probably, and am not just talking about a box of Infuse or some DBM putty, I am talking about about allografts. Why is it that some manufactures/distributions companies can dance around the "proper handling" condition and some of us play by the rules?

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  49. 11:06

    These reps are NOT "dancing around the proper handling" They are ignoring it! The problem is that most hospital personnel have not been educated on the new rules governing handling and storage of allograft. my suggestion is you perform that education as a service to your customers.... ..you just might have an opportunity to provide some more products.

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  50. Those days are gone I believe. All tissue needs to be stored in designated tissue banks with record keeping thermometer, and close records kept. FDA makes pop inspections. Everyone is now forced to play by the rules, and rightly so.

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  51. There is demineralized bone in Osteocel Plus, but not a demineralized bone matrix product, hence the difference. DBMs need a 510k due to the fact that there is a carrier added to the demineralized bone powder such as glycerol, calcium sulphate, hyaluronic acid, etc.

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  52. 11:20 you are incorrect, you do not have to be a "tissue bank" to store tissue, all you require is a FDA registration for HCT/Ps distribution

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  53. 11:34 is partially correct. You do not have to be a tissue bank and must register, but you also must have a quality system to include sop's, storage logs, training etc. I know cause I are one and the FDA will most certainly pop in and want to see them.We provide this with all of our distribution partners.

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  54. Rick Perry with a lumbar fusion! Truly presidential!

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  55. Got a question regarding Biomet Spine. Anyone have anything good or bad to say about them and the direction they are taking???
    Thanks for the input.

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  56. Biomet has one of the best deformity systems on the market.., but they have a weak sales force.

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  57. Who is Biomet Spine?

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  58. WWJD?

    Not work at Biomet Spine.

    Good deformity system? Please. Their vertebral rotation instruments stink and they don't offer all the requisite implants and sizes needed to make sure your covered in a case. Definitley some gaping holes. With deformity you need to have everything and the kitchen sink!

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  59. Biomet's spine division is down 10%. They do not have one of the best deformity systems, they have a decent deformity system.

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  60. Anyone know how Globus did this last quarter (Q2)? I heard they beat NuVasive's growth, is this true?

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  61. 4:59 who do you think has the best deformity systems please tell????

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  62. who's running with things in the Northern California area including the Sacto area for Stryker Spine now that BioInitiatives guys jumped to Depuy? Have all the Stryker reps jumped to Depuy? Must be a cluster mess trying to get 3 companies rapped into one. Gotta be some fallout with surgeons...gotta be prime for the picking if you live there.

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  63. 5:12 - I was just joking earlier. Everyone knows Biomet has the best deformity system of all time.

    Well, off to go buy a piece of the bay bridge. Which is ironically the best bridge of all time. Wish me luck!

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  64. Let's see....who has a better deformity system than Biomet. I am going to go with every other spine company that has a deformity system. I didn't even know they were still in the spine business.

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  65. MSD has the best deformity system(s)
    K2M has been gaining traction in the deformity space---both companies have nice options for en bloc derotation, redux/translation. I agree with the above statement; Biomet has a spine system? Is it in an alpha stage?

    The better question is, who has the best deformity system for a curve greater than 55-65 degrees? Even the guys who dabble in deformity (5-8 cases a year) can make ANY system work.

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  66. I would pick Biomet over K2M for deformity. Medtronic and Depuy have solid, complete systems. Synthes does not have a deformity line. Alphatec has more deformity implants than Synthes. En bloc derotational is not widely used so you may not need that for a lot of surgeons. The MSD derotation system has a lot of parts and much assembly required. It's overkill really and the same results can be achieved without it. Just make sure you have SS and Ti, good reduction instruments and implants, the full line of poly, uni and mono screws, a pelvic screw that is low profile, a full complement of hooks including smaller throats and instruments that get the job done without too many gimmicks

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  67. Spine 360 anyone?

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  68. K2M Mesa is 1000 years beyond Biomet in the deformity arena. Any system will work on adult deformity, it's the Pediatric cases that separate the men from the boys. "Best" and "Biomet spine" never belong in the same sentence. They have decent products at best.

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  69. Spine 360 is a joke. Pedicle screws break constantly not to mention they are leaders of the pack in the POD arena.

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  70. Really!! Tell me more Spine 360 scoop

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  71. If you work for them, you already know the scoop. Otherwise, look elsewhere. Also, Biomet Spine does a fair amount of deformity in our area, and seems to be pretty unique. Anyone care to weigh in on the perceived advantage of their system for pediatric/adolescents? Thx

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  72. A simple question for all the experts.

    What is an ELA cell? Google won't tell me. I know its a 'stem cell' but can we be more specific?

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  73. what happend to Zimmer Spine and the rep in Sacto area?

