Devoted HealthCommercial Clinical Policy

Skin Substitute Grafts for Treatment of DFU and VLU Form

Chat with GenHealth to automate any policy or prior auth task.


Skin Substitute Grafts for Treatment of DFU and VLU

Indications

(1) Does the request meet this criterion: Clinical documentation shows the member has either:? 
(2) Does the request meet this criterion: Chronic neuropathic diabetic foot ulcer (DFU), or? 
(3) Does the request meet this criterion: Chronic venous leg ulcer (VLU); AND? 
(4) Does the request meet this criterion: For either condition, all of the following are met:? 
(5) Does the request meet this criterion: Evidence the member has received an assessment and received all of the standard of care treatment(s) for DFU below: i. Adequate control of Type 1 or Type 2 diabetes and any exacerbating/comorbid factors ii. Documented comprehensive assessment? 

YesNoN/A
YesNoN/A
YesNoN/A

Sign up to see the rest of the questions

Unlock the remaining questions and the full coverage workflow.

Sign up for free
Effective Date

NA

Last Reviewed

NA

Original Document

  Reference



Skin Substitutes [UMGT.CL.0024] 2026-04-22 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 1 of 69

PURPOSE This medical policy outlines the coverage for application of skin substitute grafts/cellular and tissue-based products (CTP) for treatment of diabetic foot ulcers (DFU), venous leg ulcers (VLU), and other wounds. APPLICABILITY Using InterQual®, Devoted Health applies MAC LCD criteria to all requests within the MACʼs applicable geographic region noted in the table below. LCD Topic MAC States/Territories L36690 Wound Application of Cellular and/or Tissue Based Products (CTPs), Lower Extremities CGS Administrators (CGS) KY, OH L36377 Application of Skin Substitute Grafts for Treatment of DFU and LVU of Lower Extremities First Coast Service Options
FL, PR, VI L35041 Application of Bioengineered Skin Substitutes to Lower Extremity Chronic Non-Healing Wounds Novitas AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX, VA
Requests for skin substitutes or CTPs that do not fall within the LCDs for the MAC jurisdictions in the table above are reviewed using the criteria outlined in the policy section below. POLICY Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers MAC States/Territories UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 2 of 69

CGS Administrators (CGS) KY, OH First Coast Service Options
FL, PR, VI X National Government Services (NGS) CT, IL, ME, MA, MN, NH, NY, RI, VT WI X Noridian Healthcare Solutions
AS, AK, AZ, CA, GU, HI, ID, MT, NV, ND, NMI, OR, SD, UT, WA, WY Novitas AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX, VA [Part B services for City of Alexandria, Arlington and Fairfax counties only] X Palmetto AL, GA, NC, SC, TN, VA X Wisconsin Physicians Service Insurance Corporation (WPS) IA, IN, KS, MI, MO, NE Initial requests of a 12-week episode of care for treatment of DFU and VLU for the MACs noted in the table above must meet ALL the following criteria:

  1. Clinical documentation shows the member has either: a. Chronic neuropathic diabetic foot ulcer (DFU), or b. Chronic venous leg ulcer (VLU); AND
  2. For either condition, all of the following are met: a. Evidence the member has received an assessment and received all of the standard of care treatment(s) for DFU below: i. Adequate control of Type 1 or Type 2 diabetes and any exacerbating/comorbid factors ii. Documented comprehensive assessment iii. Ankle-brachial index (ABI) and diagnostic tests as indicated iv. Debridement as appropriate v. Scheduled repositioning for pressure relief vi. Mechanical offloading therapy vii. Infection prevention/control viii. Management of exudate ix. Nonsmoker or smoking cessation/counseling provided; OR b. Evidence the member has received an assessment and received all of the standard of care treatment(s) for DFU below: UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 3 of 69

i. Adequate control of systemic disease and any exacerbating/comorbid factors ii. Documented comprehensive assessment iii. Ankle-brachial index (ABI) and diagnostic tests as indicated iv. Duplex scan to confirm Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification v. Debridement as appropriate vi. Scheduled repositioning for pressure relief vii. Mechanical compression therapy viii. Infection prevention/control ix. Management of exudate x. Nonsmoker or smoking cessation/counseling provided; AND

  1. Evidence of either:
    a. DFU with clinical documentation of both: i. Failure to respond to at least 4 weeks of standard treatment resulting in at least one of the following:
  2. Ulcer increase in size or depth
  3. No change in baseline size or depth
  4. No sign of improvement
  5. No indication improvement is likely (e.g., granulation, epithelialization, progress towards closing) ii. Documented compliance with prescribed treatment b. VLU with clinical documentation of both: i. Failure to respond to at least 6 weeks of standard treatment including on-going compression therapy and resulting in at least one of the following:
  6. Ulcer increase in size or depth
  7. No change in baseline size or depth
  8. No sign of improvement
  9. No indication improvement is likely (e.g., granulation, epithelialization, progress towards closing) ii. Documented compliance with prescribed treatment
  10. For both DFU and VLU, evidence of the following: a. Skin substitute utilized per the intended use as approved/regulated by the FDA, and b. No contraindications to application of skin substitute graft/CTP UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 4 of 69

Requests for repeat treatment/application within the 12-week episode of care for DFU and VLU for the MACs noted in the table above must meet ALL the following criteria:

  1. Re-assessment shows documentation the previous application was successful with evidence of at least one of the following: a. Decrease in size or depth of ulcer b. No change in baseline size or depth but signs that that improvement is likely (e.g., granulation, epithelization, progress towards closing)
  2. Skin substitute utilized per the intended use as approved/regulate by the FDA; and
  3. No contraindications to application of skill substitute graft/CTP Note: When criteria in the LCD or above are met, the skin substitute grafts/cellular and tissue-based products in the table below are considered medically necessary. Please include the name of the product in the description field when submitting a request/claim if a HCPCS code can be used for more than one product. Medically Necessary skin substitute grafts and CTPs for DFU and VLU Product HPCPS Code AmnioBand or Guardian Human placental allograft. Q4151 Apligraf Much like human skin as it has two primary layers; the epidermal (outer) layer consists of live human keratinocytes, while the dermal (inner) layer contains living fibroblasts. Also referred to as human skin equivalent. Q4101 Epifix Biologic human amniotic membrane. Q4186 Grafix Core/Grafix Prime ECM containing growth factors. Q4132, Q4133 GraftJacket Regenerative Tissue Matrix Derived from cadaveric skin, which undergoes a process that Q4107 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 5 of 69

removes the epidermis and dermal cells. The human dermal tissue is preserved. Over time, the bodyʼs natural repair process converts the matrix into living tissue. Integra Bilayer Matrix Wound Dressing Comprised of a porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan and a semipermeable polysiloxane (silicone layer). The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth. Q4104 Integra Dermal Regeneration Template/Omnigraft Bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate). The epidermal substitute layer is made of thin polysiloxane (silicone) layer. Q4105 Integra Meshed Bilayer Wound Matrix Porous matrix of cross-linked bovine tendon collagen and glycosaminoglycan. The collagen-glycosaminoglycan biodegradable matrix provides a scaffold for cellular invasion and capillary growth. The meshed bilayer matrix allows drainage of wound exudate and provides a flexible adherent covering for the wound surface. Q4104, C9363 Kerecis Omega3 Acellular intact fish skin that contains proteins, lipids (including omega3) and other skin elements and bioactive lipid content. Q4158 Kerecis Omega3 MariGen Shield Acellular intact fish skin that contains proteins, lipids (including omega3) and other skin elements and bioactive lipid content. A2019 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 6 of 69

Oasis Ultra Tri-Layer Matrix and Oasis Wound Matrix A naturally derived, ECM created from the submucosal layer of porcine small intestine. Q4124, Q4102 TheraSkin Biologically active cryopreserved human skin allograft with both epidermis and dermis layers; the cellular and extracellular composition provides a supply of collagen, cytokines and growth factors. Q4121 Skin substitute grafts and CTPs for thermal burns MAC States/Territories X CGS Administrators (CGS) KY, OH X First Coast Service Options
FL, PR, VI X National Government Services (NGS) CT, IL, ME, MA, MN, NH, NY, RI, VT WI X Noridian Healthcare Solutions
AS, AK, AZ, CA, GU, HI, ID, MT, NV, ND, NMI, OR, SD, UT, WA, WY X Novitas AR, CO, DC, DE, LA, MD, MS, NJ, NM, OK, PA, TX, VA [Part B services for City of Alexandria, Arlington and Fairfax counties only] X Palmetto AL, GA, NC, SC, TN, VA X Wisconsin Physicians Service Insurance Corporation (WPS) IA, IN, KS, MI, MO, NE Devoted Health considers the skin substitutes and CTPs products in the table below medically necessary for the treatment of thermal burns for the noted indications. Please include the name of the product in the description field when submitting a request/claim if a HCPCS code can be used for more than one product. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 7 of 69

Medically Necessary skin substitute grafts and CTPs for thermal burns Product Appropriate use HPCPS Code Biobrane/Biobrane-L Medically necessary for full-thickness or partial-thickness burns Q4100, C9399, A2043, A2044 Epicel Medically necessary when used according to the FDA-approved Humanitarian Device Exemption (HDE) for members with deep dermal or full-thickness burns comprising a total body surface area of greater than or equal to 30% Q4100, C9399 Integra Dermal Regeneration Template Integra Bilayer Matrix Wound Dressing Integra Meshed Bilayer Wound Matrix Medically necessary when both of the following are met:

  • Post-excisional treatment of a full-thickness or deep partial-thickness burn
  • Sufficient autograft is not available at the time of excision or is contraindicated Q4015, Q4104, Q4108 Suprathel Medically necessary when used for the treatment of first- and second-degree burns A2012 Transcyte Medically necessary when used for temporary covering of a surgically excised deep partial-or full-thickness burn wound as a covering prior to autograft Q4182 Exclusions: If a request is for a condition not addressed in the covered criteria above, Devoted Health considers the use of skin substitute grafts and CTPs outside of the FDA approved/cleared labeling indications for all other conditions, not medically necessary as there is not enough support in current clinical literature to show they are standard medical treatments, therefore they are not covered. Non-covered conditions UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 8 of 69

include, but are not limited to:

  • Acute post-surgical wounds
  • Pressure ulcers other than DFU or VLUs Note: Reimbursement for routine and non-routine medical supplies is included in the payment rates for every Medicare home health patient. Application of skin substitutes and the skin substitute are not covered separately in the home setting. The following skin substitutes and CTPs are considered not medically necessary for ANY indication and therefore not covered. A review of current clinical literature shows there is no evidence to determine these products and services are standard medical treatment. There is an absence of strong clinical studies examining benefits and long-term clinical outcomes. Skin / Tissue Substitute Associated HCPCS/ CPT® Code(s) Abiomend Membrane, Abiomend Hydromembrane Amniotic membrane products. Q4356 Abiomend Xplus Membrane, Abiomend Xplus Hydromembrane Amniotic membrane products. Q4355 Absolv3 Membrane Amniotic/chorionic/amniotic membrane allograft. Q4401 AC5 Advanced Wound System Lyophilized peptide in sterile water for injection. Biocompatible and resorbable peptides that self-assemble into a nanofiber network which resembles the construct of the extracellular matrix. A2020 ACApatch Dehydrated human amniotic membrane allograft composed of three-layers: two amnion layers and one chorion layer. Q4325 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 9 of 69

A/C Wrap Q4422 Acelagraft Bi-layered, decellularized, dehydrated human amniotic allograft. Q4395 Acesso Dehydrated single layer human amniotic membrane allograft. Q4311 Acesso AC Dehydrated dual layer human amniotic/chorion membrane allograft. Q4312 Acesso DL Dehydrated dual layer human amniotic membrane allograft. Q4293 Acesso TL Dehydrated triple layer human amniotic membrane allograft. Q4300 Acesso TrifACA Full-thickness human amnion/chorion/amnion allograft. Q4386 ACTISHIELD, ACTISHIELD CF Allografts derived from dehydrated human amniotic tissue. Q4100 Activate Matrix Triple layer human amnion and chorionic membrane allograft. Q4301 ActiveBarrier, ActiveMatrix, CryoMatrix Placental connective tissue matrix. Q4100 AdvoGraft Membrane Dual Dual-layer human amniotic membrane allograft. Q4382 AdvoGraft One Single-layer human amnion membrane allograft. Q4380 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 10 of 69

AéroGuard Single-layer human amnion membrane allograft. Q4370 Affinity Minimally processed amniotic fluid membrane allograft. Q4159 AlexiGuard DL-T Dual-layer textured amniotic membrane allograft. Q4417 AlexiGuard SL-T Single-layer textured amniotic membrane allograft. Q4415 AlexiGuard TL-T Triple-layer textured amniotic membrane allograft. Q4416 Allogen Liquid Human liquid amnion. Q4212 AlloMax A sterile regenerative human collagen matrix. Q4100 Allopatch HD Acellular human dermis derived from human allograft skin that is processed to preserve and maintain the natural biomechanical, biochemical and matrix properties of the dermal graft. Q4128 alloPLY Dual layer human amniotic epithelium/basement membrane allograft. Q4323 AlloSkin, AlloSkin AC, AlloSkin RT Allograft derived from epidermal and dermal cadaveric tissue. Q4115, Q4141, Q4123 Allowrap DS or dry Double-sided epithelial layer human amniotic membrane. Q4150 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 11 of 69

