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Osiris Therapeutics, Inc. Message Board

ativaloc 205 posts  |  Last Activity: 2 hours 40 minutes ago Member since: Oct 12, 2006
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  • Reply to

    Placental Tissue

    by ativaloc May 28, 2016 11:07 PM
    ativaloc ativaloc 2 hours 40 minutes ago Flag

    podiatrytodayDOTcom/closer-look-potential-placental-membrane-grafts-chronic-diabetic-foot-ulcerations

    Dri skin company can't change the science fact

    At the present time, there are only two cryopreserved placental membrane products on the market with viable endogenous cells. They undergo a BioSmart™ process, which preserves endogenous living cells. Those two grafts are Grafix Prime (amnion) and Grafix Core (trophoblast-free chorion). All components of these placental membranes remain in their native state. Therefore, these products are a true alternative to fresh placental tissues.

    Only viable placental tissues provide sustained release of growth factors in response to a changing microenvironment. Killing endogenous viable cells in placental membranes completely loses this property of fresh tissue in devitalized commercial products.

    Scientific in vitro data demonstrate the importance of preservation of all components in placental tissues including endogenous living cells. Viable placental tissue has significantly higher magnitude of the effects (anti-inflammatory, antioxidant, chemoattractive and angiogenic) relevant to wound healing. Data indicate that different processing methods have different impacts on placental tissue integrity. Drying causes alterations in structural matrix and kills viable cells. Freezing followed by cryopreservation minimizes matrix alterations but kills viable cells. Finally, controlled rate cryopreservation retains both matrices and keeps viable cells intact. Better preservation of tissue integrity correlates with higher biological activity.

    Sentiment: Strong Buy

  • Reply to

    Placental Tissue

    by ativaloc May 28, 2016 11:07 PM
    ativaloc ativaloc May 28, 2016 11:33 PM Flag

    Understanding The Different Commercial Processing Techniques For Amniotic Membrane Grafts
    Fresh placental membranes would be optimal to use for wound treatment but their use is difficult due to short storage times. Therefore, different tissue processing methods have emerged. The main goal of tissue processing and preservation is to retain all beneficial components of the tissue as close as possible to the fresh tissue, and achieve a long shelf life.

    The most popular commercial method of tissue preservation is dehydration with terminal sterilization by radiation, also referred to as Purion™ processing (“dried” amnion or an amnion and chorion combination). The advantage of this method is storage at room temperature. However, dehydration alters the structure of the placental matrix and kills endogenous living cells. The thickness of the placental matrix after dehydration is two- to threefold less in comparison to fresh placental matrix. Examples of dehydrated commercial placental products include: EpiFix and Revitalon (Medline Industries) (amnion and chorion), AmnioExcel (Derma Sciences) and AmnioClear (Liventa Biosciences) (amnion only).16,17

    Another processing method is cryopreservation in glycerol with a freezing step, also known as CryoTek™. This method preserves structural matrix but also kills endogenous living cells. Examples include the devitalized cryopreserved amnion of Neox (Amniox Medical) and Clarix (Amniox Medical), and the devitalized cryopreserved amnion and umbilical cord of Neox Cord and Clarix Cord.18,19

    At the present time, there are only two cryopreserved placental membrane products on the market with viable endogenous cells. They undergo a BioSmart™ process, which preserves endogenous living cells. Those two grafts are Grafix Prime (amnion) and Grafix Core (trophoblast-free chorion). All components of these placental membranes remain in their native state. Therefore, these products are a true alternative to fresh placental tissues.20

    Scientific in vitro data demonstrate the importance of preservation of all components in placental tissues including endogenous living cells. Viable placental tissue has significantly higher magnitude of the effects (anti-inflammatory, antioxidant, chemoattractive and angiogenic) relevant to wound healing. Data indicate that different processing methods have different impacts on placental tissue integrity. Drying causes alterations in structural matrix and kills viable cells. Freezing followed by cryopreservation minimizes matrix alterations but kills viable cells. Finally, controlled rate cryopreservation retains both matrices and keeps viable cells intact. Better preservation of tissue integrity correlates with higher biological activity.21-23

    Only viable placental tissues provide sustained release of growth factors in response to a changing microenvironment. Killing endogenous viable cells in placental membranes completely loses this property of fresh tissue in devitalized commercial products.22,23

    Sentiment: Strong Buy

  • ativaloc by ativaloc May 28, 2016 11:07 PM Flag

    wwwDOTaofasDOTorg/PRC/meeting/Documents/Specialty%20Day%202016%20Handout%2010.pdf

    Sentiment: Strong Buy

  • There is a simple explanation of the bad etiquette and it starts at the top.

    These words will cost many $$$$$$$$$$$$$$$ and possible jail time from no other than lengthy wrap sheet parker.

    Petit added, "Unfortunately, this press release is yet another item on the growing list of issues that Osiris has had of late. Osiris also publicly disclosed that it is under investigation by the Securities and Exchange Commission related to its historical accounting practices, which impact financial reporting to the public. Additionally, over the last several years, Osiris has had three different Chief Executive Officers, two different Chief Financial Officers, two different Chief Medical Officers, and three different outside Auditors. Further, Osiris had a Sales Executive who pled guilty to Department of Justice charges of conspiracy to commit criminal conflicts of interest, bribery and health care fraud during his tenure with another company."

    OUCH

    Pressure cooker in due time.

    Now it makes sense of the type of investors parker likes to draw and paranoia stirs them up.

    Good luck maggots

    Sentiment: Strong Buy

  • ativaloc ativaloc May 28, 2016 10:20 PM Flag

    Sarcasm noted and on a minuscule scale I partially agree with you, yes hard to believe;-( but certainly it's not the end of the world.
    OSIRIS is still a great investment for those who know the science and the Company.
    It is human nature to have different opinions but what I don't understand is why so much hate from your camp.
    Good luck to you and your investment.

    OSIRIS great people and great science.

    You are totally wrong in your accusations and exaggerations and I suggest using some of the IQ you claim to have and the professional skills you acquired in your financial career you retired from, certainly your behavior lacks both. Certainly we all want to see the restatements and quarterly results, they will come in due time and then we can have a discussion. In the meantime show a little courtesy and restrain yourself from the constant bashing.

    Personal attacks and innuendo's change absolutely nothing, it only shows the immaturity and disrespect of the accuser.

    Yes it will cost money to defend against these suits and management will be distracted but again not the end of the world.

    I remain optimistic and this too shall pass, I believe OSIRIS will be stronger than ever and yes we will see $250/sh in the not too distant future.

    GRAFIX, TRUSKIN, MENVIVO, CARTIFORM, BIO-4 and more to come.

    Let the products speak for themselves. The best science and best execution will win.

    Keep your eye on the competitors everyone wants a piece of the wounded.

    wwwDOTcmsDOTgov/Medicare/Coding/MedHCPCSGenInfo/Downloads/Drug-Agenda-2016-05-19DOTpdf or simply google this
    Attachment# 16.051
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify an injectable amniotic fluid derived
    product, Trade Name: OrthoFlo.
    Applicant's suggested language: "JXXXX - OrthoFlo, per mL".

    Best for you and your band of misfits to spend more time understanding the marketplace than wasting it on ego building exercises on the M Board.

    Sentiment: Strong Buy

  • Reply to

    Sept. 12, 2016

    by bominireal123 May 27, 2016 8:04 PM
    ativaloc ativaloc May 28, 2016 10:31 AM Flag

    You must be a dri sushi wrap investor and parker follower ............. typical TROLL

    parker needs your assistance, I'm speculating you've seen many homes get constructed you may lend a hand in constructing a larger pizza oven and give him some financial advice if heinzy agrees

    come back soon now, you hear peachy .........................now there's a delightful dessert .........georgia peachy with sugar butter and cream wrapped with dri stuff baked in oven for 1 1\2 hr till golden brown served with whipped dri stuff......................guaranteed to be a summer hit...........clear your schedule looks like you and the master TROLLS will me making the food channel circuit............bon voyage ................burp

    Sentiment: Strong Buy

  • Reply to

    Truly Sorry For You Guys

    by archerspyman May 28, 2016 8:25 AM
    ativaloc ativaloc May 28, 2016 9:26 AM Flag

    archerspyman
    33 posts | Last Activity: 48 minutes ago
    Member since: Oct 26, 2013

    TROLL ..........................looks like troll smells like a troll..........must be another pizza ingredient and parker follower following his nose

    duly diagnosed with post and delete syndrome ............. sorry for you there is no cure ........don't disappoint parker and disappear..................... carry on sushi wrap

    Sentiment: Strong Buy

  • Reply to

    Sept. 12, 2016

    by bominireal123 May 27, 2016 8:04 PM
    ativaloc ativaloc May 28, 2016 7:21 AM Flag

    MiMedx Files Lawsuit Against Osiris For False And Misleading Representations
    May 17, 2016, 08:30 ET from MiMedx Group, Inc.

    MARIETTA, Ga., May 17, 2016 /PRNewswire/ -- MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent-protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that it has filed a lawsuit under the Lanham Act against Osiris Therapeutics, Inc. for permanent injunctive relief and damages.

    The lawsuit asserts that in Osiris' press release of May 2, 2016, Osiris knowingly and willfully made false and misleading representations about a retrospective database analysis review. The lawsuit further asserts that Osiris 1) deliberately used inadequate clinical study standards to produce a biased and contrived report; 2) knew that its review did not meet any of the accepted clinical standards of a comparative effectiveness study; and 3) conspired with the physician responsible for the study to retrospectively select unmatched, uncontrolled, and subjective variables, as well as nonrandomized, noncomparable, and highly variable study groups to create a report that intentionally misleads the public. The suit was filed in the United States District Court for the Southern District of New York.

    Parker "Pete" H. Petit, Chairman and CEO of MiMedx, stated, "The press release that Osiris published on their retrospective review was an absolute disservice to advanced wound care, the patients, the professionals who serve these patients and the payer community. This type of pseudoscience serves no one."

    "MiMedx invests millions of dollars annually on rigorous scientific and clinical studies. These studies document the clinical and cost effectiveness of our allografts and are published in numerous clinical and scientific peer-reviewed journals," added Bill Taylor, President and COO.

    Petit added, "Unfortunately, this press release is yet another item on the growing list of issues that Osiris has had of late. Osiris also publicly disclosed that it is under investigation by the Securities and Exchange Commission related to its historical accounting practices, which impact financial reporting to the public. Additionally, over the last several years, Osiris has had three different Chief Executive Officers, two different Chief Financial Officers, two different Chief Medical Officers, and three different outside Auditors. Further, Osiris had a Sales Executive who pled guilty to Department of Justice charges of conspiracy to commit criminal conflicts of interest, bribery and health care fraud during his tenure with another company."

    "This type of behavior needs to be discredited or it will continue. The filing of our lawsuit is essential to stop this egregious behavior. I would encourage all participants in this sector of healthcare to reject this type of misinformation. Patients who are so much in need of advanced therapies and their attending physicians should not be deceived. Organizations that conduct themselves with honesty and integrity always eventually prevail," stated Petit.

    About MiMedx

    MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other birth tissues and human skin and bone. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. Our biomaterial platform technologies are AmnioFix®, EpiFix®, OrthoFlo, Physio®, AlloBurn™, and CollaFix™. AmnioFix and EpiFix are our tissue technologies processed from human amniotic membrane derived from donated placentas. Elected in advance of delivery through our donor program, a mother delivering a healthy baby via scheduled full-term Caesarean section birth may donate the placenta in lieu of having it discarded as medical waste. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. We recently introduced OrthoFlo, an amniotic fluid derived allograft for homologous use. Amniotic fluid is donated by a consenting mother delivering a full-term healthy baby by scheduled Caesarean section. Through the recent acquisition of Stability Biologics, our newest proprietary platforms include Physio, a unique bone grafting material comprised of 100% bone tissue with no added carrier, thus maximizing bone forming potential, a demineralized bone matrix (DBM) to complement our product portfolio offerings within the Orthopedic market and AlloBurn, a skin product for burns. CollaFix, our next technology platform we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair. CollaFix is the only biological, biodegradable, biomimetic technology that matches human tendon in strength and stiffness. The Company's wholly-owned subsidiary, Stability Biologics, LLC, is accredited by the American Association of Tissue Banks (AATB) and registered with the FDA. The Company distinguishes its revenue in two primary regenerative medicine specialties of "Wound Care" and "SSO." The Company defines SSO as surgical, sports medicine and orthopedics with spinal procedures included in orthopedics and abdominal, and lower pelvic procedures included in surgical.