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  74. 7:10

    360 is the leader of the POD pack?? Name just one surgeon group doing a PKD w DJ and the boys! They're trying to sell that company - no PODs allowed, besides those might be illegal.

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  75. Might be illegal??? PODs are legal and unethical. Yes LEGAL but unethical. Stop kidding yourself into a false sense of security. Prepare to sell through PODs, or stop them now.

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  76. http://www.trademarkia.com/ela-stem-cell-77568300.html

    10:19 - it's a trademarked name by Parcell Labs.

    Guess it gives them a fancy name to throw around to make it sound more scientific than it is. Sort of like Osteocel.

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  77. 12:01pm-

    I am curious as to your opinion why it takes so long to get a 510k approval these days? I have a device that I filed for approval for in Nov. of last year that is extremely safe has valid substantial equivalents, quality systems are in place, manufacturer of record is making the products that are SE, and still I am waiting!! Are you really that bogged down or is there something else going on?

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  78. 1:40, without telling anyone FDA appears to be effectively shutting down the 510(k) system. Product classes that for years required a minimum of data to show equivalence, now have to provide multiple (pre)clinical studies for each indication on the label. Let alone that the indications as described in the FDA required labeling for most products make no sense to a practicing surgeon.

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  79. ELA= Early Lineage Adult, is already an established term in the stem cell industry lingo. Parcell just Trademarked the letters ELA, cagey move.

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  80. Alphatec screws up everything they touch.

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  81. Calling it ELA is just a stupid way of trying to get around the nuvasive IP. If the FDA doesn't shut down Puregen, nuva will.

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  82. My research pointed me to ELA being an acronym for "Embryonic Like Adult" cells. Which is correct? Early Lineage Adult or the former?

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    Replies
    1. Early Lineage Adult. These cells are derived from live, healthy donors during routine surgical procedures.

      Delete
  83. In this instance, it's probably for " Extremely Little Amount".

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  84. "Exceptionally Low Activity"?

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  85. Perhaps, "Exclusively for Loser Alphatec"

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  86. massive ATEC layoffs today. any comments?

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  87. i heard 40 people...

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  88. They recently hired a Biologics Specialists sales team for puregen. I would think those would be the first to go.

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  89. ELA- maybe for "Expect Layoffs Alphawreck?"

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  90. Alphatec said in a meeting on Friday it was to cut overhead costs!
    CFO took a 17% increase in salary this year
    CEO hired $30K
    No VP's were included in the cuts only middle management all in operations! Now that makes no sense
    Watch the new products fail again.
    Designs are not tested just launched and JP Timms now in charge of AMG watch this train wreck down the road.

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  91. The overhead is out of control 400 total employees and only 33 production employees! No wonder they always show a loss in earnings.

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  92. Is anyone worried about he FDA overstepping their boundries with the regulation of stem cells for allogeneic use? I just read that they have put the kabosh on an adipose derived stem cell that is claimed to rely on the metabolic activity of living cells for its function. duh, all cells have metabolic activity. What is the FDA doing? They seem to be pulling the same stunt with the purgen product. if the FDA is successful in derailing these as 361 products, they will take trinity and osteocel with them! what will we use for surgeries then?? I do not want to use Infuse - too much risk!!

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  93. Agreed. This is just the beginning of the FDA's assult on all stem cell products. All companies are going to be under fire before too long.

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  94. Bacterin claims that their scafold with BMA is the best stem cell product. It leaves the protiens and GFs behind molecularly bonded to the substrate. It's probably the best option at this point. They basically make the same claims a stem cell products.

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  95. They claim their product is Snake Oil, nothing more.

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  96. Bacterin claims they have the market on the sponge product, really? several other companies out there doing the same thing, but wait, the other companies don't Molly and the gang calling around behind everyone's back trying to cut deals directly with hospitals.. The other companies don't have EVP's and RVP's and Direct's dropping like flies....

    Hmm. Maybe the other companies are worth looking at, not to mention half the price....

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  97. Will this shit make my dick grow?

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    Replies
    1. better hope it makes your brain grow.

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  98. Wow, I must say one thing is completely clear here. There are some exceptionally undereducated, misinformed, poorly communicated individuals on this blog. This should be deleted and rediscussed. The product was PureGen distributed through Alphatc Spine. It is on their website, it is in use and the suregeons I have spoken with that are using it have nothing negative to say. It is a hospital level approved product so some are unable to it's not listed due to being a tissue product. It is approved for the C-spine. I would much rather use it than the Vitoss and marrow that I'm using now but our hospital wants to see the DB's first. I hear they're coming and will be on asap. I have reviewed CT's and am impressed. So, guessing the replys are from unhappy vendors that see their commissions going down. Well, if it's whats best for our patients, guess what buddy. I can afford my own vacations, thank you! Don't have time to spell check, sorry...

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    1. Well said, thank you!

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