AltiPly, AMNIOREPAIR Lyophilized placental membrane allografts. Q4235 AmchoMatrixDL Dehydrated, dual-layer amnion membrane allograft. Q4410 AmchoPlast Human amniotic/chorion membrane allograft. Q4316 AmchoPlast EXCEL Human amnion chorion membrane allograft. Q4372 AmchoPlast FD Lyophilized allograft derived from human amnion-chorion membrane, consisting of a basement membrane and stromal matrix collagen layer. Q4360 AmchoThick Human amnion chorion membrane allograft. Q4368 American Amnion Decellularized human amniotic allograft. Q4307 American Amnion AC Decellularized human amniotic and chorionic allograft. Q4306 American Amnion AC Tri-Layer Decellularized human amniotic, intermediate and chorionic allograft. Q4305 Amnio Burgeon Dual-Layer Membrane Amniotic membrane product. Q4365 Amnio Burgeon Membrane, Hydromembrane Amniotic membrane product. Q4363 Amnio Burgeon XPlus Membrane, XPlus Hydromembrane Amniotic membrane product. Q4364 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 12 of 69

Amnio Quad-Core Four layer human amniotic membrane allograft. Q4294 Amnio Tri-Core Triple layer human amniotic membrane allograft. Q4295 Amnio Wound Lyophilized human amniotic membrane allograft comprised of an epithelial layer and two fibrous connective tissue layers specifically processed to be used for the repair and replacement of lost or damaged dermal tissue. Q4181 Amnio-Maxx Dual layered, dehydrated, amniotic tissue membrane graft. Amnio-Maxx Lite Single layer, dehydrated, amniotic tissue membrane graft. Q4239 AmnioAMP-MP Decellularized dehydrated human amniotic membrane (DDHAM) which is derived from the placental amnion. Q4250 Amnioarmor Dehydrated human amniotic membrane allograft derived from the submucosa of placental tissue. Q4188 AmnioBind or DermaBind TL Dehydrated, full-thickness placental membrane (PM) allograft consisting of amnion, chorion, and the associated intermediate (spongy) layer (IL). Q4225 AmnioCord Dehydrated human umbilical cord allograft. Q4100 AmnioCore Dual layer amniotic tissue allograft. Q4227 AmnioCore Pro Dual layer human amnion and chorionic membrane allograft. Q4298 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 13 of 69

AmnioCore Pro+ Triple layer human amnion and chorionic membrane allograft. Q4299 AmnioCore SL Single-layer allogeneic amniotic membrane allograft. Q4367 AmnioCyte Plus Minimally manipulated human tissue allograft derived from the extracellular matrix of the amniotic membrane. Q4242 AmnioDefend FT Matrix Triple-layer human amnion, intermediate layer and chorion membrane allograft. Q4379 AmnioExcel, AmnioExcel Plus or BioDExcel Amniotic extracellular membrane is a sterile, resorbable, noncross-linked tissue allograft derived from the human amnion. Q4137 AmnioFill Cellular tissue matrix allograft that contains multiple ECM proteins, growth factors, cytokines, and other specialty proteins. Q4100 AmnioFix Human amniotic membrane comprises the innermost layer of the placenta and lines the amniotic cavity. Q4100 AmnioFLEX, ASG Barrier, ASG Fluid Human tissue, chorion free allograft, comprised of minimally manipulated amniotic membrane derived from placental tissue. Q4100 AmnioGraft Minimally manipulated, cryopreserved amniotic membrane. Q4100, V2790 AmnioHeal Plus Amniotic membrane graft Q4100 AmnioMatrix, BioDMatrix Cryopreserved (frozen) complex of amniotic tissue, liquid human allograft. Q4139 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 14 of 69

AmnioMatrixF3X Dehydrated, tri-layer amnion membrane allograft. Q4409 AmnioMatrixF4X Dehydrated, four-layer amnion membrane allograft. Q4411 Amnion Bio, AxoBioMembrane Human amnion allograft. Q4211 AmnioPlast 1 Monolayered human amnion membrane allograft. Q4334 AmnioPlast 2 Human amnion chorion membrane allograft. Q4335 AmnioPlast 3 Tri-layer human amnion membrane allograft. Q4369 AmnioPlast Double Dual-layer human amnion allograft. Q4391 Amniotext Minimally manipulated, amniotic membrane derived human tissue allograft. Q4245 Amniotext patch Minimally manipulated amniotic membrane derived human tissue allograft. Q4247 AmnioTX Dehydrated dual layer human amniotic membrane allograft. Q4324 AmnioWrap2 Amniotic/chorionic tissue allograft. Q4221 Amniply Collagenous membrane derived from the submucosa of the placenta. Q4249 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 15 of 69

Apis Biodegradable and absorbable gelatin, a porcine collagen derivative, is the primary material. The two other materials are Manuka honey and hydroxyapatite. A2010 Apollo FT Full-thickness human amnion/chorion allograft. Q4385 Architect, Architect PX, Architect FX ECM Stabilized collagen matrix. Q4147 ArdeoGraft Dual layer human chorionic membrane allograft. Q4333 Artacent AC Human amnion/chorion membrane graft. Q4189, Q4190 Artacent C Single layer human amnion chorion membrane allograft. Q4336 Artacent Cord Umbilical cord allograft. Q4216 Artacent Wound Amniotic tissue graft with an epithelial layer of native membrane facing out on both sides. Q4169 Artacent Trident Triple layer human amnion membrane allograft. Q4337 Artacent Velos Dual layer human amnion membrane allograft. Q4338 Artacent Vericlen Human amnion-chorion membrane allograft. Q4339 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 16 of 69

ArthroFlex Decellularized dermis patch. Q4125 Ascendion Dehydrated human amniotic allograft. Q4390 Ascent Dehydrated cell and protein concentrate (dCPC) injectable derived from human amniotic fluid. Q4213 Avance Nerve Graft Processed, decellularized nerve allograft. Q4100, C9399 Axograft Dual layer amniotic membrane. Q4100 AxoGuard – Nerve Connector, Nerve Protector Porcine submucosa ECM. C1763 Axolotl Ambient, Axolotl Cryo Human amniotic flowable allografts. Q4215 Axolotl DualGraft Human amniotic membrane allograft. Q4332 Axolotl DualGraft Ultra Chorion-free, cross-linked human amnion allograft. Q4384 Axolotl Graft Human amniotic membrane allograft. Q4331 Axolotl Graft Ultra Chorion-free, single layer, cross-linked human amnion allograft. Q4383 Barrera SL, Barrera DL Dehydrated human amniotic membrane allograft. Q4281 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 17 of 69

BellaCell HD Human acellular dehydrated dermis regenerative tissue matrix. Q4220 Bio-ConneKt Conformable and porous wound dressing made of reconstituted collagen derived from equine tendon. Q4161 Biodesign – Dural Graft, Duraplasty Graft, ENT Repair Graft, Otologic Repair Graft Nonporous, absorbable multi-layer sheet of extracellular collagen matrix derived from porcine SIS. C1763 Biodesign – Enterocutaneous Fistula Plug and Fistula Plug Cone-shaped plug made of connective tissue from porcine small intestine submucosa (SIS). C1763, 46707 Biodesign – Hernia, Hiatal Hernia, Incision Graft Multilayered sheet of extracellular collagen matrix derived from porcine small intestinal submucosa (SIS). C1763 Biodesign Nipple Reconstruction Cylinder Rolled cylinder of extracellular collagen matrix derived from porcine small intestinal submucousa (SIS). C1763 Biodesign Tissue Graft – 1 layer, 4 layer Dried single or multilayer porcine SIS sheet. C1763 BioDFactor Flowable tissue allografts derived from human amnionic tissue and components of amniotic fluid. Q4100 BioDFence Hydrated human amnionic membrane allograft. Q4140 BioDFence DryFlex Dehydrated human amnionic membrane allograft. Q4138 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 18 of 69

BioFix, BioFix Plus, BioFix Flow Amniotic allografts derived from human placental tissue. Q4100 BioLab Membrane Wrap Flow Dual-layer amniotic allograft membrane Q4418 BioLab Membrane Wrap Lite Flow Q4419 BioLab Membrane Wrap Lite Solo Q4421 BioLab Tri-Membrane Wrap Flow Q4423 BioSkin, WoundEx Human ECM placental tissue allografts. Q4163 BioSkin Flow, WoundEx Flow Human ECM placental tissue injectable allografts. Q4162 Biovance Dehydrated, decellularized human amniotic membrane. Q4154 Biovance Tri-layer, Biovance 3L Triple-layer decellularized, dehydrated human amniotic membrane. Q4283 BioWound, BioWound Plus, BioWound XPlus, WoundFix, WoundFix Plus, WoundFix XPlus Human amnion-based membranes. Q4217 CaregraFT Dehydrated human amniotic/chorion membrane allograft. Q4322 carePATCH Dehydrated amniotic membrane allograft. Q4236 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 19 of 69

Celera Dual Membrane, Celera Dual Layer Amniotic and/or chorionic allograft derived from placental tissue. Q4259 Cellesta, Cellesta Duo Minimally manipulated amniotic membrane allograft. Q4184 Cellesta Cord Umbilical cord allograft product. Q4214 Cellesta Flowable Amnion Minimally manipulated, chorion-free human amniotic membrane. Q4185 CHORIOFIX Dehydrated, dual-layered chorion membrane allograft. Q4412 ChoriPly Collagenous membrane derived from the submucosa of the placenta. Q4359 Cocoon Membrane Human amnionic membrane allograft. Q4264 Cogenex Amniotic Membrane Minimally manipulated, amniotic membrane allograft. Q4229 Cogenex Flowable Amnion Minimally manipulated, amniotic membrane allograft. Q4230 Cohealyx Collagen Dermal Matrix Absorbent, porous, collagen matrix engineered from purified collagen derived from bovine dermal tissue. A2036 Coll-e-derm Allograft derived from human dermal tissue. Q4193 Complete AA Dual layer human amnion membrane allograft. Q4303 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 20 of 69

Complete ACA Triple layer human amnion and chorionic membrane allograft. Q4302 Complete FT Resorbable full-thickness amnion/chorion allograft. Q4271 Complete SL Resorbable single layer amniotic allograft. Q4270 CopiOs Pericardium Membrane Bovine pericardium-based, noncross-linked collagen matrix. C1763 CoreCyte Whartonʼs jelly allograft. Q4240 CoreText, ProText Whartonʼs jelly allograft. Q4246 CorMatrix ECM Acellular biomaterial (porcine small intestine submucosa. C1763 Corplex Human umbilical cord allograft composed of the epithelial layer and the Whartonʼs jelly. Q4232 Corplex P / Theracor P / Allacor P Resorbable particulate device derived from human umbilical cord extracellular matrix (ECM). A2035 Cryo-Cord Minimally manipulated umbilical cord allograft. Q4237 CuraMatrix Q4440 CYGNUS Disk Multilayer allograft derived from the amnion and chorion layers of the placental membrane. Q4362 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 21 of 69

Cygnus Dual Amniotic tissue matrix. Q4282 Cygnus Matrix Amniotic tissue matrix. Q4199 Cygnus (Cryopreserved Max, Max, Max XL, Matrix) Amniotic tissue allograft. Q4170 CYGNUS Solo Single-layer amnion membrane allograft. Q4413 Cymetra Micronized particulate form of AlloDerm processed from human cadaver skin. Q4112 Cytal Wound Matrix (formerly MatriStem Wound Matrix and Multilayer Wound Matrix) Porcine derived ECM scaffold containing epithelial basement membrane, specifically known as urinary bladder matrix (UBM). Q4166 Derm-Maxx Freeze-dried decellularized dermal matrix allograft. Q4238 Derma-Gide Comprised of a porcine derived, porous, purified collagen matrix. Q4203 DermaBind CH Dehydrated human ECM chorion derived membrane allograft. Q4288 DermaBind DL Dehydrated human ECM allograft. Q4287 DermaBind FM Dehydrated human placental membrane allograft comprised of an extracellular matrix. Q4313 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 22 of 69

DermaBind SL Dehydrated human amniotic membrane allograft. Q4284 DermaBind TL + DermaBind TL X Q4426 DermaBind DL N, DermaBind DL+, or DermaBind DL X Q4427 DermaBind SL N, DermaBind SL+, or DermaBind SL X Q4428 DermaBind CH N or DermaBind CH X Q4429 Dermacyte Amniotic membrane allograft. Q4248 Dermacyte AC Matrix Amniotic Membrane Allograft Human amnion membrane allograft. Q4343 DermaMatrix Allograft derived from donated human skin. Q4100 DermaPure Derived from split-thickness grafts harvested from human cadaver tissue donors. Q4152 DermaSpan ADM derived from human allograft skin tissue. Q4126 Dermavest, Plurivest Amnion/chorion, umbilical cord and placental disk tissue preserved with attachment proteins, growth factors and cytokines. Q4153 DermMatrix (formerly InteXen) Porcine Dermal Matrix Pyrogen free, porcine dermis. Q4100 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 23 of 69

Dual Layer Amnio Burgeon X-Membrane Amniotic membrane product. Q4366 Dual Layer Impax Membrane Dehydrated dual layered human amniotic membrane allograft. Q4262 DuoAmnion Dehydrated human amniotic membrane allograft. Q4327 Duograft AA Dual-layer human amnion membrane allograft. Q4376 duoGRAFT AC Multi-layer human amnion chorion membrane allograft. Q4375 DuraGen Onlay graft comprised of a porous, purified collagen matrix. Q4100 E-Graft Thick layer human amnion rolled membrane allograft. Q4318 E-Z Derm Porcine derived xenograft in which the collagen has been chemically cross-linked with aldehyde (a chemical compound). Q4136 Emerge Matrix Dual layer human amniotic and chorionic membranes. Q4297 Enclose TL Matrix Tri-layered minimally manipulated, human placental membrane product derived from donated placental tissues. Q4351 EndoForm Dermal Template ECM derived from ovine forestomach. Q4100 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 24 of 69