    Safe Harbor Statement

    This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, that the filing of this lawsuit is essential to stopping the offending behavior. These statements are based on current information and belief, and are not guarantees of future performance. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the lawsuit may not be successful or may not otherwise stop the offending behavior, the normal risks of litigation, and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2015. By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.



    SOURCE MiMedx Group, Inc.

    Sentiment: Strong Buy

  • Reply to

    Sept. 12, 2016

    by bominireal123 May 27, 2016 8:04 PM
    ativaloc ativaloc May 28, 2016 7:13 AM Flag

    Everyone knows where this case was filed. I expect a counter suit from OSIRIS once they get cleared of any wrong doing.

    parker bit more than he can chew off of the forbidden APPLE. It will not end well for the accuser. Maybe then he will realize that he is not GOD

    thestreetDOTcom/story/13574858/2/mimedx-goes-after-osiris-with-lawsuitDOThtml

    MiMedx Goes After Osiris With Lawsuit

    The wound care provider filed the suit for allegedly falsifying and misleading consumers with clinical data.

    Wound care provider MiMedx (MDXG) is entering the legal ring again in its fight against competitors. This time, its target is Osiris Therapeutics (OSIR) .

    MiMedx has filed a lawsuit against Osiris alleging the company shared clinical data results in a false and misleading manner.

    The lawsuit comes after a May 2 press release put out by Osiris, comparing Osiris' wound care treatment, Grafix, and MiMedx's treatment, EpiFix, in a "real world study."

    "The press release that Osiris published on their retrospective review was an absolute disservice to advanced wound care, the patients, the professionals who serve these patients and the payer community, said Parker Petit, MiMedx CEO, in a release Tuesday. "This type of pseudoscience serves no one."

    The study put out by Osiris showed that 63% of wounds closed completely when the patient used Grafix, and 18.2% for EpiFix. However, the sample sizes were different - the company tested Grafix on 46 patients, while EpiFix was tested on 55.

    Further, the company did not control for types of wounds testing the products.

    "Unfortunately, this press release is yet another item on the growing list of issues that Osiris has had of late," Petit said in statement. "Osiris also publicly disclosed that it is under investigation by the Securities and Exchange Commission related to its historical accounting practices, which impact financial reporting to the public."

    MiMedx was investigated by the SEC for its marketing and sales practices in January 2015. However, by March, two months later, the Department of Justice declined to intervene with the company.

    At that time, MiMedx was embroiled in another similar lawsuit with Organogenesis, which makes skin substitute products, for allegedly interfering with its relationship with the Veteran's Administration by providing allegedly false information about wound care.

    MiMedx pulled out of the suit that Organogenesis called "frivolous" less than one month later.

    Though the drama seemed to die down, the company's beef was renewed when Petit filed a letter to Organogenesis' shareholders in December 2015, noting a short-seller note that was unidentified.

    "You may recall that our most troubled competitor, Organogenesis, has tried multiple times to injure MiMedx, and it would not surprise me if they were involved with this document," Petit wrote in a separate press release.

    The company's most recent attack against a competitor got personal, too. MiMedx called out Osiris' leadership history, including unrelated criminal charges in its press release.

    "Over the last several years, Osiris has had three different chief executive officers, two different chief financial officers, two different chief medical officers and three different outside auditors," Petit said in the release. "Further, Osiris had a sales executive who pled guilty to Department of Justice charges of conspiracy to commit criminal conflicts of interest, bribery and health care fraud during his tenure with another company."

    Neither company could be reached for comment on the lawsuit.

    Sentiment: Strong Buy

  • Reply to

    U.S. Attorney Investigation

    by volstate57 May 27, 2016 7:00 PM
    ativaloc ativaloc May 27, 2016 10:37 PM Flag

    Your hoping will change nothing, pure fiction and speculation.

    I'll wait for the truth and facts to be revealed

    innocent till proven guilty.

    Sentiment: Strong Buy

  • Reply to

    Making money with OSIR

    by homebuilder_watcher May 27, 2016 9:30 PM
    ativaloc ativaloc May 27, 2016 10:28 PM Flag

    Not only are you a carnival barker but also a fortune teller. to be so lucky

    Sentiment: Strong Buy

  • Reply to

    Sept. 12, 2016

    by bominireal123 May 27, 2016 8:04 PM
    ativaloc ativaloc May 27, 2016 10:02 PM Flag

    homebuilder_watcher

    your better served to go back an whatch your home, I believe stem cell magnet is looking for you

    "bominireal, how dumb are you? The 8K filed today did not disclose the SEC investigation that was known a long time ago but a criminal investigation by the US Attorneys Office in NY. That is an entirely and much more serious, investigation, Criminal, not civil. Some bad boys over there. And, you expect investors to believe BS press releases they issue about their product? LOL!"

    "bominireal, how dumb are you?" the same should be asked of you but not necessary now. You have spoken. bominireal is stating the facts without commentary, unlike you, pure speculation and untrue.

    "And, you expect investors to believe BS press releases they issue about their product? LOL!" investors do believe in OSIRIS and their products, so is stryker and arthrex.

    Easy to bash without any money in the game, now move along to the dri-skin board and continue to drink the dri-aid

    Sentiment: Strong Buy

  • Reply to

    Sept. 12, 2016

    by bominireal123 May 27, 2016 8:04 PM
    ativaloc ativaloc May 27, 2016 9:21 PM Flag

    Facts and not afraid of the truth

    small brain infinity imagination is just that. minuscule, just like the rest of the dry skin trolls.

    be careful not to choke on that Q, eat slowly, take small bites and chew lots.

    After Hours Volume: After Hours High: After Hours Low:

    6,847 $ 5.67 (16:24:59 PM) $ 4.72 (19:00:49 PM)

    Trade Detail

    After Hours Time (ET) After Hours Price After Hours Share Volume
    19:59 $ 4.85 100
    19:24 $ 4.85 150
    19:22 $ 4.85 900
    19:00 $ 4.84 100
    19:00 $ 4.80 100
    19:00 $ 4.72 600
    19:00 $ 4.73 300
    19:00 $ 4.73 100
    19:00 $ 4.80 800
    18:46 $ 4.80 200
    18:19 $ 4.73 100
    17:58 $ 4.73 1,000
    17:22 $ 5.10 100
    17:22 $ 5.05 100
    17:09 $ 4.98 100
    17:09 $ 5 300
    17:09 $ 5 200
    17:07 $ 5 1,000
    16:24 $ 5.67 57
    16:22 $ 5.6689 540

    Sentiment: Strong Buy

  • ativaloc ativaloc May 26, 2016 10:11 AM Flag

    You're drooling like a baby, getting all this attention sure beats listening to your wife complaints about you all day. I see you're paper trading again and dreaming about rubbing elbows with the Rockefeller's.

    Sure you and pettie petit pitty are buds and he still manages your portfolio 10/sh of dri skin 1/sh short of O. & $126.73 in savings..................keep flying and lieing heizy

    Sentiment: Strong Buy

  • ativaloc ativaloc May 25, 2016 7:05 PM Flag

    "You haven't listed or changed and you lack intelligence."

    I stand to be corrected. You have no intelligence.

    Sentiment: Strong Buy

  • ativaloc ativaloc May 25, 2016 5:46 PM Flag

    heinzy, (volstate57 )

    "They sure are which is why I suppose Anthem reimburses for Epifix and doesn't for Grafix. I'm guessing they know which facts are facts and which facts aren't."

    be careful what you boast and post about, the story may change tomorrow; Anthem is going to do what is best for them and their patients.

    If you had an ounce of sense, you would apologize to the board, sell all your love stock, take an unbiased look at OSIRIS and buy at the low. Of course only if you do own shares and have the courage.

    you're wrong on on OSIRIS and you're getting stale.

    be careful what you boast and post about, there is a lawsuit pending. Life is full of surprises ...........

    I know you're clamoring for the financials, but so what will you do with the info?

    You haven't listed or changed and you lack intelligence.

    Sentiment: Strong Buy

  • Reply to

    Cell Therapy Regulations

    by winterr2386 May 21, 2016 8:39 PM
    ativaloc ativaloc May 25, 2016 1:21 PM Flag

    Centers for Medicare & Medicaid Services (CMS) Healthcare Common Procedure Coding
    System (HCPCS) Public Meeting Agenda for Drugs/Biologicals,
    Radiopharmaceuticals/Radiologic Imaging Agents
    Thursday, May 19, 2016 9:00 am – 5:00 pm
    CMS Auditorium
    7500 Security Boulevard
    Baltimore (Woodlawn), Maryland 21244-1850
    8:15 a.m. Arrival and sign-in
    9:00 a.m. Welcome
    Background and purpose of meeting
    Meeting Format and Ground Rules
    For each agenda item, a written overview of the request and CMS’ preliminary coding
    decision is provided. Preliminary decisions are not final or binding upon any payer, and
    are subject to change. Meeting participants will hear presentations about each agenda item
    from the registered primary speaker and other speakers (if any). Presentations will be
    followed by an opportunity for questions regarding that particular agenda item. The
    public meetings provide an opportunity for the general public to provide additional input
    related to requests to modify the HCPCS code set. Final decisions are not made at the
    public meetings. Applicants will be notified of final decisions in November.
    The agenda includes a summary of each HCPCS code application on the agenda. The
    information provided in each summary reflects claims made by the applicant and should
    not be construed as a statement of fact or an endorsement by the federal government.
    AGENDA ITEM #1
    Attachment# 16.012
    Request to revise existing Level II HCPCS code Q4120, so as to include the new commercial
    brand name “Cytal” with existing commercial brand name “MatriStem”.
    Attachment# 16.013
    Request to revise existing Level II HCPCS code Q4119, so as to include the new brand name
    “Cytal” and add “Multilayer” to the code descriptor.
    AGENDA ITEM #2
    Attachment# 16.021
    Request to establish a new level II HCPCS code to identify a cryopreserved human skin
    allograft, Trade Name: TruSkin™.
    AGENDA ITEM #3
    Attachment# 16.033
    Request to establish a new Level II HCPCS code to identify a cryopreserved human placental
    matrix, Trade Name: AmnioBand™ Viable.
    Attachment# 16.034
    Request to establish a new Level II HCPCS code to identify a human placental matrix allograft,
    Trade Name: AmnioBand SL.
    Attachment# 16.035
    Request to establish a new Level II HCPCS code to identify a lyophilized placental matrix
    allograft, Trade Name: AmnioBand Particulate.
    AGENDA ITEM #4
    Attachment# 16.037
    Request to establish a new Level II HCPCS code to identify a human amniotic membrane
    allograft, Trade Name: Artacent™ Wound.
    AGENDA ITEM #5
    Attachment# 16.044
    Request to establish a new level II HCPCS code to identify a human amniotic tissue allograft,
    Trade Name: CYGNUS.
    AGENDA ITEM #6
    Attachment# 16.045
    Request to establish a new level II HCPCS code to identify decellularized particulate human
    placental connective tissue matrix, Trade Name: Interfyl.
    AGENDA ITEM #7
    Attachment# 16.046
    Request to establish new Level II HCPCS code to identify fenestrated porcine collagen products,
    Trade Names: PuraPly™ Antimicrobial Wound Matrix (PuraPly AM) and PuraPly™ Wound
    Matrix (PuraPly).
    AGENDA ITEM #8
    Attachment# 16.048
    Request to revise code Q4105, “Integra dermal regeneration template (drt), per square
    centimeter”.
    AGENDA ITEM #9
    Attachment# 16.050
    Request to establish a new level II HCPCS code to identify a human umbilical cord allograft,
    Trade Name: EpiCord™.
    Attachment# 16.051
    Request to establish a new level II HCPCS code to identify an injectable amniotic fluid derived
    product, Trade Name: OrthoFlo.
    AGENDA ITEM #10
    Attachment# 16.052
    Request to establish one new level II HCPCS code to identify human amnion allograft, Trade
    Names: PalinGen Membrane and PalinGen Hydromembrane.
    Attachment# 16.054
    Request to establish one new level II HCPCS code to identify human amnion allografts, Trade
    Names: PalinGen® XPlus Membrane and PalinGen® XPlus Hydromembrane.
    Attachment# 16.053
    Request to establish one new level II HCPCS code to identify a liquid human amnion and
    amniotic fluid allograft, Trade Name: ProMatrX ACF.
    Attachment# 16.055
    Request to establish one new level II HCPCS code to identify liquid human amnion allografts,
    Trade Names: PalinGen® Flow and PalinGen® SportFlow.
    AGENDA ITEM #11
    Attachment# 16.060
    Request to establish one new Level II HCPCS code to identify both fenestrated and nonfenestrated
    forms of a porcine derived extracellular wound matrix, Trade Name:
    MIRODERM™.
    AGENDA ITEM #12
    Attachment# 16.067
    Request to establish a new level II HCPCS code to identify placental tissue, Trade Name:
    STRAVIX.
    AGENDA ITEM #13
    Attachment# 16.069
    Request to establish a new level II HCPCS code to identify an “alloplastic” wound and burn
    dressing, Trade Name: SUPRATHEL.
    HCPCS Public Meeting Agenda Item #1
    May 19, 2016
    Attachment# 16.012
    Topic/Issue:
    Request to revise existing Level II HCPCS code Q4120, so as to include the new commercial
    brand name “Cytal” with existing commercial brand name “MatriStem”.
    Applicant's suggested language: “Q4120, MatriStem/Cytal Burn Matrix, per square centimeter”.
    Background/Discussion:
    ACell, Inc. submitted a request to revise the existing code Q4120 which currently reads,
    “Matristem burn matrix, per square centimeter”, to instead to read, “MatriStem/Cytal Burn
    Matrix, per square centimeter”. ACell is changing the product brand name MatriStem to Cytal
    over 2016. Both brand names will be commercially available during 2016. As of 1/1/17, wound
    and burn products with the brand name Matristem will be completely phased out.
    According to the applicant, MatriStem/Cytal Burn Matrix is composed of a porcine-derived
    extracellular matrix, also known as urinary bladder matrix. MatriStem/Cytal Burn Matrix is
    intended for the management of wounds and second-degree burns and injuries. The primary
    advantage of MatriStem/Cytal products is that they maintain their natural collagen structure and
    components that are gradually incorporated within the patients’ body while replacing the product
    with site-appropriate tissue. The result is constructively remodeled, site-specific tissue.
    MatriStem/Cytal burn matrix is supplied in a sheet configuration in 5 cm x 5 cm, 7 cm x 10 cm,
    and 10 cm x 15 cm sizes.
    The applicant comments that a code revision is warranted because the existing code does not
    adequately describe new and existing brand names.
    Preliminary Decision:
    This request to revise the descriptor to an existing Level II HCPCS code has not been approved,
    because the proposed revision does not improve the code.
    1) Discontinue Q4120 “MatriStem burn matrix, per square centimeter”. Effective 12/31/16.
    2) Establish Q41XX “Cytal, per square centimeter”. Effective 1/1/17.
    Attachment# 16.013
    Topic/Issue:
    Request to revise existing Level II HCPCS code Q4119, so as to include the new brand name
    “Cytal” and add “Multilayer” to the code descriptor.
    Applicant's suggested language: “Q4119, MatriStem/Cytal Wound Matrix and Multilayer
    Wound Matrix, per square centimeter”.
    Background/Discussion:
    ACell, Inc. submitted a request to revise existing code Q4119 which currently reads, “Matristem
    wound matrix, per square centimeter”, to instead read, “MatriStem/Cytal Wound Matrix and
    Multilayer Wound Matrix, per square centimeter”. ACell is changing its brand name MatriStem
    to Cytal over 2016. Both brand names will be commercially available during 2016. As of
    1/1/17, wound and burn products with the brand name Matristem will be completely phased out.
    According to the applicant, MatriStemand Cytal Wound Matrix, and MatriStemand Cytal
    Multilayer Wound Matrix are composed of porcine-derived extracellular matrix, also known as
    urinary bladder matrix. These products are intended for the management of wounds, including
    partial and full thickness wounds, pressure ulcers, tunneled wounds, surgical wounds, trauma
    wounds and draining wounds.
    MatriStemand Cytal Wound Matrix, and MatriStemand Cytal Multilayer Wound Matrix are
    supplied in a sheet configuration in sizes up to 10 cm x 15 cm.
    The applicant comments that the language of the existing code does not adequately include
    multilayer items nor the new brand name Cytal.
    Preliminary Decision:
    This request to revise the descriptor to an existing Level II HCPCS code has not been approved,
    because the proposed revision does not improve the code.
    1) Discontinue Q4119 “MatriStem wound matrix, per square centimeter”. Effective 12/31/16.
    2) Establish Q41XX “Cytal, per square centimeter”. Effective 1/1/17.
    HCPCS Public Meeting Agenda Item #2
    May 19, 2016
    Attachment# 16.021
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify a cryopreserved human skin
    allograft, Trade Name: TruSkin™.
    Applicant’s suggested language: “Qxxxx - TruSkin™, per square centimeter.”
    Background/Discussion:
    Osiris Therapeutics, Inc. submitted a request to establish a new level II HCPCS code to identify
    TruSkin. According to the applicant, TruSkin is a split-thickness cryopreserved human skin
    allograft, intended for the replacement or reconstruction of inadequate or damaged integumental
    tissue. An advanced skin substitute, TruSkin is easy-to-use, off-the-shelf alternative to fresh skin
    allograft. TruSkin addresses biological deficiencies in the wound, assists in epithelialization, and
    aids in preserving surrounding tissue. The key differentiating feature of TruSkin from all other
    preserved skin allografts is the proprietary processing, which retains all components of fresh skin
    in their native state, including: collagen-rich skin Extracellular Matrix (ECM), endogenous
    bioactive factors, and endogenous living skin cells. The applicant claims that TruSkin is
    indicated for patients with acute and chronic wounds, who have limited treatment options and are
    at great risk for wound-related morbidities and mortality. TruSkin offers patients an alternative to
    invasive procedures, including autologous skin grafting or limb amputation.
    The quantity and size of the product used will vary based upon wound size and physician
    recommendation. Application of TruSkin is recommended weekly or bi-weekly for up to 12
    weeks or until the wound is closed.
    TruSkin is supplied as a graft in two sizes: 32 cm² and 8cm².
    The applicant comments that a new code is warranted because there are no existing brandspecific
    code that identifies TruSkin.
    Preliminary Decision:
    Establish Q41XX “TruSkin, per square centimeter”.
    HCPCS Public Meeting Agenda Item #3
    May 19, 2016
    Attachment# 16.033
    Topic/Issue:
    Request to establish a new Level II HCPCS code to identify a cryopreserved human placental
    matrix, Trade Name: AmnioBand™ Viable.
    Applicant's suggested language: "QXXXX, AmnioBand Viable, per square centimeter".
    Background/Discussion:
    The Musculoskeletal Transplant Foundation submitted a request to establish a new level II
    HCPCS code to identify AmnioBand Viable. According to the applicant, AmnioBand Viable is a
    placental matrix derived from human donated amnion membranes originating from the inner
    lining of the placenta. AmnioBand Viable is intended for internal and external tissue defects,
    including acute, chronic, and surgically-created wounds. It is used as a natural wound scaffold to
    support the body’s inherent ability to restore and remodel tissue through components that have
    been preserved in the native tissue. AmnioBand Viable contains biological extracellular matrix
    proteins, cytokines, growth factors, and viable endogenous cells that work to support host tissue
    remodeling. This provides a barrier to infections and helps to maintain a moist wound
    environment for healing.
    AmnioBand Viable is supplied in 2 cm x 2 cm and 5 cm x 5 cm sizes.
    The applicant comments that a new code is warranted because no existing code describes
    AmnioBand Viable. For human allografts used in wound care, Medicare and private payers
    administer coverage and payment policies on a brand-name basis; therefore, these wound
    allografts must be issued a brand-specific HCPCS code to be eligible for claims submission and
    reimbursement.
    Preliminary Decision:
    The request to establish a new Level II HCPCS code has not been approved. Existing code
    Q4151 “Amnioband or guardian, per square centimeter” adequately describes the product that is
    the subject of this request, and is available for assignment by insurers if they deem appropriate.
    Attachment# 16.034
    Topic/Issue:
    Request to establish a new Level II HCPCS code to identify a human placental matrix allograft,
    Trade Name: AmnioBand SL.
    Applicant's suggested language: "QXXXX, AmnioBand SL, per square centimeter."
    Background/Discussion:
    The Musculoskeletal Transplant Foundation submitted a request to establish a level II HCPCS
    code to identify AmnioBand SL. According to the applicant, AmnioBand SL is a dehydrated
    single amnion layer matrix derived from human donated amnion membranes originating from the
    inner lining of the placenta. It is indicated for patients who present with chronic wounds caused
    by diabetes, obesity, COPD, obstructed blood flow and other underlying conditions. AmnioBand
    SL is a minimally processed human allograft which retains the structural properties of the
    amnion extracellular matrix. The resulting dehydrated allograft serves as a wound scaffold.