Enverse Dehydrated human amniotic membrane. Q4258 Epicel Skin cells grown or cultured from a postage stamp sized sample of the individualʼs own healthy skin. Q4100 Epicord Umbilical cord allograft. Q4187 Epieffect Human amniotic membrane allograft. Q4278 Epifix (injectable) Human amniotic membrane allograft. Q4145 EPIXPRESS Lyophilized, non-viable cellular allograft including the amnion layer, intermediate layer, and chorion layers derived from human amniotic membrane. Q4361 Esano A Single-layer, decellularized, dehydrated human amniotic membrane allograft. Q4272 Esano AAA Tri-layer, decellularized, dehydrated human amniotic membrane allograft. Q4273 Esano AC Dual-layer, decellularized, dehydrated human amniotic membrane allograft. Q4274 Esano ACA Tri-layer, decellularized, dehydrated human amniotic membrane allograft. Q4275 Excellagen Pharmaceutically formulated fibrillar Type I bovine collagen gel. Q4149 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 25 of 69

FloGraft Cryopreserved, injectable, liquid amniotic fluid derived allograft. Q4100 Floweramnioflo Premixed, ambient temperature placental tissue matrix allograft. Q4177 Floweramniopatch Dehydrated amniotic membrane allograft. Q4178 Flowerderm Acellular dermal allograft ECM composed of proteoglycans, hyaluronic acid, collagen, fibronectin and elastin. Q4179 Fluid Flow, Fluid GF Human amniotic flowable allograft. Q4206 Fortify Flowable Extracellular matrix (ECM) derived from porcine small intestinal submucosa. A4100, Q4100 Fortiva Porcine Dermis Noncross-linked porcine dermis, designed to act as a scaffold that allows for neovascularization and reincorporation with the individualʼs own tissue. Q4100 Foundation DRS+Duo A2041, A2042 Foundation DRS Solo Highly conformable, advanced wound care device comprising a porous matrix of chitosan derived from shellfish and sodium chondroitin sulfate, a glycosaminoglycan. A2034 G4Derm Plus Aqueous solution of synthetic peptide (≥ 98% sterile water) composed of a matrix of interwoven fibrils formed from individual peptide monomers. The device is completely non-animal tissue and non-cellular derived. A2037 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 26 of 69

GalaFLEX, GalaFLEX 3D and GalaFLEX 3DR Bioresorbable surgical scaffold made of monofilament fibers of the biopolymer, poly-4-hydroxybutarate (P4HB). A4100, Q4100 GammaGraft Irradiated human skin allograft acquired from cadaveric donors. Q4111 Genesis Amniotic Membrane Dehydrated, collagenous human tissue allograft. Q4198 Gentrix Surgical Matrix (formerly MatriStem Surgical Matrix) Composed of a porcine derived ECM, also known as UBM and supplied in multilayer sheet configurations. C1763, C1781 GRAFIX DUO Dual-layered, dehydrated, human amniotic allograft. Q4392 Grafix PLUS Human chorionic membrane allograft. Q4304 GraftJacket Xpress Injectable allograft treatment that is mixed with sterile saline. Q4113 Helicoll Helicoll is an ADM derived from bovine Type-1 collagen. Q4164 hMatrix Acellular, dermal scaffold processed from donated human skin. Q4134 Human Health Factor 10 Amniotic Patch (hhf10-p) Single-layer amniotic allograft derived from full-term human birth tissue, specifically the immunoprivileged amnion layer. Q4224 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 27 of 69

Hyalomatrix Bioresorbable, dermal substitute made of HYAFF, a long-acting derivative of hyaluronic acid providing a microenvironment. Q4117 InnovaBurn, InnovaMatrix XL Decellularized extracellular matrix (ECM) derived from porcine placental tissue. A2022 InnovaMatrix AC Decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. A2001 InnovaMatrix FD Extracellular matrix (ECM) derived from porcine placental material. A2039 InnovaMatrix FS Decellularized extracellular matrix (ECM) topical wound covering derived from porcine placental tissue. A2013 InnovaMatrix PD Decellularized extracellular matrix (ECM) derived from porcine placental tissue. A2023 Integra Flowable Wound Matrix Comprised of granulated cross- linked bovine tendon collagen and glycosaminoglycan; hydrated with saline. Q4114 Integra HuMend ADM Human dermal allograft that has been decellularized while preserving the noncellular natural biologic components and structure of the dermal matrix. Q4100 Integra Matrix Wound Dressing Biodegradable, porous matrix of cross-linked bovine tendon and glycosaminoglycan. Q4108 Interfyl – Flowable, Particulate Decellularized, connective ECM derived from human placental tissue. Q4171 InstaGraft Q4439 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 28 of 69

Keramatrix, Kerasorb Absorbable matrix made from a combination of keratin technology that dissolves into wounds. Q4165 Keroxx Flowable matrix made from a combination of keratin technology that dissolves into wounds. Q4202 Lamellas Dehydrated human resorbable allograft derived from placental tissue. Q4292 Lamellas XT Dehydrated human resorbable allograft derived from placental tissue. Q4291 Leneva Allograft adipose extracellular matrix (ECM). Q4100 Mantle DL Matrix Dual layer, minimally manipulated, human amniotic membrane product derived from placental tissue. Q4349 Marigen Pacto Acellular intact fish skin that contains proteins, lipids (including omega3) and other skin elements and bioactive lipid content. A2038 MatriDerm Acellular dermal substitute composed of bovine collagen and elastin. A2027 Matrion Matrix scaffold derived from an intact decellularized placental membrane comprising both amniotic and chorionic layers. Q4201 MatriStem MicroMatrix Noncross-linked basement membrane compromised of urinary bladder matrix (UBM) and various collagens. Q4118 Matrix HD Acellular human dermis allograft retains the three-dimensional intertwined multidirectional fibers and mechanical properties of the native tissue architecture. Q4128 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 29 of 69

Matrix HD Allograft Dermis Acellular human dermis allograft. Q4345 Mediskin Frozen irradiated porcine xenograft with a dermal and epidermal layer. Q4135 Membrane Graft, Membrane Wrap Human amniotic allograft. Q4205 Membrane Wrap-Hydro Human amnion membrane allograft. Q4290 Membrane Wrap-Lite Single-layer human amnion membrane allograft. Q4373 MemoDerm ADM derived from human allograft skin tissue. Q4126 Microlyte Matrix Synthetic absorbent polyvinyl alcohol hydrogel sheet with a polymeric surface coating containing ionic and metallic silver. A2005 Microlyte Matrix A2040 MicroMatrix Flex Porcine derived extracellular matrix known as urinary bladder matrix. A2028 Miro3D Fibers Non-crosslinked acellular wound dressing that is derived from porcine liver tissue. A2030 Miroderm Noncross-linked acellular wound matrix derived from porcine liver and is processed and stored in a phosphate buffered aqueous solution. Q4175 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 30 of 69

MiroDry Wound Matrix Non-crosslinked acellular wound dressing that is derived from porcine liver tissue. A2031 MiroTract Wound Matrix Non-crosslinked acellular wound dressing derived from porcine liver tissue, compressed onto the guidewire of the MiroTract delivery system. A2029 Mirragen Advanced Wound Matrix Biocompatible and resorbable borate glass fibers and particulate. A2002 MLG-Complete Full-thickness amnion-chorion derived allograft. Q4256 MOST Perforated three-layer amnion/chorion/amnion human amniotic membrane allograft. Q4328 MyOwn Skin Autologous, homologous human skin product. Q4226 Myriad ECM derived from ovine forestomach. Q4100 Myriad Matrix (Endoform Plastics and Reconstructive Matrix) Collagen matrix comprised of natural

70%, non-reconstituted collagen derived from ovine forestomach extracellular matrix (ECM). A2032 Myriad Morcells Extracellular matrix primarily composed of ovine collagen. A2033 Natalin Tri-layer, decellularized, dehydrated human amniotic allograft. Q4396 NéoGuard Double-layer human amnion membrane allograft. Q4371 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 31 of 69

NeoMatriX Wound Matrix Acellular axolotl dermal extracellular matrix. A2021 Neopatch, Therion Terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. Q4176 Neostim DL Double layer dehydrated amniotic membrane allograft. Q4267 Neostim Membrane Single layer dehydrated amniotic membrane allograft. Q4266 Neostim TL Triple layer dehydrated amniotic membrane allograft. Q4265 NeoThelium 4L Full-thickness human amnion/chorion/chorion/amnion allograft. Q4388 NeoThelium 4L+ Full-thickness quad-layer human chorion/amnion/amnion/chorion allograft. Q4389 NeoThelium FT Full-thickness human amnion/chorion allograft. Q4387 Neox 100; OR Cryopreserved human amniotic membrane and umbilical cord. Clarix 100 Cryopreserved human amniotic membrane, umbilical cord and additional proteins. Q4156 Neox Cord 1K; OR Cryopreserved human amniotic membrane and umbilical cord. Neox Cord RT; OR Hydrated human amniotic membrane allograft. Clarix Cord 1K Q4148 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 32 of 69

Cryopreserved human amniotic membrane, umbilical cord and additional proteins. Neox Flo or Clarix Flo Particulate products of the above-mentioned matrices. Q4155 NeuraGen Nerve Guide, NeuraWrap Nerve Protector Bovine derived collagen conduit. C1763 NeuroMend Nerve Wrap Resorbable, semipermeable, type I collagen nerve wrap. C9361 Novachor Chorion layer of the placental membranes. Q4194 Novafix Dehydrated human amniotic membrane allograft. Q4208 Novafix DL Dehydrated human amnion chorion membrane allograft. Q4254 NovaShield or NovaGen Wound Matrix A2045 NovoGen Absorbable, nonpyrogenic bovine type I collagen and 45S5 bioactive glass. Q4100 NovoSorb SynPath Acellular, synthetic dermal matrix of biodegradable polyurethane foam bonded with a polyurethane adhesive layer. A2006 NuCel Allograft derived from human amnion and amniotic fluid. Q4100 NuDyn, SurFactor Acellular, flowable human amniotic membrane allograft. Q4233 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 33 of 69

NuDYN DL, NuDYN DL MESH Human amnion/chorion membrane allografts. Q4285 NuDYN SL, NuDYN SLW Human amnion membrane allografts. Q4286 NuForm Amnion/chorion membrane allograft. Q4420 NuShield Allograft derived from amniotic and chorionic membranes. Q4160 Oasis Burn Matrix Naturally derived, ECM created from the submucosal layer of porcine small intestine. Q4103 ologen Collagen Matrix Biodegradable porcine-derived collagen matrix. Q4100 Omeza Collagen Matrix Hydrolyzed fish collagen infused with cod liver oil. A2014 Orion Dual-layer, dehydrated human amniotic membrane allograft. Q4276 OrthoFlo Allograft derived from amniotic fluid. Q4100 Overlay SL Matrix Single layer, minimally manipulated, human amniotic membrane product derived from placental tissue. Q4352 OviTex Bio scaffold composed of ovine (sheep) derived ECM and polyglycolic acid (PGA). Q4100 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 34 of 69

PalinGen, PalinGen Xplus (PalinGen Membrane; PalinGen Hydromembrane; PalinGen XPlus Membrane and PalinGen XPlus Hydromembrane) Human amniotic tissue allograft comprised of amnion and amniotic fluid. Q4173 PalinGen, ProMatrX (ProMatrX, PalinGen Flow and PalinGen SportFlow) Human liquid allograft comprised of amnion and amniotic fluid. Q4174 PalinGen Dual-Layer Membrane, Dual-Layer PalinGen Xmembrane Dehydrated human allograft derived from the placenta, two layers of amniotic membrane which have the epithelial side facing out. Q4354 Palisade DM Matrix Dual membrane, minimally manipulated, human amniotic and chorionic membrane product derived from placental tissue. Q4350 PelloGraft Dual layer human amniotic/chorion membrane allograft. Q4320 Permacol A porcine dermal collagen implant. C9364 PermeaDerm B Monofilament nylon knitted fabric bonded to a thin slitted silicone membrane. The nylon side of this dressing is coated with a mixture of porcine gelatin and a pure fraction of aloe vera. A2016 PermeaDerm C Monofilament nylon knitted fabric bonded to a thin slitted silicone membrane. The nylon side of this dressing is coated with a mixture of porcine gelatin and a pure fraction of aloe vera. A2018 PermeaDerm Glove Monofilament nylon knitted fabric bonded to a thin slitted silicone membrane. The nylon side of this dressing is coated with a mixture of porcine gelatin and a pure fraction of aloe vera. A2017 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 35 of 69

Phoenix Wound Matrix Bioabsorbable, conformable, non-woven, fibrous, three-dimensional matrix. Composed of poly(lactide-co-caprolactone) and polyglycolic acid. A2015 PolyCyte Minimally manipulated human tissue allograft derived from the Wharton's jelly of the umbilical cord. Q4241 Polygon3 Membrane Allograft, consisting of two layers of amniotic membrane with a chorionic layer in the middle. Q4400 PRECLUDE Vessel Guard Three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene (ePTFE) microstructure. Q4100 Pretect Q4438 PriMatrix ADM derived from fetal bovine skin. Q4110 Procenta Acellular, sterile human placental derived allograft. Q4310 ProgenaMatrix Human keratin matrix derived from human hair. Q4222 ProLayer Human acellular dermal matrix. Q4100 Promogran Matrix Freeze-dried composite prepared from bone collagen and oxidized regenerated cellulose. Q4100 PuraPly, PuraPly AM, PuraPly XT Purified Type 1 native collagen matrix creates a durable biocompatible scaffold. Q4195, Q4196, Q4197 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 36 of 69

Puros Dermis A natural biological matrix. Q4100 Rampart DL Matrix Dual layer, minimally manipulated, human amniotic membrane product derived from placental tissue. Q4347 Rebound Matrix Dehydrated human allograft derived from placental tissue. Q4296 Reeva FT Dehydrated human amniotic membrane allograft. Q4314 RegeneLink Amniotic Membrane Allograft Full thickness human amniotic/chorion membrane allograft. Q4315 REGUaRD Hydrated acellular human dermal allograft matrix. Q4255 Relese Dehydrated human amniotic membrane obtained from donated placental tissue. Q4257 Renati Membrane Q4435 Renatie AC Membrane Q4436 Renew FT Matrix Full-thickness human placental membrane allograft. Q4378 RenoGraft Triple layer human amniotic/chorion membrane allograft. Q4321 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 37 of 69