    AmnioBand SL contains growth factors and cytokines that support the membrane’s native
    function to promote cell proliferation and tissue remodeling during the wound healing phase.
    AmnioBand SL is available in rectangular and circular shapes ranging from 0.79 square
    centimeter to 49 square centimeters.
    The applicant comments that existing codes are inadequate, as they must be used in the absence
    of brand-specific codes.
    Preliminary Decision:
    The request to establish a new Level II HCPCS code has not been approved. Existing code
    Q4151 “Amnioband or guardian, per square centimeter” adequately describes the product that is
    the subject of this request, and is available for assignment by insurers if they deem appropriate.
    Attachment# 16.035
    Topic/Issue:
    Request to establish a new Level II HCPCS code to identify a lyophilized placental matrix
    allograft, Trade Name: AmnioBand Particulate.
    Applicant's suggested language: "QXXXX, AmnioBand Particulate, 1 mg".
    Background/Discussion:
    The Musculoskeletal Transplant Foundation submitted a request to establish a new level II
    HCPCS code to identify AmnioBand Particulate. According to the applicant, AmnioBand
    Particulate is derived from human donated amnion membrane originating from the inner lining
    of the placenta. AmnioBand Particulate is an allograft membrane scaffold for wounds, including
    use as a scaffold for a surgical site. It is a lyophilized placental matrix in particulate form,
    aseptically processed to preserve the tissue’s natural cytokines and tissue matrix.
    AmnioBand Particulate is intended to be used as a wound care scaffold for the replacement of
    damaged or inadequate integumental tissue, such as diabetic foot ulcers venous leg ulcers,
    pressure ulcers, or for other homologous use, particularly irregularly-shaped or crevassing
    wounds.
    AmnioBand Particulate is available in a variety of masses, ranging from 40mg to 160mg.
    The applicant comments that there are no existing codes to describe AmnioBand Particulate.
    Preliminary Decision:
    Establish Q41XX “AmnioBand, 1 mg”.
    HCPCS Public Meeting Agenda Item #4
    May 19, 2016
    Attachment# 16.037
    Topic/Issue:
    Request to establish a new Level II HCPCS code to identify a human amniotic membrane
    allograft, Trade Name: Artacent™ Wound.
    Applicant's suggested language: "QXXXX Artacent™ Wound, per sq cm".
    Background/Discussion:
    Tides Medical submitted a request to establish a new level II HCPCS code to identify Artacent
    Wound. According to the applicant, Artacent Wound is a dual-layer human amniotic membrane
    graft used for acute and chronic wound applications. It is derived from the submucosa of donated
    human placenta. It consists of collagen layers, including basement membrane and stromal
    matrix. Its dual layer and bilateral application improves handling, while its unique design permits
    easy manipulation and placement onto the wound bed. The applicant claims that Artacent Wound
    contains essential growth factors “shown to stimulate wound healing”.
    Artacent Wound is supplied in the following sizes: 1 cm x 1 cm, 2 cm x 2 cm, 2 cm x 3 cm, 4 cm
    x 4 cm, 4 cm x 6 cm, 4 cm x 8 cm, 10 mm disk, and 16 mm disk.
    The applicant comments that no currently available permanent HCPCS code appropriately
    defines Artacent Wound.
    Preliminary Decision:
    Establish Q41XX “Artacent, per square centimeter”.
    HCPCS Public Meeting Agenda Item #5
    May 19, 2016
    Attachment# 16.044
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify a human amniotic tissue allograft,
    Trade Name: CYGNUS.
    Applicant's suggested language: "QXXXX - CYGNUS, per square centimeter".
    Background/Discussion:
    Vivex Biomedical, Inc. submitted a request to establish a new level II HCPCS code to identify
    CYGNUS. According to the applicant, CYNGNUS is an amniotic tissue allograft with innate
    regenerative capability to support healing without adhesion or scar formation. It is used most
    often to treat acute wounds, chronic wounds, and burns, and it can serve as an adhesion barrier to
    keep potentially adherent surfaces apart.
    CYGNUS is a dried human amnion membrane allograft composed of a single layer of epithelial
    cells, a basement membrane, and an avascular connective tissue matrix. It is a minimally
    manipulated, dried non-viable cellular amniotic membrane allograft that preserves and delivers
    multiple extracellular matrix proteins, growth factors, cytokines, and other specialty proteins
    present in amniotic tissue to help regenerate soft tissue.
    CYGNUS is supplied in a variety of sizes, ranging from 1 cm x 2 cm to 7 cm x 7 cm.
    The applicant comments that the existing HCPCS codes do not adequately describe CYGNUS,
    since Q codes are product-specific to facilitate proper billing and coding to all payers. Currently,
    providers must use Q4100 “skin substitute, not otherwise specified”.
    Preliminary Decision:
    Establish Q41XX “Cygnus, per square centimeter”.
    HCPCS Public Meeting Agenda Item #6
    May 19, 2016
    Attachment# 16.045
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify decellularized particulate human
    placental connective tissue matrix, Trade Name: Interfyl.
    Applicant's suggested language: "QXXXX - Interfyl, 1 mg".
    Background/Discussion:
    Alliqua Biomedical, Inc. submitted a request to establish a new level II HCPCS code to identify
    Interfyl. According to the applicant, Interfyl is a decellularized and dehydrated placental disc
    (chorionic plate) derived extracellular matrix (ECM). Its connective-tissue matrix (CTM) serves
    as a scaffold for recipient cells in the wound to regenerate soft tissue. Because it is not crosslinked
    and does not contain cells, Interfyl reduces the likelihood of immunogenic and
    inflammatory responses as compared to other HCT/Ps, thereby minimizing inflammation and
    scarring.
    Interfyl is intended for use as the replacement or supplementation of damaged or inadequate
    integumental tissue by providing support for the body’s normal healing processes. Indications for
    Interfyl include treatment of deep dermal wounds, irregularly-shaped and tunneling wounds,
    augmentation of deficient/inadequate soft tissue, and the repair of small surgical defects.
    Interfyl is supplied as single-dose flowable product syringes containing 250 mg in 1.5 mL, and
    as particulate product in vials containing 50 mg and 100 mg.
    The applicant comments that a new code is warranted because no existing HCPCS code
    describes Interfyl.
    Preliminary Decision:
    Establish Q41XX “Interfyl, 1 mg”.
    HCPCS Public Meeting Agenda Item #7
    May 19, 2016
    Attachment# 16.046
    Topic/Issue:
    Request to establish new Level II HCPCS code to identify fenestrated porcine collagen products,
    Trade Names: PuraPly™ Antimicrobial Wound Matrix (PuraPly AM) and PuraPly™ Wound
    Matrix (PuraPly).
    Applicant's suggested language: "QXXXX PuraPly, and PuraPly Antimicrobial, any type, per
    square centimeter".
    Background/Discussion:
    Organogenesis, Inc. submitted a request to establish a new level II HCPCS code to identify
    PuraPly Antimicrobial Wound Matrix (PuraPly AM) and PuraPly Wound Matrix (PuraPly).
    According to the applicant, PuraPly is a single-layer fenestrated sheet of porcine collagen.
    PuraPly Am is a double-layer fenestrated and cross-linked sheet of porcine collagen, coated with
    polyhexamethylene biguanide hydrochloride (PHMB) to resist microbial colonization and reduce
    microbial penetration within the matrix.
    The two products are prescribed by a physician or other qualified health care professional and
    indicated for the management of wounds. They are typically administered in an outpatient setting
    but may be administered inpatient or in the office setting. PuraPly and PuraPly AM are
    administered by applying the product to a wound using sutures or other fixation methods.
    PuraPly AM and PuraPly are supplied in a single-layer or double-layer fenestrated sheet of
    porcine intestinal collagen, approximately 0.05 to 0.07 rnm in thickness. The products are
    available in a range of sizes from 2 cm x 4 cm to 6 cm x 9 cm.
    The applicant comments that a unique Q code is necessary to appropriately identify and
    reimburse PuraPly and PuraPly AM in the full range of site of care settings and to provide
    coding consistent with other clinically similar products. Previously, CMS established C9349 for
    PuraPly and PuraPly AM to reflect its status as a pass-through biologic, but this code is
    recognized only on hospital outpatient claims.
    Preliminary Decision:
    Establish Q41XX “PuraPly, per square centimeter”.
    HCPCS Public Meeting Agenda Item #8
    May 19, 2016
    Attachment# 16.048
    Topic/Issue:
    Request to revise code Q4105, “Integra dermal regeneration template (drt), per square
    centimeter”.
    Applicant's suggested language: "Integra dermal regeneration template (drt) or Integra Omnigraft
    dermal regeneration matrix, per square centimeter".
    Background/Discussion:
    Integra LifeSciences Corporation (Integra) submitted a request to revise the descriptor of existing
    code Q4105, which currently reads, “Integra dermal regeneration template (drt), per square
    centimeter”, to instead read, “Integra dermal regeneration template (drt) or Integra Omnigraft
    dermal regeneration matrix, per square centimeter".
    According to the applicant, Omnigraft Dermal Regeneration Matrix (Omnigraft) is an advanced
    wound care device, comprised of a porous matrix of cross-linked bovine tendon collagen and
    glycosaminoglycan with a polysiloxane (silicone) layer. The collagen-glycosaminoglycan
    biodegradable matrix provides a scaffold for cellular invasion and capillary growth.
    Integra Dermal Regeneration Template (IDRT) is indicated for the treatment of burns and scar
    contractures and is currently billed using Q4105. Through a supplemental PMA to IDRT,
    Omnigraft is indicated for use in the treatment of partial and full-thickness neuropathic diabetic
    foot ulcers that are greater than six weeks in duration, with no capsule, tendon or bone exposed,
    when used in conjunction with standard diabetic ulcer care. This new indication expands the use
    of the product to hospital outpatient departments and physician offices. Given the different brand
    name, the applicant believes that it is necessary to add the new trade name to the descriptor of
    Q4105.
    The applicant comments that the language of existing code Q4105 is insufficient to describe
    Omnigraft, because the descriptor is focused on IDRT and coders may not view it as an
    appropriate code to bill for Omnigraft. The suggested revision to the descriptor for Q4105 should
    facilitate proper billing for Omnigraft.
    Preliminary Decision:
    Revise existing code Q4105 which currently reads, “Integra Dermal Regeneration Template
    (drt), per square centimeter”, to instead read, “Integra dermal regeneration template (drt) or
    Integra Omnigraft dermal regeneration matrix, per square centimeter”.
    HCPCS Public Meeting Agenda Item #9
    May 19, 2016
    Attachment# 16.050
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify a human umbilical cord allograft,
    Trade Name: EpiCord™.
    Applicant's suggested language: "QXXXX - EpiCord™, per square centimeter".
    Background/Discussion:
    MiMedx Group, Inc. submitted a request to establish a level II HCPCS code to identify EpiCord.
    According to the applicant, EpiCord is a lyophilized, non-viable cellular umbilical cord allograft
    that provides a natural biological barrier and protective structure for wound healing
    environments. EpiCord is comprised of the protective elements of the umbilical cord with a thin
    amnion layer and a thicker Wharton Jelly mucopolysaccaride component. EpiCord provides an
    extracellular matrix (ECM) as a scaffold in the form of collagen types, fibronectin, laminins, and
    proteoglycans. This structure provides a natural wound covering and scaffold for cellular growth.
    EpiCord is indicated for diabetic elderly patients who are affected by slow healing wounds. It is
    to be used in the treatment and management of chronic and acute wounds, burns as well as a
    natural biological barrier to protect tendons. EpiCord would be used in the treatment of a chronic
    leg ulcer that requires debridement, topical care and an allograft placement and dressing for
    proper management.
    EpiCord can be stored in ambient conditions.
    The applicant comments that a new code is warranted because there is no available HCPCS code
    that appropriately describes EpiCord.
    Preliminary Decision:
    Revise existing Q4131, which currently reads, "Epifix, per square centimeter", to instead read,
    "Epifix or Epicord, per square centimeter".
    Attachment# 16.051
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify an injectable amniotic fluid derived
    product, Trade Name: OrthoFlo.
    Applicant's suggested language: "JXXXX - OrthoFlo, per mL".
    Background/Discussion:
    MiMedx Group, Inc. submitted a request to establish a new level II HCPCS code to identify
    OrthoFlo. According to the applicant, OrthoFlo is an amniotic fluid derived allograft used to
    “supplement the ability of existing synovial fluid to lubricate and protect”. OrthoFlo protects,
    reduces inflammation, lubricates and addresses pain of the joints. OrthoFlo is clinically intended
    for patients with joint pain due to disease or trauma, resulting in the reduction in lubricating
    properties of the synovial fluid. OrthoFlo is an amniotic fluid product that is optimally filtered to
    retain the natural macromolecular and physiologically active components of amniotic fluid,
    while removing low molecular weight by-products produced in utero.
    OrthoFlo is administered by a physician. It is injected in the joint with or without ultrasound
    guidance, as needed, to protect, lubricate, and reduce inflammation. Dosage is determined by the
    physician. OrthoFlo is supplied in single-use 0.5 mL, 1 mL, 2 mL, and 4 mL vials.
    MiMedx describes OrthoFlo as a Human Tissue Product for which FDA premarket approval is
    not required. While MiMedx’s packaging information describes OrthoFlo as an amniotic fluid
    derived product indicated for “homologous use”, the stated indication is supplementation of
    synovial fluid in the knee joint in order to cushion, lubricate and reduce inflammation.
    The applicant comments that a new code is warranted because no available HCPCS code
    appropriately describes OrthoFlo or similar amniotic products.
    Preliminary Decision:
    This request to establish a new Level II HCPCS code to separately identify OrthoFlo has not
    been approved, because this application is incomplete. This product does not have the FDA
    clearance that is required for the indication specified in the code application.
    HCPCS Public Meeting Agenda Item #10
    May 19, 2016
    Attachment# 16.052
    Topic/Issue:
    Request to establish one new level II HCPCS code to identify human amnion allografts, Trade
    Names: PalinGen® Membrane and PalinGen® Hydromembrane.
    Applicant's suggested language: "QXXXX - PalinGen® Membrane and PalinGen®
    Hydromembrane, per square centimeter".
    Background/Discussion:
    On behalf Amnio Technology LLC, an applicant submitted a request to establish a new level II
    HCPCS code to identify PalinGen Membrane and PalinGen Hydromembrane. According to the
    applicant, PalinGen Membrane and PalinGen Hydromembrane are human allografts comprised
    of amniotic membrane, providing a wound covering and support for native tissues. These human
    allografts provide a biological and physical barrier to support and protect naturally occurring and
    surgical wounds in vivo.
    PalinGen Membrane and PalinGen Hydromembrane are commonly used in the treatment of
    chronic wounds, and they are also indicated for the repair and reconstruction of a recipient’s cells
    or tissues, including venous leg ulcers, diabetic ulcers, pressure ulcers and in orthopedic, cardiac
    and ophthalmologic conditions.
    PalinGen Membrane and PalinGen Hydromembrane are supplied in ten different sizes, ranging
    from 1 sq.cm to 64 sq.cm.
    The applicant comments that a new code is warranted because there is no existing code to
    describe these products.
    Preliminary Decision:
    Establish Q41XX “PalinGen, per square centimeter.”
    Attachment# 16.054
    Topic/Issue:
    Request to establish one new level II HCPCS code to identify human amnion allografts, Trade
    Names: PalinGen® XPlus Membrane and PalinGen® XPlus Hydromembrane.
    Applicant's suggested language: "QXXXX - PalinGen® XPlus Membrane and PalinGen® XPlus
    Hydromembrane, per square centimeter".
    Background/Discussion:
    On behalf of Amnio Technology, an applicant submitted a request to establish a level II HCPCS
    code to identify PalinGen XPlus Membrane and PalinGen XPlus Hydromembrane. According to
    the applicant, PalinGen XPlus Membrane and PalinGen XPlus Hydromembrane are human
    allografts comprised of amniotic membrane. They provide a wound covering and support for
    native tissues. They are used to repair or replace soft tissue defects, soft trauma defects,
    tendinitis, tendinosis, chronic wound repair and localized inflammation.
    The patient population for the item are older Type I patients with diabetes for the treatment of
    chronic wounds. These products have also been used in the repair and reconstruction of a
    recipient’s cells or tissues including venous leg ulcers, diabetic ulcers, pressure ulcers, and in
    orthopedic, cardiac and ophthalmologic conditions.
    PalinGen XPlus Membrane and PalinGen XPlus Hydromembrane are supplied in ten different
    sizes, ranging from 1 sq.cm to 64 sq.cm.
    The applicant comments that a new code is warranted because no existing code describes these
    products.
    Preliminary Decision:
    Establish Q41XX “PalinGen, per square centimeter.”
    Attachment# 16.053
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify a liquid human amnion and amniotic
    fluid allograft, Trade Name: ProMatrX™ ACF.
    Applicant's suggested language: "QXXXX - ProMatrX™ ACF, 0.25 cc.”
    Background/Discussion:
    On behalf of Amnio Technology, an applicant submitted a request to establish a level II HCPCS
    code to identify ProMatrX ACF. According to the applicant, ProMatrX ACF is a human allograft
    comprised of amnion and amniotic fluid, providing a liquid allograft to “aid in the healing” and
    repair of chronic wounds. ProMatrX ACF contains key growth factors, cytokines, amino acids,
    carbohydrates, hyaluronic acid, extracellular matrix proteins, and cellular components
    recognized as intrinsic to the complex wound healing process.
    ProMatrX ACF is commonly used in the treatment of chronic wounds that are most prevalent in
    older populations, particularly in patients with Type I diabetes.
    ProMatrX ACF is amniotic membrane and fluid suspended in liquid. The product is applied
    directly on or in the wound with a 20-23 gauge needle. The prescribed dosage varies by the size
    of the wound. Typical doses range from 0.25 cc to 4.0 cc, depending on the size, depth and type
    of wound.
    ProMatrX ACF is supplied in liquid form in vials containing 0.25 cc, 0.5 cc, 1 cc, 2 cc, and 4 cc.
    These products are cryopreserved and should be stored frozen at a temperature at -80°C +/- 15°.
    The applicant comments that a new code is warranted because, as with other bioengineered skin
    substitutes, ProMatrX ACF requires a brand-specific HCPCS code in order to be readily
    identifiable for third party claims processing.
    Preliminary Decision:
    Establish Q41XX “PalinGen or ProMatrX, 0.36 mg per 0.25 cc”.
    Attachment# 16.055
    Topic/Issue:
    Request to establish one new level II HCPCS code to identify liquid human amnion allografts,
    Trade Names: PalinGen® Flow and PalinGen® SportFlow.
    Applicant's suggested language: "QXXXX - PalinGen® Flow and PalinGen® SportFlow, 0.25
    cc."
    Background/Discussion:
    On behalf of Amnio Technology, an applicant submitted a request to establish a level II HCPCS
    code to identify PalinGen Flow and PalinGen SportFlow. According to the applicant, PalinGen
    Flow and PalinGen SportFlow are human allografts comprised of amnion and amniotic fluid
    components, providing a liquid allograft to “aid in the healing” and repair of chronic wounds.
    PalinGen Flow and PalinGen SportFlow contain key growth factors, cytokines, amino acids,
    carbohydrates, hyaluronic acid, extracellular matrix proteins, and cellular components
    recognized as intrinsic to the complex wound healing process.
    PalinGen Flow and PalinGen SportFlow are commonly used in the treatment of chronic wounds
    that are most prevalent in older populations, particularly in patients with Type I diabetes.
    PalinGen Flow and PalinGen SportFlow are amniotic membrane and fluid that are suspended in
    liquid. The product is applied directly on or in the wound with a 20-23 gauge needle. The
    prescribed dosage varies by the size of the wound. Typical doses range from 0.25 cc to 4.0 cc,
    depending on the size, depth and type of wound.
    PalinGen Flow and PalinGen SportFlow are similar, but separate, products. They are supplied in
    liquid form in vials containing 0.25 cc, 0.5 cc, 1 cc, 2 cc, and 4 cc. These products are
    cryopreserved and should be stored frozen at a temperature of -80°C +/- 15°.
    The applicant comments that a new code is warranted because, as with other bioengineered skin
    substitutes, PalinGen Flow and PalinGen SportFlow require a brand-specific HCPCS code in
    order to be readily identifiable for third party claims processing.
    Preliminary Decision:
    Establish Q41XX “PalinGen or ProMatrX, 0.36 mg per 0.25 cc”.
    HCPCS Public Meeting Agenda Item #11
    May 19, 2016
    Attachment# 16.060
    Topic/Issue:
    Request to establish one new Level II HCPCS code to identify both fenestrated and nonfenestrated
    forms of a porcine derived extracellular wound matrix, Trade Name:
    MIRODERM™.
    Applicant's suggested language: "QXXXX - MIRODERM, per square centimeter".
    Background/Discussion:
    On behalf of Miromatrix Medical, an applicant submitted a request to establish a new level II
    HCPCS code to identify MIRODERM. According to the applicant, MIRODERM is a noncrosslinked
    acellular wound matrix that is derived from porcine liver and is processed and stored
    in a phosphate buffered aqueous solution. It is clinically indicated for the management of
    wounds. MIRODERM is used on a chronic wound where it provides a scaffold to maintain and
    support a healing environment through constructive remodeling. It is used to cover the entire
    surface of the wound bed and extend slightly beyond all wound margins.
    MIRODERM is available in fenestrated and non-fenestrated form, in seven sizes ranging from 9
    cm² to 120 cm².
    The applicant comments that a new code is warranted because there are no existing codes to
    describe MIRODERM.
    Preliminary Decision:
    Establish Q41XX “Miroderm, per square centimeter”.
    HCPCS Public Meeting Agenda Item #12
    May 19, 2016
    Attachment# 16.067
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify placental tissue, Trade Name:
    STRAVIX.
    Applicant's suggested language: "QXXXX - Stravix, per square centimeter".
    Background/Discussion:
    Osiris Therapeutics Inc. submitted a request to establish a new level II HCPCS code to identify
    Stravix. According to the applicant, Stravix is a cryopreserved human placental tissue, composed
    of the Wharton’s jelly and umbilical amniotic membrane. Stravix is processed from human
    umbilical cord and contains: a collagen and hyaluronic acid-rich extracellular matrix;
    endogenous biofactors with anti-inflammatory, angiogenic, anti-scarring, and anti-microbial
    properties; and viable endogenous cells, including mesenchymal stem cells.
    The applicant provided information that Stravix is currently used in inpatient surgical
    applications only, including: as a wound cover in deep, acute wounds; surgical wound repair; and
    the majority of applications are surgical, below the knee, leg and foot tendon repairs, and
    neurovascular repair.
    Stravix is supplied as a cryopreserved placental tissue packaged in a wide-mouth jar. It is
    available in two sizes (3 x 6 cm, 2 x 4 cm). When stored frozen at -80°C, Stravix has a two year
    shelf-life.
    The applicant comments that a new code is warranted because there are no existing HCPCS
    codes that appropriately define Stravix.
    Preliminary Decision:
    This request to establish a new Level II HCPCS code to separately identify Stravix has not been
    approved. The product is included in the inpatient surgical procedure. Separate reporting could
    be considered duplicative and inappropriate.
    HCPCS Public Meeting Agenda Item #13
    May 19, 2016
    Attachment# 16.069
    Topic/Issue:
    Request to establish a new level II HCPCS code to identify an “alloplastic” wound and burn
    dressing, Trade Name: SUPRATHEL.
    Applicant's suggested language: "QXXXX - Suprathel, per square centimeter".
    Background/Discussion:
    Polymedics Innovations Inc. submitted a request to establish a level II HCPCS code to identify
    Suprathel. According to the applicant, Suprathel is a copolymer of polylactides, trimethlene
    carbonate, and ε-caprolactone. It is an alloplastic, absorbable “skin substitute” with properties
    similar to the skin. It is highly permeable to oxygen and water vapor, providing a particularly
    favorable environment for wound healing. Suprathel is used for epidermal and dermal wounds,
    such as split skin graft donor sites and partial thickness burns. Suprathel may also be used for
    partial and full thickness wounds.
    Depending on the wound size, the appropriate square centimeters of the Suprathel membrane(s)
    shall be applied. A protective gauze should be applied over Suprathel on areas subject to
    mechanical stress, such as the extremities and the dorsal side of the torso. This protective
    dressing should comprise a fatty gauze and absorbent gauze. Suprathel, together with the gauze,
    shall remain unchanged until wound healing is completed. If Suprathel remains longer on the
    skin, it will be absorbed completely in approximately 60 days, without irritation to the upper
    epithelial layers.
    Suprathel is available in four sizes: 5 x 5 cm; 9 x 10 cm; 18 x 10 cm; and 18 x 23 cm square
    sheet membranes. Suprathel is also available in hand-shaped pads that can be used on the flexor
    and/or exterior side of the hand.
    The applicant comments that a new code is warranted because none of the existing brandspecific
    Q codes for skin substitutes appropriately describes Suprathel.
    Preliminary Decision:
    A national program operating need was not identified by Medicare, Medicaid or the Private
    Insurance sector to establish a new HCPCS code to separately identify this synthetic product.
    Existing code A4649 "Surgical supply; miscellaneous" is available for assignment by insurers if
    they deem appropriate.