Repliform Acellular human dermis. Q4100 Repriza Pre hydrated, ready to use, ADM prepared from human skin allograft. Q4143 Resolve Matrix Non-crosslinked acellular wound dressing derived from porcine peritoneum membrane. A2024 Restorigin Amnion umbilical cord tissue. Q4191, Q4192 Restrata Resorbable nanofiber wound matrix. A2007, A2026 Revita Dehydrated, sterile human amniotic membrane and chorionic membrane. Q4180 Revitalon Composed of native human amnion and chorion in addition to collagen and growth factors. Q4157 Revival AC Q4437 Revive FT Q4424 Revive TL Q4425 RevoShield + Amniotic Barrier Dual layer amniotic membrane. Q4289 RX Flow, RX Membrane Placental connective tissue matrix. Q4100 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 38 of 69

SanoGraft Dehydrated single layer human amniotic membrane allograft. Q4319 Sanopellis Human amniotic membrane allograft. Q4308 Sentry SL Matrix Single layer, minimally manipulated, human amniotic membrane product derived from placental tissue. Q4348 Shelter DM Matrix Dual membrane, minimally manipulated, human amniotic and chorionic membrane derived from placental tissue. Q4346 Signature APatch Amniotic membrane allograft. Q4260 SimpliChor Dehydrated chorion membrane allograft. Q4414 SimpliDerm Human acellular dermal matrix. Q4100 SimpliGraft Single layer human amnion membrane allograft. Q4340 SimpliMax Dual layer human amnion membrane allograft. Q4341 Singlay Perforated single layer human amniotic membrane allograft. Q4329 SkinTE Autologous, homologous, full – thickness skin product composed of viable skin cells and an organized extracellular matrix. Q4200 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 39 of 69

StrataGraft Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat. Q4100 Strattice Reconstructive Tissue Matrix Derived from porcine dermis, which undergoes nondamaging processing that removes cells and reduces the key component in the xenogeneic rejection response. Q4130 Stravix, StravixPL Cryopreserved human placental tissue composed of umbilical amnion and Whartonʼs jelly. Q4133 Summit AAA Dehydrated human amniotic allograft. Q4397 Summit AC Dual layer amnion/chorion membrane allograft. Q4398 Summit FX Fenestrated dual-layer amnion/amnion membrane allograft. Q4399 Supra SDRM Biodegradable matrix wound dressing fabricated from a tri-polymer of polylactide, trimethylene carbonate, ε-caprolactone and polyvinyl alcohol. A2011 Suprathel Bioresorbable dermal covering, composed entirely of synthetic materials, including a tripolymer of polylactide, s-caprolactone and trimethylene carbonate. A2012 SureDerm Human acellular dermal matrix. Q4220 SurgiCORD Umbilical tissue membrane allograft. Q4218 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 40 of 69

Surgigraft Human amnion-only regenerative extracellular tissue matrix. Q4183 SurgiGRAFT-DUAL Minimally processed bilayer allograft. Q4219 SurgiMend Collagen Matrix Acellular tissue matrix of either fetal or neonatal bovine origin. C9358, C9360 SurGraft Dehydrated amniotic membrane sheet. Q4209 SurGraft AC Dual-layer human amnion/chorion allograft. Q4393 SurGraft ACA Triple-layer human amnion/chorion/amnion allograft. Q4394 SurGraft FT Full-thickness amnion/chorion tissue allograft. Q4268 SurGraft TL Triple layer amniotic tissue allograft. Q4263 SurGraft XT Dual layer amniotic tissue allograft. Q4269 Symphony Extracellular matrix (ECM) derived from ovine forestomach tissue. A2009 TAG Triple layer amniotic allograft derived from placental tissue. Q4261 Talymed Advanced matrix composed of shortened fibers isolated from microalgae. Q4127 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 41 of 69

TenSIX Acellular Dermal Matrix Acellular matrix with natural histomorphology preserved. Q4146 TheraGenesis Bilayered wound matrix comprised of a porcine tendon-derived atelocollagen layer and a silicone film layer. A2008 Theramend Patch product from human amnion membrane allograft that can be meshed or fenestrated. Q4342 TissueMend Remodeled collagen matrix created from bovine skin. Q4100 TOTAL Perforated human amniotic/chorion membrane allograft. Q4330 TranZgraft (InteguPly) ADM derived from human allograft skin tissue. Q4126 Tri-Membrane Wrap Human amnion membrane allograft. Q4344 triGRAFT FT Triple-layer human amnion, spongy layer and chorion membrane allograft. Q4377 Truskin Split-thickness, cryopreserved skin allograft extracellular matrix with growth factors and endogenous living skin cells. Q4167 Tutomesh, Tutopatch Noncross-linked acellular collagen matrices derived from bovine pericardium. C1763 Vendaje Dehydrated human amniotic membrane composed of the amnion layer. Q4252 Vendaje AC Decellularized amniotic and chorionic allograft derived from placental tissue. Q4279 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 42 of 69

Veritas Collagen Matrix Acellular tissue matrix derived from bovine pericardium. C9354 Via Matrix Full-thickness amnion and chorion allograft. Q4309 Viaflow, Viaflow C Flowable placental tissue matrices. Q4100 VIM Allograft sheet of human amnion. Q4251 VitoGraft Dual layer human amniotic membrane allograft. Q4317 WoundPlus Dehydrated human amniotic membrane allograft. Q4326 Xceed TL Matrix Human placental tissue and consists of three layers of placental membranes. Q4353 Xcell Amnio Matrix Lyophilized amniotic membrane allograft. Q4280 XCellerate Lyophilized human amniotic membrane allograft. Q4234 XCelliStem Extracellular matrix (ECM) composed of porcine collagen. A2004 XCM Biologic Tissue Matrix Noncross-linked 3-D matrix derived from porcine dermis. Q4142 Xelma ECM protein Q4100 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 43 of 69

XenMatrix Acellular noncross-linked porcine collagen scaffold with open collagen structure. C1763 XWrap Resorbable, chorion-free, human amnion allograft. Q4204 XWRAP 2.0 Dehydrated, single-layer, chorion-free amniotic membrane allograft. Q4402 XWRAP Dual Double layer, chorion-free amniotic membrane allograft. Q4358 XWRAP Dual Plus Dehydrated, double-layer, chorion-free amniotic membrane allograft. Q4403 XWRAP Fenestra Fenestrated, single-layer, chorion-free amniotic membrane allograft. Q4406 XWRAP Fenestra Plus Dehydrated, single-layer, chorion-free amniotic membrane allograft. Q4405 XWRAP Hydro Hydrated, single-layer, chorion-free amniotic membrane allograft. Q4408 XWRAP Hydro Plus Hydrated, single-layer, chorion-free amniotic membrane allograft. Q4404 XWRAP Plus Single layer, chorion-free amniotic membrane allograft. Q4357 XWRAP Tribus Triple-layer, chorion-free amniotic membrane allograft. Q4407 Zenapro Combination of ultra-lightweight polypropylene and small intestinal submucosa (SIS). Q4100 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 44 of 69

Zenith Amniotic Membrane Dehydrated amniotic membrane allograft. Q4253 References:

  1. Hayes, Inc. Microlyte Matrix (Imbed Biosciences) for Treatment of Wounds. Evidence Analysis Research Brief, March 20, 2023.
  2. Hayes, Inc. Skin substitutes for Venous Leg Ulcers in Adults. Health Technology Assessment, July 11, 2023.
  3. Pourmoussa A, Gardner DJ, Johnson MB, Wong AK. An update and review of cell-based wound dressings and their integration into clinical practice. Ann Transl Med. 2016;4(23):457.
  4. O'Donnell TF, Jr., Lau J. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. J Vasc Surg. 2006;44(5):1118-1125.
  5. Snyder D, Sullivan N, Margolis D, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program Project ID No. WNDT0818. (Prepared by the ECRI Institute-Penn Medicine Evidence-based Practice Center under Contract No. HHSA 290-2015-00005-I) Skin Substitutes for Treating Chronic Wounds Web site. https://www.ncbi.nlm.nih.gov/pubmed/321013 Published 2020.
  6. Marston W, Tang J, Kirsner RS, Ennis W. Wound Healing Society 2015 update on guidelines for venous ulcers. J Wound repair. 2016;24(1):136-144.
  7. Frykberg R, Banks J. Challenges in the Treatment of Chronic Wounds. J Advances in wound care. 2015;4(9):560-582. doi:doi:10.1089/wound.2015.0635.
  8. Hingorani A, LaMuraglia GM, Henke P, et al. The management of diabetic foot: A clinical practice guideline by the Society for Vascular Surgery in collaboration with the American Podiatric Medical Association and the Society for Vascular Medicine. J Vasc Surg. 2016;63(2 Suppl):3S-21S.
  9. Frykberg R, Cazzell S, Arroyo-Rivera J, et al. Evaluation of tissue engineering products for the management of neuropathic diabetic foot ulcers: an interim analysis. Journal of wound care. 2016;25(Sup7):S18-S25.
  10. O'Donnell TF, Jr., Passman MA, Marston WA, et al. Management of venous leg ulcers: clinical practice guidelines of the Society for Vascular Surgery (R) and the American Venous Forum. J Vasc Surg. 2014;60(2 Suppl):3S-59S.
  11. Eriksson E, Liu PY, Schultz GS, et al. Chronic wounds: Treatment consensus. Wound repair and regeneration. 2022;30(2):156-171. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 45 of 69
  1. Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: diabetic foot ulcer treatment guidelines. 2016;24(1):112-126.
  2. Rayman G, Vas P, Dhatariya K, Driver V, Hartemann A, Londahl M. IWGDF Guideline on interventions to enhance healing of foot ulcers in persons with diabetes. https://iwgdfguidelines.org/wp-content/uploads/2021/03/06-Wound-Healing-Guideline.pdf. Published 2019.
  3. Tettelbach WH, Driver V, Oropallo A, et al. Treatment patterns and outcomes of Medicare enrollees who developed venous leg ulcers. Journal of Wound Care. 2023;32(11):704-718.
  4. Tettelbach WH, Cazzell SM, Hubbs B, Jong JLD, Forsyth RA, Reyzelman AM. The influence of adequate debridement and placental-derived allografts on diabetic foot ulcers. Journal of Wound Care. 2022;31(Sup9):S16-S26.
  5. Tettelbach W, Forsyth A. Specialty specific quality measures needed to improve outcomes in wound care. International Wound Journal. 2023;20(5):1662-1666.
  6. Evidence-based Practice Center Technical Brief Protocol. Project Title: Skin substitute graft for Treating Chronic Wounds. Agency for Healthcare Research and Quality (AHRQ) https://effectivehealthcare.ahrq.gov/products/skin-substitutes/protocol. Published 2018 (rev 2019).
  7. FDA. FDA announces comprehensive regenerative medicine policy framework. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-announces-comprehensive-regene rative-medicine-policy-framework. Published 2017.
  8. Schaper NC vNJ, Apelqvist J, Bus SA, Hinchliffe RJ, Lipsky BA; IWGDF Editorial Board. Practical Guidelines on the prevention and management of diabetic foot disease (IWGDF 2019 update). Diabetes Metab Res Rev. 2020 36:Suppl 1:e3266.
  9. Carpenter S F, A, Bahadur D,Estapa A, Bahm J. Evaluating the Number of Cellular or Tissue-Based Product Applications Required for Treating Diabetic Foot Ulcers and Venous Leg Ulcers in Non-Hospital Outpatient Department Settings. WOUNDS. 2024;35(8).
  10. Armstrong DG, Tettelbach WH, Chang TJ, et al. Observed Impact of Skin Substitutes in Lower Extremity Diabetic Ulcers: A Retrospective Analysis of a Medicare Limited Database (2015-2018).
  12. Evans K., Orapallo A. Overview of treatment of chronic wounds. UpToDate. www.uptodate.com. Updated 6/3/25.
  13. Wu S, Carter M, Cole W, et al. Best practice for wound repair and regeneration use of cellular, acellular and matrix-like products (CAMPs). J Wound Care. 2023;32(Sup4b):S1-s31. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 46 of 69
  1. F2312-11 A. Standard Terminology Relating to Tissue Engineered Medical Products. https://www.astm.org/f2312-11r20.html. Published 2020. Updated 4/22/2020..
  2. Widgerow AD. Deconstructing the stalled wound. Wounds: a compendium of clinical research and practice. 2012;24(3):58-66.
  3. Armstrong DG, Boulton AJM, Bus SA. Diabetic Foot Ulcers and Their Recurrence. New England Journal of Medicine. 2017;376(24):2367-2375.
  4. Ferreira MC, Paggiaro AO, Isaac C, Teixeira Neto N, Santos GBd. Skin substitutes: current concepts and a new classification system. Revista Brasileira de Cirurgia Plástica. 2011;26:696-702.
  5. Davison-Kotler E, Sharma V, Kang NV, Garcia-Gareta E. A Universal Classification System of Skin Substitutes Inspired by Factorial Design. Tissue Eng Part B Rev. 2018;24(4):279-288.
  6. Vecin NM, Kirsner RS. Skin substitutes as treatment for chronic wounds: current and future directions. Frontiers in Medicine. 2023;10.
  7. Koob TJ, Lim JJ, Zabek N, Massee M. Cytokines in single layer amnion allografts compared to multilayer amnion/chorion allografts for wound healing. Journal of Biomedical Materials Research Part B: Applied Biomaterials. 2015;103(5):1133-1140.
  8. Banerjee J, Lasiter A, Nherera L. Systematic review of cellular, acellular and matrix-like products (CAMPs) and indirect treatment comparison between cellular/acellular and amniotic/non-amniotic grafts in the management of diabetic foot ulcers. Advances in Wound Care. 2024(ja).
  9. Vyas KS, Vasconez HC. Wound healing: biologics, skin substitutes, biomembranes and scaffolds. Paper presented at: Healthcare 2014.
  10. Winkler J, Abisoye-Ogunniyan A, Metcalf KJ, Werb Z. Concepts of extracellular matrix remodelling in tumour progression and metastasis. Nature communications. 2020;11(1):5120.
  11. Sorber R, Abularrage, Christopher J. Diabetic foot ulcers: Epidemiology and the role of multidisciplinary care teams. Seminars in vascular surgery. 2021;34(1):47-53.
  12. Santema TB, Poyck PP, Ubbink DT. Systematic review and meta-analysis of skin substitutes in the treatment of diabetic foot ulcers: Highlights of a Cochrane systematic review. Wound Repair Regen. 2016;24(4):737-744.
  13. Jones JE NE, Al-Hity A. Skin grafting for venous leg ulcers. Cochrane Database of Systematic Reviews. 2013; Art. No.: CD001737(1).
  14. Haugh AM, Witt JG, Hauch A, et al. Amnion membrane in diabetic foot wounds: a meta-analysis. Plastic and Reconstructive Surgery Global Open. 2017;5(4).
  15. Luthringer M, Mukherjee T, Arguello-Angarita M, Granick MS, Alvarez OM. Human-derived Acellular Dermal Matrix Grafts for Treatment of Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. Wounds. 2020;32(2):57-65. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 47 of 69
  1. Guo X, Mu D, Gao F. Efficacy and safety of acellular dermal matrix in diabetic foot ulcer treatment: a systematic review and meta-analysis. International Journal of Surgery. 2017;40:1-7.
  2. Hankin CS, Knispel J, Lopes M, Bronstone A, Maus E. Clinical and cost efficacy of advanced wound care matrices for venous ulcers. Journal of Managed Care Pharmacy. 2012;18(5):375-384.
  3. Laurent I, Astère M, Wang KR, Cheng Q-f, Li QF. Efficacy and time sensitivity of amniotic membrane treatment in patients with diabetic foot ulcers: a systematic review and meta-analysis. Diabetes Therapy. 2017;8:967-979.
  4. DiDomenico LA, Orgill DP, Galiano RD, et al. Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. Plast Reconstr Surg Glob Open. 2016;4(10):e1095.
  5. DiDomenico LA, Orgill DP, Galiano RD, et al. Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients. Int Wound J. 2018;15(6):950-957.
  6. Lavery L, Fulmer J, Shebetka K, et al. The efficacy and safety of Grafix®) for the treatment of chronic diabetic foot ulcers: results of a multi-centre, controlled, randomised, blinded, clinical trial. Int Wound J. 2014 5:554-560.
  7. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers. Int Wound J. 2013;10(5):502-507.
  8. Zelen C, Gould L, Serena TE, Carter MJ, Keller J, Li WW. A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers. Int Wound J. 2015;12(6):724-732.
  9. Zelen CM, Serena TE, Gould L, et al. Treatment of chronic diabetic lower extremity ulcers with advanced therapies: a prospective, randomised, controlled, multi-centre comparative study examining clinical efficacy and cost. International wound journal. 2016;13(2):272-282.
  10. Tettelbach W, Cazzell S, Reyzelman AM, Sigal F, Caporusso JM, Agnew PS. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers: A prospective, multicentre, randomised, controlled study of 110 patients from 14 wound clinics. Int Wound J. 2019;16(1):19-29.
  11. Snyder RJ, Shimozaki K, Tallis A, et al. A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. Wounds: a compendium of clinical research and practice. 2016;28(3):70-77. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 48 of 69
  1. Serena TE, Yaakov R, Moore S, et al. A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. Journal of Comparative Effectiveness Research. 2020;9(1):23-34.
  2. Chen P, Vilorio NC, Dhatariya K, et al. Effectiveness of interventions to enhance healing of chronic foot ulcers in diabetes: a systematic review. Diabetes/Metabolism Research and Reviews. 2024;40(3):e3786.
  3. Padula WV, Ramanathan S, Cohen BG, Rogan G, Armstrong DG. Comparative Effectiveness of Placental Allografts in the Treatment of Diabetic Lower Extremity Ulcers and Venous Leg Ulcers in US Medicare Beneficiaries: a retrospective observational cohort study using real-world evidence. Advances in Wound Care. 2024.
  4. McQuilling JP, Vines JB, Mowry KC. In vitro assessment of a novel, hypothermically stored amniotic membrane for use in a chronic wound environment. International wound journal. 2017;14(6):993-1005.
  5. Zelen C, Orgill D, Serena T, et al. A prospective, randomised, controlled, multicentre clinical trial examining healing rates, safety and cost to closure of an acellular reticular allogenic human dermis versus standard of care in the treatment of chronic diabetic foot ulcers. Int Wound J. 2017;14(2):307-315.
  6. Zelen CM, Orgill DP, Serena TE, et al. Human Reticular Acellular Dermal Matrix in the Healing of Chronic Diabetic Foot Ulcerations that Failed Standard Conservative Treatment: A Retrospective Crossover Study. Wounds: a Compendium of Clinical Research and Practice. 2017;29(2):39-45.
  7. Dasgupta A, Orgill D, Galiano RD, et al. A novel reticular dermal graft leverages architectural and biological properties to support wound repair. Plastic and Reconstructive Surgery Global Open. 2016;4(10).
  8. Barber FA, Aziz-Jacobo J. Biomechanical testing of commercially available soft-tissue augmentation materials. Arthroscopy: the journal of arthroscopic & related surgery. 2009;25(11):1233-1239.
  9. Agrawal H, Tholpady SS, Capito AE, Drake DB, Katz AJ. Macrophage phenotypes correspond with remodeling outcomes of various acellular dermal matrices. Open Journal of Regenerative Medicine. 2012;1(03):51-59.
  10. Glat P, Orgill DP, Galiano R, et al. Placental Membrane Provides Improved Healing Efficacy and Lower Cost Versus a Tissue-Engineered Human Skin in the Treatment of Diabetic Foot Ulcerations. Plast Reconstr Surg Glob Open. 2019;7(8):e2371.
  11. DiDomenico LA, Orgill DP, Galiano RD, et al. A Retrospective Crossover Study of the Use of Aseptically Processed Placental Membrane in the Treatment of Chronic Diabetic Foot Ulcers. Wounds. 2017;29(10):311-316. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 49 of 69
  1. Veves A, Falanga V, Armstrong DG, Sabolinski ML, Apligraf Diabetic Foot Ulcer S. Graftskin, a human skin equivalent, is effective in the management of noninfected neuropathic diabetic foot ulcers: a prospective randomized multicenter clinical trial. Diabetes Care. 2001;24(2):290-295.
  2. Steinberg JS, Edmonds M, Hurley DP, Jr., King WN. Confirmatory data from EU study supports Apligraf for the treatment of neuropathic diabetic foot ulcers. J Am Podiatr Med Assoc. 2010;100(1):73-77.
  3. Edmonds M, European, Australian Apligraf Diabetic Foot Ulcer Study G. Apligraf in the treatment of neuropathic diabetic foot ulcers. Int J Low Extrem Wounds. 2009;8(1):11-18.
  4. Kirsner RS, Sabolinski ML, Parsons NB, Skornicki M, Marston WA. Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting. Wound Repair Regen. 2015;23(5):737-744.
  5. Rodríguez I AA, Massey C, et al. . Novel bioengineered collagen with Manuka honey and hydroxyapatite sheet for the treatment of lower extremity chronic wounds in an urban hospital wound care setting. Wounds 2023;35(1):E35-E38.
  6. Rodriguez IA, Strombergsson A, Weinstein R, et al. Preliminary clinical evaluation using a novel bioengineered wound product to treat lower extremity ulcers. The International Journal of Lower Extremity Wounds. 2023;22(1):139-145.
  7. Williams M, Rodriguez I, Strombergsson A, Fabbri S, Westgate S. A Novel Bioengineered Wound Product with In Vitro Capabilities to Reduce Bacteria. Biomedical and Translational Science. 2021;1(1):1-3.
  8. Rodriguez I, Conti T, Bionda N. Microenvironment influence of a novel bioengineered wound product, APIS®: a preliminary in vitro analysis of inflammatory marker and growth factor secretion. International journal of biomaterials. 2021;2021(1):6612870.
  9. Rodriguez I, Conti T, Bionda N. A Preliminary Direct Comparison of the Inflammatory Reduction and Growth Factor Production Capabilities of Three Commercially Available Wound Products: Collagen Sheet, Manuka Honey Sheet, and a Novel Bioengineered Collagen Derivative+ Manuka Honey+ Hydroxyapatite Sheet. International Journal of Molecular Sciences. 2022;23(18):10670.
  10. Sledge I, Maislin D, Bernarducci D, Snyder R, Serena TE. Use of a dual-layer amniotic membrane in the treatment of diabetic foot ulcers: an observational study. Journal of Wound Care. 2020;29(Sup9):S8-S12.
  11. Smiell JM, Treaduvell T, Hahn HD. Real-world Experience with a Decellularized Dehydrated Human Amniotic Membrane Allograft. Wounds. 2015;27(6):158-169.
  12. Letendre S, LaPorta G, O'Donnell E, Dempsey J, Leonard K. Pilot trial of biovance collagen-based wound covering for diabetic ulcers. Advances in Skin & Wound Care. 2009;22(4):161-166. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 50 of 69
  1. Brigido S, Carrington S, Protzman N, et al. The use of an acellular connective tissue matrix in hindfoot and ankle fusions: understanding the cellular bench top data with a consecutive patient series: a pilot study. Clin Res Foot Ankle. 2018;6(3):276.
  2. Guo X, Kaplunovsky A, Zaka R, et al. Modulation of cell attachment, proliferation, and angiogenesis by decellularized, dehydrated human amniotic membrane in in vitro models. Wounds: a Compendium of Clinical Research and Practice. 2016;29(1):28-38.
  3. Walters J, Cazzell S, Pham H, Vayser D, Reyzelman A. Healing rates in a multicenter assessment of a sterile, room temperature, acellular dermal matrix versus conventional care wound management and an active comparator in the treatment of full-thickness diabetic foot ulcers. Eplasty. 2016;16.
  4. Cazzell S, Vayser D, Pham H, et al. A randomized clinical trial of a human acellular dermal matrix demonstrated superior healing rates for chronic diabetic foot ulcers over conventional care and an active acellular dermal matrix comparator. Wound Repair Regen. 2017;25(3):483-497.
  5. Cazzell S, Moyer PM, Samsell B, Dorsch K, McLean J, Moore MA. A prospective, multicenter, single-arm clinical trial for treatment of complex diabetic foot ulcers with deep exposure using acellular dermal matrix. Advances in Skin & Wound Care. 2019;32(9):409.
  6. Capito AE, Tholpady SS, Agrawal H, Drake DB, Katz AJ. Evaluation of host tissue integration, revascularization, and cellular infiltration within various dermal substrates. Annals of Plastic Surgery. 2012;68(5):495-500.
  7. David G. Armstrong DPO, Robert D. Galiano, Paul M. Glat, Jarrod P. Kaufman, Marissa J. Carter, Lawrence A. DiDomenico, Charles M. Zelen, Paul M. Glat, Jarrod P. Kaufman, Marissa J. Carter, Lawrence A. DiDomenico, Charles M. Zelen. Use of a purified reconstituted bilayer matrix in the management of chronic diabetic foot ulcers improves patient outcomes vs standard of care: Results of a prospective randomised controlled multi-centre clinical trial. Int Wound J. 2022;19(5):1197-1209.
  8. Armstrong D, Orgill D, Galiano R, et al. A purified reconstituted bilayer matrix shows improved outcomes in treatment of non-healing diabetic foot ulcers when compared to the standard of care: Final results and analysis of a prospective, randomized, controlled, multi-centre clinical trial. International Wound Journal. 2024;21(4):e14882.
  9. Armstrong D, Orgill D, Galiano R, et al. Functional Properties of a Purified Reconstituted Bilayer Matrix Design Support Natural Wound Healing Activities. Plastic and Reconstructive Surgery - Global Open. 2021;9(5):e3596.
  10. Armstrong D, Orgill D, Galiano R, et al. An observational pilot study using a purified reconstituted bilayer matrix to treat non-healing diabetic foot ulcers. International Wound Journal. 2020;17(4):966-973. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 51 of 69
  1. Isaac AL TM. Use of a Novel Purified Reconstituted Bilayer Matrix for Treatment of Chronic Diabetic Foot Ulcers: A Retrospective Case Series. Wounds. 2023;35(1):E29-E34.
  2. Marston WA, Hanft J, Norwood P, Pollak R, Dermagraft Diabetic Foot Ulcer Study G. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003;26(6):1701-1705.
  3. Gentzkow GD, Iwasaki SD, Hershon KS, et al. Use of dermagraft, a cultured human dermis, to treat diabetic foot ulcers. Diabetes care. 1996;19(4):350-354.
  4. Sanders L, Landsman AS, Landsman A, et al. A prospective, multicenter, randomized, controlled clinical trial comparing a bioengineered skin substitute to a human skin allograft. Ostomy/wound management. 2014;60(9):26-38.
  5. Greaves NS, Benatar B, Baguneid M, Bayat A. Single-stage application of a novel decellularized dermis for treatment-resistant lower limb ulcers: Positive outcomes assessed by SIA scopy, laser perfusion, and 3 D imaging, with sequential timed histological analysis. Wound repair and regeneration. 2013;21(6):813-822.
  6. Kimmel H, Gittleman H. Retrospective observational analysis of the use of an architecturally unique dermal regeneration template (Derma Pure®) for the treatment of hard-to-heal wounds. International wound journal. 2017;14(4):666-672.
  7. Greaves NS, Morris J, Benatar B, Alonso-Rasgado T, Baguneid M, Bayat A. Acute cutaneous wounds treated with human decellularised dermis show enhanced angiogenesis during healing. PLoS One. 2015;10(1):e0113209.
  8. Greaves NS, Iqbal SA, Hodgkinson T, et al. Skin substitute-assisted repair shows reduced dermal fibrosis in acute human wounds validated simultaneously by histology and optical coherence tomography. Wound Repair and Regeneration. 2015;23(4):483-494.
  9. Tettelbach W, Cazzell S, Sigal F, et al. A multicentre prospective randomised controlled comparative parallel study of dehydrated human umbilical cord (EpiCord) allograft for the treatment of diabetic foot ulcers. International wound journal. 2018;16(1):122-130.
  10. Gordon AJ, Alfonso AR, Nicholson J, Chiu ES. Evidence for Healing Diabetic Foot Ulcers With Biologic Skin Substitutes: A Systematic Review and Meta-Analysis. Ann Plast Surg. 2019;83(4S Suppl 1):S31-S44.
  11. Paggiaro AO, Menezes AG, Ferrassi AD, De Carvalho VF, Gemperli R. Biological effects of amniotic membrane on diabetic foot wounds: a systematic review. Journal of wound care. 2018;27(2):S19-S25.
  12. NICE. EpiFix for chronic wounds National Institute for Health and Care Excellence. https://www.nice.org.uk. Published 1/30/2018. Accessed 9/20/23. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 52 of 69
  1. Raspovic KM, Wukich DK, Naiman DQ, et al. Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting. Wound Repair and Regeneration. 2018;26(2):213-220.
  2. Frykberg RG, Gibbons GW, Walters JL, Wukich DK, Milstein FC. A prospective, multicentre, open-label, single-arm clinical trial for treatment of chronic complex diabetic foot wounds with exposed tendon and/or bone: positive clinical outcomes of viable cryopreserved human placental membrane. International wound journal. 2017;14(3):569-577.
  3. Brigido SA, Boc SF, Lopez RC. Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study. In. Vol 27: SLACK Incorporated Thorofare, NJ; 2004:S145-S149.
  4. Brigido SA. The use of an acellular dermal regenerative tissue matrix in the treatment of lower extremity wounds: a prospective 16-week pilot study. International wound journal. 2006;3(3):181-187.
  5. Reyzelman A, Crews RT, Moore JC, et al. Clinical effectiveness of an acellular dermal regenerative tissue matrix compared to standard wound management in healing diabetic foot ulcers: a prospective, randomised, multicentre study. International wound journal. 2009;6(3):196-208. 100. Reyzelman A, Bazarov I. Human acellular dermal wound matrix for treatment of DFU: literature review and analysis. Journal of Wound Care. 2015;24(3):128-134. 101. Driver VR LL, Reyzelman AM, et al. . A clinical trial of Integra Template for diabetic foot ulcer treatment. Wound Repair Regen 2015 23(6):891-900. 102. Yao M, Attalla K, Ren Y, French MA, Driver VR. Ease of use, safety, and efficacy of integra bilayer wound matrix in the treatment of diabetic foot ulcers in an outpatient clinical setting: a prospective pilot study. Journal of the American Podiatric Medical Association. 2013;103(4):274-280. 103. Kirsner RS, Margolis DJ, Baldursson BT, et al. Fish skin grafts compared to human amnion/chorion membrane allografts: a double-blind, prospective, randomized clinical trial of acute wound healing. Wound repair and regeneration. 2020;28(1):75-80. 104. Baldursson BT, Kjartansson H, Konrádsdóttir F, Gudnason P, Sigurjonsson GF, Lund SH. Healing rate and autoimmune safety of full-thickness wounds treated with fish skin acellular dermal matrix versus porcine small-intestine submucosa: a noninferiority study. The international journal of lower extremity wounds. 2015;14(1):37-43. 105. Lullove EJ, Liden B, Winters C, McEneaney P, Raphael A, JC LI. A Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Effect of Omega-3-Rich Fish Skin in the Treatment of Chronic, Nonresponsive Diabetic Foot Ulcers. Wounds: a Compendium of Clinical Research and Practice. 2021;33(7):169-177. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 53 of 69