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    by frozenyogurt41 May 24, 2016 6:47 PM
    ativaloc ativaloc May 24, 2016 11:54 PM Flag

    Grafix®, a Cryopreserved Placental Membrane, for the Treatment of Chronic/Stalled Wounds
    Gary W. Gibbons
    Author information ► Article notes ► Copyright and License information ►
    Go to:
    Abstract
    Objective: To discuss the use of Grafix®, a commercially available, cryopreserved placental membrane, for the treatment of chronic/stalled wounds of different etiologies.

    Approach: To describe the unique composition of Grafix, to provide an overview of the existing clinical evidence supporting the benefits of Grafix for wound treatment, and to share the experience of the South Shore Hospital Center for Wound Healing (Weymouth, MA) with Grafix for the treatment of nonhealing wounds.

    Results: Clinical evidence supports the safety and efficacy of Grafix for the treatment of chronic/stalled wounds, including those that have failed other advanced treatment modalities.

    Innovation: Grafix is a cryopreserved placental membrane manufactured utilizing a novel technology that enables the preservation of all placental membrane components in their native state. Placental membranes have a unique composition of extracellular matrix, growth factors, and cells (including mesenchymal stem cells), which makes this tissue unique among other advanced biological wound treatment modalities.

    Conclusion: Clinical evidences support the benefits of Grafix for head-to-toe wound treatment.

    figure fig-6
    Gary W. Gibbons, MD, FACS
    Go to:
    Introduction
    Chronic wounds are wounds that fail to repair in a timely and orderly manner due to their inability to progress from the inflammatory phase into the proliferative phase and ultimately into the remodeling phase.1 Chronic wounds are estimated to affect more than 6.5 million patients in the United States alone, and more than $50 billion annually is spent.2,3 Some new economic data suggest that $15 billion is spent treating diabetic foot ulcers (DFUs), $18 billion on venous leg ulcers (VLUs), and $13 billion on pressure ulcers without even the inclusion of acute and traumatic wounds.4–8 One to two percent of the population in developed countries will experience a chronic wound due to increased life expectancy coupled with a rise in comorbidities—specifically diabetes, obesity, venous hypertension, and peripheral vascular disease.9

    Various standardized treatment algorithms for the treatment of chronic wounds have been developed by the American Diabetes Association (ADA), the Wound Healing Society (WHS), the American Society of Plastic Surgeons, and other societies for different wound types.10–12 Early aggressive surgical debridement and control of infection, appropriate compression for venous ulcers, off-loading or complete pressure relief for diabetic foot and pressure ulcers, and timely revascularization are the most common approaches recommended by the Chronic Wound Care Guidelines, a publication of the WHS. However, the implementation of these guidelines is frequently fragmented or silo/specialty driven. For example, the evidence to support the use of off-loading devices for healing foot ulcers is clear. A total contact cast (TCC) is considered the gold standard for off-loading plantar foot ulcers; however, it is the preferred treatment in only 2% of centers in the United States.13–15 Closure rates, even when using appropriate standard of care (SOC) for chronic wounds, vary from 21% to 35% depending on the type of wound.16 SOC for VLUs, for instance, is often insufficient as evidenced by stalled healing and high recurrence rates.17 Wounds that do not heal with SOC place the patient at an increased risk for wound-related morbidities and mortality, as well as increased costs to the patient and the healthcare system.15 In such cases, physicians should consider advanced therapies that provide the components necessary for wound healing—cells, including mesenchymal stem cells (MSCs), growth factors, and extracellular matrix (ECM) proteins—as found in autologous skin grafts.18–20

    Recently, literature has supported the early adoption of advanced care products for wounds that do not respond to SOC in a timely manner (4 weeks).21 These advanced products, such as human skin equivalents and topical recombinant growth factors, have been shown to reduce overall costs and prevent amputations.22,23 Skin substitutes have held the most promise for healing chronic wounds because they contain some components needed for wound healing, but they are deficient due to a lack of MSCs, which are present in normal healthy skin.24 The beneficial effect of MSCs on wound healing has been observed in a variety of animal models and in reported clinical cases. Specifically, MSCs have been successfully used to treat chronic wounds and stimulate the stalled healing processes.18,25,26

    Recent studies have revealed that human placental membranes are a rich source of MSCs, collagen matrix, and growth factors, and they can support tissue regeneration and repair.27,28 Placental membranes have a long history of use for wound treatment, and their beneficial effects have been, in part, attributed to their anti-inflammatory, antimicrobial, and angiogenic activities.29–32 The membranes also create a moist environment, which is important for healing.33 Currently, there are more than 25 commercial placental products, but they are all devitalized. Grafix® (Osiris Therapeutics, Inc., Columbia, MD) is a cryopreserved, human placental membrane and the only commercially available placental membrane product to contain viable endogenous cells. Grafix is manufactured using a novel technology that facilitates the retention of all inherent components of the native tissue: three-dimensional extracellular matrix, inherent growth factors, and living cells (including epithelial cells, fibroblasts, and MSCs).18 Recent in vitro studies demonstrate that preservation of endogenous viable cells in placental membranes enhances the anti-inflammatory, antioxidant, chemoattractive, and angiogenic activities of placental membranes compared to devitalized membranes.34–36 In clinical studies, treatment with Grafix led to high wound closure rates for difficult-to-treat chronic wounds, which suggests that Grafix is a promising new wound treatment therapy.37,38 The purpose of this technology report is to overview the composition of Grafix and clinical evidence for the use of Grafix for stalled wounds.

    Go to:
    Clinical Problem Addressed
    Despite a variety of advanced wound care products available, nonhealing wounds remain a large and growing problem, particularly chronic wounds such as DFUs, VLUs, and pressure ulcers. Patients with nonhealing wounds have a poor quality of life and are at the greatest risk for wound-related morbidities.38 Treatment of such patients puts an enormous financial burden on our society. Grafix, a cryopreserved placental membrane allograft, is a new advanced wound care product that has recently become available for such patients. The unique composition of Grafix offers a safe and effective treatment modality for patients with nonhealing wounds.

    Go to:
    Materials and Methods
    Grafix technology

    Grafix is a cryopreserved placental membrane in which the structural and cellular integrity of fresh placental membranes is preserved through an innovative technology. Grafix contains a collagen-rich matrix, growth factors, cytokines, and endogenous viable cells, including epithelial cells, fibroblasts, and MSCs (Fig. 1).18,34 Previous attempts to preserve viable endogenous cells in placental membranes have resulted in 80% cell viability post-thaw.34 The benefits of retaining viable endogenous cells in placental membranes have been demonstrated in a series of in vitro studies. Results show that preservation of viable cells enhances wound-relevant properties, such as anti-inflammatory and cell recruitment, of cryopreserved placental membranes compared to devitalized membranes.34,35 The cells and growth factors present in Grafix are integrally associated with a collagen-rich ECM. Current bioengineered or advanced wound care products are deficient in one or more of these components. The presence of MSCs is a unique characteristic of Grafix, which differentiates this product from other advanced wound care therapies. Although the contribution of MSCs to the biological activities of placental membranes remains to be fully elucidated, accumulated data demonstrate that MSCs play an important role in all phases of healing, and their presence supports the achievement of full wound closure.18,25,26 As such, the therapeutic application of MSCs has been shown to enhance and improve wound healing in clinical settings.18

    Figure. 1.
    Figure. 1.
    Grafix®, a cryopreserved placental membrane, maintains all components of fresh placental tissue, which includes extracellular matrix, growth factors, and viable endogenous cells (epithelial cells, fibroblasts, and mesenchymal stem cells), in their ...
    Grafix regulatory status and intended use

    Grafix is regulated by the FDA under 21 CFR Part 1271 Part 361 Human Cells, Tissues, and Cellular and Tissue-based Products (HCT/Ps). It is intended for use as a wound cover and can be used for the treatment of both acute and chronic wounds, including but not limited to DFUs, VLUs, pressure ulcers, burns, surgical incisions and dehiscence, pyoderma gangrenosum, and epidermolysis bullosa. Extensive donor screening and serological, bioburden, and sterility testing are performed on every lot to demonstrate suitability for transplantation. Each lot is additionally tested to confirm at least 70% cellular viability post-thaw.

    Grafix storage, preparation, and application to the wound

    Grafix is stored at −80°C before use and has a 2-year shelf life. Grafix is supplied in a cryogenic bag filled with a cryoprotectant solution. It is mounted on a plastic applicator for easy handling. Grafix should be thawed before application. Figure 2 shows the preparation and application procedure as per the manufacturer's recommendations. To apply, slightly bend the plastic applicator to remove the top solid cover, and slide Grafix from the perforated backing onto the wound bed using aseptic technique (Fig. 2). Grafix is flexible and conforms and adheres to complex anatomies. Thus, it does not require suturing or other methods of fixation. Before treatment with any wound care product, wounds are recommended to be appropriately cleaned and debrided. After applying Grafix, a nonadherent dressing should be placed over Grafix to fully cover both the membrane and the wound bed. Saline-moistened gauze (for dry wounds) or a foam dressing (for draining wounds) should be placed on top of the nonadherent dressing, followed by an appropriate compressive or off-loading outer dressing. Patients should use an appropriate off-loading shoe, boot, or walker. It is recommended to apply Grafix on a weekly basis.37

    Figure. 2.
    Figure. 2.
    Preparation and application of Grafix. This preparation and application guide is provided by Osiris Therapeutics, Inc., the manufacturer of Grafix.
    Grafix should not be applied to acute or chronic wounds with an active untreated infection and in patients with known hypersensitivity to gentamicin, vancomycin, or Amphotericin B. These three antibiotics are used during tissue processing for bioburden reduction. Although the antibiotics are removed from the tissue by rinsing, some residual amount may remain.

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    Clinical Results
    Previously published clinical data

    The safety and efficacy of Grafix have been demonstrated in two recently published clinical studies, the results of which are recently reported.37,38 One study was a multicenter, single-blinded, randomized controlled clinical trial conducted by Lavery et al. comparing the treatment of DFUs with SOC versus Grafix. The primary endpoint was the proportion of patients with complete wound closure after 12 weeks, and secondary endpoints included time to wound closure, number of adverse events, and wound closure in the crossover phase (open-label treatment for patients who failed to close with SOC).37 One unique, important trial design element was blinded imaging verification of wound closure. This was the first randomized controlled trial (RCT) for advanced wound care products, in which the primary endpoint was confirmed by third party, blinded wound care experts to further remove potential bias and to increase the reliability of the results. Lavery et al. have also stated that this is the only multicenter DFU trial to date that meets statistically significant prespecified interim analysis.37 Ninety-seven patients were enrolled in the trial: 50 were treated with Grafix & SOC and 47 received SOC alone. SOC included wound debridement of necrotic tissues, application of a nonadherent dressing (Adaptic®, Systagenix, Gatwick, UK), and either saline-moistened gauze or Allevyn® (Smith & Nephew, London, United Kingdom) for moderately draining wounds followed by an outer dressing. Patients received walking boots if the wound was on the sole of the foot or a postoperative shoe if the wound was on the dorsum of the foot or ankle. Patients were evaluated weekly, and Grafix was applied weekly. There were no statistically significant differences in patient demographics or baseline characteristics between the Grafix and SOC groups. Results revealed that treatment of DFUs with Grafix showed a statistical improvement in wound closure compared to SOC—62% versus 21.3%, respectively (p=0.0001). Relative improvement is a measure comparing the effect of the treatment arm to the control arm, which allows comparisons between different trials. In the clinical study by Lavery et al., the relative improvement was 191% compared with SOC—calculated as (% wound closure with Grafix−% wound closure with SOC) / % wound closure with SOC.37 A previously published analysis of RCTs shows that among cellular products, the highest relative improvement was 64% for Dermagraft (Organogenesis, Canton, MA) over the control group.41 Overall, TCC had the highest relative improvement of 81%.41 Therefore, to date, Grafix has the highest relative improvement among advanced wound care products with RCT data.

    In addition, Grafix also demonstrated decreased complications associated with DFUs, particularly the rate of wound-related infection, which translated into decreased hospitalizations. There were significantly fewer patients with wound-related infections in the Grafix treatment arm compared to SOC (18.0% vs. 36.2%, p=0.044), which can be explained by faster wound closure in the Grafix arm (42 days vs. 69.5 days median time to wound closure for Grafix vs. SOC, p=0.019).37 In addition, it is known that placental membranes have antibacterial properties, which could contribute to the lower rate of infections that may be linked to these properties.29 In the Lavery et. al. trial, no immunological adverse events related to the use of allogeneic tissue containing viable cells were recorded.37 These data are in agreement with previous clinical reports in which placental tissue was used for wound treatment.40,42 The wound closure with Grafix was durable: 82.1% of patients remained closed after 12 weeks of follow-up. Patients in the control arm who failed to heal during the initial 12-week treatment period could cross over to receive Grafix in the open-label crossover phase of the trial (26 patients enrolled). After Grafix treatment for up to an additional 12 weeks, the probability of wound closure in the crossover phase was 67.8% with a mean time to closure of 42 days.37

    The second study was a large, retrospective single-center study conducted by Regulski et al.38 Data for all wound care patients who received at least one Grafix application between April 2010 and March 2012 were collected retrospectively through chart review by the treating physicians at the Ocean County Foot and Ankle and the Wound Institute of New Jersey. At each visit, the physician would assess the wound and determine if the Grafix treatment was appropriate. Grafix was applied to patients whose wounds were present for 4 weeks or longer, and the underlying morbidity and infection were adequately treated. Grafix was applied directly to wounds that were prepared by sharp debridement followed by application of a non-adherent dressing, saline-moistened gauze, and dry gauze. Depending on the wound type, multilayer compressing bandaging (for VLUs) and/or off-loading devices, such as TCC, surgical shoe, or DH Offloading Walker® (Ossur Americas, Foothill Ranch, CA), were provided. Wounds were measured with a ruler, and the treating physician determined wound closure by 100% reepithelialization and no evidence of drainage.