106. Lantis J, Lullove, Eric J, Liden, Brock, McEneaney, Patrick, Raphael, Allen, Klein, Robert, Winters, Christopher, Huynh, Ruby N. Final efficacy and cost analysis of a fish skin graft vs standard of care in the management of chronic diabetic foot ulcers: a prospective, multicenter, randomized controlled clinical trial. Wounds: a Compendium of Clinical Research and Practice. 2023;35(4):71-79. 107. Dardari D P, A, Potier, L et al. Intact fish skin graft to treat deep diabetic foot ulcers: The Odinn Trial. NEJM. 2024.. 108. Seth N, Chopra D, Lev-Tov H. Fish skin grafts with omega-3 for treatment of chronic wounds: exploring the role of omega-3 fatty acids in wound healing and a review of clinical healing outcomes. Surg Technol Int. 2022;40:38-46. 109. Esmaeili A, Biazar E, Ebrahimi M, Heidari Keshel S, Kheilnezhad B, Saeedi Landi F. Acellular fish skin for wound healing. International Wound Journal. 2023. 110. Zehnder T, Blatti M. Faster Than Projected Healing in Chronic Venous and Diabetic Foot Ulcers When Treated with Intact Fish Skin Grafts Compared to Expected Healing Times for Standard of Care: An Outcome-Based Model from a Swiss Hospital. The International Journal of Lower Extremity Wounds.0(0):15347346221096205. 111. Jeon H, Kim J, Yeo H, Jeong H, Son D, Han K. Treatment of diabetic foot ulcer using matriderm in comparison with a skin graft. Arch Plast Surg. 2013;40(4):403-408. 112. Buzea C. One-Stage Closure of Venous Ulcers with Matriderm and Split-Thickness Skin Grafts. Journal of Clinical and Medical Images. 2020;5(3):1-3. 113. Cervelli V, Lucarini L, Cerretani C, et al. The use of Matriderm® and autologous skin grafting in the treatment of diabetic ulcers: a case report. International wound journal. 2010;7(4):291-296. 114. Wollina U, Heinig B, Stelzner C, et al. The Role of Complex Treatment in Mixed Leg Ulcers–A Case Report of Vascular, Surgical and Physical Therapy. Open access macedonian journal of medical sciences. 2018;6(1):67. 115. De Angelis B, Gentile P, Agovino A, et al. Chronic ulcers: MATRIDERM® system in smoker, cardiopathic, and diabetic patients. Journal of tissue engineering. 2013;4:2041731413502663. 116. Manning SW HD, Shillinglaw WR, et al. Efficacy of a Bioresorbable Matrix in Healing Complex Chronic Wounds: An Open-Label Prospective Pilot Study. Wounds. 2020;32(11):309-318. 117. Solanki AK, Lali FV, Autefage H, et al. Bioactive glasses and electrospun composites that release cobalt to stimulate the HIF pathway for wound healing applications. Biomaterials research. 2021;25:1-16. 118. Cannio M, Bellucci D, Roether JA, Boccaccini DN, Cannillo V. Bioactive glass applications: A literature review of human clinical trials. Materials. 2021;14(18):5440. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 54 of 69

119. Naseri S, Lepry WC, Nazhat SN. Bioactive glasses in wound healing: hope or hype? Journal of Materials Chemistry B. 2017;5(31):6167-6174. 120. Armstrong DG, Orgill DP, Galiano RD, et al. A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. Int Wound J. 2022;19(4):791-801. 121. Buck DW. Innovative bioactive glass fiber technology accelerates wound healing and minimizes costs: a case series. Advances in Skin & Wound Care. 2020;33(8):1-6. 122. Jung S, Day T, Boone T, Buziak B, Omar A. Anti-biofilm activity of two novel, borate based, bioactive glass wound dressings. Biomedical glasses. 2019;5(1):67-75. 123. Ottomeyer M, Mohammadkah A, Day D, Westenberg DJ. Broad-spectrum antibacterial characteristics of four novel borate-based bioactive glasses. 2016. 124. Rahaman MN, Day DE, Bal BS, et al. Bioactive glass in tissue engineering. Acta biomaterialia. 2011;7(6):2355-2373. 125. Marston WA, Lantis 2nd JC, Wu SC, et al. An open-label trial of cryopreserved human umbilical cord in the treatment of complex diabetic foot ulcers complicated by osteomyelitis. Wound Repair and Regeneration. 2019;27(6):680-686. 126. Marston WA, Lantis JC, Wu SC, et al. One-year safety, healing and amputation rates of Wagner 3-4 diabetic foot ulcers treated with cryopreserved umbilical cord (TTAX01). Wound Repair and Regeneration. 2020;28(4):526-531. 127. Couture M. A Single-center, Retrospective Study of Cryopreserved Umbilical Cord for Wound Healing in Patients Suffering From Chronic Wounds of the Foot and Ankle. Wounds. 2016;28(7):217-225. 128. Raphael A. A single-centre, retrospective study of cryopreserved umbilical cord/amniotic membrane tissue for the treatment of diabetic foot ulcers. Journal of Wound Care. 2016;25(Sup7):S10-S17. 129. Caputo WJ, Vaquero C, Monterosa A, et al. A retrospective study of cryopreserved umbilical cord as an adjunctive therapy to promote the healing of chronic, complex foot ulcers with underlying osteomyelitis. Wound Repair Regen. 2016;24(5):885-893. 130. Pacaccio DJ, Cazzell SM, Halperin GJ, et al. Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study. Journal of Wound Care. 2018;27(Sup7):S28-S37. 131. Cazzell SM, Caporusso J, Vayser D, Davis RD, Alvarez OM, Sabolinski ML. Dehydrated Amnion Chorion Membrane versus standard of care for diabetic foot ulcers: a randomised controlled trial. Journal of Wound Care. 2024:EV1-EV10. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 55 of 69

132. Tursi FJ, Donnelly JV, Seiler DR. An Integrative Approach To Healing Diabetic Foot Wounds. Podiatry Today. 2019;32(6). 133. Caporusso J, Abdo R, Karr J, Smith M, Anaim A. Clinical experience using a dehydrated amnion/chorion membrane construct for the management of wounds. Wounds. 2019;31(4 Suppl):S19-S27. 134. Landsman A, Roukis TS, DeFronzo DJ, Agnew P, Petranto RD, Surprenant M. Living cells or collagen matrix: which is more beneficial in the treatment of diabetic foot ulcers? Wounds: a compendium of clinical research and practice. 2008;20(5):111-116. 135. Niezgoda JA, Van Gils CC, Frykberg RG, Hodde JP. Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Adv Skin Wound Care. 2005;18(5 Pt 1):258-266. 136. Cazzell SM, Lange DL, Dickerson JE, Jr., Slade HB. The Management of Diabetic Foot Ulcers with Porcine Small Intestine Submucosa Tri-Layer Matrix: A Randomized Controlled Trial. Adv Wound Care (New Rochelle). 2015;4(12):711-718. 137. Lambert Jr CJ, Aviles Jr F, Eckert KA, Garoufalis M, Schilling RA. Efficacy of a 3D Electrospun Synthetic Polymer Matrix on Hard-to-Heal Wounds. Surgical Technology International. 2023;43:sti43/1744-sti1743/1744. 138. Lantis JC, Snyder R, Reyzelman AM, et al. Fetal bovine acellular dermal matrix for the closure of diabetic foot ulcers: a prospective randomised controlled trial. J Wound Care. 2021;30(Sup7):S18-S27. 139. Kavros SJ, Dutra T, Gonzalez-Cruz R, et al. The use of PriMatrix, a fetal bovine acellular dermal matrix, in healing chronic diabetic foot ulcers: a prospective multicenter study. Advances in skin & wound care. 2014;27(8):356-362. 140. Strauss NH, Brietstein RJ. Fetal Bovine Dermal Repair Scaffold Used for the Treatment of Difficult-to-Heal Complex Wounds. Wounds: a Compendium of Clinical Research and Practice. 2012;24(11):327-334. 141. Karr JC. Retrospective comparison of diabetic foot ulcer and venous stasis ulcer healing outcome between a dermal repair scaffold (PriMatrix) and a bilayered living cell therapy (Apligraf). Advances in skin & wound care. 2011;24(3):119-125. 142. Lullove E. Acellular fetal bovine dermal matrix in the treatment of nonhealing wounds in patients with complex comorbidities. Journal of the American Podiatric Medical Association. 2012;102(3):233-239. 143. Bain MA, Koullias GJ, Morse K, Wendling S, Sabolinski ML. Type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of cutaneous wounds. Journal of Comparative Effectiveness Research. 2020;9(10):691-703. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 56 of 69

144. Menack MJ, Thibodeaux KT, Trabanco C, Sabolinski ML. Effectiveness of type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of pressure injuries. Wounds: a compendium of clinical research and practice. 2022;34(6):159-164. 145. Gorenstein SA, Bain MA, Oropallo A, Koullias G, Sabolinski ML. Effectiveness of a purified type I collagen matrix plus the antimicrobial polyhexamethylene biguanide for use in cutaneous wounds: analysis of a population of three combined registries. Wounds: a Compendium of Clinical Research and Practice. 2023;35(9):E290-E296. 146. Sabolinski ML, Archambault T. Real-World Comparative Effectiveness Assessment Study of a Native Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial and a Cryopreserved Cadaveric Skin Allograft for Use in Diabetic Foot Ulcers - A Non-inferiority Analysis. Eplasty. 2024;24:e16. 147. MacEwan MR, MacEwan S, Kovacs TR, Batts J. What Makes the Optimal Wound Healing Material? A Review of Current Science and Introduction of a Synthetic Nanofabricated Wound Care Scaffold. Cureus. 2017;9(10):e1736. 148. Abicht BP, Deitrick GA, MacEwan MR, Jeng L. Evaluation of wound healing of diabetic foot ulcers in a prospective clinical trial using a synthetic hybrid-scale fiber matrix. Foot & Ankle Surgery: Techniques, Reports & Cases. 2022;2(1):100135. 149. Regulski MJ, MacEwan MR. Implantable Nanomedical Scaffold Facilitates Healing of Chronic Lower Extremity Wounds. Wounds. 2018;30(8):E77-E80. 150. Barton EC, Abicht BP. Lower extremity wounds treated with a synthetic hybrid-scale fiber matrix. Foot & Ankle Surgery: Techniques, Reports & Cases. 2021;1(3):100076. 151. Husain K, Malik A, Kirchens J, Choi G. A prospective, blinded, randomized controlled clinical trial evaluating the effect of the synthetic electrospun fiber matrix in the treatment of chronic diabetic foot ulcers. Foot & Ankle Surgery: Techniques, Reports & Cases. 2024;4(1):100362. 152. Sallade E, Grimes D, Jeng L, MacEwan MR. Antimicrobial Effectiveness Testing of Resorbable Electrospun Fiber Matrix per United States Pharmacopeia (USP)< 51. Cureus. 2023;15(12). 153. Herron K. Impact of a novel synthetic nanofibre matrix to treat hard-to-heal wounds. Journal of Wound Care. 2022;31(11):962-968. 154. Benson B. Utility of synthetic hybrid-scale fiber matrix in complex lower extremity wounds: A case series. Foot & Ankle Surgery: Techniques, Reports & Cases. 2023;3(3):100317. 155. Husain K, Malik A, Kirchens J. Synthetic Hybrid-Scale Fiber Matrix for the Treatment of Complex Lower-Extremity Wounds. Journal of the American Podiatric Medical Association. 2023;113(1). UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 57 of 69

156. Liden BA, & Ramirez-GarciaLuna, J. L. Efficacy of a polylactic acid matrix for the closure of Wagner grade 1 and 2 diabetic foot ulcers: a single-center, prospective randomized trial. Wounds: a compendium of clinical research and practice. 2023;35(8):E257-E260. 157. Armstrong DG, Galiano RD, Orgill DP, et al. Multi-centre prospective randomised controlled clinical trial to evaluate a bioactive split thickness skin allograft vs standard of care in the treatment of diabetic foot ulcers. International Wound Journal. 2022;19(4):932-944. 158. DiDomenico L, Landsman AR, Emch KJ, Landsman A. A prospective comparison of diabetic foot ulcers treated with either a cryopreserved skin allograft or a bioengineered skin substitute. Wounds. 2011;23(7):184-189. 159. Gurtner G, Garcia, AD, Bakewell, K, Alarcon, JB. A retrospective matched-cohort study of 3994 lower extremity wounds of multiple etiologies across 644 institutions comparing a bioactive human skin allograft, TheraSkin, plus standard of care, to standard of care alone. International Wound Journal. 2020;17(1):55-64. 160. Barbul A GG, Gordon H, Bakewell K, Carter MJ. Matched-cohort study comparing bioactive human split-thickness skin allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers: A retrospective analysis across 470 institutions. Wound Repair Regen. 2020 28(1):81-89. 161. Barbul A, Gelly H, Obradovic K, Landsman A. The Economic Impact of Living Cell Tissue Products in Treating Diabetic Foot Ulcers and Venous Leg Ulcers in Patients with Commercial Insurance: A Retrospective Matched-Cohort Study. Advances in Skin & Wound Care. 2023;36(5):243. 162. Flood MS, Weeks B, Anaeme KO, et al. Treatment of Deep Full-thickness Wounds Containing Exposed Muscle, Tendon, and/or Bone Using a Bioactive Human Skin Allograft: A Large Cohort Case Series. Wounds. 2020;32(6):164-173. 163. Landsman AS, Cook JD, Cook ED. Retrospective Cohort Study of 188 Patients treated with a Biologically Active Human Skin Allograft (TheraSkin) for Diabetic Foot & Venous Leg Ulcers. 2011. 164. Kirsner RS, Margolis D, Masturzo A, Bakewell K. A real-world experience with the bioactive human split thickness skin allograft for venous leg ulcers. Wound Repair Regen. 2020;28(4):547-552. 165. Budny A, Ley A. Cryopreserved allograft as an alternative option for closure of diabetic foot ulcers. Podiatry Manage. 2013:131-136. 166. Wilson TC, Wilson JA, Crim B, Lowery NJ. The Use of Cryopreserved Human Skin Allograft for the Treatment of Wounds With Exposed Muscle, Tendon, and Bone. Wounds: a Compendium of Clinical Research and Practice. 2016;28(4):119-125. 167. Henn D, Chen K, Maan ZN, et al. Cryopreserved human skin allografts promote angiogenesis and dermal regeneration in a murine model. International Wound Journal. 2020;17(4):925-936. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 58 of 69

168. Lou X, Xue H, Li G, et al. One-stage Pelnac reconstruction in full-thickness skin defects with bone or tendon exposure. Plastic and Reconstructive Surgery Global Open. 2018;6(3). 169. Maruccia M, Marannino P, Elia R, et al. Treatment of finger degloving injury with acellular dermal matrices: functional and aesthetic results. Journal of Plastic, Reconstructive & Aesthetic Surgery. 2019;72(9):1509-1517. 170. Chen X, Chen H, Zhang G. Management of wounds with exposed bone structures using an artificial dermis and skin grafting technique. Clinics in Plastic Surgery. 2012;39(1):69-75. 171. Muangman P, Wetwittayanugoon C, Chinaroonchai K, Somcharit L, Sirikun J, Chunhasuwankul R. Outcomes of porcine acellular dermal matrix in patients with extensive burn scars. JOURNAL OF THE MEDICAL ASSOCIATION OF THAILAND. 2017;100(4):150. 172. Nam YO, Lee JW, Koh JH, Seo DK, Oh SJ, Jang YC. Burn Management and Reconstruction Using Artificial Dermis Pelnac ?. Korean burn society. 2006;9(2):115-120. 173. Akita S, Tanaka K, Hirano A. Lower extremity reconstruction after necrotising fasciitis and necrotic skin lesions usinga porcine-derived skin substitute. Journal of plastic, reconstructive & aesthetic surgery. 2006;59(7):759-763. 174. Wosgrau ACC, Jeremias TdS, Leonardi DF, Pereima MJ, Di Giunta G, Trentin AG. Comparative experimental study of wound healing in mice: Pelnac versus Integra. PLoS One. 2015;10(3):e0120322. 175. Mizunuma M, Yanai A, Seno H, Hirabayashi S. Experience in repair utilizing artificial skin for exposed bone surfaces. European Journal of Plastic Surgery. 2000;23:305-308. 176. Widjaja W, Maitz P. The use of dermal regeneration template (Pelnac®) in acute full-thickness wound closure: a case series. European Journal of Plastic Surgery. 2016;39:125-132. 177. Eo S, Kim Y, Cho S. Vacuum-assisted closure improves the incorporation of artificial dermis in soft tissue defects: Terudermis® and Pelnac®. International wound journal. 2011;8(3):261-267. 178. Kashimura T, Nagasaki K, Horigome M, Yoshida K, Soejima K. Selection of artificial dermis for shortening treatment period: Integra versus Pelnac. Plastic and Reconstructive Surgery Global Open. 2021;9(6). 179. Serena TE, Orgill DP, Armstrong DG, et al. A Multicenter Randomized Controlled Clinical Trial Evaluating Two Application Regimens of Dehydrated Human Amniotic Membrane and Standard of Care vs Standard of Care Alone in the Treatment of Venous Leg Ulcers. Plastic and Reconstructive Surgery. 2022. 180. Falanga V. Apligraf treatment of venous ulcers and other chronic wounds. J Dermatol. 1998;25(12):812-817. 181. Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999;7(4):201-207. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 59 of 69

182. Towler MA, Rush EW, Richardson MK, Williams CL. Randomized, Prospective, Blinded-Enrollment, Head-To-Head Venous Leg Ulcer Healing Trial Comparing Living, Bioengineered Skin Graft Substitute (Apligraf) with Living, Cryopreserved, Human Skin Allograft (TheraSkin). Clin Podiatr Med Surg. 2018;35(3):357-365. 183. Cazzell S. A Randomized Controlled Trial Comparing a Human Acellular Dermal Matrix Versus Conventional Care for the Treatment of Venous Leg Ulcers. Wounds. 2019;31(3):68-74. 184. Harding K SM, Cardinal M. . A prospective, multicentre, randomised controlled study of human fibroblast-derived dermal substitute (Dermagraft) in patients with venous leg ulcers. . Int Wound J. 2013;10(2):132-137. 185. Serena TE, Carter MJ, Le LT, Sabo MJ, DiMarco DT, EpiFix VLUSG. A multicenter, randomized, controlled clinical trial evaluating the use of dehydrated human amnion/chorion membrane allografts and multilayer compression therapy vs. multilayer compression therapy alone in the treatment of venous leg ulcers. Wound Repair Regen. 2014;22(6):688-693. 186. Bianchi C, Cazzell S, Vayser D, et al. A multicentre randomised controlled trial evaluating the efficacy of dehydrated human amnion/chorion membrane (EpiFix((R)) ) allograft for the treatment of venous leg ulcers. Int Wound J. 2018;15(1):114-122. 187. Romanelli M, Dini V, Bertone MS. Randomized comparison of OASIS wound matrix versus moist wound dressing in the treatment of difficult-to-heal wounds of mixed arterial/venous etiology. Advances in skin & wound care. 2010;23(1):34-38. 188. Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D, Group OVUS. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. Journal of vascular surgery. 2005;41(5):837-843. 189. Marston WA, Sabolinski ML, Parsons NB, Kirsner RS. Comparative effectiveness of a bilayered living cellular construct and a porcine collagen wound dressing in the treatment of venous leg ulcers. Wound repair and regeneration. 2014;22(3):334-340. 190. Tchanque-Fossuo CN, Dahle SE, Lev-Tov H, et al. Cellular versus acellular matrix devices in the treatment of diabetic foot ulcers: Interim results of a comparative efficacy randomized controlled trial. J Tissue Eng Regen Med. 2019;13(8):1430-1437. 191. Romanelli M, Dini V, Bertone M, Barbanera S, Brilli C. OASIS® wound matrix versus Hyaloskin® in the treatment of difficult-to-heal wounds of mixed arterial/venous aetiology. International wound journal. 2007;4(1):3-7. 192. Demling RH, Niezgoda JA, Haraway GD, Mostow E. Small intestinal submucosa wound matrix and full-thickness venous ulcers: preliminary results. Wounds. 2004;16(1):18-22. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 60 of 69

193. Koullias GJ, Bain MA, Thibodeaux K, Sabolinski M. A Prospective Noninterventional Study of Type I Collagen Matrix Plus Polyhexamethylene Biguanide Antimicrobial for the Treatment of Venous Leg Ulcers: A Secondary Analysis. Wound management & prevention. 2022;68(6):11-17. 194. Kelechi TJ, Mueller M, Hankin CS, Bronstone A, Samies J, Bonham PA. A randomized, investigator-blinded, controlled pilot study to evaluate the safety and efficacy of a poly-N-acetyl glucosamine–derived membrane material in patients with venous leg ulcers. Journal of the American Academy of Dermatology. 2012;66(6):e209-e215. 195. Maus EA. Successful treatment of two refractory venous stasis ulcers treated with a novel poly-N-acetyl glucosamine-derived membrane. Case Reports. 2012;2012:bcr0320126091. 196. Hill CM, An YH, Kang QK, Demcheva MV, Whitson SW, Vournakis J. Poly-N-acetyl glucosamine as a scaffold for cartilage tissue engineering in nude mice. Key Engineering Materials. 2005;288:71-74. 197. Vournakis JN, Eldridge J, Demcheva M, Muise-Helmericks RC. Poly-N-acetyl glucosamine nanofibers regulate endothelial cell movement and angiogenesis: dependency on integrin activation of Ets1. Journal of vascular research. 2008;45(3):222-232. 198. Lindner HB, Felmly LM, Demcheva M, et al. pGlcNAc nanofiber treatment of cutaneous wounds stimulate increased tensile strength and reduced scarring via activation of Akt1. PLoS One. 2015;10(5):e0127876. 199. Kang QK, Hill CM, Demcheva MV, Vournakis J, An YH. Poly-N-acetyl glucosamine-SO4 for repairing osteochondral defect in rabbits. Key Engineering Materials. 2005;288:83-86. 200. Sterne JAC SJ, Page MJ, Elbers RG, Blencowe NS, Boutron I, Cates CJ, Cheng H-Y, Corbett MS, Eldridge SM, Hernán MA, Hopewell S, Hróbjartsson A, Junqueira DR, Jüni P, Kirkham JJ, Lasserson T, Li T, McAleenan A, Reeves BC, Shepperd S, Shrier I, Stewart LA, Tilling K, White IR, Whiting PF, Higgins JPT. . RoB 2: a revised tool for assessing risk of bias in randomised trials. . BMJ. 2019:366: l4898. 201. Higgins JPT SJ, Page MJ, Elbers RG, Sterne JAC. . Chapter 8: Assessing risk of bias in a randomized trial.Cochrane Handbook for Systematic Reviews of Interventions version 6.4 (updated August 2023). Available from www.training.cochrane.org/handbook. Published 2023. Accessed10/10/23. 202. Schünemann H, Brozek J, Guyatt G, Oxman A. The GRADE handbook. In: Cochrane Collaboration London, UK; 2013. 203. Zelen CM, Orgill DP, Serena TE, et al. An aseptically processed, acellular, reticular, allogenic human dermis improves healing in diabetic foot ulcers: A prospective, randomised, controlled, multicentre follow-up trial. Int Wound J. 2018;15(5):731-739. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 61 of 69