    This study consisted of 66 patients with 67 chronic wounds and demonstrated a 76.1% wound closure rate for all types of wounds. The types of wounds in this study included DFUs (n=27), VLUs (n=34), and other chronic wounds (n=6). The average wound size at baseline was 6.65±9.68 cm2, and the average wound duration before Grafix treatment was 38±70.8 weeks. Fifty patients (74.6%) had failed to heal using other advanced therapies, which included collagen dressings, acellular matrices, skin grafts, cellular skin substitutes, hyperbaric oxygen therapy, wound vacuum, and topical growth factors. After 12 weeks of care, 51 of the 67 wounds (76.1%) were healed: 23 of 27 (85.2%) DFUs, 23 of 34 (67.6%) VLUs, and 5 of 6 (83.3%) other wounds. The average time to closure in these wounds was 5.8±2.5 weeks with an average 3.2 applications for patients who healed. No adverse events attributed to the use of Grafix were reported for this study. No wound recurrences occurred during an average follow-up time of 20.4 months.38 This study demonstrates that Grafix shows benefits not only for DFUs but also for other types of chronic wounds. In addition, the patient population includes refractory or difficult-to-treat patients, which is usually excluded from controlled clinical trials. However, the absence of a control group is a limitation of the study due to its retrospective nature.

    The South Shore Hospital Center for Wound Healing experience with Grafix

    The South Shore Hospital Center for Wound Healing (Weymouth, Massachusetts) has a growing experience using Grafix in patients experiencing difficult-to-heal wounds, which have an adverse impact on their quality of life. The short form 36 health survey (SF-36) is used to assess patients' quality of life, and we observed that the scores for many patients with chronic wounds are comparable to those of cancer patients. Patients are selected to be treated with Grafix if their wound does not reduce by 50% after 4 weeks of treatment with proper off-loading and adequate vascular status or if wounds persist for 2 years. In addition, many of the wounds seen at the wound care center have failed other advanced wound therapies, including Apligraf® (Organogenesis, Canton, MA), and therefore, are also candidates for treatment with Grafix. To date, approximately 10–15 patients have been treated or continue to receive treatment with Grafix. Although it is recommended for Grafix to be applied weekly, we sometimes apply Grafix bi-weekly if the wound size is rapidly decreasing. Below is a presentation of three unique cases of nonhealing wounds of different etiologies treated with Grafix at the South Shore Hospital Center for Wound Healing.

    Stage IV sacral wound case
    An 82-year-old male was transferred to the wound care clinic from a rehabilitation center where he had been admitted after sustaining a fall and developing pneumonia. The patient presented with a stage IV sacral wound of 3 months duration measuring 2.5×2.5×1.6 cm (Fig. 3A). Past medical history included Parkinson's disease and both urinary and bowel incontinence. A collagenase ointment was being applied at the time of admission to our clinic. Neither off-loading nor cushioning for the wound was previously prescribed.

    Figure. 3.
    Figure. 3.
    (A) A 2.5×2.5×1.6 cm stage IV sacral wound persisting for 3 months in an 82-year-old male before treatment. (B) Wound was surgically debrided to a 2 cm depth. A negative pressure wound vacuum (VAC), off-loading cushion, ...
    The patient was taken to the operating room where the wound was radically debrided to a depth of 2.0 cm (Fig. 3B). Cultures taken at this time were negative. Postoperatively, a negative pressure wound vacuum (VAC) (125 mm/Hg) was prescribed as well as an off-loading cushion and air alternating mattress.

    After 12 weeks of VAC and proper off-loading, the wound showed a well granulating base that measured 0.8×0.8×0.3 cm (Fig. 3C). At this point, VAC was discontinued because the noise and its effect on patient mobility had a significant negative impact on the quality of life for the patient. Grafix was a convenient option for this patient, and we believed that Grafix would close this wound faster than VAC. The wound was primed to receive Grafix, and upon application, the patient was discharged to return home where proper off-loading and cushioning were continued.

    After 3 weeks of follow-up care in the wound clinic, the wound measured 0.5×0.6×0.1 cm (Fig. 3D). The wound was cleansed and debrided of nonviable tissue, and a second application of Grafix was applied to the wound. The patient was maintained on proper off-loading and followed for the next 2 weeks. In conclusion, 4 months after initial presentation of this patient, while under the management of a multidisciplinary team dedicated to wound healing, the wound was completely reepithelialized after two applications of Grafix over a 5-week period (Fig. 3E). To date, 15 months post Grafix application, this patient's wound has remained closed restoring him with improved quality of life and function.

    Diabetic foot ulcer case
    A 69-year-old insulin-dependent diabetic female presented to the wound care center with an ulceration on the medial aspect of the right first metatarsal head after wearing new shoes and cellulitis extending up the lower extremity was noted. The wound measured 1.5×2.9×0.3 cm and probed to capsule, but not into the joint (Fig. 4A). There was a mild peripheral arterial disease upon examination. The wound was aggressively debrided; radiographs were negative for osteomyelitis. Cultures were taken, the foot was off-loaded, and the patient was prescribed clindamycin and levaquin and instructed to return to the wound care center in 48 h. Upon return, it was noted that the cellulitis was responding to the antibiotic treatment. Wound cultures were positive for Streptococcus aureus and α-Streptococcus, and clindamycin therapy was continued. The wound was further debrided down to the exposed capsule, and negative pressure wound therapy (125 mm/Hg) was applied. The patient was followed up in the clinic for the following 3 weeks with serial debridements, negative pressure therapy, and off-loading (multilayer felt foam) to achieve optimal wound bed preparation.

    Figure. 4.
    Figure. 4.
    (A) An ulceration on the medial aspect of the right first metatarsal head from wearing a new shoe in a 69-year-old insulin-dependent diabetic female before treatment. Cellulitis extending up the lower extremity was noted. The wound probed down to capsule, ...
    After 3 weeks of continued negative pressure wound therapy, the wound bed showed signs of granulation, but was not progressing to closure; therefore, the team elected to discontinue the negative pressure therapy and apply an advanced regenerative therapy (Fig. 4B). Grafix was selected as a treatment modality, and six bi-weekly applications of Grafix were performed. After six bi-weekly applications of Grafix, the wound was completely reepithelialized, and no further dressings were needed (Fig. 4C). To prevent re-ulceration, the patient's shoes were adjusted with appropriate inserts. Despite initial joint capsule exposure and infection, admission and potential readmissions were avoided by following an evidence-based algorithm recommended for DFU by ADA and WHS, including the use of advanced regenerative therapy to achieve closure.

    Refractory (49-year persistence) shrapnel leg wound case
    A 68-year-old Vietnam veteran sustained a shrapnel injury, open fractures, and a wound to the right lower leg in 1966. Since that time, he had been hospitalized for 13 months and had multiple surgeries, including debridement of osteomyelitis, fixations, muscle and skin flaps, and grafts. His leg wound never completely closed over the 49-year period and required periodic hospital admissions, IV antibiotics, and surgeries. In 2012, he had a series of surgeries, negative pressure therapy, 50 treatments of hyperbaric oxygen therapy, multiple skin grafts, and bioengineered skin applications without reaching complete sustained wound closure. In October 2014, he was admitted to the South Shore Hospital with significant wound infection and staphylococcal septicemia requiring 4 weeks of IV antibiotics. After that, he was re-admitted with severe generalized muscle weakness, fever, fatigue, and a diagnosis of polymyalgia, which was treated with a prednisone course tapered to 10 mg/day. He was discharged from the hospital in November 2014 with a referral to our wound center where the wound was debrided and biopsied. There was no remaining shrapnel and no indication of osteomyelitis, vascular disease, or chronic infection in the wound. The tissue near the wound was fibrotic, which created tension on the surrounding tissues and might be one of the reasons for nonhealing. The wound size was 1.1×1.2×0.1 cm and 1.1×1.2×0.2 cm pre- and postdebridement, respectively (Fig. 5A). After 2 weeks and negative results for the biopsy culture, the wound was debrided and the first application of Grafix was performed. The patient's visits were scheduled on a weekly basis. Four applications of Grafix were performed (Fig. 5B, C) after wound debridement: the first three applications were done biweekly and the last application was applied 3 weeks after application number 3. Complete wound closure was recorded 10 weeks after the first Grafix application, and to date, the wound has remained closed (Fig. 5D).

    Figure. 5.
    Figure. 5.
    A 68-year-old Vietnam veteran who sustained shrapnel injury and open fractures resulting in a wound on the right lower leg in 1966. Over a period of 49 years, the wound was never completely closed. (A) 1.1×1.2×0.1 cm wound before ...
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    Discussion
    The use of placental membranes for wound treatment has been reported for over 100 years as an allogeneic wound covering.43 Human placental membranes have been shown to have anti-inflammatory, antibacterial, and antiscarring properties, which are favorable for wound healing.29,30 Despite these benefits, the short shelf life of fresh tissue and the risk of disease transmission associated with insufficient time for testing have hindered its use.44 To overcome these limitations and utilize the beneficial properties of placental membranes, different preservation methods have been developed.

    Recently, a new preservation technology was developed that retains all components found in fresh placental tissue in their native state.18 This novel technology is utilized to manufacture Grafix, a cryopreserved placental membrane, which is the only commercially available placental product to preserve viable endogenous cells, including MSCs. All other commercial placental membrane products are all devitalized or decellularized.45 The role of viable cells in placental membranes remains to be determined; however, accumulated data point to the importance of preserving complete tissue integrity, including viable cells, for the functionality of placental membranes.34–36

    The preservation of endogenous MSCs within placental membranes sets Grafix apart from other advanced wound therapies that do not contain MSCs. Currently, there are no skin substitutes containing MSCs on the market. MSCs have been shown to enhance and improve wound healing in clinical settings and are especially important in the elderly as aging is associated with a reduced number and function of MSCs and a diminished healing response.18,47,48

    Key Findings

    • Grafix is a human cryopreserved placental membrane in which all components of the native tissue are preserved: three-dimensional extracellular matrix, growth factors, and viable cells, including epithelial cells, fibroblasts, and MSCs.
    • Clinical data indicate that Grafix can be beneficial for treatment of a broad variety of wounds, including nonhealing DFUs, VLUs, pressure ulcers, surgical dehiscence, wounds with exposed tendons and bone, and others.
    • Grafix is regulated as a human cellular tissue product and can be used for the treatment of both acute and chronic wounds. It offers wound care providers a treatment modality for wounds of different etiologies.
    The safety and efficacy of Grafix have been demonstrated in two clinical studies, one of which is a high-quality multicenter RCT.37,38 Lavery et al. showed that DFUs closed 4 weeks faster when treated with Grafix compared to SOC (42 days vs. 69.5 days for Grafix vs. SOC respectively, p=0.019).37 This correlated with a significantly lower rate of wound-related infections and fewer hospitalizations. In addition, in the crossover open-label phase of the trial, Grafix closed wounds in patients who failed SOC during the initial 12 weeks of treatment.37 These data point to potential cost effectiveness of Grafix compared to SOC. In addition, a multicenter, open-label, single-arm study to evaluate the safety and efficacy of Grafix for the treatment of complex diabetic foot wounds with exposed tendon and/or bone is ongoing.48 Data suggest that Grafix combined with SOC might be beneficial for the treatment of different types of wounds, regardless of their size, persistence, location, and etiology. Grafix shows effectiveness in closing wounds that have failed other advanced modalities and treatments. The South Shore Hospital Wound Care Center has also shown that a systematic approach for patient and wound evaluation should be applied, and thorough wound bed preparation is required before the application of any advanced wound modality for the achievement of wound closure.

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    Innovation
    Grafix is a commercially available placental membrane product based on a unique tissue processing and cryopreservation technology that retains all placental membrane components, including viable endogenous cells, in their native state. Clinical data indicate that wounds of different etiologies, which have not responded to standard of care in a timely manner, can benefit from treatment with Grafix.

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    Abbreviations and Acronyms
    ADAAmerican Diabetic AssociationDFUdiabetic foot ulcerECMextracellular matrixHCT/Pshuman cells, tissues, and cellular- and tissue-based productsMSCmesenchymal stem cellRCTrandomized controlled trialSOCstandard of careTCCtotal contact castVACnegative pressure wound vacuumVLUvenous leg ulcerWHSWound Healing Society
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    Acknowledgments and Funding Sources
    This work was not funded by any organization and represents the author's personal analysis and experience.