204. Huang W, Chen Y, Wang N, Yin G, Wei C, Xu W. The efficacy and safety of acellular matrix therapy for diabetic foot ulcers: a meta-analysis of randomized clinical trials. Journal of Diabetes Research. 2020;2020. 205. Landsman A, Rosines E, Houck A, et al. Characterization of a cryopreserved split-thickness human skin allograft–TheraSkin. Advances in Skin & Wound Care. 2016;29(9):399-406. 206. Falanga V, Margolis D, Alvarez O, et al. Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent. Human Skin Equivalent Investigators Group. Arch Dermatol. 1998;134(3):293-300. 207. Bianchi C, Tettelbach W, Istwan N, et al. Variations in study outcomes relative to intention-to-treat and per-protocol data analysis techniques in the evaluation of efficacy for treatment of venous leg ulcers with dehydrated human amnion/chorion membrane allograft. Int Wound J. 2019;16(3):761-767. 208. Regulski M, Lambert N, Vinke E, Barrett T. Application of amniotic membrane allografts in advanced venous leg ulcer: a case study and literature review. 2022. 209. Audet R, Tabor A, Diller R, Kellar R. Amniotic membrane and amnion-conditioned media promote chronic wound healing–a case report. J Med Case Rep Case Series. 2023;4:15. 210. Ingraldi AL, Galbreath K, Jones D, Lee D, Tabor AJ. A clinical case report: utility of amniotic membrane in treating a geriatric diabetic patient with a chronic pressure ulcer. J Diabetes Clin Res. 2024;6(1):8-14. 211. Singh R, Chacharkar M. Dried gamma-irradiated amniotic membrane as dressing in burn wound care. J Tissue Viability. 2011;20(2):49-54. 212. Kraemer BA, Geiger SE, Deigni OA, Watson JT. Management of open lower extremity wounds with concomitant fracture using a porcine urinary bladder matrix. Wounds. 2016;28(11):387-394. 213. Geiger SE, Deigni OA, Watson JT, Kraemer BA. Management of Open Distal Lower Extremity Wounds With Exposed Tendons Using Porcine Urinary Bladder Matrix. Wounds: a Compendium of Clinical Research and Practice. 2016;28(9):306-316. 214. Ditmars FS, Lind RA, Broderick TC, Fagg WS. Safety and efficacy of acellular human amniotic fluid and membrane in the treatment of non-healing wounds in a patient with chronic venous insufficiency. SAGE Open Med Case Rep. 2022;10:2050313X221100882. 215. Ditmars FS, Kay KE, Broderick TC, Fagg WS. Use of amniotic membrane in hard-to-heal wounds: a multicentre retrospective study. Journal of wound care. 2024;33(Sup3):S44-S50. 216. Ganesh P, Puranik S, Abhaya M, Misra P, Guruvigneshwari M, Daniel JI. Connective tissue matrices from placental disc for wound healing: mini-review. Biotechnology Letters. 2023:1-9. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 62 of 69

217. Schwartz J, Koutsoumbelis S, Parikh Z, et al. The use of human amnion/chorion for the enhancement of collagen synthesis and acceleration of wound healing in a diabetic rat model. Regenerative Engineering and Translational Medicine. 2021;7:41-46. 218. Arif MMA, Fauzi MB, Nordin A, Hiraoka Y, Tabata Y, Yunus MHM. Fabrication of bio-based gelatin sponge for potential use as a functional acellular skin substitute. Polymers. 2020;12(11):2678. 219. Sivak WN, Bourne DA, Miller MP, Manders EK. Simplified calvarial reconstruction: coverage of bare skull with gammagraft promotes granulation and facilitates skin grafting. Journal of Craniofacial Surgery. 2016;27(7):1808-1809. 220. Farivar BS, Toursavadkohi S, Monahan TS, et al. Prospective study of cryopreserved placental tissue wound matrix in the management of chronic venous leg ulcers. Journal of Vascular Surgery: Venous and Lymphatic Disorders. 2019;7(2):228-233. 221. Caravaggi C, Grigoletto F, Scuderi N. Wound Bed Preparation With a Dermal Substitute (Hyalomatrix(R) PA) Facilitates Re-epithelialization and Healing: Results of a Multicenter, Prospective, Observational Study on Complex Chronic Ulcers (The FAST Study). Wounds. 2011;23(8):228-235. 222. Motolese A, Vignati F, Brambilla R, Cerati M, Passi A. Interaction between a regenerative matrix and wound bed in nonhealing ulcers: results with 16 cases. Biomed Res Int. 2013;2013:849321. 223. Simman R, Mari W, Younes S, Wilson M. Use of Hyaluronic Acid-Based Biological Bilaminar Matrix in Wound Bed Preparation: A Case Series. Eplasty. 2018;18:e10. 224. Caravaggi C, Sganzaroli A, Pogliaghi I, Cavaiani P, Fabbi M, Ferraresi R. Safety and efficacy of a dermal substitute in the coverage of cancellous bone after surgical debridement for severe diabetic foot ulceration. EWMA Journal. 2009;9(1). 225. Simman R, Hermans MHE. Managing Wounds with Exposed Bone and Tendon with an Esterified Hyaluronic Acid Matrix (eHAM): A Literature Review and Personal Experience. J Am Coll Clin Wound Spec. 2017;9(1-3):1-9. 226. Fairbairn NG RM, Redmond RW. . The clinical applications of human amnion in plastic surgery. . J Plast Reconstr Aesthet Surg 2014;67(5):662-675. 227. Rice AH, Mallory Przbylski D. A Closer Look At Acellular Dermal Matrices For Chronic Diabetic Foot Ulcers. Podiatry Today. 2012;25(11). 228. Fridman R, Engelhardt J. A pilot study to evaluate the effects of perfusion-decellularized porcine hepatic-derived wound matrix on difficult-to-heal diabetic foot ulcers. Wounds: a Compendium of Clinical Research and Practice. 2017;29(10):317-323. 229. Fridman R, Rafat P, Van Gils CC, Horn D, Vayser D, Lambert Jr JC. Treatment of Hard-to-heal Diabetic Foot Ulcers With a Hepatic-derived Wound Matrix. Wounds: a compendium of clinical research and practice. 2020;32(9):244-252. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 63 of 69

230. Swan, J. Use of Cryopreserved, Particulate Human Amniotic Membrane and Umbilical Cord (AM/UC) Tissue: A Case Series Study for Application in the Healing of Chronic Wounds. Surg Technol Int. 2014;25:73-78. 231. Greenwood J, Wagstaff M. The use of biodegradable polyurethane in the development of dermal scaffolds. In: Advances in Polyurethane Biomaterials. Elsevier; 2016:631-662. 232. Greenwood JE DB. Split skin graft application over an integrating, biodegradable temporizing polymer matrix: immediate and delayed. J Burn Care Res. 2012;33(1):7-19. 233. Yamada S, Yamamoto K, Ikeda T, Yanagiguchi K, Hayashi Y. Potency of fish collagen as a scaffold for regenerative medicine. BioMed research international. 2014;2014. 234. Panggabean JA, Adiguna SbP, Hardhiyuna M, et al. Cutting Edge Aquatic-Based Collagens in Tissue Engineering. Marine Drugs. 2023;21(2):87. 235. Bettle III G, Bell DP, Bakewell SJ. A Novel Comprehensive Therapeutic Approach to the Challenges of Chronic Wounds: A Brief Review and Clinical Experience Report. Advances in Therapy. 2024;41(2):492-508. 236. Koullias GJ. Efficacy of the Application of a Purified Native Collagen With Embedded Antimicrobial Barrier Followed by a Placental Allograft on a Diverse Group of Nonhealing Wounds of Various Etiologies. Wounds: a Compendium of Clinical Research and Practice. 2021;33(1):20-27. 237. Lintzeris D, Vernon K, Percise H, et al. Effect of a New Purified Collagen Matrix With Polyhexamethylene Biguanide on Recalcitrant Wounds of Various Etiologies: A Case Series. Wounds. 2018;30(3):72-78. 238. Oropallo AR. Use of native type I collagen matrix plus polyhexamethylene biguanide for chronic wound treatment. Plastic and Reconstructive Surgery Global Open. 2019;7(1). 239. Durham EL, Howie RN, Hall S, et al. Optimizing bone wound healing using BMP2 with absorbable collagen sponge and Talymed nanofiber scaffold. Journal of translational medicine. 2018;16(1):1-8. 240. Howie RN, Durham E, Oakes B, et al. Testing a novel nanofibre scaffold for utility in bone tissue regeneration. Journal of tissue engineering and regenerative medicine. 2018;12(10):2055-2066. 241. Mulder G, Lee DK. Case presentation: xenograft resistance to protease degradation in a vasculitic ulcer. The International Journal of Lower Extremity Wounds. 2009;8(3):157-161. 242. Lullove EJ. Use of a dehydrated amniotic membrane allograft in the treatment of lower extremity wounds: a retrospective cohort study. Wounds: a Compendium of Clinical Research and Practice. 2017;29(11):346-351. 243. Diabetic foot problems: Prevention and management National Institute for Health and Care Excellence. https://www.nice.org.uk. Published 2019. Accessed 12/14/23. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 64 of 69

244. Jeffcoate WJ BS, Game FL, Hinchliffe RJ, Price PE, Schaper. Reporting standards of studies and papers on the prevention and management of foot ulcers in diabetes: required details and markers of good quality. Lancet Diabetes Endocrinol 2016;;4(9):781-788. 245. Driver VR, Gould LJ, Dotson P, et al. Identification and content validation of wound therapy clinical endpoints relevant to clinical practice and patient values for FDA approval. Part 1. Survey of the wound care community. Wound Repair and Regeneration. 2017;25(3):454-465. 246. Driver VR, Gould LJ, Dotson P, Allen LL, Carter MJ, Bolton LL. Evidence supporting wound care end points relevant to clinical practice and patientsʼ lives. Part 2. Literature survey. Wound Repair and Regeneration. 2019;27(1):80-89. 247. Gould LJ, Liu J, Wan R, Carter MJ, Dotson M, Driver VR. Evidence supporting wound care end points relevant to clinical practice and patients' lives. Part 3: The Patient Survey. Wound Repair and Regeneration. 2021;29(1):60-69. 248. Serena T, Bates-Jensen B, Carter MJ, et al. Consensus principles for wound care research obtained using a Delphi process. Wound repair and regeneration. 2012;20(3):284-293. 249. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia. 2008;51:747-755. ACRONYMS AND DEFINITIONS CTP: Cellular and tissue based products CMS: Centers for Medicare and Medicaid Services
DFU: Diabetic Foot Ulcers LCD: Local Coverage Determinations
MCD: CMS Medicare Coverage Database NCD: National Coverage Determination UM: Utilization Management VLU: Venous Leg Ulcers RESPONSIBILITIES National Director, Network Clinical Services:
The Director is responsible for, but not limited to, the following activities: ● Revisions, implementation, workforce education, interpretation, and enforcement of this policy. UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 65 of 69

REGULATORY REFERENCE CMS. Medicare Managed Care Manual Chapter 16 -General Exclusions From Coverage. 2016, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c16.pdf IOM Citations: ● CMS IOM Publication 100-02, Medicare Benefit Policy Manual ○ Chapter 15, Section 50.4.1 Approved Use of Drug ● CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual ○ Chapter 1, Part 4 Section 270.3 Blood-Derived Products for Chronic Non-Healing Wounds, Section 270.4 Treatment of Decubitus Ulcers, and Section 270.5 Porcine Skin and Gradient Pressure Dressings ● CMS IOM Publication 100-04, Medicare Claims Processing Manual ○ Chapter 17, Section 40 Discarded Drugs and Biologicals ● CMS IOM Publication 100-08, Medicare Program Integrity Manual ○ Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD ● CMS IOM Publication 100-04, Medicare Program Integrity Manual, ○ Chapter 17, Section 10 Payment Rules for Drugs and Biologicals Social Security Act (Title XVIII) Standard References: ● Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. ● Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. Code of Federal Regulations (CFR) References: ● CFR, Title 21, Volume 8, Chapter 1, Subchapter L, Part 1271.10 Human cells, tissues, and cellular and tissue-based products ● Title 42 Chapter IV Subchapter B Part 422 Subpart C § 422.101 https://www.ecfr.gov/current/title-42/chapter-IV/subchapter-B/part-422/subpart-C/section-422.101 UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 66 of 69

RELATED POLICIES, DOCUMENTS, AND CONTROLS NA REVIEW AND VERSION HISTORY Policy Title: Skin Substitute Grafts and Cellular and Tissue-based Products Policy #: MM.74 Department: Utilization Management Owner: Utilization Management Committee Version #: 4.0 Effective Date: June 10, 2024 Revision Date: 4/13/26 Next Review Date: 4/15/27 Date Version # Review or reason for change June 10, 2024 1.0 New Medical Policy April 13, 2025 2.0 Updated policy with new medical necessity criteria May 1, 2025 2.1 Ad hoc update for minor language updates. No change in coverage or criteria. June 16, 2025 2.2 Ad hoc update for minor language updates. Included additional clinical literature references.
September 8, 2025 2.3 Ad hoc update. Added additional non-covered code Q4332 December 8, 2025 3.0 Ad hoc update. Added new non-covered codes.
April 13, 2026 4.0 Annual update. Added criteria for DFU and VLU UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 67 of 69

when no LCD is applicable. Added covered products. Added section addressing products covered for burns. New section for excluded conditions and services and non-covered codes.
UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 68 of 69

REVIEW AND VERSION HISTORY Date Document # Version # 2026-04-22 UMGT.CL.0024 3.0 2025-12-16 UMGT.CL.0024 2.4 2025-09-12 UMGT.CL.0024 2.3 2025-06-17 UMGT.CL.0024 2.2 2025-05-22 UMGT.CL.0024 2.1 2025-04-23 UMGT.CL.0024 2.0 2024-06-10 MM.74 1.0 Prior versions are available upon request UMGT.CL.0024 - 2026-04-22 v3.0 DEVOTED HEALTH FOR PUBLIC USE | Page 69 of 69

Book a walkthrough

Walk through this policy with us

Review how this policy can be converted into cited criteria, prior authorization checks, and operational automation.