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    Author Disclosure and Ghostwriting
    The opinions expressed are those of the author and do not represent those of the South Shore Hospital Center for Wound Care and Hyperbaric Medicine. The content of this article was expressly written by the author listed. No ghostwriters were used to write this article.

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    About the Author
    Dr. Gary W. Gibbons, MD, FACS, has focused his vascular surgical career on advancing the treatment of diabetic patients with lower extremity wounds and vascular disease. He is a pioneer of the Dorsalis Pedis Bypass and has helped to develop many of the currently used algorithms and multidisciplinary care models used today in the treatment of diabetic patients with lower extremity wound and/or ischemia. He is an international lecturer and has published hundreds of articles. Dr. Gibbons received his undergraduate with Summa Cum Laude honors from the University of Maine and received his medical degree from the University of Cincinnati School of Medicine in 1971. He completed his surgical residency and chief residency at the New England Deaconess Hospital, where he also completed a nutrition fellowship specializing in the nutritional complications of cardiac disease and surgery. Dr. Gibbons is the Medical Director of the South Shore Hospital Center for Wound Healing, a full-time clinical vascular surgery and wound healing/limb preservation practice. He has received accolades and national and international recognition, including the prestigious International Edward James Olmos Award for Advocacy in Amputation Prevention and the Georgetown Distinguished Achievement Award in Diabetic Limb Salvage.

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    by frozenyogurt41 May 24, 2016 6:47 PM
    ativaloc ativaloc May 24, 2016 11:01 PM Flag

    Management of Diabetic Foot Ulcers: A Review
    Early diagnosis and a multidisciplinary team approach to managing comorbidities are essential in treating foot ulcerations.
    Am J Orthop. 2016 February;33(02):16-23.
    Robert G. Frykberg, DPM, MPH; and Jaminelli Banks, DPM
    Dr. Frykberg is podiatry chief and residency director and Dr. Banks is a research fellow, both at the Phoenix VA Health Care System in Arizona. Dr. Frykberg is a professor of practice at the University of Arizona College of Medicine in Phoenix. Dr. Banks is a professor at Grand Canyon University in Phoenix.
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    The prevalence of diabetes mellitus (DM) is growing at epidemic proportions in the U.S. and has been reported as the most common reason for hospital admissions in western countries.1 There continues to be an alarmingly steady increase in the incidence of type 2 DM (T2DM), especially among the young and obese. Long-term diabetes-related complications also are likely to rise in prevalence. In particular, the diabetic foot is associated with morbidity and disability, leading to a significant impairment of quality of life.2 People with DM develop foot ulcers because of neuropathy (sensory, motor, and autonomic deficits), ischemia, or both.3 The initiating injury may be from acute mechanical or thermal trauma or from repetitively or continuously applied mechanical stress.4
    From foot ulcerations to neuropathy to peripheral vascular disease, the challenges are significant and can result in amputations and even premature death. To address these challenges, early diagnosis and a multidisciplinary team approach should be employed. Managing the numerous comorbidities is essential for treatment.1,2,5
    Due to the longevity of patients with DM, diabetes-associated complications are expected to rise in prevalence.6 The American Diabetes Association recently reported that T2DM accounts for about 90% to 95% of all persons with DM.7,8 Today, many hospitalizations for patients with DM are for lower extremity conditions, such as ulceration, infection, or gangrene. Diabetic foot ulcerations (DFUs) are painful and costly for both the patient and the health care system. Every year, more than 1 million people with DM worldwide lose a leg as a consequence of this disease.9 Most DM-related amputations are preceded by a foot ulcer.
    Diabetic foot ulcerations are the most common foot condition leading to lower extremity amputation (Figure 1).10 About 14 million individuals in the U.S. with diagnosed and undiagnosed DM will experience pathologic changes of their lower extremities that, when combined with minor trauma and infection, may lead to serious foot problems.11 Although the triad of vasculopathy, neuropathy, and susceptibility to infection are the primary permissive factors in its pathogenesis, DFU can also be attributed to other important risk factors. The presence of peripheral neuropathy and peripheral arterial disease (PAD) are considered to be the most significant risk factors for all types of diabetic foot complications.12

    Related: A Combined Treatment Protocol for Patients With Diabetic Peripheral Neuropathy
    Optimal care of foot ulceration depends on the treating physician’s understanding of the pathophysiology involved, familiarity with accepted principles of treatment, and the knowledge that a coordinated, multidisciplinary team approach will best accomplish the goal of limb salvage. All efforts should be made to prevent foot lesions, and when present, existing ulcers should be treated promptly and aggressively, which can often prevent an exacerbation of the problem and decrease the incidence of amputations. Even when ulcers have healed, patients with DM and a history of a lower extremity ulcer should consider it a lifelong condition that requires monitoring to prevent recurrence.13,14
    This review provides a brief overview of DFU, including etiology, evaluation, treatment, and prevention, to provide clinicians with the clinical markers, evidence, and DFU treatment recommendations.
    ETIOLOGIES
    Multiple risk factors contribute to the development and pathogenesis of DFUs.5,6,15,16 Neuropathy and PAD are major factors in the pathogenesis of diabetic foot ulcers.17 However, there are several additional factors leading to the occurrence of foot complications. Reiber and colleagues have determined that 63% of their patients’ ulcers were attributed to the critical triad of peripheral sensory neuropathy, trauma, and deformity.15
    Other factors also implicated in the causal pathway to ulceration were ischemia, callus, and edema. Infection was rarely implicated in the etiology of these lesions, although once an ulcer has developed, infection and PAD were found to be the major causes for amputation.10,18,19 Many of the risk factors for foot ulcer are also predisposing factors for amputation, because ulcers are primary antecedent events leading to amputation.20-23Other contributing causes for ulceration that have been identified are gender (male), duration of DM longer than 10 years, advanced age, high body mass index, prior ulceration, and other comorbidities, such as retinopathy, glycated hemoglobin level, limited joint mobility, foot deformity (Charcot foot, prior partial foot amputation, etc), high plantar pressures, and inappropriate foot self-care habits (Table 1).3-6,22,24,25

    EVALUATION
    The clinical evaluation must include a thorough and systematic lower extremity examination when starting DFU treatment. It is important to have a thorough assessment of the ulcer’s size and depth, and the evaluation should include a description of its appearance and measurement of its diameter at each visit. Evaluation for the presence of local and systemic infection and potential for osteomyelitis, using a small sterile blunt probe, is critical in determining depth of penetration and tracking along tendon sheaths (Figure 2). Directly probing to bone (positive probe to bone test) has a high predictive value for underlying osteomyelitis even without acute signs of infection.26 In addition, inspecting the wound for gangrene, necrosis, cellulitis, or infection and inspection of shoes for proper fit, foreign objects, and wear patterns can provide insight into other complications and underlying issues.

    Peripheral arterial disease is directly linked to lower extremity disorders, such as intermittent claudication, pain on exertion, pain at rest, and, in severe cases, critical limb ischemia and gangrene.1 Bilateral lower extremity pulses should routinely be palpated. When dorsalis pedis or posterior tibial artery pulses are absent or diminished, Doppler segmental pressures to the toes, pulse volume recording, skin perfusion pressure, or transcutaneous oxygen evaluation is indicated, and vascular consultation should be sought.3 Ischemia is caused by peripheral arterial occlusive disease of larger vessels, not by microangiopathy.13 Poor arterial inflow is associated not only with impaired ulcer healing, but also subsequent infection, gangrene, and amputation.13
    Diabetic peripheral neuropathy is characterized by loss of protective sensation, allowing ulceration in areas of high pressure. Peripheral sensory neuropathy as measured by vibration perception thresholds can impart a 3.4-fold to 32-fold risk of ulceration.19,21 Patients insensitive to a 10-g monofilament, commonly used to assess peripheral neuropathy, has been shown in several studies to convey a 2.2-fold to18-fold risk of ulceration.6,19,27,28 In the large, population-based North-West Diabetes Foot Care Study, loss of protective sensation to the 10-g monofilament increased the risk of ulceration 80%, whereas abnormal ankle reflexes increased this risk 55%.29
    Peripheral neuropathy has been demonstrated as a strong risk factor for foot ulceration in many cross-sectional studies and is present in 80% of affected patients.29 Recent studies suggested that impaired sensation makes the foot increasingly vulnerable to damage caused by mechanical, thermal, or pressure-related injury.30 Autonomic neuropathy by virtue of subsequent anhidrosis causes dryness of the skin and, therefore, vulnerability to fissuring.13
    Unhealed cracks in the skin can easily lead to infection, especially in the presence of PAD. Neuropathy has an insidious and nonhomogeneous manifestation, making it difficult to identify its onset and a challenge for patients and clinicians.31,32
    Sacco and colleagues reviewed current literature and the International Consensus on the Diabetic Foot recommendation and concluded that most attention is given to patients with imminent foot ulceration rather than attempting to develop and improve assessment techniques that detect early impairments.31,33 They propose that effort should be made that detect patients at risk of developing diabetic polyneuropathy. Although the 10-g monofilament pressure perception threshold is a common screening technique for early detection, tests of the vibration perception threshold may be more sensitive.
    The authors propose that different monofilament sizes could probably better help determine the disease status, as the vibration tests do. In addition to the considerable subjectivity of both methods of assessing sensitivity, they are unquestionably clinical resources that can contribute to early detection of DPN. Future studies should focus on developing assessment strategies and tools that better detect early neuropathic changes. Early diagnosis of impending problems will aid in preventing further limb-threatening complications.
    TREATMENT
    The management of diabetic foot disease is focused primarily on avoiding lower extremity amputation and should be carried out through 3 main strategies: identification of the at risk foot, treatment of the acutely diseased foot, and prevention of further complications.34 The primary goal in the treatment of DFUs is to obtain wound closure. Prompt, aggressive treatment of DFUs can often prevent an exacerbation of the problem and the potential need for amputation. The aim of therapy, therefore, should be early intervention to allow prompt healing of the lesion and, once healed, prevent its recurrence.3,20,25,35
    Management of the foot ulcer is largely determined by its severity (grade), vascularity, and presence of infection.3,14,36 A multidisciplinary team approach should be used due to the multifaceted nature of foot ulcers, as well as for managing the numerous comorbidities attendant with these patients. The choice of treatment methods is determined by patient and ulcer characteristics. Equally important is the ability of patients to comply with the treatment as well as with the location and severity of the ulcer.4
    Rest, elevation, and removal of pressure (off-loading) are essential components of treatment and should be initiated at first presentation. Recent studies provided evidence that indicated proper off-loading promotes more rapid DFU healing.37,38 Ill-fitting footwear should be discarded and replaced with an appropriate off-loading device for mitigating pressure at the site of the ulceration. Although many off-loading modalities are currently in use, only a few studies describe the frequency and rate of wound healing associated with their use.
    The total contact cast (TCC) is considered the superior standard therapy in management for neuropathic ulcers due to its proven ability to redistribute pressure, thereby promoting expeditious wound closure. Another inherent benefit is to ensure patient adherence with off-loading as well as reducing activity levels.24,39 Previous randomized controlled trials have demonstrated that patients treated with TCC healed a higher percentage of plantar ulcers at a faster rate than did patients in the control groups. One unique study demonstrated histologic evidence of more rapid angiogenesis with formation of granulation tissue in the casted group compared with the standard treatment group.40,41
    Potential disadvantages of the TCC include the need for expertise in its proper application, the need for weekly cast changes, and related costs.24,35 Although a number of new devices have been introduced as alternatives to the TCC, only several clinical studies demonstrating their efficacy have been published.5,14,25,36 If nonweight bearing with crutches, wheelchair, or more effective devices are not feasible, even a pressure-attenuating insert can be used in a simple postoperative shoe until specialty referral is made.
    Related: A Call to Action: Intensive Lifestyle Intervention Against Diabesity
    Debridement of necrotic, callus, fibrous, and senescent tissues is a mainstay of ulcer therapy.42,43 It is considered the first and the most important therapeutic step leading to wound closure in patients with DFU.42-44 Unhealthy tissue must be sharply debrided back to bleeding tissue to fully visualize the extent of the ulcer as well as to detect any underlying abscesses or sinuses. It has been reported that regular (weekly) sharp debridement is associated with more rapid healing of ulcers compared with less frequent debridement.45-47 Wilcox and colleagues indicated that frequent debridement healed more wounds in a shorter time (P

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